Determination of the Sun Protection Factor (SPF) and in Vitro UVA Protection Factor (UVAPF) of Four Developmental Sunscreen Formulations
Phase: NA
Conditions: Sunscreening Agents
Sponsor: GlaxoSmithKline

Copyright:  GlaxoSmithKline.  An unpublished work subject to trade secret 
protection.  This work contains confidential and proprietary information of 
GlaxoSmithKline and should not be copied, circulated, or distributed to persons not 
employed by GlaxoSmithKline unless specifically authorized.  Unauthorized 
disclosure of this work is expressly prohibited.
Clinical Protocol
207583
 
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CONFIDENTIAL
SUMMARY INFORMATION
Title:
Determination of the Sun Protection Factor (SPF) and 
in vitroUVA Protection Factor (UVAPF) of four 
developmental sunscreen formulations
Protocol Number:
207583
Sponsor:
GlaxoSmithKline Consumer Healthcare (GSKCH)
St George’s Avenue, Weybridge, Surrey, KT13 0DE, 
UK.
Tel:
Product Name:
Developmental sunscreen
Development Phase:
N/A
Expert Advice Outside of Normal 
Working Hours:
Tel: 
Key Protocol Authors:
PRIMARY CONTACT
Clinical Study Manager:
GSKCH, St George’s Avenue, 
Weybridge, Surrey,KT13 0DE, UK.
Tel: 
PRIMARY CONTACT
Clinical Research Scientist:
, Ph.D.
GSKCH, St George’s Avenue,
Weybridge, Surrey,KT13 0DE, UK.
Tel: 
Biostatistician:
Medical Affairs Lead:
Clinical Supplies:
Data Manager:
Principal Investigator:
MARIANNE BRANDT (DIPL.-PHYS.)
EMAIL: 
TEL: 
Study Site Name & Address:
proDERM Institute for Applied 
Dermatological Research
 
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Kiebitzweg 2
22869 Schenefeld/Hamburg
Germany
Study Site Telephone Number:
Tel: 
Study Examiner(s):
To be assigned per site staff designation 
log at study start.
 
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PRINCIPAL INVESTIGATOR PROTOCOL AGREEMENT PAGE
1) I confirm agreement to conduct the study in compliance with the protocol and 
any amendments and according to the current ICH GCP guidelines.
2) I acknowledge that I am responsible for overall study conduct. I agree to 
personally conduct or supervise the described study.
3) I agree to ensure that all associates, colleagues and employees assisting in the 
conduct of the study are informed about their obligations. Mechanisms are in 
place to ensure site staff receives all appropriate information throughout the 
study.
4) I agree toconduct this study in full conformance with the laws and regulations 
of the country in which the research is conducted and the Declaration of 
Helsinki.
Investigator Name:
Investigator Qualifications:
Investigator Signature:
Date of Signature/ Agreement:
DD/MMM/YYYY
 
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TABLE OF CONTENT
SUMMARY INFORMATION...............................................2
PRINCIPAL INVESTIGATOR PROTOCOL AGREEMENT 
PAGE..............................................................................4
TABLE OF CONTENT..........................................................5
PROCESS FOR AMENDING THE PROTOCOL...............10
PROTOCOL AMENDMENT PAGE....................................11
SCHEDULEOF EVENTS.....................................................13
PROTOCOL SYNOPSIS FOR STUDY 207583...................14
Brief Summary........................................................................14
1. INTRODUCTION...............................................................20
2. OBJECTIVE(S) AND ENDPOINT(S)...............................21
3. STUDY PLAN.....................................................................22
3.1. Study Design.......................................................................22
3.2. Subject Restrictions...........................................................25
3.3. Type and Planned Number of Subjects............................25
3.4. Study Design.......................................................................25
4. SELECTION OF STUDY POPULATION AND 
WITHDRAWAL CRITERIA........................................27
4.1. Inclusion Criteria...............................................................27
4.2. Exclusion Criteria..............................................................28
4.3. Screening/ Baseline Failures..............................................29
4.4. Withdrawal/ Stopping Criteria.........................................29
4.5. Subject Replacement..........................................................30
4.6. Subject and Study Completion..........................................30
5. PRODUCT INFORMATION.............................................31
 
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5.1. Study Product.....................................................................31
5.2. Application Schedule.........................................................31
5.3. Application Modification...................................................32
5.4. Product Compliance..........................................................33
5.5. Precautions.........................................................................33
5.6. Overdose.............................................................................33
5.7. Rescue Therapy..................................................................33
5.8. Product Assignment...........................................................33
5.8.1 Randomization...................................................................33
5.8.2 Blinding...............................................................................34
5.8.3 Code Breaks........................................................................34
5.9. Packagingand Labelling...................................................35
5.9.1. Accountability of Product.................................................35
5.9.2. Storage of Product............................................................35
6. STUDY ASSESSMENTS AND PROCEDURES..............36
6.1. Visit 1 –Subject Screening................................................36
6.1.1. Informed Consent.............................................................36
6.1.2. Demographics and Baseline Characteristics....................36
6.1.3. Medical History and Concomitant Medication...............36
6.1.4. Individual Typology Angle (ITA°)...................................37
6.1.5. Fitzpatrick Skin Type Assessment...................................37
6.1.6. Inclusion/Exclusion Criteria.............................................38
6.1.7. Subject Eligibility..............................................................38
6.2. Visit 2 –Provisional MED Irradiation (UV Exposure)....38
6.2.1. Concomitant Medication..................................................38
6.2.2. Exclusion Criteria.............................................................38
6.2.3. Subject Eligibility..............................................................38
6.2.4. Continued Eligibility.........................................................38
6.2.5. Randomisation...................................................................38
 
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6.2.6. Provisional Minimal Erythemal Dose Irradiation...........39
6.2.7. Adverse Events..................................................................40
6.3. Visit 3 –Provisional MEDu Determination......................40
6.3.1. Concomitant Medication..................................................40
6.3.2. Continued Eligibility.........................................................40
6.3.3. Visual Grading of Exposure Sub-Sites (Test Sites).........40
6.3.4. Adverse Events..................................................................40
6.4. Visit 4 –Test Irradiation (UV Exposure).........................41
6.4.1. Concomitant Medication..................................................41
6.4.2. Continued Eligibility.........................................................41
6.4.3. Study Product Application to Randomly Assigned Test 
Sites on the Back...............................................................41
6.4.4. UV Exposure of Test Product Treated, Reference 
Sunscreen Formulation Treated and Unprotected Test 
Sites....................................................................................42
6.4.5. Adverse Events..................................................................43
6.5. Visit 5 –MEDp and MEDu Determination and SPF 
Calculation for Test and Reference Sunscreens............44
6.5.1. Concomitant Medication..................................................44
6.5.2. Continued Eligibility.........................................................44
6.5.3. Visual Grading of Exposure Sub-Sites to Determine 
MEDp and MEDu.............................................................44
6.5.4. Adverse Events..................................................................44
6.5.5. Study Conclusion...............................................................45
7. SAFETY ASSESSMENTS..................................................46
7.1. Definitions of an Adverse Event and Serious Adverse 
Event.................................................................................46
7.1.1. Adverse Events..................................................................46
7.1.2. Serious Adverse Events.....................................................47
7.2. Recording Adverse Events and Serious Adverse Events.48
7.3. Evaluating Adverse Events and Serious Adverse Events48
 
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7.4. Reporting Adverse Events and Serious Adverse Events..49
7.5. Follow-up of Adverse Events and Serious Adverse Events
..........................................................................................51
7.6. Collection of Pregnancy Information................................52
7.6.1. Time Period for Collecting of Pregnancy Information...52
7.6.2. Action to be Taken if Pregnancy Occurs.........................52
8. DATA MANAGEMENT....................................................53
8.1. Source Documents/ Data....................................................53
8.2.Case Report Form..............................................................53
8.3. Data Handling....................................................................54
8.3.1. Data Queries......................................................................54
8.4. External Data.....................................................................55
9. STATISTICALCONSIDERATIONS AND DATA 
ANALYSES....................................................................55
9.1 Sample Size Determination.................................................55
9.2. General Considerations.....................................................56
9.2.1. Definition of Analysis Populations...................................56
9.2.2. Exclusion of Data from Analysis......................................56
9.2.3. Handling of Dropouts and Missing Data.........................56
9.3. Statistical Methods and Analytical Plan...........................57
9.3.1. Demographic and Baseline Characteristics.....................57
9.3.2. Primary Analysis...............................................................57
9.3.3. Safety Analysis..................................................................58
10. STUDY GOVERNANCE CONSIDERATIONS.............58
10.1. Posting of Information on Publicly Available Clinical 
Trials Registers................................................................58
10.2. Regulatory and Ethical Considerations, Including the 
Informed Consent............................................................58
10.3. Quality Control (Study Monitoring)...............................59
 
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10.4. Quality Assurance............................................................60
10.5. Conditions for Terminating the Study............................60
10.6. Records Retention............................................................61
10.7. Provision of Study Results to Investigators, Posting of 
Information on Publicly Available Clinical Trials 
Registers and Publication................................................62
11. REFERENCES..................................................................63
12. APPENDICES...................................................................64
12.1. Appendix 1 -Abbreviations.............................................64
12.2. Appendix 2 –Exclusion Criteria to be reassessed at Visit 
2........................................................................................65
12.3. Appendix 3 –Specification of the Solar Simulator Output
..........................................................................................65
12.4. Appendix 4 –Procedure for the determination of the 
UVAPF of the Test Products per ISO24443:2012.........67
12.5. Appendix 5 –Reference Sunscreen Formulation S2 
Specifications...................................................................77
12.6. Appendix 6 –Calibration of the UV Exposure Source..77
12.7. Appendix 7 –Calibration of the UV Spectrophotometer
..........................................................................................79
12.8. Appendix 8 –PMMA Test Plate Surface Specifications81
12.9. Appendix 9 –Calculation of Critical Wavelength..........86
 
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PROCESS FOR AMENDING THE PROTOCOL
Protocol modifications to ongoing studies which could potentially adversely affect the 
safety of subjects or which alter the scope of the investigation, the scientific quality of 
the study, the experimental design, dosages, duration of therapy, assessment 
variables, the number of subjects treated, or subject selection criteria are considered 
major/substantial amendments and must be made onlyafter appropriate consultation 
between an appropriate representative of GSKCH and the investigator.
Details of amendments to the protocols should be recorded on the following page. 
Protocol modifications must be prepared by a representative of GSKCH.  All changes 
must be justified in the Reason for Amendment section of the following Protocol 
Amendment Page. Approval of amendments will be made by the original protocol 
signatories or their appropriate designees.
All major/substantial protocol modificationsmust be reviewed and approved by the 
appropriateIndependent Ethics Committee (IEC)in accordance with local 
requirements, before the revised edition can be implemented. 
All non-substantial/ minor/ administrative amendments should be submitted to the 
IEC as per country specific requirements. In some countries pre-approval of a minor 
amendment isnot required and will just be held on file by the sponsor and 
investigator.
 
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PROTOCOL AMENDMENT PAGE
Details of all amendments should be recorded in the table below. Affected sections should be listed in the table; the actual 
amendment/ change should be made in the relevant section of the main protocol. 
To highlight the change, the following features will be used: 
To addtext: Use of CAPITAL LETTERS, BOLD AND UNDERLINE
To delete text:Use of Strikethrough e.g. strikethrough
Amendment 
No. & New 
Protocol 
Version No.
Type of Amendment
Reason for Amendment
Other Documents 
Requiring Amendment
Section(s) Amended 
PI Amendment 
Agreement
Signature & 
Date
Amendment 
No.:1
Non-Substantial/Minor    The Principal 
Investigatorand Data 
Manager for this study 
were changed.
Informed Consent   
Yes No
Safety Statement     
Yes No
CRF                       
Yes No
Summary 
Information, Page 2
Signature:
Protocol 
Version No.:
2
Substantial/ Major           
Date:
Amendment 
No.:2
Non-Substantial/Minor    To address 
inconsistencies in the 
numbering and 
articulation of several 
exclusion criteria 
checked at visits 1 and 
2.
Informed Consent   
Yes No
Safety Statement     
Yes No
CRF                      
Yes No
Exclusion criteria, 
Page 29
Appendix 2, Page 65
Signature:
Protocol 
Version No.:
3
Substantial/ Major           
Date:
 
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Amendment 
No. & New 
Protocol 
Version No.
Type of Amendment
Reason for Amendment
Other Documents 
Requiring Amendment
Section(s)Amended 
PI Amendment 
Agreement
Signature & 
Date
Amendment 
No.:
Non-Substantial/Minor    
Informed Consent   
Yes No
Safety Statement     
Yes No
CRF                       
Yes No
Signature:
Protocol 
Version No.:
Substantial/ Major           
Date:
Amendment 
No.:
Non-Substantial/Minor    
Informed Consent   
Yes No
Safety Statement     
Yes No
CRF                       
Yes No
Signature:
Protocol 
Version No.:
Substantial/ Major           
Date:
 
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SCHEDULE OF EVENTS
Procedure/Assessment
Visit 1
Visit 21
0-7 Days 
after Visit 1
Visit 3
1 Day after 
Visit 2
Visit 41
0-7 Days 
after Visit 3
Visit 5
1 Day after 
Visit 4
Subject
Screening
Provisional 
MED 
Irradiation
(UV 
exposure)
Provisional 
MED 
Determination
Test 
Irradiation
(UV 
exposure)
MEDp and 
MEDu 
Determination 
and SPF 
Calculation 
for Test and 
Reference 
Sunscreens
Informed Consent
X
Demographics
X
Medical History
X
Current / Concomitant 
Medication
X
X2
X
X2
X
Individual TypologyAngle 
(ITA°)
X
Fitzpatrick Skin Type 
Assessment
X
In/Exclusion Criteria
X
X2,3
Subject Eligibility
X
X2
Continued Eligibility
X2
X
X2
X
Randomisation
X
Provisional Minimum 
Erythemal Dose (MEDu) 
Irradiation
X
Visual Grading of Exposure 
Sub-Sites (Test Sites)
4
X
X
Study Product Application 
to Randomly Assigned Test 
Sites on the Back
X
Study Irradiation
X
Adverse Events
X
X
X2
X
Subject Discharge from 
Study
X
1. Visit 2 may be combined with Visit 1; Visit 4 may be combined with Visit 3. If these visits are not combined, they 
must happen within 7 calendar days of one another.Therefore, the total duration of the study for each subject could 
range from 3 to 16 calendar days.
2. Not required if this visit is combined with the previous visit. 
3. To include a review of exclusion criteria in Appendix 2.
4. Visual Grading of skin must happen 16-24 hours after irradiation.
 
