Determination of the Sun Protection Factor of a Cosmetic Daily Defence Skin Cream
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  An unpublished work subject to trade secret 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
207640
 
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CONFIDENTIAL
SUMMARY INFORMATION
Title:
Determination of the Sun Protection Factor of a 
Cosmetic Daily Defence Skin Cream
Protocol Number:
207640
Sponsor:
GlaxoSmithKline Consumer Healthcare (GSKCH)
St George’s Avenue, Weybridge, Surrey, KT13 0DE, 
UK.
Tel: 
Product Name:
Physiogel Daily Defence Protective Day Cream Light
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 
Kiebitzweg 2
 
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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 to conduct this study in full conformance with the laws and regulations 
of the country in which the research is conducted and theDeclaration 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
SCHEDULE OF EVENTS.....................................................13
PROTOCOL SYNOPSIS FOR STUDY 207640...................14
1. INTRODUCTION...............................................................20
2. OBJECTIVE(S) AND ENDPOINT(S)...............................20
3. STUDY PLAN.....................................................................21
3.1. Study Design.......................................................................21
3.2. Subject Restrictions...........................................................23
3.3. Type and Planned Number of Subjects............................24
3.4. Study Design.......................................................................25
4. SELECTION OF STUDY POPULATION AND 
WITHDRAWAL CRITERIA........................................26
4.1. Inclusion Criteria...............................................................26
4.2. Exclusion Criteria..............................................................27
4.3. Screening/ Baseline Failures..............................................28
4.4. Withdrawal/ Stopping Criteria.........................................28
4.5. Subject Replacement..........................................................29
4.6. Subject and Study Completion..........................................29
5. PRODUCT INFORMATION.............................................30
 
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5.1. Study Product.....................................................................30
5.2. Application Schedule.........................................................30
5.3. Application Modification...................................................31
5.4. Product Compliance..........................................................31
5.5. Precautions.........................................................................32
5.6. Overdose.............................................................................32
5.7. Rescue Therapy..................................................................32
5.8. Product Assignment...........................................................32
5.8.1 Randomization...................................................................32
5.8.2 Blinding...............................................................................33
5.8.3 Code Breaks........................................................................33
5.9. Packaging and Labelling...................................................33
5.9.1. Accountability of Product.................................................34
5.9.2. Storage of Product............................................................34
6. STUDY ASSESSMENTS AND PROCEDURES..............35
6.1. Visit 1 –Subject Screening................................................35
6.1.1. Informed Consent.............................................................35
6.1.2. Demographics....................................................................35
6.1.3. Medical History and Concomitant Medication...............35
6.1.4. Individual Typology Angle (ITA°)...................................36
6.1.5. Fitzpatrick Skin Type Assessment...................................36
6.1.6. Inclusion/Exclusion Criteria.............................................36
6.1.7. Subject Eligibility..............................................................37
6.2. Visit 2 –Provisional MED Irradiation (UV Exposure)....37
6.2.1. Concomitant Medication..................................................37
6.2.2. Exclusion Criteria.............................................................37
6.2.3. Subject Eligibility..............................................................37
6.2.4. Continued Eligibility.........................................................37
6.2.5. Randomisation...................................................................37
 
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6.2.6. Provisional Minimal Erythemal Dose Irradiation...........37
6.2.7. Adverse Events..................................................................38
6.3. Visit 3 –Provisional MEDu Determination......................38
6.3.1. Concomitant Medication..................................................38
6.3.2. Continued Eligibility.........................................................39
6.3.3. Visual Grading of Exposure Sub-Sites (Test Sites).........39
6.3.4. Adverse Events..................................................................39
6.4. Visit 4 –Test Irradiation (UV Exposure).........................39
6.4.1. Concomitant Medication..................................................39
6.4.2. Continued Eligibility.........................................................39
6.4.3. Study Product Application to Randomly Assigned Test 
Sites on the Back...............................................................40
6.4.4. UV Exposure of Test Product Treated, Reference 
Sunscreen Formulation Treated and Unprotected Test 
Sites....................................................................................41
6.4.5. Adverse Events..................................................................42
6.5. Visit 5 –MEDp and MEDu Determination and SPF 
Calculation for Test and Reference Sunscreen..............42
6.5.1. Concomitant Medication..................................................42
6.5.2. Continued Eligibility.........................................................42
6.5.3. Visual Grading of Exposure Sub-Sites to Determine 
MEDp and MEDu.............................................................42
6.5.4. Adverse Events..................................................................43
6.5.5. Study Conclusion...............................................................43
7. SAFETY ASSESSMENTS..................................................44
7.1. Definitions of an Adverse Event and Serious Adverse 
Event.................................................................................44
7.1.1. Adverse Events..................................................................44
7.1.2. Serious Adverse Events.....................................................45
7.2. Recording Adverse Events and Serious Adverse Events.46
7.3. Evaluating Adverse Events and Serious Adverse Events46
 
