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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.

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.

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.

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.

Current Label and Proposed Label

FDA / Zebulon Rogerson

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 OTCdrug 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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Last modified: 08/29/07