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PROTOCOL SYNOPSIS FOR STUDY 207583
Brief Summary
An important parameter of efficacy for sunscreen products is the Sun Protection 
Factor (SPF). SPF is a measure of how muchsolar energy (ultraviolet (UV) radiation)
is required to produce sunburn on protected skin (i.e. in the presence of sunscreen) 
relative to the amount of solar energy required to produce sunburn on unprotected 
skin.In this screening study, the SPFof the test products are to be determined 
according to the International Standards Organization (ISO) 24444:2010 
methodology (In vivodetermination of the sun protection factor)in accordance with 
the Declaration of Helsinki and according to the current International Council for 
Harmonisation (ICH) Good Clinical Practice (GCP) guidelines.As this is a screening 
study, a limited number of subjects will be enrolled, to achieve 5 valid individual SPF 
results. 
A second important parameter of efficacy for sunscreen products is the ultraviolet-A 
protection factor (UVAPF). The UVAPF provides a measure of the ability of a 
sunscreento protect against solar energy across the UVA spectral range (320 
nanometers (nm) to 400 nm). In this study, the UVAPF of the test products are to be 
determined according to the ISO 24443:2012 methodology (Determination of 
sunscreenUVA photoprotection in vitro).
Objective(s) and Endpoint(s)
Objective(s)
Endpoint(s)
Primary
To determine the Sun Protection Factor 
of the test products
Arithmetic mean of all valid individual 
sun protection factor (SPFi) values; 
where SPFi = Minimal Erythemal Dose 
of product treated (MEDp) test sites in 
relation to unprotected (MEDu) test sites 
16-24 hours after exposure to ultraviolet 
(UV) radiation
Secondary
To determine the UVA Protection Factor 
of the test products
Arithmetic mean of all valid individual 
UVA protection factor (UVAPFi) values
To determine the critical wavelength of 
the test products
Wavelength for which the section under 
the integrated UV absorbance curve 
starting at 290 nm is equal to 90% of the 
integrated curve between 290 and 400 nm
 
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To determine whether the test products
provide broad spectrum sun protection
Ratio of the arithmetic mean SPF to the 
arithmeticmean UVAPF
To evaluate the general safety of the test 
products
Frequency and severity of Adverse 
Events
Study Design
The body of this protocol details the procedures for the determination of the Sun 
Protection Factor of the Test Products perISO24444:2010(Step 1). Details of the 
procedures to be followed for the in vitrodetermination of the UVA Protection Factor 
per ISO24443:2012 (Step 2) are described in Appendix 4.
Overall Design
Determination of the SPF of the test products will be performed as a single-center, 
randomized, evaluator blind, intra-individual comparison, no treatment and positive 
controlled clinical study per ISO24444:2010.As this is a screening study, a limited 
number of subjects will be enrolled, to achieve 5 valid individual SPF results.
The provisional minimal erythemal dose of unprotected skin (MEDu) for each subject 
will be determined before starting the main test in order to center the UV dose ranges 
for the exposures of MEDu and MEDp. As the first step, a virgin area of skin on the 
back will be exposed to a preliminaryseries of UV exposures. The location of the 
irradiated test site for the provisional MEDu measurement will be randomised for all 
subjects. In this study, there will be a total of seven irradiated test sites. Three test 
sites will be located below the scapula line and above the waist on the left side of the 
spine. The remaining four test sites will be located below the scapula line and above 
the waist on the right side of the spine.
To determine the provisionalMEDu, six exposure sub-sites positionedwithin one 
randomised test site and centered on the estimated MEDu will be exposed to 
incremental UV doses using a geometric progression of 1.25. Thedose of UV 
radiation administered will be chosen so that the estimatedMEDu will be irradiated at 
the 4
thof the 6 sub-sites.  The estimated MEDu will be predicted based on the 
subject’s mean Individual Typology Angle (ITA°) value.  As the second step, a 
trained evaluator will assess the irradiated sub-sites for signs of unambiguous 
erythema 16-24 hours afterUV exposure. The provisional MEDu will be the lowest 
dose of UV radiation that produces the first perceptible unambiguous erythema with 
defined borders appearing over most of the field of UV exposure.
 
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Once the provisional MEDu for a subject has been determined, the six remaining test 
sites will be demarcated. The four test products and positive control (P3 reference 
sunscreen formulation) will be applied to five of the six virgin test sites. The other
test site will remain unprotected. The order of product application (test products, 
reference product and unprotected test site) will be randomised over the entire test 
group.  Once the test products and positive control have been applied to the assigned 
test sites, the subject will undergo a second series ofincremental UV exposures.  For 
the unprotected site, the range of UV doses administered shall be selected using the 
subject’s provisional MEDu. Six exposure sub-sites centered on the provisional 
MEDu shall be exposed with incremental UV doses using a geometric progression of 
1.12. The dose of UV radiation administered to subjects will be chosen such that the 
provisional MEDu will be irradiatedat the 4
thof the 6 sub-sites. For the product 
protected sites, the UV doses administered shall be selected using the subject’s 
expected MEDp, which is the multiple of the provisional MEDu for the subject and 
the expected SPF of either the test products (30)or reference sunscreen formulation 
(16). A minimum of 6 sub-sites centered on the expected MEDp shall be exposed 
with incremental UV doses using a geometric progression of 1.12.  The dose of UV 
radiation administered to subjects will be chosen such that the expectedMEDpwill 
be irradiatedat the 4
thof the 6 sub-sites.  
The target number of valid individual SPF (SPFi) results shall be 5.  In order to 
achieve 5 valid results, a maximum of 3individual invalid results may be excluded 
from the calculation of the mean SPF. Consequently, the actual number of test 
subjects randomisedwill fall between a minimum of 5and a maximum of 8subjects 
(i.e. a maximum of 5valid results plus 3rejected invalid results).
The study will include subjects of more than oneFitzpatrick phototype (I, II or III). 
As this is a screening study, it will be permitted to adjust the expected SPF of each of 
the test products from subject to subject.
Visit 1–Subject Screening
The following assessments will be conducted:
1. InformedConsent
2. Demographics
3. Medical History
4. Current / Concomitant Medication
5. ITA° Measurement
6. Fitzpatrick Skin Type Assessment
7. In/Exclusion Criteria
 
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8. Subject Eligibility
Visit 2–Provisional MED Irradiation (UV Exposure)
The following assessments will be conducted:
1. Current / Concomitant Medication*
2. Continued Eligibility*
3. Exclusion Criteria*
4. Subject Eligibility*
5. Randomisation
6. Provisional Minimal Erythemal Dose (MED) Irradiation 
7. Adverse Events
*Not required if Visit 2 is combined with Visit 1. If Visit 1 and 2 are not combined, 
Visit 2 shall happen within 7 calendar days of Visit 1.
Visit 3–Provisional MED Determination
The following assessments will be conducted:
1. Current / Concomitant Medication
2. Continued Eligibility
3. Visual Grading of Exposure Sub-Sites (Test Sites)*
4. Adverse Events
*Visual grading of skin must occur 16-24 hours after completion of the Provisional 
MED Irradiation procedure
Visit 4–Test Irradiation (UV Exposure)
The following assessments will be conducted:
1. Current / Concomitant Medication*
2. Continued Eligibility*
3. Test Products and Reference Sunscreen Applicationto Randomly Assigned 
Test Sites on the Back
4. UV Exposure of Test Product Treated, Reference Sunscreen Formulation 
Treated and Unprotected Test Sites.
5. Adverse Events
*Not required if Visit 4 is combined with Visit 3. If Visit 3 and 4 are not combined, 
Visit 4 shall happen within 7 calendar days of Visit 3.
Visit 5– MEDp and MEDu determination and SPF calculation for test and 
reference sunscreens
The following assessments will be conducted:
1. Current / Concomitant Medication
2. Continued Eligibility
3. Visual Grading of Exposure Sub-Sites to Determine MEDp and MEDu and 
calculate SPF*
 
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4. Adverse Events
5. Subject Discharge from Study
*Visual grading of skin must occur 16-24 hours after completion of the test 
irradiation procedure
Type and Planned Number of Subjects
Healthy males and females aged between 18-70 years (inclusive) with Fitzpatrick 
phototype I, II or III, an ITA° value greater than 28° and who are untanned on the test
area will be recruited for thisstudy. The study will contain a population of subjects of 
more than one Fitzpatrick phototype. 
The SPF forthe test productsand for the reference sunscreen formulation are 
calculated as the arithmetical mean of all valid SPFi values.  The target number of 
valid SPFi values shall be 5. A maximum of 3 results may be excluded from the 
calculation of the mean SPF, but each exclusion shall be justified. If a fourth invalid 
result occurs for a particular test product, that test product shall not be tested further
but an SPF may still be calculated. If a fourth invalid result occurs for the reference 
sunscreen formulation, the study shall be stopped. Consequently, the total number of 
subjects randomised may fall between 5 and 8, requiring approximately 11 subjects to 
be screened.
Subjects will be recruited from the site database and via advertisement in local 
newspapers.
 
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Product Information
Product Name
Product
Formulation 
Code (MFC)
Expected 
SPF
Application 
Quantity
Application 
Route
Reference 
Product
P3 Standard
N/A
(Sourced 
Commercially)
16
80±2 mg
Dermal 
Topical
Test 
Product 1
30
80±2 mg
Dermal 
Topical
Test 
Product 2
30
80±2 mg
Dermal 
Topical
Test 
Product 3
30
80±2 mg
Dermal 
Topical
Test 
Product 4
30
80±2 mg
Dermal 
Topical
Statistical Methods
The SPF result for the test product and for the reference sunscreen formulation is 
calculated as the arithmeticmean of all valid SPFi values.The 95% Confidence 
Interval (CI) of the mean SPF shall also be calculated for each of the 4 test products
and reference sunscreen formulation.
 
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1. INTRODUCTION
The International Standard ISO24444:2010 specifies a method for the in vivo 
determination of the SPF of sunscreen products. It is applicable to products that 
contain any component able to absorb, reflect or scatter ultraviolet (UV) rays and 
which are intended to be placed in contact with human skin. It provides a basis for the 
evaluation of sunscreen products for the protection of human skin against erythema 
induced by solar UV rays. 
The test is restricted to an area of the back of selected human subjects. A section of 
each subject’s skin is exposed to UV light without any protection and another 
(different) section is exposed after application of the sunscreen product under test. 
One further section is exposed after application of an SPF reference sunscreen 
formulation which is used for validation of the procedure.
To determine the SPF, incremental series of delayed erythemal responses are induced 
on a number of small sub-sites within the test area. These responses are visually 
assessed for presence of erythema 16 hours (h) to 24 h after UV exposure, by the 
judgment of a competentevaluator. Individual subject SPF values are determined by 
dividing the lowest dose of irradiation that results in erythema on skin protected with 
the sunscreen by the lowest dose of irradiation that results in erythema on unprotected 
skin. The SPF for a sunscreen is the arithmetic mean of all valid individual subject 
SPF results.As this is a screening study, a limited number of subjects will be 
enrolled, to achieve 5 valid individual SPF results.
The International Standard ISO24443:2012 specifiesa method for the in vitro 
determination of the ultraviolet-A protection factor (UVAPF) of sunscreen products. 
The UVAPF provides a measure of the ability of the test product to protect against 
solar energy across the UVA spectral range (320 nanometers (nm) to 400 nm).
 
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2. OBJECTIVE(S) AND ENDPOINT(S)
Objective(s) and Endpoint(s)
Objective(s)
Endpoint(s)
Primary
To determine the Sun Protection Factor 
of the test products
Arithmetic mean of all valid individual 
sun protection factor (SPFi) values; 
where SPFi = Minimal Erythemal Dose 
of product treated (MEDp) test sites in 
relation to unprotected (MEDu) test sites 
16-24 hours after exposure to ultraviolet 
(UV) radiation
Secondary
To determine the UVA Protection Factor 
of the test products
Arithmetic mean of all valid individual 
UVA protection factor (UVAPFi) values
To determine the critical wavelength of 
the test products
Wavelength for which the section under 
the integrated UV absorbance curve 
starting at 290 nm is equal to 90% of the 
integrated curve between 290 and 400 nm
To determine whether the test products 
provide broad spectrum sun protection
Ratio of the arithmetic mean SPF to the 
arithmeticmean UVAPF
Toevaluate the general safety of the test 
products
Frequency and severity of Adverse 
Events
 
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3. STUDY PLAN
3.1. Study Design
The body of this protocol details the procedures for the determination of the Sun 
Protection Factor of the Test Products perISO24444:2010(Step 1). Details of the 
procedures to be followed for the in vitrodetermination of the UVA Protection Factor 
per ISO24443:2012 (Step 2) are describedin Appendix 4.
Overall Design
Determination of the SPF of the test products will be performed as a single-center, 
randomized, evaluator blind, intra-individual comparison, no treatment and positive 
controlled clinical study per ISO24444:2010.As this is a screening study, a limited 
number of subjects will be enrolled, to achieve 5 valid individual SPF results.
The provisional minimal erythemal dose of unprotected skin (MEDu) for each subject 
will be determined before starting the main test inorder to center the UV dose ranges 
for the exposures of MEDu and MEDp. As the first step, a virgin area of skin on the 
back will be exposed to a preliminary series of UV exposures. The location of the 
irradiated test site for the provisional MEDu measurement will be randomised for all 
subjects. In this study, there will be a total of seven irradiated test sites. Three test 
sites will be located below the scapula line and above the waist on the left side of the 
spine. The remaining four test sites will be located below the scapula line and above 
the waist on the right side of the spine.
To determine the provisionalMEDu, six exposure sub-sites positioned within one 
randomised test site and centered on the estimated MEDu will be exposed to 
incremental UV doses using a geometric progression of 1.25. Thedose of UV 
radiation administered will be chosen so that the estimatedMEDu will be irradiated at 
the 4
thof the 6 sub-sites.  The estimated MEDu will be predicted based on the 
subject’s mean Individual Typology Angle (ITA°) value.  As the second step, a 
trained evaluator will assess the irradiated sub-sites for signs of unambiguous 
erythema 16-24 hours after UV exposure. The provisional MEDu will be the lowest 
dose of UV radiation that produces the first perceptible unambiguous erythema with 
defined borders appearing over most of the field of UV exposure.
Once the provisional MEDu for a subject has been determined, the six remaining test 
sites will be demarcated. The four test products and positive control (P3 reference 
sunscreen formulation) will be applied to five of the six virgin test sites. The other 
 