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7.4. Reporting Adverse Events and Serious Adverse Events..47
7.5. Follow-up of Adverse Events and Serious Adverse Events
..........................................................................................49
7.6. Collection of Pregnancy Information................................50
7.6.1. Time Period for Collecting of Pregnancy Information...50
7.6.2. Action to be Taken if Pregnancy Occurs.........................50
8. DATA MANAGEMENT ....................................................51
8.1. Source Documents/ Data....................................................51
8.2. Case Report Form..............................................................51
8.3. Data Handling....................................................................52
8.3.1. Data Queries......................................................................52
8.4. External Data.....................................................................52
9. STATISTICAL CONSIDERATIONS AND DATA 
ANALYSES....................................................................53
9.1 Sample Size Determination.................................................53
9.2. General Considerations.....................................................53
9.2.1. Definition of Analysis Populations...................................53
9.2.2. Exclusion of Data from Analysis......................................54
9.2.3. Handling of Dropouts and Missing Data.........................54
9.3. Statistical Methods and Analytical Plan...........................54
9.3.1. Demographic and Baseline Characteristics.....................54
9.3.2. Primary Analysis...............................................................55
9.3.3. Safety Analysis..................................................................56
10. STUDY GOVERNANCE CONSIDERATIONS.............56
10.1. Posting of Information on Publicly Available Clinical 
Trials Registers................................................................56
10.2. Regulatory and Ethical Considerations, Including the 
Informed Consent............................................................56
10.3. Quality Control (Study Monitoring)...............................57
 
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10.4. Quality Assurance............................................................57
10.5. Conditions for Terminating the Study............................58
10.6. Records Retention............................................................58
10.7. Provision of Study Results to Investigators, posting of 
Information on Publicly Available Clinical Trials 
Registers and Publication................................................59
11. REFERENCES..................................................................60
12. REPORTING....................................................................61
13. APPENDICES...................................................................62
13.1. Appendix 1 -Abbreviations.............................................62
13.2. Appendix 2 –Exclusion Criteria to be Reassessed at Visit 
2........................................................................................63
13.3. Appendix 3 –Specification of the Solar Simulator Output
..........................................................................................63
 
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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 only after 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 bejustified 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 modifications must be reviewedand 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 deletetext: 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.:
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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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 
Sunscreen
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
StudyIrradiation
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 207640

Brief Summary
An important parameter of efficacy for sunscreen products is the Sun Protection 
Factor (SPF). SPF is a measure of how muchsolar energy (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 
study, the SPFof the test productis to be determined according to the International 
Standards Organization (ISO) 24444:2010 methodology (In vivodetermination of the 
sun protection factor).
This study will be conducted in accordance with the Declaration of Helsinki and 
according to the current International Council for Harmonisation (ICH) Good Clinical 
Practice (GCP) guidelines.
Objective(s) and Endpoint(s)
Objective(s)
Endpoint(s)
Primary
To determine the Sun Protection Factor 
of the test product
Arithmetical 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.
To evaluate the general safety of the test 
product
Frequency and severity of Adverse 
Events
Study Design

Overall Design
A single-center, randomized, evaluator blind, intra-individual comparison, no 
treatment and positive controlled clinical study to determine the SPF of Physiogel 
Daily Defence Protective Day Cream Light as per ISO 24444:2010.
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 preliminary series ofUV exposures. The location of the 
irradiated test sitefor the provisional MEDu measurement will be randomised for all 
 
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subjects. In thisstudy, there will be a total of four irradiatedtest sites. Two test sites 
will be located below the scapula line, either side of the spine. The remaining two 
areas will be located below these sites and above the waist.
Six exposure sub-sites positioned within the randomised test area and centered on the 
estimated MEDu will be exposed toincremental 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 4thof the 6 sub-sites.  The estimated MEDu 
will be predicted based on the subject’s mean Individual TypologyAngle (ITA°) 
value.  As the second step, a trained evaluator will assess the irradiated sub-sitesfor 
signs of unambiguous erythema 16-24 hours after UV exposureto determine the 
provisional MEDu. 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 provisionalMEDu for a subject has been determined, the three remaining 
test sites will be demarcated. The test product (Physiogel Daily Defence Protective 
Day Cream Light) and positive control (P3reference sunscreen formulation) will be 
applied to two of the three virgin test sites. The other test sitewill remain 
unprotected. The order of product application(test product, reference product and 
unprotected test site)will be randomisedover the entire test group.  Once the test 
product and positive control have been applied to the assigned test sites, the subject 
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 1.25. 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 product (21)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 1.25.  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 minimum number of valid individual SPF (SPFi) results shall be 10 and the 
maximum number of valid SPFi results shall be 20. In order to achieve between 10 
and 20 valid results, a maximum of five individual invalid results may be excluded 
 
