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FDA Wrapping Up Sunscreen Label Changes

FDA Wrapping Up Sunscreen Label Changes Among the Label Changes: SPF Claims of More Than 50+ Won’t Be Allowed WebMD Medical News By Salynn Boyles Reviewed by Louise Chang, MD...

May 21, 2009 -- After years of delay, the FDA is poised to finalize long-awaited sunscreen label changes designed to give consumers a better idea of the sun protection they’re getting.

For the first time, sunscreen manufacturers will be required to provide information on the amount of ultraviolet A (UVA) screening provided by their products. UVA rays do not cause sunburns, but they do contribute to skin cancer and sun-related skin aging.

The new regulation will also prohibit manufacturers from claiming sun protection factors (SPF) of more than 50+, so those very high SPF sunscreens that now line drugstore and grocery-store shelves may go away.

In an interview with WebMD, Rita Chappelle of the FDA confirmed that the agency hopes to finalize the label rules before the end of the year and that SPF claims will be capped at 50+.

But sunscreen companies will have a year to 18 months after the new rules are enacted to make the label changes or provide scientific evidence justifying a higher SPF rating.

Chappelle also confirmed that the terms “sunblock,” "waterproof,” “sweat-proof,” and “all-day protection” will no longer be allowed on sunscreen labels under the new regulations.

“No product can completely block out the rays from the sun and no product is completely waterproof,” Chappelle says. “And labels will have to advise consumers to limit their time in the sun, wear protective clothing, and reapply sunscreen at a minimum of every two hours, especially after swimming or perspiring."

 

Label Changes a Decade in the Making

It has been a decade since the FDA first proposed a standardized UVA rating system, but there was widespread disagreement about how to best evaluate the level of UVA protection that sunscreens provide.

“It took some time for the science to catch up,” Chappelle says.

Under the new regulations, sunscreens will be subjected to lab and human skin tests using a standardized sun simulator.

Almost two years ago, the FDA unveiled a proposed four-star rating system, with one star representing low UVA protection and four stars representing the highest UVA protection available in an over-the-counter product.

The stars would appear near the SPF rating on sunscreen labels.

Chappelle would not say if the proposed star system will be adopted in the finalized plan.

She says the agency received more than 3,000 comments about the proposed label changes and an “unprecedented” amount of scientific data from companies challenging those changes.

“Typically when we put out a proposed rule we get five or 10 submissions of scientific data,” she says. “We received over 100 on this and they all had to be analyzed.”

Sunscreen Companies Respond

Representatives of sunscreen manufacturers Neutrogena, Banana Boat, Hawaiian Tropic, and Coppertone all told WebMD they will comply with the FDA label changes.

But they also left the door open for challenging the SPF 50+ cap.

“The FDA has asked for data supporting high SPF products,” Coppertone spokeswoman Jennifer Samolewicz notes in a written statement. “Many manufacturers, including Coppertone, have submitted new data for review and are awaiting the FDA’s response.”

A spokeswoman for Energizer Personal Care, which makes Banana Boat and Hawaiian Tropic sunscreens, tells WebMD that the company will assess its options after seeing the final FDA label requirements.

Farah Ahmed, who is general council for the cosmetics industry group Personal Care Products Council, tells WebMD that although the group doesn’t object to capping SPF levels at 50+, it strongly disagrees with a proposal to prohibit sunscreens from claiming that they protect against skin cancer and premature skin aging.

“We are not saying that sunscreens alone prevent skin cancer and wrinkles,” she says. “What we are saying is that when used as an overall sun-safe regimen, sunscreens reduce the risk of certain types of skin cancer and photo damage.”

Sonya Lunder, who is a senior analyst for the environmental advocacy organization Environmental Working Group, says the FDA rule changes are long overdue and urgently needed.

“It’s kind of a Wild West environment out there now,” she tells WebMD  “Companies can make all kinds of claims, and they are making them. Claims like ‘all-day protection’ and ‘complete-protection’ are proof that manufacturers are not following the (now voluntary) FDA guidelines.”

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