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test site willremain unprotected. The order of product application (test products, 
reference product and unprotected test site) will be randomised over the entire test 
group.  Once the test products and positive control have been applied to the assigned 
test sites, thesubject will undergo a second series of incremental UV exposures.  For 
the unprotected site, the range of UV doses administered shall be selected using the 
subject’s provisional MEDu. Six exposure sub-sites centered on the provisional 
MEDu shall be exposed with incremental UV doses using a geometric progression of 
1.12. The dose of UV radiation administered to subjects will be chosen such that the 
provisional MEDu will be irradiatedat the 4
thof the 6 sub-sites. For the product 
protected sites, the UV doses administered shall be selected using the subject’s 
expected MEDp, which is the multiple of the provisional MEDu for the subject and 
the expected SPF of either the test products (30)or reference sunscreen formulation 
(16). A minimum of 6 sub-sites centered on the expected MEDp shall be exposed 
with incremental UV doses using a geometric progression of 1.12.  The dose of UV 
radiation administered to subjects will be chosen such that the expectedMEDpwill 
be irradiatedat the 4
thof the 6 sub-sites.  
The target number of valid individual SPF (SPFi) results shall be 5.  In order to 
achieve 5 valid results, a maximum of 3 individual invalid results may be excluded 
from the calculation of the mean SPF. Consequently, the actual number of test 
subjects randomised will fall between a minimum of 5 and a maximum of 8 subjects 
(i.e. a maximum of 5 valid results plus 3 rejected invalid results).
The study will include subjects of more than one Fitzpatrick phototype (I, II or III). 
As this is a screening study, it will be permitted to adjust the expected SPF of each of 
the test products from subject to subject.
Visit 1–Subject Screening
The following assessments will be conducted:
1. Informed Consent
2. Demographics
3. Medical History
4. Current / Concomitant Medication
5. ITA° Measurement
6. Fitzpatrick Skin Type Assessment
7. In/Exclusion Criteria
8. Subject Eligibility
Visit 2–Provisional MED Irradiation (UV Exposure)
The following assessments will be conducted:
 
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1. Current / Concomitant Medication*
2. Continued Eligibility*
3. Exclusion Criteria*
4. Subject Eligibility*
5. Randomisation
6. Provisional Minimal Erythemal Dose (MED) Irradiation 
7. Adverse Events
*Not required if Visit 2 is combined with Visit 1. If Visit 1 and 2 are not combined, 
Visit 2 shall happen within 7 calendar days ofVisit 1.
Visit 3–Provisional MED Determination
The following assessments will be conducted:
1. Current / Concomitant Medication
2. Continued Eligibility
3. Visual Grading of Exposure Sub-Sites (Test Sites)*
4. Adverse Events
*Visual grading of skin must occur 16-24 hours after completion of the Provisional 
MED Irradiation procedure
Visit 4–Test Irradiation (UV Exposure)
The following assessments will be conducted:
1. Current / Concomitant Medication*
2. Continued Eligibility*
3. Test Products and Reference Sunscreen Applicationto Randomly Assigned 
Test Sites on the Back
4. UV Exposure of Test Product Treated, Reference Sunscreen Formulation 
Treated and Unprotected Test Sites.
5. Adverse Events
*Not required if Visit 4 is combined with Visit 3. If Visit 3 and 4 are not combined, 
Visit 4 shall happen within 7 calendar days of Visit 3.
Visit 5– MEDp and MEDu determination and SPF calculation for test and 
reference sunscreens
The following assessments will be conducted:
1. Current / Concomitant Medication
2. Continued Eligibility
3. Visual Grading of Exposure Sub-Sites to Determine MEDp and MEDu and 
calculate SPF*
4. Adverse Events
5. Subject Discharge from Study
*Visual grading of skin must occur 16-24 hours after completion of the test 
 
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irradiation procedure
3.2. Subject Restrictions
Lifestyle, Medications and Treatments
During the entire study (screening –Last Subject Last Visit (LSLV)):
1. Subjects must not applyany leave-on cosmetics (e.g. creams, lotions, oily 
cleansing products) to the test area.
2. Subjects must not apply any detergents (e.g. soaps, shampoos, and bath and 
shower products) to the test area throughout the entire course of the study.
3. Subjects must avoid any sun exposure, UV-therapy and/or artificial tanning.
4. Subjects must notuse any of the medications or treatments outlined in the 
exclusion criteria throughout the entire course of the study.
3.3. Type and Planned Number of Subjects
Healthy males and females aged between 18-70 years (inclusive) with Fitzpatrick 
phototype I, II or III, an ITA° value greater than 28° and who are untanned on the test 
area will be recruited for this study. The study will also contain a population of 
subjects of more than one Fitzpatrick phototype. 
The SPF result for the test product and for the reference sunscreen formulation is 
calculated as the arithmeticmean of all valid SPFi values.  The targetnumber of valid 
SPFi values shall be 5. A maximum of 3 results may be excluded from the calculation 
of the mean SPF, but each exclusion shall be justified. If a fourth invalid result occurs 
for a particular test product, that test product shall not be tested further but an SPF 
may still be calculated. If a fourth invalid result occurs for the reference sunscreen 
formulation, the study shall be stopped. Consequently, the total number of subjects 
randomised may fall between 5 and 8, requiring approximately 11 subjects to be 
screened.
Subjects will be recruited from the site database and via advertisement in local 
newspapers.
3.4. Study Design
As UV rays areresponsible for most of the Sun’s damaging effects on the skin, the 
erythemal protective efficiency of sunscreen products is tested within this range of 
wavelengths. Therefore, the definition of the spectrum of the UV solar simulator is 
 
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limited to the terrestrial UV wavelengths, i.e. from 290 nanometers (nm) to 400 nm. 
Wavelengths below this range (<290 nm) do not occur in terrestrial sunlight and 
should be excluded, whilstthose above this range (>400 nm) may cause undesirable 
side effects (particularly thermal effects) and should be removed using appropriate 
devices.
This study is designed to be compliant with international standard ISO24444:2010 
which mandates a controlled product dose of 2.00 ± 0.05 milligrams (mg) per square 
centimeter (cm
2) oftest site area.
The dorsum (back) is chosen as the anatomical region for the test. The individual 
product treated test sites and the unprotected test site will be delineated within the 
region between the scapula line and the waist. Skeletal protrusions and extreme areas 
of curvature will be avoided and test sites will be free from blemishes and have an 
even colourtone. 
The total area of the individual test sites for provisional MEDu determination, 
product application and the untreated sitewill be 40 cm2and there will be a minimum 
distance of 1 centimeter (cm) between the borders of adjacent test sites to ensure no
overlap of product and UV exposure.In addition, the minimum distance between 
borders of each exposure sub-site will be at least 0.8 cm and the distance between any 
exposure sub-site and any edge of the test site will be at least 1 cm.  Test sites will be
delineated using a marker and template made from non-absorbent materials in a 
manner which will not interfere with the test or harm the subject. Prior to product 
application, test sites may be cleaned by using a dry cotton pad or equivalent.
The positions of the test productsand reference sunscreen test sites will be distributed 
randomly on the backs of subjects over the whole test group in order to reduce error 
arising from anatomical differences in the skin. The test site used to determine the 
unprotected minimal erythemal dose (MEDu) will be randomised as one of the test 
sites across the back and across subjects. Test site demarcation, product application 
and irradiation procedures will be conducted with the subject lying horizontally on 
their front. 
A reference sunscreen formulation (P3)will be included as a comparator to verify the 
test procedure.  
 
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4. SELECTION OF STUDY POPULATION AND WITHDRAWAL 
CRITERIA
Specific information regarding warnings, precautions, contraindications, adverse 
events, and other pertinent information on the GSK investigational product or other 
study treatment that may impact subject eligibility is provided in the Safety 
Statement.
Deviations from inclusion and exclusion criteria are not allowed because they can 
potentially jeopardize the scientific integrity of the study, regulatory acceptability or 
subject safety. Therefore, adherence to the criteria as specified in the protocol is 
essential.
4.1. Inclusion Criteria
A subject will be eligible for inclusion in this study only if all of the following criteria 
apply:
1. CONSENT
Demonstrates understanding of the study procedures, restrictions and willingness to 
participate as evidenced by voluntary written informed consent and has received a 
signed and dated copy of theinformed consent form
2. AGE
Aged between 18 and 70years inclusive and will not turn 71 years old before 
completing all assessment visits
3. GENDER
Subject is male or female
4. GENERAL HEALTH
Good general and mental health with, in the opinion of the investigator or medically 
qualifieddesignee no clinically significant and relevant abnormalities in medical 
history or upon physicalexamination
5. SKIN TYPE/CONDITION
A. Subjects with a Fitzpatrick Skin Type of I, II or III
B. Subjects with an ITA° greater than 28°
 
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4.2. Exclusion Criteria
A subject will not be eligible for inclusion in this study if any of the following criteria 
apply:
1. PREGNANCY
Women who are known to be pregnant or who are intending to become pregnant over 
the duration of the study
2. BREAST-FEEDING
Women who are breast-feedingor lactating
3. CONCURRENT MEDICATION/ MEDICAL HISTORY
A. Subjects having used medication with known photo-toxic and/or photo-
sensitizing potential (e.g. hypericum perforatum, antibiotics, blood pressure 
regulating agents) up to 14 days prior to screening
B. Subjects with a history of systemic therapy with anti-inflammatory agents or 
analgesics (e.g. diclofenac) up to 3days prior to screening
C. Subjects with dermatological conditions
D. Subjects with a history of abnormal response to the sun
E. Subjects having marks, blemishes or nevi or presenting existing sun damage 
in the test area
F. Subjects having excessive hair, moles, tattoos, scarsor other imperfections in 
the test area that could influence the investigation
G. Subjects with a history of systemic therapy with immuno-suppressive drugs 
(e.g. corticosteroids) and/or antihistamines (e.g. anti-allergics) up to 7 days 
prior to screening
H. Subjects with a non-uniform skin colour or hyperpigmentation in the test area
I. Subjects with a medical history of dysplastic nevi or melanoma
J. Subjects with one of thefollowing illnesses that might require regular 
systemic medication: Insulin-dependent diabetes, cancer
K. Subjects with asthma, unless medicated
L. Subjects with an electronic implant (e.g. pace maker, insulin pump, hearing 
aid) that cannot be removed during irradiation
M. AIDS and infectious hepatitis, if known to the subjects
4. ALLERGY/ INTOLERANCE
A. Known or suspected intolerance or hypersensitivity to the study materials (or 
closely related compounds) or any of their stated ingredients
B. Known allergy to latex
 
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5. CLINICAL STUDY/ EXPERMENTAL PRODUCT
A. Participation in another clinical study (including cosmetic studies) or receipt 
of an investigational drug within 30 daysprior to screening
B. Participation in another clinical study involving UV exposure to the same test 
site up to 2 months prior to screening
C. Previous participation in this study
6. SUBSTANCE ABUSE
Recent history (within the last 5 years) of alcohol or other substance abuse
7. LIFESTYLE
A. Subjects who have used a tanning bed or other tanning treatment on the back 
area WITHIN THE PRIOR up to1 month prior to screening
B. Subjects accustomed to using tanning beds
C. Subjects who have used self-tanning products on the back area in the previous 
1 month prior to screening
D. SUBJECTS HAVING HAD SUN EXPOSURE ON THE BACK AREA 
IN THE PREVIOUS FOUR WEEKS PRIOR TO SPF TESTING
8. PERSONNEL
An employee of the sponsor or the study site or members of their immediate family
4.3. Screening/ Baseline Failures
Screen failures are defined as subjects who consent to participate in the study but are 
never subsequentlyrandomized.  In order to ensure transparent reporting of screen 
failure subjects, a minimal set of screen failure information is required including 
Demography, Screen Failure details, Eligibility Criteria, and any Serious Adverse 
Events(SAEs). Re-screening of subjectswill not be allowedin this study.
4.4. Withdrawal/ Stopping Criteria
A subject may withdraw from the study at any time at his/her own request, or may be 
withdrawn at any time at thediscretion of the investigator for safety, behavioural or 
administrative reasons.
If the reason for removal of a subject from the study is anAdverse Event (AE)or an 
abnormal laboratorytest result, the principal specific event or test will be recorded on 
the case report form (CRF).  If a subject is withdrawn from the study because of a 
product limiting AE, thorough efforts should be clearly made to document the 
 
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outcome. Any AEs ongoing at the final visit will be followed up until resolved, the 
condition stabilizes, is otherwise explained, or the subject is lost to follow-up.
The following actions must be taken in relation to a subject who fails to attend the 
clinic for a requiredstudy visit:
1. The site must attempt to contact the subject and re-schedule the missed visit as 
soon as possible. 
2. The site must counsel the subject on the importance of maintaining the 
assigned visit schedule and ascertain whether or not the subject wishes to 
and/or should continue in the study. 
3. In cases where the subject is deemed ‘lost to follow up’, the investigator or 
designee must make every effort to regain contact with the subject (where 
possible, at least2 telephone calls). The contact attempt should be 
documented in the subject’s record. 
Should the subject continue to be unreachable, only then will he/she be considered to 
have withdrawn from the study with a primary reason of “Lost to Follow-up”.
4.5. Subject Replacement
Subjects who withdraw from the study post-randomization will not be replaced.A 
sufficient number of subjects will be randomised to achieve 5 valid individual SPF 
results with a maximum of 3 invalid individual SPF results permitted. 
4.6. Subject and Study Completion
A completed subject is one who has completed all phases of the study.The end of the 
study is defined as thedate of completion of thein vitroUVAPF measurements, 
which will be conducted after the last subject’s last visit.
 