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from the calculation of the mean SPF. Consequently the actual number of test 
subjects used will fall between a minimum of 10 and a maximum of 25 subjects (i.e. a 
maximum of 20 valid results plus 5 rejected invalid results).
The study will include subjects of more than one Fitzpatrick phototype(I, II orIII). 
It will not be permitted to adjust the expected SPF of the test product 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 beconducted:
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
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:
 
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1. Current / Concomitant Medication*
2. Continued Eligibility*
3. TestProductand 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
Visit 5–MEDp and MEDu determination and SPF calculation for test and 
reference sunscreen
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 
irradiation procedure
Type and Planned Number of Subjects

Healthy volunteers 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 contain a population of subjects of more than 
one Fitzpatrick phototype. 
To complete the study successfully, the minimum number of valid individual sun 
protection factor (SPFi) results will be 10 and the maximum number of valid SPFi 
results will be 20 for both the test product and positive control. In order to achieve 
between 10 and 20 valid SPFi results, a maximum of 5 individual invalid results may 
be excluded from the calculation of the mean SPF. Consequently, the actual number 
of subjects used for the study will fall between a minimum of 10 and a maximum of 
25 (i.e. a maximum of 20 valid SPFi results plus 5 rejected invalid results). 
In order to determine the number of test subjects, the 95% confidence interval (95% 
CI) of the mean SPF shall be taken into account. A minimum of 10 subjects shall be 
tested. The test shall be considered valid for the first 10 subjects if the resulting range 
of the 95% CI of the mean SPF is within ±17% of the mean SPF. If it is not within 
±17% of the mean SPF, the number of subjects shall be increased stepwise from the 
minimum number of 10 until the 95% CI statistical criterion is met (up to a maximum 
 
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of 20 valid results from a maximum of 25 subjects tested). If the statistical criterion 
has not been met after 20 valid results from a maximum of 25 subjects, then the test 
shall be rejected.
Product Information
Test Product
Reference Product
Product Name 
Physiogel Daily Defence 
Protective Day Cream Light
P3 Standard
Product 
Formulation 
Code (MFC)
Commercially Available
Expected SPF
21
16
Application 
Quantity
2.00 ± 0.05 milligrams per 
square centimeter (mg / cm2)
2.00 ± 0.05 mg / cm
2
Route of 
Administration
Topical
Topical
Statistical Methods
The SPF result for the test product and for the reference sunscreen formulation is 
calculated as the arithmetical mean of all valid SPFi values.  The minimum number of 
valid SPFi values shall be 10 and the maximum number of valid SPFi values 20. A 
maximum of 5 results may be excluded from the calculation of the mean SPF, but 
each exclusion shall be justified. A sixth invalid result automatically invalidates the 
whole test for that test product and no SPF can be calculated for it. In addition, if the 
mean SPF obtained for the reference sunscreen formulation (P3) does not fall within 
the acceptance limits of the reference values (i.e. between SPF 13.7-17.7, inclusive) 
then the entire test shall be rejected.
The statistical criterion for all SPF measurements is that the 95% confidence interval
(CI) of the mean SPF measured shall fall within a range of ±17 % of the mean 
measured SPF. This applies to test and reference sunscreen products. 
Consequently, the actual number of subjects tested is defined as the number 
(minimum 10) required to produce a mean test product SPF with a 95% CI which 
falls within a range of ±17 % of the measured mean SPF for the test product and a 
mean reference product SPF between 13.7-17.7, inclusive, and which has a 95 % CI 
which falls within the range of ±17 % of the measured mean SPF for the reference 
product. 
A minimum of 10 valid results is only sufficient if the statistical criterion is fulfilled 
for the test product and positive control. If not, the number of subjects is increased 
 
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from 10, for both the test product and positive control, until the statistical criterion is 
met, with up to a maximum of 20 valid results.
 
