From Our 2007 Archives

FDA Proposes New Sunscreen Rules

Proposed Sunscreen Regulation Includes a Rating System, New Warning

By Miranda Hitti
WebMD Health News

Reviewed By Louise Chang, MD

Aug. 23, 2007 -- Sunscreens may get a new rating system and a warning, thanks to a new FDA proposal.

The FDA today proposed a new regulation that sets standards for formulating, testing, and labeling over-the-counter sunscreens with ultraviolet A (UVA) and ultraviolet B (UVB) protection.

The proposal includes a four-star rating system for sunscreen protection against UVA light, along with a warning that stresses the importance of not relying solely on sunscreens to prevent skin cancer and skin damage.

Sunlight contains the visible light that we can see and ultraviolet (UV) light that we cannot. There are two types of UV light, UVA and UVB. UVA light is responsible for tanning and UVB for sunburn. Both can damage the skin and increase the risk of skin cancer.

SPF ratings on sunscreens refer only to UVB protection, not UVA protection. For years, the FDA has been studying UVA's effects on skin, but until now hasn't required sunscreens to carry specific information on UVA protection.

"Only a few countries have addressed UVA protection in their product labeling," says Douglas Throckmorton, MD, deputy director of the FDA's Center for Drug Evaluation and Research.

The proposed new regulation would include cosmetics that tout sun protection but not insect repellents that include SPF, according to Matthew Holman, PhD, interdisciplinary scientist team leader at the FDA's Office of Nonprescription Products.

New UVA Sunscreen Ratings

The FDA's proposed sunscreen regulation is designed to be a consumer-friendly rating system for identifying the level of UVA protection offered by a product. It rates UVA sunscreen products on a scale of one to four stars.

One star would represent low UVA protection, two stars would represent medium protection, three stars would represent high protection, and four stars would represent the highest UVA protection available in an over-the-counter sunscreen product.

If a sunscreen product does not provide at least a low level (one star) of protection, the FDA is proposing to require that the product to bear a "no UVA protection" marking on the front label near the SPF value.

The UVA ratings would be based on two tests the FDA proposes to assess the effectiveness of sunscreens in providing protection against UVA light. One would be a lab test that measures a product's ability to reduce the amount of UVA radiation that passes through it. The other test would be conducted on people, checking the product's ability to prevent tanning. This test is nearly identical to the SPF test used to determine the effectiveness of UVB sunscreen products.

If a sunscreen scores higher on one test than the other, it would bear the lower rating, says Holman.

The proposal also includes tweaking the SPF information on sunscreens. For instance, a sunscreen that currently says "SPF 45" would say "UVB SPF 45" with the word "high" to indicate a high level of UVB protection.

To see an example of what the new labeling would look like, visit the FDA's web page on the proposed sunscreen labeling at http://www.fda.gov/consumer/updates/sunscreen082307.html.

New Sunscreen Warning

The FDA also proposes requiring all sunscreens to include a "Warnings" statement in the "Drug Facts" box.

The warning would say: "UV exposure from the sun increases the risk of skin cancer, premature skin aging, and other skin damage. It is important to decrease UV exposure by limiting time in the sun, wearing protective clothing, and using a sunscreen." The warning is intended to increase awareness that sunscreens are only one part of a sun protection program.

The proposed new sunscreen regulation will also stress instructions to reapply sunscreen at least every two hours and to use sunscreen as directed, says Holman.

The FDA will accept comments on the proposed new rule for 90 days, ending on Nov. 26, 2007.

Trade Group Responds

The Cosmetic, Toiletry, and Fragrance Association (CTFA) states that it is "pleased that the FDA has proposed these new sunscreen regulations" and that it looks forward to working with the FDA as it finalizes the sunscreen rules.

The CTFA points out that "while the final rulemaking is ongoing, there are currently strong FDA safety and effectiveness regulations that govern the manufacture and marketing of all sunscreen products."

"Consumers should have a high level of confidence that sunscreen products are safe and effective when used as directed," states the CTFA.

Like the FDA, AAD, ACS, and other health experts, the CTFA stresses that besides wearing sunscreen, people should minimize their sun exposure -- especially from 10 a.m. to 4 p.m., when UVA/UVB exposure is highest -- and to wear protective clothing to safeguard skin.

SOURCES: News release, FDA. Douglas Throckmorton, MD, deputy director, Center for Drug Evaluation and Research, FDA. Matthew Holman, PhD, interdisciplinary scientist team leader, Office of Nonprescription Products, FDA. News release, American Academy of Dermatology. News release, American Cancer Society. News release, Cosmetic, Toiletry, and Fragrance Association.

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