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5. PRODUCT INFORMATION
5.1. Study Product
The followingstudy products will be supplied by the Clinical Supplies Department, 
GSKCH:
Product Name
Product Formulation 
Code (MFC)
Expected 
SPF
Reference Product
P3 Standard
N/A
(Sourced Commercially)
16
Test Product 1
30
Test Product 2
30
Test Product 3
30
Test Product 4
30
Other items to be supplied by the Clinical Supplies Department, GSKCH:
Name of Item
Purpose
Not applicable
Not applicable
5.2. Application Schedule
Test sites intendedfor UV exposure shall be free from blemishes and have an even 
colour tone. The total area for test site study product application will be 40 cm
2.  Test 
site demarcation, product application, UV exposures and MED assessments will be 
conducted with the subject lying horizontally on their front in stable conditions and in 
a room with controlled temperature (22 ± 4degrees Celsius (°C)).
The positions of the unprotected test site for provisional MEDu, test products, 
reference sunscreen and unprotected test sites will be randomisedon each subject and
over the whole group in order to reduce error arising from anatomical differences in 
skin. There willbe a minimum distance of 1 cm between the borders of adjacent test 
sites to ensure no overlap of product and UV exposure. Prior to product application, 
the test site may be cleaned using a dry cotton pad or equivalent. The test sites will be 
delineated by a method which does not interfere with the procedures or assessments 
or harm the subject, using a skin marker and template made from non-absorbent 
material. Test sites will not overlap with the site previously used for the provisional 
MEDu assessment.
 
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The amount of test product and reference sunscreen formulation applied to the skin 
before spreadingwill be 2.00 ± 0.05 mg / cm2(i.e. 78.0 –82.0 mg, inclusive). The 
balance used to weigh the products must be calibrated and capable of weighing to the 
nearest 0.0001 grams (g) (i.e. to the nearest 0.1 mg).  All products will be 
homogeneous and will be shaken,if necessary, before weighing to ensure uniform 
dispersion.
When handling the product during weighing or before application to the skin, 
appropriate measures willbe taken to prevent evaporative loss of the volatile 
componentsas it is important that the total quantity of weighed product is transferred 
to the product application site. In particular, study staff will apply each test product to 
subjects immediately after weighing and the containers filled with product will 
remain sealed when not in use.
The amountof product to be applied will be weighed in a sy
ringe. The syringe will be 
loaded with sufficient product to deliver 2.00 ± 0.05 mg / cm
2to the test site and 
weighed alongside a new, unsaturated finger cot. The syringe will then be evacuated 
directly on to the test site. To aid uniform coverage, droplets (approximately 20) of 
the product will be deposited within the test site, then spread over the whole test site 
using the weighed finger cot, applying a light pressure. The spreading time will be in 
the range of 35 ± 15 seconds. Once spreading is complete, the used finger cot and 
evacuated syringe will be weighed again and the total mass of applied product 
calculated and recorded. If the massof total applied product is less than 78.0 mg or 
greater than 82.0 mg the test site will not undergo UV exposure. If there is sufficient 
space on the subject’s back, between the scapula line and waist, a new 40 cm
2site 
will be demarcated and will be positioned at least 1 cm from the borders of the other 
four test sites. The new test site will only undergo UV exposure if the total mass of 
applied product is 78.0 to 82.0 mg, inclusive. If there is insufficient space on the 
subject’s back to accommodate the test products, positive control and unprotected 
sites then the subject will not undergo any UV exposure and they will be discontinued 
from further participation in the study.
5.3. ApplicationModification
No modificationof product application is permitted.
 
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5.4. Product Compliance
Controlled application of studyproduct to test sites will be conducted by a trained 
technician. A second technician will oversee product application to ensure 
compliance with the protocol. 
5.5. Precautions
No special precautions are necessary provided the study is carried out in accordance 
with thisprotocol. 
5.6.Overdose
An overdose is a deliberate or inadvertent administration of a product at a dose higher 
than specified in the protocol.
Overdose is not likely to occur in this study.  Limited quantities of the product will be 
suppliedandthe applications will be performed and closely monitored by the site for 
each subject.
Overdose per se is not an AE.  However, any clinical sequelae of an overdose should 
be reported as an AE (and serious adverse event if appropriate).  For reporting, follow 
the AE and SAE reporting instructions.
5.7. Rescue Therapy
No rescuetherapy is required in this study.
5.8. Product Assignment
The positions of the unprotected test site for provisional MEDu, test products, 
reference product and unprotected test site will be distributed randomly on the backs 
of subjects over the whole test group in accordance with the randomisation schedule 
generated by the Biostatistics Department, GSKCHor assignedContract Research 
Organization (CRO), prior to the start of the study, using validated software.
5.8.1Randomization
A unique screening number will identify each subject screened for study 
participation.  Screeningnumbers will be assigned in ascending numerical order as 
each subject signs their consent form.  Subjects who meet all inclusion and exclusion 
 
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criteria will be randomized according to the randomization scheduleto achieve 
balance between sites as per Figure 1.
Figure 1: Test site locations and numbering
5.8.2Blinding
This is a single-blind (outcome evaluator) study. Therefore, the trained grader 
responsible for assessing MEDu and MEDp at Visit 5will be blinded to the product 
allocation of subjects.Thetrained grader responsible for assessing the provisional 
MEDu at Visit 3 will, necessarily, not be blinded since only one test site will be 
exposed to UV radiation.
5.8.3Code Breaks
The blind must only be broken in an emergency where it is essential to know which 
product a subject received in order to give the appropriate medical care.  Wherever 
possible the Investigator (or designee) must contact the Sponsor prior to breaking the 
blind.  The investigator must document the reason for breaking the code and sign and 
date the appropriate document.
The studyblind must be returned to GSKCH at the end of the study.
1
2
3
4
5
6
Head
Waistline
7
 
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5.9. Packaging and Labelling
The contents of the label will be in accordance with all applicable regulatory 
requirements and will be the responsibility of the Clinical Supplies Department, 
GSKCH.
The test productswill be supplied in white pumps with a study label affixed. Each 
study label will contain, but not be limited to, protocol number, treatment group code 
and directions for storage.
The reference product (P3 Standard) will be supplied in 2 ounce bottles. The original 
bottle label will be over-wrapped with white vinyl wrap. A study label will be affixed 
to each bottle supplied and the label text will contain, but not be limited to, protocol 
number, treatment group code and directions for storage.
Care should be taken with the supplied products and their labels so that they are 
maintained in good condition.  It is important that all labels remain intact and legible 
for the duration of the study. 
5.9.1. Accountability of Product
All products supplied are for use only in this clinical study and should not be used for 
any other purpose.
The investigator or designee will maintain a full record of study product 
accountability. A Product Dispensing Log must be kept current and will contain the 
following information:
1. The identification of the subject to whom the study product was dispensed.
2. The date(s) and quantity of the study product applied to the subject.
The inventory must be available for inspection by the study monitor during the study. 
At the end of the study, study product supplies will be verified by the monitor.  Study 
product supplies will then be either collected by the study monitor or returned by the 
investigator or designee to the GSKCH Clinical Supplies Department or designated 
vendor.
5.9.2. Storageof Product
Study product suppliesmust be stored in compliance with the label requirements in a 
secure place, protected from sunlight,with limited or controlled access.
 
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6. STUDY ASSESSMENTS AND PROCEDURES
This section lists the procedures and parameters of each planned study assessment.  
The exact timing of each assessment is listed in the Schedule of Events section.
Adherence to the study design requirements, including all assessments and 
procedures are essential and required for study conduct.
6.1. Visit 1 –Subject Screening
6.1.1. Informed Consent
The investigator, or designee, must obtain written (signed and dated by the subject) 
informedconsent from each subject participating in this study after adequate 
explanation of the aims, methods, objectives, and potential hazards of the study.
The investigator, or designee, must also explain to the subjects that they are 
completelyfree to refuse to enter the study or to withdraw from it at any time.  
Appropriate forms for documenting a written consent will be provided by the 
investigator or by GSKCH.  The investigator, or designee, should sign and date the 
consent form to confirm that the consent process was completed correctly.  The 
subject, will be provided with a copy of their signed and dated consent form and any 
other written information which they should be instructed to retain.
If, during a subject’s participation in the study, any new information becomes 
availablethat may affect the subject’s willingness to participate in the study, each 
ongoing subject should receive a copy of this new information and be re-consented 
into the study. Subjects should be provided with a copy of the signed and dated 
amended consent form. The date of consent will be recorded on the CRF.
6.1.2. Demographicsand Baseline Characteristics
The followingdemographic parameters will be captured by the Investigator or 
designee and recorded on the CRF: year of birth, gender,race,Fitzpatrick skin type 
(see 6.1.5 for details)and Individual Typology Angle (see 6.1.4 for details).
6.1.3. Medical History and Concomitant Medication
Medical history will be assessed as related to the inclusion/exclusion criteria by the 
Investigator or medically qualified designee.  Details of any relevant medical or
surgical history (within the last year), including allergies or drug sensitivity, will be 
 
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recorded on the CRF.  Any concomitant therapy taken in the 30 days prior to the 
Screening Visit and throughout the study will also be recorded.
6.1.4.Individual TypologyAngle(ITA°)
A tri-stimulus chromameter (Minolta CR 400, Langenhagen, Germany) which utilizes 
the L*, a*, b* colour space and complies with International Commission on 
Illumination (CIE) recommendations will be used to measure the colour of each 
subject’s skin (dorsum). Subjects will rest for 10 minutes in the prone position, with 
the skin area uncovered, to eliminate contact or stress-related redness and marks. 
During measurements, care will be taken to apply the cone aperture of the reflectance 
colorimeter sensing head so that it just makes contact with the skin, without any 
pressure, to avoid any skin “blanching” effect.  Four measurements will be taken on 
the back of each subject,between the waist and shoulder line,and the individual L*, 
and b* values will be recordedas source data.  The ITA° will be calculated as per 
Equation 1 and recorded on the CRF.
(Equation 1)
*arc tangentis expressed in radians.
The mean ITA° and historical data will be used to estimate theMEDu for each 
subject.Theestimated MEDu will be recorded on the CRF.
6.1.5. Fitzpatrick Skin Type Assessment
Fitzpatrick skin type assessment will be conducted by a trained, qualified technician 
or physicianusing the scale below.
Type
Description
I
Always burnseasily: never tans
II
Always burns easily: tans minimally
III
Burns moderately: tans gradually
IV
Burns minimally: always tans well
V
Very rarely burns: tans profusely
VI
Never burns: deeply pigmented
The Fitzpatrickskin type will be recorded on the CRF. 

















14159
.
3
180
*
50
*
 tangent
arc
ITA
b
L
 
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6.1.6. Inclusion/Exclusion Criteria
Inclusion/exclusion criteria will be assessed by the Investigator or designee and 
subject compliancewith each criterion recorded on the CRF.
6.1.7. Subject Eligibility
Subject eligibility to participate in the study will be assessed by the Investigator or 
medically qualified designee and recorded on the CRF.
6.2. Visit 2 –Provisional MED Irradiation(UV Exposure)
Before starting themain test, a provisional MEDu will be determined for each subject 
in order to centre theUV dose rangesfor the exposures of MEDu and MEDp.
6.2.1. Concomitant Medication
Any concomitant therapy taken since the last visitand throughout the study will be 
recorded on the CRFby the Investigator or medically qualified designee.
6.2.2. Exclusion Criteria
Subject compliance with exclusion criteriain Appendix 2 will be re-assessed by the 
Investigator or designee and subject compliance with each criterion recorded on the 
CRF.
6.2.3. Subject Eligibility
Following the review of the exclusion criteriaspecified in 6.2.2, subject eligibility to 
continue in the study will be assessed by the Investigator or medically qualified 
designee and recorded on the CRF.
6.2.4. Continued Eligibility
The Investigator or designee will ascertain whether there have been any deviations 
from the protocol since the last visit, whetherthe subject has adhered to the lifestyle 
restrictions since the last visit and whether, in their opinion, the subject is eligible to 
continue in the study and their decision will be recorded on the CRF.
6.2.5. Randomisation
Subject randomisationwill be conducted as per the process detailed in Section 5.8.1. 
 
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6.2.6. Provisional Minimal Erythemal Dose Irradiation 
The specification of the solar simulator output is included in Appendix 3. A UV dose 
is the result of multiplying the UV source irradiance by the episode duration.  In this 
study, a solar simulator with 6 light guides exposing all sub-sites for the same 
duration but with varied irradiance values will be used. Before UV exposure of each 
test site, irradiance values will be measured and recorded with a radiometer which has 
been calibrated with a spectroradiometric measurement of the solar simulator output.
A suitable warm-up time of at least 10 minutes will be allowed for the UV solar 
simulator to stabilize before starting exposures. This is to ensure a consistent 
irradiance over the whole exposure period.Subject exposure to UV radiation will be 
conducted in stable conditions, with the subject lying horizontally on their front 
(prone) and in a room with controlled temperature (22 ± 4 °C).
Test sites intended for UV exposure shall be free from blemishes and have an even 
colour tone. In this study, there will be a total of seven irradiated test sites. Three test 
sites will be demarcated belowthe scapula lineand above the waist on the leftsideof 
the spine. The remaining four test sites will be demarcated below the scapula line and 
above the waist on the right side of the spine. The location of the test site for the 
provisional MEDu measurement will be randomised over the whole test group in 
order to reduce error arising from anatomical differences in skin.
Six exposure sub-sites centered on the estimated MEDu will be exposed with 
incremental UV doses using a geometric progression of 1.25. Thedose of UV 
radiation administered will be chosen so that the 4
thof the 6 sub-sites will be 
irradiated with the estimatedMEDu.  The estimated MEDu will be predicted based on 
the subject’s mean ITA°value.  
The minimum area of each exposure sub-site will be 0.5 cm
2. The minimum distance 
between borders of each exposure sub-site (spots) will be at least 0.8 cm. The 
distance between any exposure sub-site and any edge of the test site will be at least 1 
cm.
Any extraneous exposure of the test sites to UV light (artificial or natural) will be 
avoided during this period and fora period of 24 hours after exposure. Any additional 
UV exposure to the test area will invalidate the whole test for the subject concerned.
 