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1. INTRODUCTION
The International Standard specifies a method for the in vivodetermination 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 sectionis 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 competent evaluator.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.
2. OBJECTIVE(S) AND ENDPOINT(S)
Objective(s)
Endpoint(s)
Primary
To determine the Sun Protection Factor 
of the test product
Arithmetical 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.
To evaluate the general safety ofthe test 
product
Frequency and severity of Adverse 
Events
 
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3. STUDY PLAN
3.1. Study Design

Overall Design
A single-center, randomized, evaluator blind, intra-individual comparison, no 
treatment and positive controlled clinical study to determine the SPF of Physiogel 
Daily Defence Protective Day Cream Light as per ISO 24444:2010.
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 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 four irradiated test sites. Two test sites 
will be located below the scapula line, either side of the spine. The remaining two 
areas will be located below these sites and above the waist.
Six exposure sub-sites positioned within the randomised test area 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 4thof 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 to determine the 
provisional MEDu. 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 three remaining 
test sites will be demarcated. The test product (Physiogel Daily Defence Protective 
Day Cream Light) and positive control (P3 reference sunscreen formulation) will be 
applied to two of the three virgin test sites. The other test site will remain 
unprotected. The order of product application (test product, reference product and 
unprotected test site) will be randomised over the entire test group.  Once the test 
product and positive control have been applied to the assigned test sites, the subject 
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 
 
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MEDu. Six exposure sub-sites centered on the provisional MEDu shall be exposed 
with incremental UV doses using a geometric progression of 1.25. 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 product (21)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 1.25.  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 minimum number of valid individual SPF (SPFi) results shall be 10 and the 
maximum number of valid SPFi results shall be 20. In order to achieve between 10 
and 20 valid results, a maximum of five individual invalid results may be excluded 
from the calculation of the mean SPF. Consequently the actual number of test 
subjects used will fall between a minimum of 10 and a maximum of 25 subjects (i.e. a 
maximum of 20 valid results plus 5 rejected invalid results).
The study will include subjects of more than one Fitzpatrick phototype (I, II or III). 
It will not be permitted to adjust the expected SPF of the test product 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:
1. Current / Concomitant Medication*
2. Continued Eligibility*
3. Exclusion Criteria*
4. Subject Eligibility*
 
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5. Randomisation
6. ProvisionalMinimal Erythemal Dose (MED) Irradiation 
7. Adverse Events
*Not required if Visit 2 is combined with Visit 1
Visit 3–Provisional MED Determination
The following assessments will be conducted:
1. Current / Concomitant Medication
2. Continued Eligibility
3. VisualGrading 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 Product 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
Visit 5– MEDp and MEDu determination and SPF calculation for test and 
reference sunscreen
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 
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 
 
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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 mustavoid any sun exposure, UV-therapy and/or artificial tanning.
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 contain a population of subjects of 
more than one Fitzpatrick phototype. 
The SPF result for the test product andfor the reference sunscreen formulation is 
calculated as the arithmetical mean of all valid SPFi values.  The minimum number of 
valid SPFi values shall be 10 and the maximum number of valid SPFi values 20. A 
maximum of 5 results may be excluded from the calculation of the mean SPF, but 
each exclusion shall be justified. A sixth invalid result automatically invalidates the 
whole test for that test product and no SPF can be calculated for it.  In addition, if the 
mean SPF obtained for the reference sunscreenformulation (P3) does not fall within 
the acceptance limits of the reference values (i.e. between SPF 13.7-17.7, inclusive) 
then the entire test shall be rejected.
The statistical criterion for all SPF measurements is that the 95% confidence interval 
(CI) of the mean SPF measured shall fall within a range of ±17 % of the mean 
measured SPF. This applies to test and reference sunscreen products. 
Consequently, the actual number of subjects tested is defined as the number 
(minimum 10) required to produce a mean test product SPF with a 95% CI which 
falls within a range of ±17 % of the measured mean SPF for the test product and a 
mean reference product SPF between 13.7-17.7, inclusive, and which has a 95 % CI 
which falls within the range of ±17 % of the measured mean SPF for the reference 
product. 
A minimum of 10 valid results is only sufficient if the statistical criterion is fulfilled 
for the test product and positive control. If not, the number of subjects is increased 
from 10, for both the test product and positive control, until the statistical criterion is 
met, with up to a maximum of 20 valid results.
Subjects will be recruited from the site database and via advertisement in local 
papers.
 
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3.4. Study Design
As UV rays are responsible 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 
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, whilst those 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 ISO 24444:2010 
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 regionfor the test. The individual 
product 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 fromblemishes and have an even 
colour tone. 
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 product and 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. 
 
