I 

111TH CONGRESS 

1ST SESSION H. R. 2088 

To require the Food and Drug Administration to finalize a standard for 

broad-spectrum protection in sunscreen products, and for other purposes. 

IN THE HOUSE OF REPRESENTATIVES 

APRIL 23, 2009 

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 finalize 

a standard for broad-spectrum protection in sunscreen 

products, and for other purposes. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Skin Cancer Preven5 tion, Education, and Consumer Right-To-Know Act’’. 

6 SEC. 2. FINDINGS. 

7 The Congress finds as follows: 

8 (1) Skin cancer is a growing epidemic in the 

9 United States with more than 1,000,000 new cases 

10 diagnosed each year. 


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1 (2) About 10,000 Americans die each year from 

2 skin cancer. 

3 (3) The most deadly form of skin cancer, mela4 noma, has tripled among Caucasians since 1980. 

5 (4) One in five Americans and one in three 

6 Caucasians will develop skin cancer in the course of 

7 a lifetime. 

8 (5) A person’s risk for skin cancer doubles if he 

9 or she has had five or more sunburns. 

10 (6) More than 90 percent of all skin cancers are 

11 caused by sun exposure, yet fewer than 33 percent 

12 of adults, adolescents, and children routinely use sun 

13 protection. 

14 (7) Most skin cancer is caused by prolonged ex15 posure to the ultraviolet rays from the sun. This in16 visible radiation is classified as UVA radiation and 

17 UVB radiation. 

18 (8) UVB radiation is the chief cause of sunburn 

19 and skin cancer. 

20 (9) UVA radiation is more constant, year21 round, and penetrates the skin more deeply, causing 

22 both premature aging and skin cancer. 

23 (10) Current United States sunscreen stand24 ards set by the Food and Drug Administration 


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1 (FDA) require protection from UVB radiation but 

2 not UVA radiation. 

3 (11) The current United States sunscreen 

4 standards provide a false sense of security to Ameri5 cans, since their sunscreen is protecting successfully 

6 against sunburn, but not adequately against other 

7 forms of skin damage, including skin cancers. Con8 sumers may wrongly believe that their sunscreen is 

9 sufficiently protecting them and therefore stay in the 

10 sun longer. 

11 SEC. 3. EFFECTIVE DATE FOR RULE RELATING TO SUN12 SCREEN DRUG PRODUCTS FOR OVER-THE13 COUNTER HUMAN USE. 

14 Notwithstanding subchapter II of chapter 5, and 

15 chapter 7, of title 5, United States Code (commonly known 

16 as the ‘‘Administrative Procedure Act’’) and any other 

17 provision of law, the proposed rule issued by the Commis18 sioner of Food and Drugs entitled ‘‘Sunscreen Drug Prod19 ucts for Over-the-Counter Human Use; Proposed Amend20 ment of Final Monograph’’, 72 Fed. Reg. 49070 (August 

21 27, 2007), shall take effect on the date that is 180 days 

22 after the date of enactment of this Act, unless such Com23 missioner issues the final rule, which includes formulation, 

24 labeling, and testing requirements for both ultraviolet B 


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1 (UVB) and ultraviolet A (UVA) radiation protection, be2 fore such effective date. 

3 SEC. 4. EDUCATION. 

4 (a) EDUCATION.—The Secretary of Health and 

5 Human Services shall implement a general, nationwide 

6 education campaign identifying the risks posed by sun ex7 posure without the use of a sunscreen providing broad8 spectrum protection. 

9 (b) CONTENTS.—The education campaign under this 

10 section shall be designed to increase the level of knowledge 

11 and awareness among the general public of the causes of 

12 skin cancer, the risks posed by unprotected sun exposure, 

13 the respective roles of ultraviolet B (UVB) and ultraviolet 

14 A (UVA) radiation in the development of skin cancer, the 

15 effective application of sunscreen, and the promulgation 

16 under section 3 of the standard requiring broad-spectrum 

17 protection in sunscreen products. 

18 (c) DURATION.—The education campaign under this 

19 section shall be implemented for not less than one year. 

Æ 


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