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FDA Wrapping Up Sunscreen Label Changes

Among the Label Changes: SPF Claims of More Than 50+ Won’t Be Allowed

Label Changes a Decade in the Making continued...

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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