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A reference sunscreen formulation (P3)will be included as a comparator to verify the 
test procedure.  
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 allof 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 the informed consent form
2. AGE
Aged between 18 and 70years inclusive
3. GENDER
Subject is male or female
4. GENERALHEALTH
Good general and mental health with, in the opinion of the investigator or medically 
qualified designee 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. diclophenac) upto 3days prior to screening
C. Subjects with dermatological conditions
D. Subjects with a history of abnormal response to the sun
E. Subjects who are tanned or have had sun exposure onthe back area in the 
previous 4 weeks prior to screening
F. Subjects having marks, blemishes or nevi or presenting existing sun damage 
in the test area
G. Subjects having excessive hair, moles, tattoos, scarsor other imperfections in 
the test area that could influence the investigation
H. 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
I. Subjects with a non-uniform skin colour or hyperpigmentation in the test area
J. Subjects with a medical history of dysplastic nevi or melanoma
K. Subjects with one of the following illnesses that might require regular 
systemic medication: Insulin-dependent diabetes, cancer
L. Subjects with asthma, unless medicated
M. Subjects with an electronic implant (e.g. pace maker, insulin pump, hearing 
aid) that cannot be removed during irradiation
N. AIDS and infectious hepatitis, if known to the subjects
 
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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
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 up to 1 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
8. PERSONNEL
An employee of the sponsor or the study site or members of their immediate family
9. AGE
Subjects who will turn 71 years old before completing all assessment visits
4.3. Screening/ Baseline Failures
Screen failures are defined as subjects who consent to participate in the study but are 
never subsequently randomized.  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. Re-screeningof 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 the discretion of the investigator for safety, behavioural or 
administrative reasons.
 
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If the reason for removal of a subject from the study is an AE or an abnormal 
laboratory test 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 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 required study 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 isdeemed ‘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. 
4. Should the subject continueto 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 studypost-randomization will be replacedif 
necessary to meet the ISO statistical criteria.No more than 25 subjects will be 
randomisedfor this study.
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 the date of the last subject’s last visit.
 
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5. PRODUCT INFORMATION
5.1. Study Product
The following study products will be supplied by the Clinical Supplies Department, 
GSKCH:
Test Product
Reference Product
Product Name 
Physiogel Daily Defence 
Protective Day Cream Light
P3 Standard
Product 
Formulation 
Code (MFC)
Commercially Available
Expected SPF
21
16
Application 
Quantity
2.00 ± 0.05 mg / cm
2
2.00 ± 0.05 mg / cm
2
Route of 
Administration
Topical
Topical
Other items to be supplied by the Clinical Supplies Department, GSKCH:
Name of Item
Purpose
N/A
N/A
5.2. Application Schedule
Test sites intended for 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 ± 4 °C).
The positions of the unprotected test site for provisional MEDu, test product, 
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 will be a minimum distance of 1 cm between the borders of adjacent test 
sitesto 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 spreading will 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 will be 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 the test product to 
subjects immediately after weighing and the containers filled with product will 
remainsealed when not in use.
The amount of 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 syringewill 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 product, positive controland 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 modification of product application is permitted.
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. 
 
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5.5. Precautions
No special precautions are necessary provided the study is carried out in accordance 
with this protocol. 
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 applicationswill 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 (SAE), if appropriate).  For 
reporting, follow the AE and SAE reporting instructions.
5.7. Rescue Therapy
No rescue therapy is required in this study.
5.8. Product Assignment
The positions of the unprotected test site for provisional MEDu, test product, 
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 assigned 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.  Screening numbers will be assigned in ascending numerical order as 
each subject signs their consent form.  Subjects who meet all inclusion and exclusion 
criteria will be randomized according to the randomization scheduleto achieve 
balance between left upper(Site 1), left lower(Site 2), right upper(Site 3)and right 
lower (Site 4) of backas per Figure 1.
 
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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.The trained 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 study blind must be returned to GSKCH at the end of the study.
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.
 
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The test product Physiogel Daily Defence Day Cream Light ( 
) will 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 withthe 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 monitorduring 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 supplies must 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 ofeach 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) 
informed consent 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 
completely free 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 
available that 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. Demographics
The following demographic 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 
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.
 
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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 coneaperture 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 tangent is expressed in radians.
The mean ITA° and historical data will be used to estimate theMEDu for each 
subject.The estimated MEDu will be recorded on the CRF.
6.1.5. Fitzpatrick Skin Type Assessment
Fitzpatrick skin type assessment will be conducted by a trained, qualifiedtechnician 
or physician using the scale below.
The Fitzpatrick skin type will be recorded on the CRF. 
6.1.6. Inclusion/Exclusion Criteria
Inclusion/exclusion criteria will be assessed by the Investigator or designee and 
subject compliance with each criterion recorded on the CRF.


