[Congressional Record Volume 157, Number 73 (Wednesday, May 25, 2011)]
[Senate]
[Pages S3343-S3344]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

      By Mr. REED (for himself, Mr. Schumer, Mr. Kerry, Mr. Leahy, and 
        Mr. Franken):
  S. 1064. A bill to make effective the proposed rule of the Food and 
Drug Administration relating to sunscreen drug products, and for other 
purposes; to the Committee on Health, Education, Labor, and Pensions.
  Mr. REED. Mr. President, as families prepare for Memorial Day 
festivities, and plan outings this summer, most will be outdoors 
without adequate sun protection, even if they use sunscreen.

[[Page S3344]]

This is because there are currently no rules that sunscreen makers must 
follow when making claims about the level of protection their products 
provide.
  Currently, sunscreen products are only required to protect against 
UVB rays, the rays that cause tans and sunburns and the level of 
protection is documented with a Sun Protection Factor, SPF. 
Unfortunately, even these numbers can be misleading or worse, 
inaccurate. Researchers have found that a sunscreen product with a SPF 
of 30 protects against 98 percent of the sun's UVB rays, while a 
sunscreen labeled with a SPF of 100 protects against 99 percent of the 
sun's UVB rays. The larger the SPF number doesn't always result in 
significantly better protection.
  Moreover, sunscreen products are not required to protect against 
cancer-causing UVA rays. UVA rays actually penetrate deeper into the 
skin and can cause more damage. Some sunscreens and products containing 
sun protection claim to protect against these rays, but there are no 
scientific standards by which to measure their validity.
  We have seen the effects that a lack of reliable sun protection can 
have in the rising rates of melanoma in this country, which has doubled 
in the past 30 years. This year alone, over 2 million people will be 
informed that they have a preventable form of skin cancer. My state of 
Rhode Island is among the top ten for reported melanoma diagnoses.
  After years of working with my colleagues to press the Food and Drug 
Administration to act, in August of 2007, the FDA finally proposed a 
rule that would require sunscreen labels to disclose the level of UVA 
protection in a standard format that appears near the sun protection 
factor rating, and ensure that the SPF rating actually corresponds to a 
product's protection against UVB rays. This was a step in the right 
direction. The downside is that nearly 4 years later this proposal has 
still not been finalized.
  For this reason, today I am introducing the Sunscreen Labeling 
Protection Act, the SUN Act, along with my colleagues, Senators 
Schumer, Kerry, Leahy, and Franken. This legislation would require the 
FDA to finalize the sunscreen labeling monograph. If the FDA fails to 
finalize its proposed monograph of August 27, 2007 within 180 days of 
enactment of the SUN Act, the monograph, as proposed, would become 
effective. I look forward to a summer when Americans can finally feel 
protected from the sun's harmful rays.
  Mr. President, I ask unanimous consent that the text of the bill be 
printed in the Record.
  There being no objection, the text of the bill was ordered to be 
printed in the Record, as follows:

                                S. 1064

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

     SECTION 1. SHORT TITLE.

       This Act may be cited as the ``Sunscreen Labeling 
     Protection Act of 2011'' or the ``SUN Act''.

     SEC. 2. EFFECTIVE DATE FOR RULE RELATING TO SUNSCREEN DRUG 
                   PRODUCTS FOR OVER-THE-COUNTER HUMAN USE.

       Notwithstanding subchapter II of chapter 5, and chapter 7, 
     of title 5, United States Code (commonly known as the 
     ``Administrative Procedure Act'') and any other provision of 
     law, the proposed rule issued by the Commissioner of Food and 
     Drugs entitled ``Sunscreen Drug Products for Over-the-Counter 
     Human Use; Proposed Amendment of Final Monograph'', 72 Fed. 
     Reg. 49070 (August 27, 2007), shall take effect on the date 
     that is 180 days after the date of enactment of this Act, 
     unless such Commissioner issues the final rule, which 
     includes formulation, labeling, and testing requirements for 
     both ultraviolet B (UVB) and ultraviolet A (UVA) radiation 
     protection, before such effective date.
                                 ______