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6.2.7. Adverse Events
Adverse events will be assessed by the Investigator or designee and recorded on the 
CRF, as per the process detailed in Section 7. Localised erythema caused by exposure 
of the skin to UV radiation is expected and will not be reported as an adverse event.
6.3. Visit 3 –Provisional MEDuDetermination
6.3.1. Concomitant Medication
Any concomitant therapy taken since the last visitand throughout the study will be 
recordedon the CRF by the Investigator or medically qualified designee.
6.3.2. Continued Eligibility
The Investigatoror designee will ascertain whether there have been any deviations 
from the protocol since the last visit, whether the subject has adhered to the lifestyle 
restrictions since the last visit and whether, in their opinion, the subject is eligible to 
continue in the studyand their decision will be documented on the CRF.
6.3.3. Visual Grading of Exposure Sub-Sites (Test Sites)
The MED is defined as the lowest dose of UV radiation that produces the first 
perceptible unambiguous erythema with defined borders appearing over most of the 
field of UV exposure, 16 to 24 hours after UV exposure.
The provisional MED will be assessed visually by a trained grader with the subject 
lying horizontally on their front and in a room withcontrolled temperature (22 ± 4
°C). The same grader will assess all subjects in the study
. The grader’s eyesight must 
have been checked for normal colour vision and acuity within the previous year. 
Visual assessment will be performed in a room with matt, neutral wall colours with 
sufficient and uniform illumination. As only one site will be exposed to UV radiation 
for the detection of the provisional MEDu, the grader will, necessarily, not be blinded
at this point in the study.
The provisionalMEDuof each subject will be recorded on the CRFwith units of 
millijoules per square centimeter (mJ/cm2).
6.3.4. Adverse Events
Adverse events will be assessed by the Investigator or designee and recorded on the 
CRF, as per the processdetailed in Section 7. Localised erythema caused by exposure 
of the skin to UV radiation is expected and will not be reported as an adverse event.
 
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6.4. Visit 4 –Test Irradiation(UV Exposure)
6.4.1. Concomitant Medication
Any concomitant therapy taken since the last visitand throughout the study will be 
recorded on the CRF by theInvestigator or medically qualified designee.
6.4.2. Continued Eligibility
The Investigator or designee will ascertain whether there have been any deviations 
from the protocol since the last visit, whether the subject has adhered to the lifestyle 
restrictions since the last visit and whether, in their opinion, the subject is eligible to 
continue in the studyand their decision will be documented on the CRF.
6.4.3. Study Product Application to Randomly Assigned Test Siteson the 
Back
Test sites intended for UV exposure shall be free from blemishes and have an even
colour tone. The total surface area of eachtest site shallbe 40 cm
2.  Test site 
demarcationand product applicationwill be conducted in stable conditions with the 
subject lying horizontally on their front and in a room with controlled temperature (22 
± 4°C).
 
 
 
 
 
 
 
 
 
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6.4.4. UV Exposure of Test Product Treated, Reference Sunscreen 
Formulation Treated and Unprotected Test Sites
The specification of the solar simulator output is included in Appendix 3.  A UV dose 
is the result of multiplying the UV source irradiance by the episode duration.  In this 
study, a solar simulator with 6 light guides exposing all sub-sites for the same 
duration but with varied irradiance values will be used. Before UV exposure of each 
test site, irradiance valueswill be measured and recorded with a radiometer which has 
been calibrated with a spectroradiometric measurement of the solar simulator output.
A suitable warm-up time of at least 10 minutes will be allowed for the UV solar 
simulator to stabilize before starting exposures. This is to ensure a consistent 
irradiance over the whole exposure period.Subject exposure to UV radiation will be 
conducted with the subject lying horizontally on their front and in a room with
controlled temperature (22 ± 4°C).
The minimum area of eachexposure sub-site will be 0.5 cm
2. The minimum distance 
between borders of each exposure sub-site (spots) will be at least 0.8 cm. The 
 
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distance between any exposure sub-site and any edge of the test site will be at least 1 
cm.
Exposure of the test product and positive control treatedsitesto UV radiation will 
start 15 to 30 minutes after each product application has completed.Exposure of the 
unprotected site to UV radiation may happen at any point after demarcation of the test 
sites and after the 10 minutes required for the solar simulator to warm up. Exposure 
of the unprotected site, positive control and test product sites will be conducted 
sequentially, in any order, on same subject on the same day.
For the unprotected site, the range of UV doses administered shall be selected using 
the subject’s provisionalMEDu. Six exposure sub-sites centered on the provisional 
MEDu shallbe exposed with incremental UV doses using a geometric progression of 
1.12. The dose of UV radiation administered to subjects will be chosen such that the 
provisional MEDu will be irradiatedon the 4thof the 6 sub-sites. 
For thetest product and reference formulation protected sites, the UV doses 
administered shall be selected using the subject’s expected MEDp, which is the 
multipleof the expected SPF of the study product and the provisional MEDu for the 
subject. A minimum of 6 sub-sites centered on the expected MEDp shall be exposed 
with incremental UV doses using a geometric progression of 1.12.  The dose of UV 
radiation administered to subjects will be chosen such that the expectedMEDpwill 
be irradiatedon the 4thof the 6 sub-sites.  After the UV exposure procedures are 
complete, reference and test product may be gently removed by wiping with a dry 
tissue. 
Any extraneous exposure of the test sites to UV light (artificial or natural) will be 
avoidedduring this period and until visual evaluation is completed.Any additional 
UV exposure to the test area will invalidate the whole test for the subject concerned.
6.4.5. Adverse Events
Adverse events will be assessed by the Investigator or designee and recorded on the 
CRF, as per the process detailed in Section7. Localised erythema caused by exposure 
of the skin to UV radiation is expected and will not be reported as an adverse event.
 
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6.5. Visit 5 –MEDp and MEDu Determination and SPF Calculation 
for Test and Reference Sunscreens
6.5.1. Concomitant Medication
Any concomitant therapy taken since the last visitand throughout the study will be 
recordedon theCRF by the Investigator or medically qualified designee.
6.5.2. Continued Eligibility
The Investigator or designee will ascertain whether there have been any deviations 
from the protocol since the last visit, whether the subject has adhered to the lifestyle 
restrictions since the last visit and whether, in their opinion, the subject is eligible to 
continue in the studyand their decision will be recorded on the CRF.
6.5.3. Visual Grading of Exposure Sub-Sites to Determine MEDp and 
MEDu 
The MED is defined as the lowest dose of UV radiation that produces the first 
perceptible unambiguous erythema with defined borders appearing over most of the 
field of UV exposure, 16 to 24 hours after UV exposure.
The MED determination will be assessed visually by a trained grader with the subject 
lying horizontally on their front in a room with controlled temperature (22 ± 4°C). 
The same grader will assess all subjects in the study. The grader’s eyesight must have 
been checked for normal colour visionand acuitywithin the previous year. Visual 
assessment will be performed in a room with matt, neutral wall colourswith sufficient
and uniform illumination.Erythemal responses will be observed in a blind manner. 
The grader must not be the same person as the one who performed product 
application and exposure nor will the grader be aware of the test design 
(randomisation of test sites) for any subject.
The MEDu and MEDp values for each subject will be recorded on the CRF with units 
of mJ/cm
2.
6.5.4. Adverse Events
Adverseevents will be assessed by the Investigator or designee and recorded on the 
CRF, as per the process detailed in Section 7. Localised erythema caused by exposure 
of the skin to UV radiation is expectedand will not be reported as an adverse event.
 
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6.5.5. Study Conclusion
Subjects will be evaluated to determine if they completed all study procedures or if 
they were discontinued from the study early.  If the subject is discontinued at any 
point during the study, the primary reason for withdrawal shall be recorded on the 
Study Conclusion page of the CRF by selecting one of the options below.
1.
Subject did not meet study criteria
2.
Adverse Event
3.
Lost to Follow Up
4.
Protocol Violation
5.
Withdrawal of Consent
6.
Other
 
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7. SAFETY ASSESSMENTS
7.1. Definitions of an Adverse Event and Serious Adverse Event 
7.1.1. Adverse Events
The investigator or site staff will be responsible for detecting, documenting and 
reporting events that meet the definition of an AE or SAE.
Adverse Event Definition:
1. An AE is any untoward medical occurrence in a patient or clinical 
investigation subject, temporally associated with the use of an investigational 
or washout product, whether or not considered related to the investigational or 
washout product.
2. NOTE: An AE can therefore be any unfavorable and unintended sign 
(including an abnormal laboratory finding), symptom, or disease (new or 
exacerbated) temporally associated with the use of an investigational or 
washout product.
Events meeting AE definition include:
1. Any abnormal laboratory test results (if applicable) or other safety 
assessments, including those that worsen from baseline, and felt to be 
clinically significant in the medical and scientific judgment of the 
investigator.
2. Exacerbation of a chronic or intermittent pre-existing condition including 
either an increase in frequency and/or intensity of the condition.
3. New condition(s) detected or diagnosed after study product administration 
even though it may have been present prior to the start of the study.
4. Signs, symptoms, or the clinical sequelae of a suspected interaction.
5. Signs, symptoms, or the clinical sequelae of a suspected overdose of either 
study product or a concomitant medication (overdose per se will not be 
reported as an AE/SAE).
Events NOT meeting definition of an AE include:
1. Any clinically significant abnormal laboratory findings (if applicable) or other 
abnormal safety assessments which are associated with the underlying disease, 
unless judged by the investigator to be more severe than expected for the 
subject’s condition. 
2. The disease/disorder/ condition being studied or expected progression, signs, 
or symptoms of the disease/disorder being studied, unless more severe than 
expected for the subject’s condition.
3. Medical or surgical procedure (e.g., endoscopy, appendectomy): the condition 
that leads to the procedure is an AE.
4. Situations where an untoward medical occurrence did not occur (social and/or 
 
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convenience admission to a hospital).
5. Anticipated day-to-day fluctuations of pre-existing disease(s) or condition(s) 
present or detected at the start of the study that do not worsen.
6. Localised erythema caused by exposure of the skin to UV radiation.
7.1.2. Serious Adverse Events
Serious Adverse Event is defined as any untoward medical occurrence that, at 
any dose:
A. Results in death
B. Is life-threatening
NOTE: The term 
'life-threatening
' in the definition of 
'serious
' refers to an 
eventin which the subject was at risk of death at the time of the event.  It does 
not refer to an event, which hypothetically might have caused death, if it were 
more severe.
C. Requires hospitalization or prolongation of existing hospitalization
NOTE: In general, hospitalization signifies that the subject has been detained 
(usually involving at least an overnight stay) at the hospital or emergency 
ward for observation and/or treatment that would not have been appropriate in 
the physician’s office or out-patient setting.  Complications that occur during 
hospitalization are AEs.  If a complication prolongs hospitalization or fulfills 
any other serious criteria, the event is serious.  When in doubt as to whether 
“hospitalization” occurred or was necessary, the AE should be considered 
serious.
Hospitalization for elective treatment of a pre-existing condition that did not 
worsen from baseline is not considered an AE.
D. Results in disability/incapacity
NOTE: The term disability means a substantial disruption of a person’s ability 
to conduct normal life functions.
This definition is not intended to include experiences of relatively minor 
medical significance such as uncomplicated headache, nausea, vomiting, 
diarrhea, influenza, and accidental trauma (e.g. sprained ankle) which may 
interfere or prevent everyday life functions but do not constitute a substantial 
disruption.
E. Is a congenital anomaly/birth defect
F. Other Situations
1. Medical or scientific judgment should be exercised in deciding 
whether reporting is appropriate in other situations, such as important 
medical events that may not be immediately life-threatening or result 
in death or hospitalization but may jeopardize the subject or may 
require medical or surgical intervention to prevent one of the other 
outcomes listed in the above definition. These should also be 
 
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considered serious.
2. Examples of such events are invasive or malignant cancers, intensive 
treatment in an emergency room or at home for allergic bronchospasm, 
blood dyscrasias or convulsions that do not result in hospitalization or 
development of drug dependency or drug abuse or reports of 
spontaneous abortion.
7.2. RecordingAdverse Eventsand Serious Adverse Events
Recording of adverse events and serious adverse events:
1. The investigator or site staff will be responsible for detecting, documenting 
and reporting events that meet the definition of an AE or SAE. 
2. The investigator or site staff will then record all relevant information 
regarding an AE/SAE in the CRF.
3. There maybe instances when copies of medical records for certain cases are 
requested by GSK.  In this instance, all subject identifiers, with the exception 
of the subject number, will be blinded on the copies of the medical records 
prior to submissionto GSK.
4. The investigator will attempt to establish a diagnosis of the event based on 
signs, symptoms, and/or other clinical information.  In such cases, the 
diagnosis will be documented as the AE/SAE and not the individual 
signs/symptoms. Clinical AEs will be described by diagnosis and not by 
symptoms when possible (e.g., upper respiratory tract infection, seasonal 
allergy, etc. instead of runny nose).
5. AEs will be collected from the start of the provisional MEDu irradiation
procedureand until 5 daysfollowing last administration of the study product.
6. SAEs will be collected over the same time period as stated above for AEs.  
However, any SAEs assessed as relatedto study participation (e.g., 
investigational product, protocol mandated procedures, invasive tests, or 
change in existing therapy) or related to a GSK concomitant medication will 
be recorded from the time a subject consents to participate in the study up to 
and including any follow-up contact.  
7. Medical conditions reported prior to the time period for reporting AEs/SAEs 
should be recorded as part of the subject’s medical history.
7.3. Evaluating Adverse Eventsand Serious Adverse Events
Assessment of Intensity:
The investigator or designee will make an assessment of intensity for each AE and 
SAE reported during the study and will assign it to one of the following categories:
1. Mild:  An event that is easily tolerated by the subject, causing minimal 
discomfort and not interfering with everyday activities.
2. Moderate:  An event that is sufficiently discomforting to interfere with normal 
 
