I 
110TH CONGRESS 
1ST SESSION H. R. 3084 
To require the Food and Drug Administration to establish a standard for 
broad-spectrum protection in sunscreen products, and for other purposes. 
IN THE HOUSE OF REPRESENTATIVES 
JULY 18, 2007 
Mrs. LOWEY introduced the following bill; which was referred to the 
Committee on Energy and Commerce 
A BILL 
To require the Food and Drug Administration to establish 
a standard for broad-spectrum protection in sunscreen 
products, and for other purposes. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Skin Cancer Preven-
tion, Education, and Consumer Right-To-Know Act’’. 
SEC. 2. FINDINGS. 
The Congress finds as follows: 
(1) Skin cancer is a growing epidemic in the 
United States with more than 1,000,000 new cases 
diagnosed each year. 
VerDate Aug 31 2005 
20:57 Jul 23, 2007
Jkt 059200
PO 00000
Frm 00001
Fmt 6652
Sfmt 6201
E:\BILLS\H3084.IH
H3084
mstockstill on PROD1PC66 with BILLS
(2) About 10,000 Americans die each year from 
skin cancer. 
(3) The most deadly form of skin cancer, mela-
noma, has tripled among Caucasians since 1980. 
(4) One in 5 Americans and one in 3 Cauca-
sians will develop skin cancer in the course of a life-
time. 
(5) A person’s risk for skin cancer doubles if he 
or she has had 5 or more sunburns. 
(6) More than 90 percent of all skin cancers are 
caused by sun exposure, yet fewer than 33 percent 
of adults, adolescents, and children routinely use sun 
protection. 
(7) Most skin cancer is caused by prolonged ex-
posure to the ultraviolet rays from the sun. This in-
visible radiation is classified as UVA radiation and 
UVB radiation. 
(8) UVB radiation is the chief cause of sunburn 
and skin cancer. 
(9) UVA radiation is more constant, year- 
round, and penetrates the skin more deeply, causing 
both premature aging and skin cancer. 
(10) Current United States sunscreen stand-
ards set by the Food and Drug Administration 
VerDate Aug 31 2005 
20:57 Jul 23, 2007
Jkt 059200
PO 00000
Frm 00002
Fmt 6652
Sfmt 6201
E:\BILLS\H3084.IH
H3084
mstockstill on PROD1PC66 with BILLS
(FDA) require protection from UVB radiation but 
not UVA radiation. 
(11) The current United States sunscreen 
standards provide a false sense of security to Ameri-
cans, since their sunscreen is protecting successfully 
against sunburn, but not adequately against other 
forms of skin damage, including skin cancers. Con-
sumers may wrongly believe that their sunscreen is 
sufficiently protecting them and therefore stay in the 
sun longer. 
SEC. 3. BROAD-SPECTRUM SUNSCREEN STANDARD. 
(a) IN GENERAL.—Chapter V of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is amend-
ed— 
(1) in section 502, by adding at the end the fol-
lowing: 
‘‘(y) If it is a drug that is a sunscreen product and 
its labeling is in violation of section 566 .’’; and 
(2) by inserting after section 565 the following: 
‘‘SEC. 566. BROAD-SPECTRUM SUNSCREEN STANDARD. 
‘‘(a) LABELING.—The labeling of a drug that is a 
sunscreen product and fails to meet the standard adopted 
under subsection (b)(1) shall not— 
‘‘(1) describe the product using the term 
‘broad-spectrum’ (or any variant of such term); or 
VerDate Aug 31 2005 
20:57 Jul 23, 2007
Jkt 059200
PO 00000
Frm 00003
Fmt 6652
Sfmt 6201
E:\BILLS\H3084.IH
H3084
mstockstill on PROD1PC66 with BILLS
‘‘(2) include the symbol described in subsection 
(b)(2). 
‘‘(b) STANDARD; SYMBOL.—The Secretary shall— 
‘‘(1) adopt a standard for broad-spectrum pro-
tection in sunscreen products in order to better pro-
tect Americans from skin cancer and premature 
aging; and 
‘‘(2) adopt an easily recognized symbol for in-
clusion in the labeling of sunscreen products meeting 
such standard. 
‘‘(c) MINIMUM REQUIREMENTS.— 
‘‘(1) MINIMUM
REQUIREMENTS.—In 
estab-
lishing the standard under subsection (b)(1), the 
Secretary shall require— 
‘‘(A) a minimum ratio 1 to 3 of UVA pro-
tection factor (UVA–PF) to sun protection fac-
tor (SPF); 
‘‘(B) 
a 
critical 
wavelength 
of 
370 
nanometers, as obtained in application of the 
critical wavelength testing method; 
‘‘(C) a minimum level of UVB radiation 
protection of sun protection factor 6 as ob-
tained in application of the International Sun 
Protection Factor Test Methods (2006) or an 
VerDate Aug 31 2005 
20:57 Jul 23, 2007
Jkt 059200
PO 00000
Frm 00004
Fmt 6652
Sfmt 6201
E:\BILLS\H3084.IH
H3084
mstockstill on PROD1PC66 with BILLS
equivalent degree of protection obtained with 
any in vitro method; and 
‘‘(D) truth in labeling requirements such 
that— 
‘‘(i) claims of broad-spectrum protec-
tion from ultraviolet radiation can only be 
made in cases where the product meets the 
requirements established under this sec-
tion; and 
‘‘(ii) labels claiming broad-spectrum 
protection include the symbol described in 
subsection (b)(2) only if the sunscreen 
product meets the standard adopted under 
subsection (b)(1). 
