I 
119TH CONGRESS 
1ST SESSION H. R. 3686 
To amend the Federal Food, Drug, and Cosmetic Act to improve the regu-
latory review process to determine the safety and effectiveness of non-
prescription sunscreen active ingredients, and for other purposes. 
IN THE HOUSE OF REPRESENTATIVES 
JUNE 3, 2025 
Mr. JOYCE of Pennsylvania (for himself, Mrs. DINGELL, Mr. JOYCE of Ohio, 
and Ms. ROSS) introduced the following bill; which was referred to the 
Committee on Energy and Commerce 
A BILL 
To amend the Federal Food, Drug, and Cosmetic Act to 
improve the regulatory review process to determine the 
safety and effectiveness of nonprescription sunscreen ac-
tive ingredients, 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 ‘‘Supporting Accessible, 
Flexible, and Effective Sunscreen Standards’’ or the 
‘‘SAFE Sunscreen Standards Act’’. 
SEC. 2. FINDINGS. 
Congress finds the following: 
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(1) Skin cancer is the most common cancer in 
the United States. 
(2) More people are diagnosed with skin cancer 
each year in the United States than all other cancers 
combined. 
(3) The United States Surgeon General issued 
a Call to Action to Prevent Skin Cancer in 2014 
based on finding that nearly 5,000,000 Americans 
are treated for skin cancer each year at a cost that 
exceeds $8,100,000,000. 
(4) It is estimated that the number of new 
melanoma cases diagnosed in 2024 will increase by 
7.3 percent, with an estimated 200,340 cases of 
melanoma diagnosed. 
(5) Skin cancer is a deadly disease, and it is ex-
pected that there will be 8,290 deaths from mela-
noma in 2024. 
(6) Skin cancer affects individuals of all ages, 
and melanoma is one of the most common cancers 
in young adults. 
(7) In the United States, more than 9,500 peo-
ple are diagnosed with skin cancer every day and 
more than 2 people die of the disease every hour. 
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(8) According to the World Health Organiza-
tion (‘‘WHO’’), 4 out of 5 cases of skin cancer can 
be prevented by adopting sun-safe practices. 
(9) According to the Environmental Protection 
Agency (‘‘EPA’’), the Ultraviolet (UV) Index in the 
United States continues to rise, increasing the risk 
of melanoma and other skin cancers for Americans. 
(10) The EPA recommends Americans ‘‘Use a 
broad spectrum sunscreen with a Sun Protection 
Factor (‘SPF’) of at least 30’’ to protect against the 
risks of a rising UV Index. 
(11) Congress unanimously passed the Sun-
screen Innovation Act in 2014 to streamline the ap-
proval process for sunscreen active ingredients to 
improve access to new sunscreens, but no new sun-
screen active ingredients have been approved 
through the Food and Drug Administration’s over- 
the-counter approval process since 1999. 
SEC. 3. REGULATIONS ESTABLISHING REQUIREMENTS FOR 
SUNSCREEN ACTIVE INGREDIENTS. 
Section 505G of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 355h) is amended by adding at the 
end the following: 
‘‘(r) REGULATIONS ESTABLISHING REQUIREMENTS 
FOR SUNSCREEN ACTIVE INGREDIENTS.— 
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‘‘(1) EVIDENCE AND TESTING STANDARDS FOR 
SUNSCREEN ACTIVE INGREDIENTS.—The Secretary 
shall establish, through guidance or regulation, 
standards for evaluating the safety and efficacy of 
sunscreen active ingredients, provided that such 
standards— 
‘‘(A) ensure the safety of consumers based 
on a comprehensive evaluation of scientific evi-
dence; 
‘‘(B) allow for the use of real-world evi-
dence (as defined in section 505F(b)), observa-
tional studies, and other scientifically valid ap-
proaches in place of, or to supplement, tradi-
tional clinical tests to demonstrate safety and 
effectiveness; and 
‘‘(C) apply subsection (b)(6)(C) to the reg-
ulation of sunscreen active ingredients in dem-
onstrating a prima facie safe nonprescription 
marketing and use. 
‘‘(2) NON-ANIMAL TESTING METHODS FOR SUN-
SCREEN ACTIVE INGREDIENTS.— 
‘‘(A) IN
GENERAL.—The Secretary shall 
consider the types of nonclinical tests described 
in paragraphs (1) through (4) of the first sub-
section (z) of section 505 (as inserted by sec-
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tion 3209(a)(2) of the Health Extenders, Im-
proving Access to Medicare, Medicaid, and 
CHIP, and Strengthening Public Health Act of 
2022 (division FF of Public Law 117–328)), or 
any other alternative to animal testing that the 
Secretary deems appropriate, in the consider-
ation of sunscreen active ingredients. 
‘‘(B) GUIDANCE.—Not later than 180 days 
after the date of enactment of this subsection, 
the Secretary shall issue new guidance on how 
sponsors can use nonclinical testing alternatives 
to animal testing to meet safety and efficacy 
standards for sunscreen active ingredients.’’. 
SEC. 4. SUNSCREEN FINAL ADMINISTRATIVE ORDER. 
The final administrative order on pending over-the- 
counter sunscreen active ingredient submissions issued 
under section 3854 of the Coronavirus Aid, Relief, and 
Economic Security Act (Public Law 116–136; 21 U.S.C. 
360fff–3 note) shall— 
(1) account for historical data demonstrating 
safe use of sunscreen active ingredients that have 
previously been accepted for marketing in the United 
States; 
(2) emphasize that sunscreen is an effective 
skin cancer prevention tool; and 
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(3) incorporate the evidence and testing stand-
ards for sunscreen active ingredients detailed in sec-
tion 505G(r) of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 355h) (as added by section 3). 
SEC. 5. REPORTING AND TRANSPARENCY. 
(a) TO CONGRESS.—The Secretary of Health and 
Human Services (in this section referred to as the ‘‘Sec-
retary’’) shall, beginning not later than 1 year after the 
date of enactment of this Act, annually submit to the 
Committee on Energy and Commerce of the House of 
Representatives and the Committee on Health, Education, 
Labor, and Pensions of the Senate a report describing— 
(1) the status of implementation of evidence 
and testing standards for sunscreen active ingredi-
ents, including— 
(A) any adjustments to evidence or testing 
standards made under section 505G(r) of the 
Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 355h) (as added by section 3); and 
(B) the number and types of sunscreen ac-
tive ingredient applications reviewed using the 
standards under such section 505G(r); and 
(2) the progress of the Food and Drug Admin-
istration in allowing nonclinical testing alternatives 
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to animal testing for the consideration of sunscreen 
active ingredients. 
(b) PUBLICATION.—Not later than 7 days after the 
date on which the Secretary submits a report under sub-
section (a), the Secretary shall publish such report on the 
website of the Food and Drug Administration. 
Æ 
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