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













14159
.
3
180
*
50
*
 tangent
arc
ITA
b
L
 
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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 the main test, a provisional MEDu will be determined for each subject 
in order to centre to UV dose ranged for 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 CRF by the Investigator or medically qualified designee.
6.2.2. Exclusion Criteria
Subject compliance with exclusion criteria in 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 criteria specified 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, 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 study and their decision will be recorded on the CRF.
6.2.5. Randomisation
Subject randomisation will be conducted as per the process detailed in Section 5.8.1. 
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.
 
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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.UV exposures and MED assessments 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 four irradiated areas. Two areas will 
be located below the scapula line, either side of the spine. The remaining two areas 
will be located below these sites and above the waist. The location of the irradiated 
area 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 4thof the 6 sub-sites will be 
irradiated with the estimatedMEDu.  The estimated MEDu will be predicted based on 
the subject’s mean Individual TypologyAngle (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 for a period of 24 hours after exposure. Any additional 
UV exposure to the test area will invalidate the whole test for the subject concerned.
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 
recorded on the CRF by the Investigator or medically qualified designee.
 
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6.3.2. 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.
6.3.3. 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 MED assessment 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 provisional MEDuof each subject will be recorded on the CRFwith units of 
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 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.
6.4. Visit 4 –Test Irradiation(UV Exposure)
6.4.1. Concomitant Medication
Any concomitant therapy taken since thelast visitand throughout the study will be 
recorded on the CRF by the Investigator 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.
 
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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 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 in stable conditions with the subject lying horizontally on their front andin 
a room with controlled temperature (22 ± 4°C).
The positions of the test product, reference sunscreen and unprotected test sites will 
be randomised over the whole group in order to reduce error arising from anatomical 
differences in skin. There will be 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.
Theamount of test product and reference sunscreen formulation applied to the skin 
before spreading will 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 
nearest0.0001 grams (g) (i.e. to the nearest 0.1 mg).  All products will be 
homogeneous and will be shaken before weighing to ensure uniform dispersion.
When handling the product during weighing or before application to the skin, 
appropriate measures will be taken to prevent evaporative loss of the volatile 
components. In particular, study staff will apply the test product to subjects 
immediately after weighing and the containers filled with product will remain sealed 
when not in use.
The amount of product to be applied will be weighed in a syringe. 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 mass of 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 
 
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applied product is 78.0 to 82.0 mg, inclusive. If there is insufficient space on the 
subject’s back to accommodate the test product, 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.
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 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.Irradiation procedures will be conducted 
with the subject lying horizontally
 on their front and in a room withcontrolled 
temperature (22 ± 4°C).
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 thetest site will be at least 1 
cm.
Exposure of the test site to UV radiation will start 15 to 30 minutes after the 
application of the test product. Exposure of the positive control site to UV radiation 
will start 15 to 30 minutes after application of the positive control. 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 provisional MEDu. Six exposure sub-sites centered on the provisional 
MEDu shall be exposed with incremental UV doses using a geometric progression of 
1.25. 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 
multiple of 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 
 
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with incremental UV doses using a geometric progression of 1.25.  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 
avoided during 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 Section 7. Localised erythema caused by exposure 
of the skin to UV radiation is expected and will not be reported as an adverse event.
6.5. Visit 5 –MEDp and MEDu Determination and SPF Calculation 
for Test and Reference Sunscreen
6.5.1. Concomitant Medication
Any concomitant therapy taken since the last visitand throughout the study will be 
recorded on the CRF 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 thelowest 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 
 
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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
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.
6.5.5. 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 discontinued at any point 
during the study, the primary reason for withdrawal should 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.
 
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4. Situations where an untoward medical occurrence did not occur (social and/or 
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 
event in 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 shouldbe 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 
 
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outcomes listedin the above definition. These should also be 
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 may be 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 tothe 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.
 
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2. Moderate:  An event that is sufficiently discomforting to interfere with normal 
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 
 
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must ask the subject the following question during each visit including any 
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 8.3)
5. Criterion for seriousness.
The following are desirable and are of particular relevance for investigator and 
GSKCH assessment of theSAE 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 as soon 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 or email.
Fax Serious Adverse Eventsto:
UK: 
The GSKCH Study Manager will be responsible for forwarding the SAE form to the 
Case Management Group, Global Clinical Safety and Pharmacovigilance, the 
Medical Director responsible for the study and other GSKCH personnel as 
appropriate via email.
 