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everyday activities
3. Severe:  An event that prevents normal everyday activities. An AE that is 
assessed as severe will not be confused with an SAE. Severity is a category 
utilized for rating the intensity of an event; and both AEs and SAEs can be 
assessed as severe.
Note: An event is defined as ‘serious’ when it meets at least one of the pre-defined 
outcomes as described in the definition of an SAE.
Assessment of Causality:
1. The investigator is obligated to assess the relationship between study product 
and the occurrence of each AE/SAE.
2. A "reasonable possibility" is meant to convey that there are facts/evidence or 
arguments to suggest a causal relationship, rather than a relationship cannot be 
ruled out.
3. The investigator will use clinical judgment to determine the relationship.
4. Alternative causes, such as natural history of the underlying diseases, 
concomitant therapy, other risk factors, and the temporal relationship of the 
event to the study product will be considered and investigated.
5. The investigator will also consult the Safety Statement, in the determination of 
his/her assessment.
6. For each AE/SAE the investigator mustdocument in the medical notes 
(source document) or CRF that he/she has reviewed the AE/SAE and has 
provided an assessment of causality.
7. There may be situations when an SAE has occurred and the investigator has 
minimal information to include in the initial report to GSK.  However, it is 
very important that the investigator always make an assessment of 
causality for every event prior to the initial transmission of the SAE data 
to GSK.
8. The investigator may change his/her opinion of causality in light of follow-up 
information, amending the SAE data collection tool accordingly.
9. The causality assessment is one of the criteria used when determining 
regulatory reporting requirements.
7.4. Reporting Adverse Eventsand Serious Adverse Events
AE Reporting to GSKCH:
1. AEs will be recorded in the AE section of the CRF. 
2. Medical conditions recorded by the subject on a diary
 card or similar 
document that meet the definition of an AE must also be recorded in the AE 
section of the CRF, if not previously well-characterized by the investigator in 
the subject’s medical history. 
3. AEs elicited by the investigator in a standard manner at the study visits should 
also be recorded in the AE section of the CRF.  The investigator or designee 
must ask the subject the following question during each visit including any 
 
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follow-up visits: “Have you felt unwell, experienced any symptoms or taken 
any medication (since your last visit) (today) (since your last dose) (since the 
last session)?”
4. The medically qualified investigator should review adverse events in a timely 
manner; this review should be documented in writing in the source document 
or in the CRF. 
5. After the study is completed at a given site, and the site has received their 
study data on Compact Discs (CDs), the electronic data collection tool will be 
removed from the internet to prevent the entry of new data or changes to 
existing data.
SAE Reporting to GSKCH:
A paper copy of the SAE form provided in the investigator study master file should 
be completed as fully as possible.
It is essential to enter the following information: 
1. Protocol and subject identifiers
2. Subject’s demography
3. Description of events, with diagnosis if available
4. Investigator opinion of relationship to study product (see section 7.3)
5. Criterion for seriousness.
The following are desirable and are of particular relevance for investigator and 
GSKCH assessment of the SAE report:
1. Date of onset of AE 
2. Date AE stopped, if relevant
3. Study product start date
4. Study product end date if relevant
5. Action taken on study product
6. Outcome if known
The SAE form, completed as fully as possible, and SAE fax cover sheet must be 
faxed or e-mailed to the appropriate GSKCH Study Manager assoon as possible, but 
not later than 24 hoursafter study site personnel learn of the event. The GSKCH 
Study Manager should be notified of the situation by telephone andemail.
Fax Serious Adverse Events to:
UK: 
Email Serious Adverse Events to:
 
The GSKCH Study Manager will be responsible for forwarding the SAE form to the 
Case Management Group, Global Clinical Safety and Pharmacovigilance, the 
 
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PPD
PPD

Medical Director responsible for the study and other GSKCH personnelas 
appropriate via email.
The initial report will be followed up with more information as relevant, or as 
requested by the GSKCH study manager.
7.5. Follow-up of Adverse Eventsand Serious Adverse Events
Follow-up of AEs and SAEs:
1. After the initial report, the investigator is required to proactively follow up 
with each subject and provide further information on the subject’s condition.
2. All AEs/SAEs will be followed until resolution, until the condition stabilizes, 
until the event is otherwise explained, or until the subject is lost to follow-up.  
3. The investigator is obligated to perform or arrange for the conduct of 
supplemental measurements and/or evaluations as may be indicated or as 
requested by GSK to elucidate as fully as possible the nature and/or causality 
of the AE or SAE.
4. Investigators are not obliged to actively seek AEs or SAEs in former subjects.  
However, if the investigatorlearns of any SAE, including the death, at any 
time after a subject has been discharged from the study, and considers the 
event reasonably related to the investigational product or study participation, 
the investigator will promptly notify GSKCH.
5. The investigator will submit any updated SAE data to GSK within the 
designated reporting time frames.
Regulatory and ethics reporting requirements for SAEs:
1. The investigator will promptly report all SAEs to GSKCH within the 
designated reporting timeframes (within 24 hours of learning of the event).  
GSKCH has a legal responsibility to notify, as appropriate, the local 
regulatory authority and other regulatory authorities about the safety of a 
product under clinical investigation.  Prompt notification of SAEs by the 
investigator to GSKCH is essential so that legal obligations and ethical 
responsibilities towards the safety of subjects are met.
2. GSKCH will comply with country specific regulatory requirements relating to 
safety reporting to the regulatory authority, Independent Ethics Committee 
(IEC)and investigators.
3. Investigator safety reports are prepared according to GSKCH policy and are 
forwarded to investigators as necessary.  An investigator safety report is 
prepared for a SAE(s) that is both attributableto investigational product and 
unexpected.  The purpose of the report is to fulfill specific regulatory and 
GCP requirements, regarding the product under investigation.
4. An investigator who receives an investigator safety report describing a SAE(s) 
or other specific safety information (e.g., summary of listing of SAEs) from 
GSKCH will file it with the Investigator Brochure (or safety statement) and 
 
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will notify the IEC, if appropriateaccording to local requirements.
7.6. Collection of Pregnancy Information
7.6.1. Time Period for Collectingof Pregnancy Information
Collection of Pregnancy Information:
1. Pregnancy information will be collected on all pregnancies reported following 
the screening visit.
7.6.2. Action to be Taken ifPregnancy Occurs
Action to be Taken:
1. The investigator will collect pregnancy information on any subject who 
becomes pregnant while participating in the study after the screening visit. 
The investigator will record pregnancy information on the appropriate form 
and submit it to GSKCH within 2 weeks of learning of the subject becoming 
pregnant. The subject will be followed to determine the outcome of the 
pregnancy. Information on the status of the mother and infant / neonate 
(including concomitant medications taken by the mother during the 
pregnancy) will be forwarded to GSKCH. Generally, follow-up will be no 
longer than 6 to 8 weeks following the estimated delivery date. Any 
termination of the pregnancy will be reported.
2. While pregnancy itself is not considered to be an AE, any pregnancy 
complication or elective termination for medical reasons will be recorded as 
an AE or SAE.
3. A spontaneous abortion is always considered to be an SAE and will be 
reported as such. An SAE occurring in association with a pregnancy, brought 
to the investigator’s attention after the subject completed the study and 
considered by the investigator as possibly related to the investigational 
product, must be promptly forwarded to GSK.
4. While the investigator is not obliged to actively seek this information in 
former study participants, he or she may learn of an SAE through spontaneous 
reporting.
5. If a subject becomes pregnant over the duration of the study,they must be 
withdrawn and their withdrawal should be recorded in the appropriate section 
of the CRF.If a subject later discovers they were pregnant after their
participation in the study completed, their data will be considered valid for 
statistical analysis.
 
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8. DATA MANAGEMENT
For this studysubject data will be entered into an electronic case report form, using a 
GSKCH validated data system.
8.1. Source Documents/ Data
The source documents (e.g. hospital records, clinical and office charts, laboratory 
notes, memoranda, subjects’ diaries or evaluation checklists, pharmacy dispensing 
records, recorded data from automated instruments, microfiches, photographic 
negatives, microfilm or magnetic media, x-rays, subject files and records kept at the 
pharmacy, at the laboratory and at the medico-technical departments involved in the 
clinical study) which contain the source of data recorded in the CRF should be 
specified in the Source Document Designation Form.  In some cases,the CRF can be 
used as a source document.
Each subjectwill be assigned and identified by a unique Screening Number. Any 
reference made to an individual subject within the study must be done using the 
unique Screening Number.
8.2. Case Report Form
A CRF is a printed, optical, or electronic document designed to record all of the 
protocol requiredinformation to be reported to the sponsor on each trial subject.
For each subject who has given informed consent/assent and has been screened, CRF 
must be completedand signed by the Principal Investigator (or authorized designee) 
to certify that the data are complete and correct.  
Management of clinical data will be performed in accordance with applicable 
GSKCH standards and data cleaning procedures to ensure the integrity of the data e.g. 
removing errors and inconsistencies in the data. 
In order to protectthe privacy of subjects, no Personally Identifiable Information 
(PII) (including the subject
's name or initials or birth date) is to be recorded in the 
CRF or as part of the query text.
 
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Adverse eventsand concomitant medications terms (if applicable) will be coded 
using MedDRA (Medical Dictionary for Regulatory Activities) and an internal 
validated medication dictionary, GSKDrug.  
Subject data will be entered into GSKCH defined CRFs and transmitted electronically 
to GSKCH in a validated (21 CFR Part 11 compliant) web-based electronic data 
capture system (InForm
TM).
All CRF pages shouldbe completed during a subject assessment when the CRF has 
been designated as the source.  Data that is sourced elsewhere should be entered into 
the CRF in an agreed upon timeframe between the Investigator and Sponsor.  
The CRFs (including queries, query responses and audit trails) will be retained by 
GSKCH. Site dataarchived CDs prepared by a third party will be sent to the 
investigator to maintain as the investigator copy following the decommissioning of 
the study.
8.3. Data Handling
Documentation of all data management activities should allow step-by-step 
retrospective assessment of data quality and study performance. Any changes or 
corrections to data will be performed in the Electronic Data Capture (EDC) System, 
and it will include rationale for changes. The EDC system has an audit trail, which 
will provide a complete record of the changes and corrections endorsed by the 
Investigator.
8.3.1. Data Queries
Programmed edit checks will be generated automatically, as the data is being entered 
into the system. Data Management will also run reports and listings on the CRF data, 
in addition to the queries already programmed and generated by the system, to raise 
manual queries as needed for site clarification or correction. The Clinical Dictionary 
Development and Management Group will raise queries as needed on safety data to 
code the terms (Adverse Events and Drugs) are reported appropriately. 
The study monitor at the study site will review the CRFs in accordance with the 
monitoring plan, and any queries will be generated in the EDC System to the 
Investigator or designee, enabling the errors to be addressed in parallel with Data 
Management review. Monitor can also run reports and listings on the CRFs, to raise 
manual queries as needed for site clarification or correction
 
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8.4. External Data
ExternalData are subject data obtained externally to the CRF. These data are 
generated from laboratory instruments, computers or other sources and then 
transcribed into a file and format agreed upon by GSKCH to identify the subject and 
time point referenced in the CRF and/or protocol. 
An agreed upon quality control process is performed against the transcribed data to 
the source to ensure the accuracy of the transcription. The transcribed data is 
transmitted in an agreed upon format to GSKCH via secured web portal or CD via 
mail carrier with tracking capabilities. 
Proper reconciliation will be performed between the transcribed data and the clinical 
databaseto ensuresubject and time point referenced in the Clinical Database match 
before Clinical Database Freeze(locking of the database) can occur.
9. STATISTICAL CONSIDERATIONS AND DATA ANALYSES
9.1 Sample Size Determination
Healthy males and females aged between 18-70 years (inclusive) with Fitzpatrick 
phototype I, II or III, an ITA° value greater than 28° and who are untanned on the test 
area will be recruited for this study. Thestudy will contain a population of subjects of 
more than one Fitzpatrick phototype. 
The SPF resultsfor each test product and for the reference sunscreen formulation are
calculated as the arithmetic mean ofall valid SPFi values.  The targetnumber of valid 
SPFi values shall be 5. A maximum of 3 results may be excluded from the calculation 
of the mean SPF, but each exclusion shall be justified. If a fourth invalid result occurs 
for a particular test product, that test product shall not be tested further but an SPF 
may still be calculated. If a fourth invalid result occurs for the reference sunscreen 
formulation, the study shall be stopped. Consequently, the total number of subjects 
randomised may fall between 5 and 8, requiring approximately 11 subjects to be 
screened.
 
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9.2.General Considerations
9.2.1.Definition of Analysis Populations
All valid subject data with no major protocol deviations will be included in the SPF 
calculations. All subjects exposed toUV radiation will be included the safety 
population, irrelevant of whether they successfully complete the study. 
9.2.2.Exclusion of Data from Analysis
Test dataare deemed invalid and shall be rejected under the following circumstances:
1. The series of UV exposures on a subject failto elicit an erythemal response on 
any sub-site, 16-24 hours after exposure.
2. Erythemal responses within an exposure series are randomly absent 16-24 
hours after exposure.
3. All sub-sites in the exposure series show an erythemal response 16-24 hours 
after exposure.
When one of the above criteria applies to the exposure of unprotected skinor
reference sunscreen formulation exposure sites, then all data for all products on that 
subject are invalidand shall be rejected. When one of the above criteria applies to the 
exposure of a particular test product exposure site then data for that test productalone
shall be invalid and rejected.
Any additional exposure of a test area to natural or artificial UV radiation will 
invalidate thewhole test for that subject.
Major violations will be identified and any exclusion of subject data justified. Data 
deemed invaliddue to protocol violations which are not related to the UV exposure 
procedures, such as illness, equipment failure, and subject drop out will not be 
included in analysis of efficacy and will not count towards the maximum of 3invalid 
subject data. Data deemed invalid due to protocol violations related to the UV 
exposure procedures such as subject moving during irradiation will count towards the 
maximum of 3invalid subject data. 
9.2.3.Handling of Dropouts and Missing Data
No interpolationof missing data is permitted. Subjects with missing data will be 
declared invalid and excluded from analysis.
 