‘‘(2) MEASUREMENT
OF
PROTECTION
LEV-
ELS.—The protection factors described in paragraph 
(1) shall be measured using standardized, reproduc-
ible testing methods that take photo-degradation 
into account. In considering such methods, the Sec-
retary shall give preference to in vitro testing meth-
ods. 
‘‘(d) REGULATIONS.—Not later than December 31, 
2007, the Secretary shall issue comprehensive final regula-
tions for carrying out this section with respect to sun-
screen products. 
VerDate Aug 31 2005 
20:57 Jul 23, 2007
Jkt 059200
PO 00000
Frm 00005
Fmt 6652
Sfmt 6201
E:\BILLS\H3084.IH
H3084
mstockstill on PROD1PC66 with BILLS
‘‘(e) DEFINITIONS.— 
‘‘(1) 
BROAD-SPECTRUM
PROTECTION.—The 
term ‘broad-spectrum protection’ means protection 
from both UVA radiation and UVB radiation. 
‘‘(2) SUN
PROTECTION
FACTOR.—The term 
‘sun protection factor’ is the ratio between the ultra-
violet dose required to produce minimal erythema re-
action (redness) in protected skin (skin with sun-
screen) compared to unprotected skin (skin without 
any sunscreen). The number indicates how many 
times longer a person can stay in the sun before be-
ginning to burn while wearing sun protection than if 
he or she were not wearing any sunscreen at all. 
‘‘(3) UVA PROTECTION
FACTOR.—The term 
‘UVA protection factor’ means the ratio of the min-
imum UVA radiation dose necessary to induce a per-
sistent pigment darkening on the skin protected by 
a sunscreen product to the minimal UVA radiation 
dose necessary to induce the minimal darkening ef-
fect on the same unprotected skin. 
‘‘(4) UVA RADIATION.—The term ‘UVA radi-
ation’ means sun radiation in the spectrum of 320 
to 400 nanometers. 
VerDate Aug 31 2005 
20:57 Jul 23, 2007
Jkt 059200
PO 00000
Frm 00006
Fmt 6652
Sfmt 6201
E:\BILLS\H3084.IH
H3084
mstockstill on PROD1PC66 with BILLS
‘‘(5) UVB RADIATION.—The term ‘UVB radi-
ation’ means sun radiation in the spectrum of 290 
to 320 nanometers.’’. 
(b) EFFECTIVE DATE.—The requirements of sections 
502(y) and 566(a) of the Federal Food, Drug, and Cos-
metic Act, as added by subsection (a), shall take effect 
on the earlier of— 
(1) the date determined appropriate by the Sec-
retary of Health and Human Services; or 
(2) the date that is 1 year after the date of the 
enactment of this Act. 
SEC. 4. EDUCATION. 
(a) EDUCATION.—Upon issuing the regulations re-
quired by subsection (d) of section 566 of the Federal 
Food, Drug, and Cosmetic Act, as added by section 3, the 
Secretary of Health and Human Services shall implement 
a general, nationwide education campaign identifying the 
risks posed by sun exposure without the use of a sunscreen 
providing broad-spectrum protection. 
(b) CONTENTS.—The education campaign under this 
section shall be designed to increase the level of knowledge 
and awareness among the general public of the causes of 
skin cancer, the risks posed by unprotected sun exposure, 
the respective roles of UVA radiation and UVB radiation 
(as defined in such section 566) in the development of skin 
VerDate Aug 31 2005 
20:57 Jul 23, 2007
Jkt 059200
PO 00000
Frm 00007
Fmt 6652
Sfmt 6201
E:\BILLS\H3084.IH
H3084
mstockstill on PROD1PC66 with BILLS
cancer, the effective application of sunscreen, and the re-
lease of the standard requiring broad-spectrum protection 
(as defined in such section 566) in sunscreen products. 
(c) DURATION.—The education campaign under this 
section shall be implemented for not less than one year. 
Æ 
VerDate Aug 31 2005 
20:57 Jul 23, 2007
Jkt 059200
PO 00000
Frm 00008
Fmt 6652
Sfmt 6301
E:\BILLS\H3084.IH
H3084
mstockstill on PROD1PC66 with BILLS