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PPD

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 isotherwise 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 investigator learns 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, 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 attributable to 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 
will notify the IEC, if appropriateaccording to local requirements.
 
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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 study subject 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 DocumentDesignation Form.  In some cases the CRF can be 
used as a source document.
Each subject will 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 required information 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 completed and 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 protect the 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.
Adverse events and concomitant medications terms (if applicable) will be coded 
using MedDRA (Medical Dictionary for Regulatory Activities) and an internal 
validated medication dictionary, GSKDrug.  
 
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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 should be 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 data archived compact discs (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
8.4. External Data
External Data 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. 
 
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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 
database to ensure subject 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 volunteers 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 contain a population of subjects of more than 
one Fitzpatrick phototype. 
To complete the study successfully, the minimum number of valid individual sun 
protection factor (SPFi) results will be 10 and the maximum number of valid SPFi 
results will be 20 for both the test product and positive control. In order to achieve 
between 10 and 20 valid SPFi results, a maximum of 5 individual invalid results may 
be excluded from the calculation of the mean SPF. Consequently, the actual number 
of subjects used for the study will fall between a minimum of 10 and a maximum of 
25 (i.e. a maximum of 20 valid SPFi results plus 5 rejected invalid results). 
In order to determine the number of test subjects, the 95% confidence interval(95% 
CI) of the mean SPF shall be taken into account. A minimum of 10 subjects shall be 
tested. The test shall be considered valid for the first 10 subjects if the resulting range 
of the 95% CI of the mean SPF is within ±17% of the mean SPF. If it is not within 
±17% of the mean SPF, the number of subjects shall be increased stepwise from the 
minimum number of 10 until the 95% CI statistical criterion is met (up to a maximum 
of 20 valid results from a maximum of 25 subjects tested). If the statistical criterion 
has not been met after 20 valid results from a maximum of 25 subjects, then the test 
shall be rejected.
9.2.General Considerations
9.2.1.Definition of Analysis Populations
All valid subject data with no major protocol deviations will be included inthe SPF 
calculations. All subjects exposed to UV radiation will be included the safety 
population, irrelevant of whether they successfully complete the study. 
 
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9.2.2.Exclusion of Data from Analysis
Test data are deemed invalid and shall be rejected under the following circumstances:
- The series of UV exposures on a subject fails to elicit an erythemal response 
on any sub-site, 16-24 hours after exposure.
- Erythemal responses within an exposure series are randomly absent 16-24 
hours after exposure.
- 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 skin, test 
productorreference sunscreen formulation exposure sites, then all data for all 
products on that subject are invalid and shall be rejected. If data have to be rejected 
for the unprotected skin, test productor reference sunscreen formulation on more than 
five subjects, then the whole test is invalid and shall be rejected. 
Any additional exposure of a test area to natural or artificial UV radiation will 
invalidate the whole test for that subject.
Major violations will be identified and any exclusion of subject data justified. Data 
deemed invalid due 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 5 invalid 
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 5 invalid subject data. 
9.2.3.Handling of Dropouts and Missing Data
No interpolation of missing data is permitted. Subjects with missing data will be 
declared invalid and excluded from analysis.
9.3. Statistical Methods and Analytical Plan
Additional details of the proposed statistical analysis will be documented in the 
statistical analysis 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 (age, identification code, Fitzpatrick skin phototype, ITA° value, 
age and gender) will be tabulated and reported.
 
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9.3.2.Primary Analysis
The SPFi of each product on each subject is calculated from the individual MED on 
unprotected skin (MEDu) and the individual MED on product protected skin (MEDp) 
according to Equation 2:
MEDu
MEDp
MED
MED
SPFi


skin)
ed
(unprotect
skin)
(protected
(Equation 2)
SPFi values are 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 standard deviation, s, is given by Equation 4.
 

 
 

 
























1
2
2
n
n
SPFi
SPFi
s
(Equation 4)
The 95 % confidence interval (95 %CI) of the mean SPF is expressed by Equation 5.
c
SPF
c
SPF



 to
%CI
95
(Equation 5)
Where c is calculated as:
 



n
s
t
t
c




 value
SEM
 value
(Equation 6)
n
s
t
c


(Equation 7)
SPF
c

100
CI[%]
(Equation 8)
And where 
 
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SEM is the standarderror 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
The mean SPF of the reference sunscreen formulation (P3) used in the test shall fall 
within the defined acceptance limits (lower limit, SPF 13.7; upper limit, 17.7) and 
shall comply with the ±17 % statistical criterion.If the acceptance SPF limits are not 
met, the entire test shall be rejected.
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.
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. Beforeinitiating a trial, the investigator/institution should have written and 
dated approval/favorable opinion from the IEC for the trial protocol (including 
 