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9.3. Statistical Methods and Analytical Plan
Additional details of the proposed statistical analysis will be documented in the 
statisticalanalysis plan (SAP), which will be written following finalization of the 
protocol and prior to study unblinding / analysis (as appropriate).
9.3.1.Demographic and Baseline Characteristics
Subject information (Identification code, Fitzpatrick skin phototype, ITA° value, age,
race and gender) will be tabulated and reported.
9.3.2.Primary Analysis
The SPFi foreach product on each subject is calculated from the individual MED on 
unprotectedskin (MEDu) and the individual MED on product protected skin (MEDp) 
according to Equation 2:
MEDu
MEDp
skin)
ected
MED(unprot
skin)
ted
MED(protec
SPFi


(Equation 2)
SPFi valuesare expressed to 1 decimal place. 
The SPF of the product is the arithmetical mean of the valid individual SPFi values 
obtained from the total number, n, of subjects used, expressed to one decimal place as 
per Equation 3.


n
SPFi
SPF


(Equation 3)
Its standarddeviation, s, is given by Equation 4.
 

 
 

 
























1
SPF
SPFi
2
2
n
n
i
s
(Equation 4)
The 95 % confidence interval (95 %CI) of the mean SPF is expressed by Equation 5.
c
c



SPF
 to
SPF
%CI
95
(Equation 5)
 
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Where cis calculated as:
 



n
s
t
t
c




 value
SEM
 value
(Equation 6)
n
s
t
c


(Equation 7)
SPF
100
CI[%]
c


(Equation 8)
And where
SEM is the standard error of the mean;
n
is the total number of subjects used;
t
is the t value from the “two-sided” Student-tdistribution (Table 1) at a 
probability level p= 0.05 and with degrees of freedom v= (n-1). 
Table 1–Student-tDistribution
n
10 
11 
12 
13 
14 
15 
16 
17 
18 
19 
20
tvalue
2.262 2.228 2.201 2.179 2.160 2.145 2.131 2.120 2.110 2.101 2.093
9.3.3.Safety Analysis
Adverse events details will be listed by subject.
10. STUDY GOVERNANCE CONSIDERATIONS
10.1.Posting of Information on Publicly Available Clinical Trials 
Registers
Study information from this protocol will be posted on publicly available clinical trial 
registers before enrollment of subjects begins.
10.2.Regulatory and Ethical Considerations, Including the Informed 
Consent
The study will be conducted in accordance with all applicable regulatory 
requirements, and with GSK policy.
 
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The study will also be conducted in accordance with ICH Good Clinical Practice 
(GCP), all applicable subject privacy requirements, and the guiding principles of the 
current version of the Declaration of Helsinki.  This includes, but is not limited to, the 
following:
1.
Before initiating a trial, the investigator/institution should have written and 
dated approval/favorable opinion from the IEC for the trial protocol 
(including amendments), written informed consent form, consent form 
updates, subject recruitment procedures (e.g., advertisements), investigator 
brochure/ safety statement (including any updates) and any other written 
information to be provided to subjects. A letter or certificate of approval 
will be sent by the investigator to the sponsor prior to initiation of the 
study, and also when subsequent amendments to the protocol are made.
2.
Signed informed consent to be obtained for each subject before 
participation in the study (andfor amendments as applicable)
3.
Investigatorreporting requirements (e.g. reporting of AEs/SAEs/protocol 
deviations to IEC)
GSK will provide full details of the above procedures, either verbally, in writing, or 
both.
ICH GCP and the guiding principles of the current version of the Declaration of 
Helsinki do not apply to the determination of the UVAPF of the test products per 
ISO24443 as this is an in vitro technical test that does not involve human subjects.
10.3.Quality Control (Study Monitoring)
In accordance with applicable regulations including GCP, and GSK procedures, GSK 
or designee (i.e. third party vendor) monitors will contact the site prior to the start of 
the studyto review with the site staff the protocol, study requirements, and their 
responsibilities to satisfy regulatory, ethical, and GSK requirements.
When reviewingdata collection procedures, the discussion will include identification, 
agreement and documentation of data items for which the CRF will serve as the 
source document.
GSK or designee will monitor the study and site activity to verify that the:
1. 
Data are authentic, accurate, and complete.
2.
Safety and rights of subjects are being protected.
 
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3.
Study is conducted in accordance with the currently approved protocol and 
any other study agreements, GCP, and all applicable regulatory 
requirements.
The extentand nature of monitoring will be described in a written monitoring plan on 
file at GSKCH. The investigator (or designee) agrees to allow the monitor direct 
access to all relevantdocuments and agrees to co-operate with the monitor to ensure 
that any problems detected in the course of these monitoring visits are resolved.
10.4.Quality Assurance
To ensure compliance with GCP and all applicable regulatory requirements, GSK 
may conduct a quality assurance assessment and/or audit of the site records, and the 
regulatory agencies may conduct a regulatory inspection at any time during or after 
completion of the study. 
In the event of an assessment, audit or inspection, the investigator (and institution) 
must agree to grant the advisor(s), auditor(s) and inspector(s) direct access to all 
relevant documents and to allocate their time and the time of their staff to discuss the 
conduct of the study, any findings/relevant issues and to implement any corrective 
and/or preventative actions to address any findings/issues identified.
The sponsor willbe available to help investigators prepare for an inspection.
10.5.Conditions for Terminating the Study
Upon completion or premature discontinuation of the study, the GSKCH monitor will 
conduct site closureactivities with the investigator or site staff, as appropriate, in 
accordance with applicable regulations including GCP, and GSKCH Standard 
Operating Procedures.
Both GSKCH and the Investigator reserve the right to temporarily suspend or 
prematurely discontinue this study at any time for reasons including, but not limited 
to, safety or ethicalissues or severe non-compliance. For multicenter studies (if 
applicable), this can occur at one or more or at all sites.  
If the trial is prematurelyterminated or suspended for any reason, the investigator site 
should promptly inform the trial subjects and should assure appropriate therapy/ 
follow-up for the subjects. Where required by the applicable regulatory requirements, 
GSKCH should informthe regulatory authority(ies).
 
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In addition: 
1.
If the investigatorterminates or suspends a trial without prior agreement 
of GSKCH, the investigator site should promptly inform the sponsor and 
the IEC, and should provide the sponsor and the IEC a detailed written 
explanationof the termination or suspension.
2.
If the GSKCH terminates or suspends a trial, the investigator should 
promptly inform the IEC and provide the IEC a detailed written 
explanation of the termination or suspension. 
3.
If the IEC terminates or suspends its approval/favorable opinion of a trial, 
the investigatorshouldpromptly notify the GSKCH and provide GSKCH 
with a detailed written explanation of the termination or suspension.
10.6.Records Retention
Following closure of the study, the investigator must maintain all site study records 
(except for those required by local regulations to be maintained elsewhere), in a safe 
and secure location.  
The records (study/ site master file) must be maintained to allow easy and timely 
retrieval, whenneeded (e.g., for a GSK audit or regulatory inspection) and must be 
available for review in conjunction with assessment of the facility, supporting 
systems, and relevant site staff.
Where permittedby local laws/regulations or institutional policy, some or all of these 
records can be maintained in a format other than hard copy (e.g., microfiche, scanned, 
electronic); however, caution needs to be exercised before such action is taken. 
The investigatormust ensure that all reproductions are legible and are a true and 
accurate copy of the original and meet accessibility and retrieval standards, including 
re-generating a hard copy, if required.  Furthermore, the investigator must ensure 
there is an acceptable back-up of these reproductions and that an acceptable quality 
control process exists for making these reproductions.
The investigatormust assure that the subject’s anonymity will be maintained.  On 
CRFs or other documents submitted to GSKCH, subjects should not be identified by 
their names or initials, but by an identification code. The investigator should keep a 
separate log of subjects’ codes, names and addresses.  Documents not for submission 
to GSKCH, e.g. subjects’ written consent forms, should be maintained by the 
investigator in strict confidence.
 
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GSK will inform the investigator of the time period for retaining these records to 
comply with all applicable regulatory requirements (GSKCH recommends that
documents be kept for 10 years). The investigator is also required to keep subject 
identification codes on file for at least 15 years after completion or discontinuation of 
the study. The minimum retention time will meet the strictest standard applicable to 
that site for the study, as dictated by any institutional requirements or local laws or 
regulations, GSK standards/procedures, and/or institutional requirements.  
No study document should be destroy
ed without a prior written agreement between 
GSKCH and the investigator. The investigator must notify GSK of any changes in the 
archival arrangements, including, but not limited to, archival at an off-site facility or 
transfer of ownership of the records in the event the investigator is no longer 
associated with the site.
10.7.Provision of Study Results to Investigators, Posting of 
Information on Publicly Available Clinical Trials Registers 
and Publication
Where required by applicable regulatory requirements, an investigator signatory will 
be identified forthe approval of the clinical study report.  The investigator will be 
provided reasonable access to statistical tables, figures, and relevant reports and will 
have the opportunity to review the complete study results at a GSK site or other 
mutually-agreeable location.
GSK will also provide the investigator with the full summary of the study results.  
The investigatoris encouraged to share the summary results with the study subjects, 
as appropriate.
The procedures and timing for public disclosure of the results summary and for 
development of a manuscript for publication will be in accordance with GSK Policy.
A manuscript willbe progressed for publication in the scientific literature if the 
results provide important scientific or medical knowledge.
 
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11. REFERENCES
Hatcher RA, Trussell J, Nelson AL, Cates W Jr, Stewart F, Kowal D, editors. 
Contraceptive Technology. 19th edition. New York: Ardent Media, 2007(b): 28.
ICH Topic 6 Guideline for Good Clinical Practice CPMP/ICH/135/95 17th July 
1996.
World Medical Association Declaration of Helsinki, 59th General Assembly, Seoul 
2008.
Cosmetics -Sun Protection Test Methods -In vivoDetermination of the Sun 
Protection Factor (SPF) (ISO24444:2010)
Cosmetics -Sun Protection Test Methods -Determination of Sunscreen UVA 
photoprotection in vitro(ISO24443:2012)
The Commission of the European Communities, Commission Recommendation of 
22 September 2006 on the efficacy of sunscreen products and the claims made 
relating thereto. Official Journal of the European Union L 265/39 –L 265/43, date 
26.9.2006.
 
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12. APPENDICES
12.1. Appendix 1 -Abbreviations
AE 
Adverse Event
°C
Degrees Celsius
CD
Compact Disc
CI
Confidence Interval
CIE
International Commission on Illumination
CRF
Case Report Form
cm
Centimeter
cm
2
Square Centimeter
EDC
Electronic Data Capture
g
Gram
GCP
Good Clinical Practice
GSK
GloxoSmithKline
GSKCH
GlaxoSmithKline Consumer Healthcare
h
Hour
ICH
International Conference on Harmonisation of Technical Requirements 
for Registration of Pharmaceuticals for Human Use
IEC
Independent Ethics Committee
IR
Infrared
ISO
International Standards Organisation
ITA°
Individual TypologyAngle
ITT
Intention to Treat
J
Joule
LSLV
Last Subject, Last Visit
m
Meter
m2
Square Meter
MED
Minimal Erythemal Dose
MEDu
Minimal Erythemal Dose of Unprotected Skin
MEDp
Minimal Erythemal Dose of Protected Skin
mg
Milligram
mJ
Millijoule
mm
Millimeter
nm
Nanometer
PI
Principal Investigator
PII
Personally Identifiable Information
PP
Per Protocol
RCEE
Relative Cumulative Erythemal Effectiveness
SAE
Serious Adverse Event
SEM
Standard Error of the Mean
 
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SPFi
Individual Subject Sun Protection Factor
SPF
Sun Protection Factor
UV
Ultraviolet
UVA
Ultraviolet A
UVB
Ultraviolet B
W
Watt
12.2. Appendix 2–Exclusion Criteria to be reassessedat Visit 2
1. PREGNANCY
Women who are known to be pregnant or who are intending to become pregnant over 
the duration of the study
2. BREAST-FEEDING
Women who are breast-feedingor lactating
3. CONCURRENT MEDICATION/ MEDICAL HISTORY
C. Subjects with dermatological conditions
E. Subjects who are tanned or have had sun exposure on the back area in the 
previous 4 weeks prior to screening
E. Subjects having marks, blemishes or nevi or presenting existing sun damage 
in the test area
H. Subjects with a non-uniform skin colour or hyperpigmentation in the test area
7. LIFESTYLE
A. SUBJECTS WHO HAVE USED A TANNING BED OR OTHER 
TANNING TREATMENT ON THE BACK AREA WITHIN THE 
PRIOR 1 MONTH
D. SUBJECTS HAVING HAD SUN EXPOSURE ON THE BACK AREA 
IN THE PREVIOUS FOUR WEEKS PRIOR TO SPF TESTING
12.3. Appendix 3–Specification of the Solar Simulator Output
A multiport solar simulator utilizing a 300 W xenon arc lamp (Model 601–300 Solar 
Light, PhiladelphiaPA) fitted with 6 liquid light guides 8 mm in diameter and two 
filters (Schott WG 320/1 mm dichroic mirror and UG 11/1mm) will be used for this 
study. 
 
 
 
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12.4. Appendix 4–Procedure for the determination of the UVAPF of 
the Test Products per ISO24443:2012
Study Design
Determination of the UVAPF of the test products will be performed as a single-
center, open-label, negative and positive controlled technical test per ISO24443:2012.
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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Study Design and Dose Justification
The test is based onthe assessment of UV-transmittance through a thin film of 
sunscreen sample spread on a roughened substrate, before and after exposure to a 
controlled dose of radiation from a defined UV exposure source. Because of the 
several variables that cannot be controlled with typical thin film spectroscopic 
techniques, each set of sunscreen transmission data is mathematically adjusted so that 
the in vitroSPF data yield the same measured in vivoSPF value that was determined 
by in vivotesting. Samples are then exposed to a specific measured dose of UV 
radiation to account for the photostability characteristics of the test product. The 
resulting spectral absorbance data have been shown to be a useful representation of 
both the widthand height of the UVA protection characteristics of the sunscreen 
product being tested. The mathematical modelling procedure has been empirically 
derived to correlate with human in vivo(persistent pigment darkening) test results.
The spectral irradianceat the exposure plane of the UV exposure source that is used 
for irradiation (to take into account any photo instability) shall be as similar as 
possible to the irradiance at ground level under a standard zenith sun as defined by 
COLIPA or in DIN 67501. 
This test is designed to be compliant with international standard ISO24443:2012 
which utilizes roughened PMMAplates asthe substrate to which the test and 
reference products are applied. The size of the PMMA substrate should be chosen 
such that the application area is not less than 16 cm
2and the test and reference 
products should be applied at a rate of 1.3 mg/cm
2.
 
