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FDA Aims to Upgrade Sunscreen Labeling

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On this page:

• What do "UVA" and "UVB" stand for?
• The Four-Star System
• Sunscreen Not the Only Option
• Changes With SPFs, Too

FDA wants the labeling on your sunscreen to tell you more about protection against the sun's harmful rays.

Under a new regulation, the agency has proposed that sunscreen labeling be expanded to provide

• a four-star rating system that informs consumers how well the product protects them against "Ultraviolet A" (UVA) light.
• Information on other ways people can limit their risks to dangers posed by overexposure to sunlight.

What do "UVA" and "UVB" stand for?

UVA and UVB are types of ultraviolet (UV) radiation emitted by the sun. Although the atmosphere's ozone layer shields us from most of this radiation, the UV light that gets through can cause problems.

UVB light is primarily responsible for sunburn. UVA light penetrates the skin more than UVB light does, and causes tanning. Both types of UV light contribute to premature skin aging, skin cancer, and other types of skin damage.

Currently, sunscreen labels are required to carry a "Sunburn Protection Factor" (SPF) value that informs potential users how well the product protects against UVB light.

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The Four-Star System

Under the proposed regulation, a UVA star rating would be prominently displayed on sunscreen labels, near the SPF rating.

"For more than 30 years, consumers have been able to identify the level of UVB protection provided by sunscreens using only sunburn protection factor or SPF values," said Andrew C. von Eschenbach, M.D., Commissioner, Food and Drugs. Under this proposal, "consumers will also now know the level of UVA protection in sunscreens, which will help them make informed decisions about protecting themselves and their children against the harmful effects of the sun."

With the proposed UVA rating system

• One star will represent low UVA protection
• Two stars, medium protection
• Three stars, high protection
• Four stars, the highest UVA protection available in an over-the-counter (OTC) sunscreen product.
• If a sunscreen product does not rate at least one star, FDA is proposing that its labeling bear a "no UVA protection" marking on the front label, near the SPF value.

FDA / Zebulon Rogerson

Sunscreen Not the Only Option

In addition to the new rating system, FDA wants sunscreen labels to advise consumers that using a sunscreen is just one way they can protect themselves against the sun. Limiting time in the sun and wearing protective clothing as part of a comprehensive sun protection regimen are other recommendations that would be prominently displayed on labels. Using sunscreens liberally and reapplying frequently would also be advised.

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Changes With SPFs, Too

FDA also wants to make changes regarding protection against UVB light. The agency has proposed amending its existing rule on UVB products to increase the maximum sunburn protection factor from SPF 30+ to SPF 50+.

The proposed rule is asking the public to comment on the use of nanoparticle ingredients in sunscreens, and is proposing to

• make minor changes in SPF (UVB) testing procedures consistent with current science, to further enhance the accuracy of SPF values.
• allow new combinations of active ingredients.

For More Information

FDA Press Release
www.fda.gov/bbs/topics/NEWS/2007/NEW01687.html

Questions and Answers
www.fda.gov/cder/drug/infopage/sunscreen/qa.htm

FDA Sunscreen Web page
www.fda.gov/cder/drug/infopage/sunscreen/default.htm

FDA's Web site for OTC drug products
www.fda.gov/cder/Offices/OTC/consumer.htm

FDA's Tanning Web site
www.fda.gov/cdrh/tanning/

Sun Safety: Save Your Skin!
www.fda.gov/consumer/updates/sun072407.html

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Date Posted: August 23, 2007

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