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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 (and for amendments as applicable)
3. Investigator reporting requirements (e.g. reporting of AEs/SAEs/protocol 
deviations to IEC)
4. GSK will provide full details of the above procedures, either verbally, in 
writing, or both.
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 study to review with the site staff the protocol, study requirements, and their 
responsibilities to satisfy regulatory, ethical, and GSK requirements.
When reviewing data 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.
3. Study is conducted in accordance with the currently approved protocol and 
any other study agreements, GCP, and all applicable regulatory requirements.
The extent and 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 relevant documents 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 
completionof 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 
 
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relevant documents and to allocate their time and the time of theirstaff 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 will be 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 closure activities 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 ethical issues or severe non-compliance. For multicenter studies (if 
applicable), this can occur at one or more or at all sites.  
If the trial is prematurely terminated 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 inform the regulatory authority(ies). 
In addition: 
1. If the investigator terminates 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 
explanation of 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 
investigator shouldpromptly 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, when needed (e.g., for a GSK audit or regulatory inspection) and must be 
 
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available for review in conjunction with assessment of the facility, supporting 
systems, and relevant site staff.
Where permitted by 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 investigator must 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 investigator must assure that the subject’s anonymitywill 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.
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 for the 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.
 
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GSK will also provide the investigator with the full summary of the study results.  
The investigator is encouraged toshare 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 will be progressed for publication in the scientific literature if the 
results provide important scientific or medical knowledge.
11. REFERENCES
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) (ISO 24444:2010).
Fitzpatrick, T.B., The validity and practicability of sun-reactive skin typesI through 
VI. Arch. Dermatol.124, pp. 869-871, 1988.
 
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12. REPORTING
The clinical study report will contain at least the following information:
a) Product identifier and expected SPF
b) Subject information (number, Fitzpatrick skin phototype, ITA°value, age and 
gender)
c) Characterization of the UV source (% RCEE compliance and intensity in units 
of radiant flux)
d) Reference sunscreen used
e) Individual MED for unprotected skin, test product protected skin and 
reference sunscreen protected skin
f) Individual SPFi valuesexpressed to one decimal place, including all valid data 
and rejected data for the test product and for the reference sunscreen
g) Mean SPF values, standard deviation on the mean and 95% CIof the test 
product and reference formulation
h) Protocol deviations, if any
i) Identification, by subject, of the technician who conducted the test
j) Date of the test
k) PI signature page to confirm the study was conducted in compliance with this
protocoland any amendments, the Principles of GCP and the Declaration of 
Helsinki.
Theclinical study report will be authored by GSKCH and statistical analyses 
overseen by a member of the GSKCH Biostatistics and Data Management team. 
GSKCH may commission a professional medical writing service to support the
reporting process. The PI will review the clinical study report to ensure the report 
accurately reflects the way the study was conducted. The PI will sign a page to 
confirm the study was conducted in compliance with the protocol, the Principles of 
GCP and the Declaration of Helsinki. 
 
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13. APPENDICES
13.1. 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
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
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
SPFi
Individual Subject Sun Protection Factor
 
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SPF
Sun Protection Factor
UV
Ultraviolet
UVA
Ultraviolet A
UVB
Ultraviolet B
W
Watt
13.2. Appendix 2–Exclusion Criteria to be reassessedat Visit 2
1. PREGNANCY
Women who are known to be pregnant or who are intendingto 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 onthe back area in the 
previous 4 weeks prior to screening
F. Subjects having marks, blemishes or nevi or presenting existing sun damage 
in the test area
I. Subjects with a non-uniform skin colour or hyperpigmentation in the test area
13.3. Appendix 3–Specification of the Solar Simulator Output
 
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CCI

Table 1-% RCEE acceptance limits for the UV solar simulator output
 
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SIGNATURE PAGE 
 
  
 
Date 
Signed By
 
Justification 
 
 
 
Date 
Signed By
 
Justification 
 
 
 
Date 
Signed By
 
Justification 
 
 
 
Date 
Signed By
 
 
Justification 
 
 
 
Date 
Signed By
 
 
Justification 
 
 
 
Date 
Signed By
 
 
Justification 
 
 
11-May-2017 13:45:23
 
Biostatistics Approval
Clinical Operations Approval
11-May-2017 08:53:18
Approved
207640 Protocol.doc
10-May-2017 10:03:48
 
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PPD
PPD
PPD