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As the technician conducting the study is required to use the in vivoSPF of the test 
products as an input for calibration of the UV absorbance curve, this is necessarily an 
open-label technical test.
Two (2) glycerin treated plates will be used as a reference “blank” anda reference 
sunscreen formulation (S2) will be included as a comparator to verify the test 
procedure.The reference sunscreen formulation (S2) must fall within the 
specification defined in Appendix 5, otherwise the test procedure should be modified 
to achieve it.
Product Information
The followingstudy products will be supplied by the Clinical Supplies Department, 
GSKCH:
Product Name
Product Formulation Code 
(MFC)
Test Product 1
Test Product 2
Test Product 3
Test Product 4
The following study products will be supplied by the study site:
Product Name
Product Formulation Code 
(MFC)
Reference Product
S2 Standard
Not Applicable (Sourced
Commercially)
Other items to be supplied by theClinical Supplies Department, GSKCH:
Name of Item
Purpose
Not applicable
Not applicable
 
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Study Assessments and Procedures
The following assessments/procedures will be performed:
Blank Measurements of a Glycerin-Treated Reference Plate
Two (2) “blank” PMMA plates will be prepared by spreading a few microliters of 
glycerin on the roughened side of the plate. The amount of glycerin shall be chosen 
such that the entire surface of the plate is just completely covered (approximately 15 
mg fora 50 × 50 mm plate). Any excess of glycerin should be avoided and should be 
wiped away with a bare fingertip. 
The absorbance through each “blank” plate shall be measured with a 
spectrophotometer with a range that spans the primary waveband of 290 nm to 400 
nm in incremental step of 1 nm. The UV spectrophotometer input optics should be 
designed for diffuseillumination and/or diffuse collection of the transmitted 
irradiance through the roughened PMMA substrate, with and without the sunscreen 
layer spread on its surface. The size of the diameter of the entrance port of the UV 
spectrophotometer probe shall be smaller than the size of the light spot to be 
measured at the sample level in order to account for stray light. The area of each 
reading site should beat least 0.5 cm
2in order to reduce the variability between 
readings and to compensate for the lack of uniformity in the product layer. The 
wavelength should be accurate to within 1 nm, as checked using a holmium-doped 
filterand the minimum required dynamic range for this methodology is 2.2 
absorbance units(AU)(Appendix 7). The maximum measured absorbance should be 
within the dynamic range of the device used. If the test measurements yield 
absorbance curves that exceed the determined upper limit of the UV 
spectrophotometer, the product should be re-tested using an instrument with increased 
sensitivity and dynamic range. The lamp in the UV spectrophotometer that is used to 
measure the transmittance shall emit continuous radiation over the range of 290 nm to 
400 nm, and the level of irradiance should be sufficiently low, so that the 
photostability of the product is not unduly challenged.  Therefore,the UV dose during 
one measurement cycle should not exceed 0.2 Joules per square centimeter (J/cm
2).
The absorbance spectra for the “blank” plates shall be used as the baseline for 
subsequent absorbance measurementsof the test products. Nine (9) observations of 
absorbance shall be made per plate and the mean value shall be determined for each 
plate.
 
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In addition, the transmission through each plate shall be measured with the same 
spectrophotometer.Both plates must conform to the transmission specification 
defined in Appendix 8, otherwise the batch of PMMA plates should be rejected.
Test Product Treated Plate Preparation
Each test product is applied to a minimum of 4 new untreated roughened PMMA 
plates (with the roughened side uppermost) by
 mass, at an application rate of 1.3 
mg/cm2. To ensuredose accuracy and repeatability, the application area should be not 
less than 16 cm
2. The application dose shall be determined by measuring the mass 
loss of the pipette before and after application of the product.
Each test product shall be applied as a large number of small droplets of approximate 
equal volume, distributed evenly over the whole surface of the plate using a fingertip. 
The fingertip used for spreading should be dipped into the test product and then 
wiped to remove excess product before spreading the test product applied to the plate. 
The fingertip used to spread the product shall be cleaned between applications of 
different test products. Finger cots must not be used to spread the product on the 
plate.
After a test product is deposited on the surface of the plate, it shall be spread 
immediately over the whole surface using light strokes with a fingertip (without 
finger cot). Spreading should be completed in a two-phase process. First, the product 
should be distributed over the whole area asquickly as possible (less than 30 seconds) 
using smallcircular motions with minimal pressure. Then the sample should be 
rubbed on the plate surface using alternating horizontal and vertical strokes with 
increased moderate pressure. The second phase should take 20 to 30 seconds.
Each test product treated sample shall be allowed to dry for at least 30 minutes in the 
dark at the same temperature that will be experienced under the UV exposure 
conditions. In this study, the UV source exposure conditions and drying conditions 
shall be 30 °C.
Absorbance Measurements of the Product-Treated Plates
Each product-treated plate shall beplaced in the light-path of the UV 
spectrophotometer and the absorbance of UV radiation through the sampleshall be
determinedfor each wavelength, from 290 nm to 400 nm, in 1 nm steps. Nine (9) 
observations of absorbance shall be made per plate and the mean value shall be 
determined for each plate.
 
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At least four plates prepared with each test sunscreen shall be used to establish the 
protection aspects of eachtest sample. Additional plates shall be added incrementally 
to the sampling if the 95 % CI is greater than 17 % of the mean value of the UVAPF 
value, until the 95 %CI is less than 17 % of the mean UVAPF value.
The individual and mean UV absorbance values at each 1 nm wavelength increment 
for each test product willbe recorded in the test report.
DeterminationofInitial CalculatedSPF (SPFin vitro)
The UV solarsimulator radiation (UV-SSR) source spectrum, I(λ), is multiplied with 
the corresponding erythema action spectrum sensitivity value, E(λ), at that 
wavelength to yield the sunburning effective energy at that wavelength. The resulting 
sunburning effective irradiance is integrated over the 290 nm to 400 nm range.  
The sunscreen transmission values at each wavelength are multiplied with the 
erythemal effectiveenergy at that wavelength and integrated over the same interval to 
yield the effective sunburning energy transmitted through the test product. The ratio 
of these two integrals is the in vitrocalculated SPF value (SPF
in vitro).
Calculation of SPFin vitrois shown in Equation 9.















400
290
400
290
d
10
d
SPF
0











A
in vitro
I
E
I
E
(Equation 9)
Where
E(λ)
is the erythema action spectrum (Appendix 9)
I(λ)
is the spectral irradiance received from the UV source (SSR for SPF testing, 
Appendix 9)
A0(λ) is the mean monochromatic absorbance of the test product layer before UV 
exposure; 
dλ
is the wavelength step (1 nm).
 
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Determination of the “C”value
The initial absorbance curve values are multiplied by a scalar value “C” until the in 
vitrocalculated SPF values are equal to the in vivomeasured SPF. This is 
accomplished in an iterative calculation process. The initial absorbance values 
multiplied bythis “C” value become the adjusted sunscreen absorbance curve that is 
used for determination of the initial UVAPF
0value, and the exposure dose. Equation 
10shows the calculation of the adjusted in vitroSPF (SPFin vitro,adj) and determination 
of the coefficient of adjustment “C”:
















400
290
400
290
,
d
10
d
SPF
SPF
0











C
A
in vitro
adj
in vitro
I
E
I
E
(Equation 10)
The “C” value typically lies between 0.8 and 1.6 for valid interpretation. If it is 
outside this range, new samples should be prepared to validate the original 
observations. The“C” value for the reference S2 shall lie in this range 0.8 to 1.6 or 
the applicationprocedure should be modified to achieve it.
The “C” value for each testproduct shall be recorded in the test report.
Determination of Initial UVA Protection Factor Before UV exposure 
(UVAPF
0)
The initial UVAPF
0value is calculated for the purpose of determining the UV 
exposure dose. It is calculated in a manner similar to the calculation of the initial 
SPFin vitro. The intensityspectrum for a UVA radiation source, I(λ), as described in 
Appendix 9,is multiplied at each wavelength with the persistent pigment darkening 
action spectrum sensitivity values, P(λ), to yield the pigment darkeningenergy at that 
wavelength. Theresulting pigment darkening effective irradiance is integrated over 
the 320 nm to 400 nm range. The initial absorbance values from the test product at 
each wavelength are used to calculate the effective intensity at each wavelengthto 
yield the effective pigment darkening energy transmitted through the test product as 
shown in Equation 11. The ratio of these two integrals is the initial in vitroUVAPF0
value.
 
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














400
320
400
320
0
d
10
d
UVAPF
0











C
A
I
P
I
P
(Equation 11)
Where 
P(λ) is the PPD action spectrum (Appendix 9);
I(λ)
is the spectral irradiance received from the UVA source (UVA 320 nm to 400 
nm for PPD testing, Appendix 9);
A0(λ) is the mean monochromatic absorbance of the test product layer before UV 
exposure;
C
is the coefficient of adjustment, previously determined in Equation 10; 
dλ
is the wavelength step (1 nm).
Determination of the UV Exposure Dose
The UV exposuredose, D, is the UVAPF
0value multiplied by a factor of 1.2 in J/cm2
(Equation 12).
2
.
1
UVAPF
0

D
(Equation 12)
The sample is exposed to full spectrum UV radiation but the dose is being defined by 
the UVA content. The UV exposure dose, D,for each test productshall be recorded 
in the test report.
UV Exposure of the Sample Plates
The sample plates are exposedto the radiation from the UV exposure source. The 
spectral irradiance of the exposureplane of the UV exposure source that is used for 
irradiation shall be as similar as possible to irradiance at ground level under a 
standard zenith sun as defined by COLIPA or in DIN 67501. The UV irradiance shall 
be within the acceptance limits defined in Appendix 6.
During the exposure the samples shouldbe maintained at the same temperature (30 
°C) used for the drying period. The PMMA plates should be fixed above a non-
 
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reflective UV background behind each plate to reduce back exposure. The UV 
exposure source must not be switchedoff while the samples are placed under the 
lamp. If this happens, the output irradiance of the lamp should be confirmed to be the 
same on restart as it was before the lamp was turned off.Personnel working with the 
irradiator system should be protected adequately against UV rays (glasses, gloves, 
etc.).
Measurement of Final Adjusted Absorbance Spectrum
After the UV exposure, the absorbance of the testsamples shall be re-measured on 
the same spotsas measured before the UV exposureusing the same UV 
spectrophotometer and UV light source. The final absorbance values are equal to the 
observed absorbance values after the UV exposure, multiplied by the “C”value
(Equation 13).

C
A
A
e

f
(Equation 13)
Where
Ae    is the mean monochromatic absorbance of the test product layer after UV 
exposure;
Af
is the mean final monochromatic absorbance of the test product.
The mean UV absorbance valuesat each 1 nm wavelength increment for each test 
product after irradiation will be recorded in the test report.
Calculation of UVAPF of Plates after UV Exposure of the Sample
TheindividualUVAPF (UVAPFi)shall be calculated according to Equation 14 for 
each plate, using the mean value from the multiple observations on that plate.















400
320
400
320
d
10
d
UVAPFi











C
Ae
I
P
I
P
(Equation 14)
 
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Statistical Methods and Analytical Plan
Primary Analysis
The individualUVAPF (UVAPFi) of each plate is calculated as per Equation 15.















400
320
400
320
d
10
d
UVAPFi











C
Ae
I
P
I
P
(Equation 15)
The UVAPF ofthe product is the arithmeticmean of the individual plate UVAPFi 
values obtained fromthe total number, n,of plates used, expressed to one decimal 
point (Equation 16).
n
UVAPFi
UVAPF 

(Equation 16)
Its standarddeviation, s, is:
 

 

 

1
UVAPFi
UVAPFi
s
2
2























n
n
(Equation 17)
The 95% CI for the mean UVAPF is expressed as:



c
c


UVAPF
 to
-
UVAPF
CI
95%
(Equation 18)
Where ciscalculated as:
 



n
s
t
t
c




 value
SEM
 value
(Equation 19)
n
s
t
c


(Equation 20)
UVAPF
100
CI[%]
c


(Equation 21)
And where 
 
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SEM is the standard errorof the mean;
n
is the total number of plates used;
t
is the t value from the “two-sided” Student-tdistribution (Table 2) at a 
probability level p= 0.05 andwith degrees of freedom v= (n-1). 
Table 2–Student-tDistribution
n
4 
5 
6 
7 
8 
9 
10
tvalue
3.182
2.776
2.571 
2.447 
2.365
2.306 
2.262
If the calculated 95% CI is greater than 17 % of the provisional mean UVAPF value, 
then testing of the product shall continue on additionalplates until the 95% CI is <17 
% of the mean provisional UVAPF. If this criterion is not fulfilled after 10 valid
plates, then the entiretest shall be rejected and repeated.
12.5. Appendix 5–Reference Sunscreen Formulation S2 
Specifications
 
 
 
 
 
12.6. Appendix 6–Calibration of the UV Exposure Source
 
 
 
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12.7. Appendix 7–Calibration of the UV Spectrophotometer
 
 
 
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12.8. Appendix 8–PMMA Test Plate Surface Specifications
 
 
 
 
 
 
 
 
 
 
 
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12.9. Appendix 9–Computation Values: PPD and Erythema Action 
Spectra and UVA and UV-SSR Spectral Irradiances
 
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12.9. Appendix 9–Calculation of Critical Wavelength
 
 
 
 
 
 
 
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