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Policy

New Sunscreen

L'Oreal has won FDA approval for the first new organic sunscreen in the U.S. in 18 years

by Marc S. Reisch
July 31, 2006 | APPEARED IN VOLUME 84, ISSUE 31

FDA has approved a sunscreen formula from L'Oreal that includes the first new organic UV-blocking molecule the agency has cleared since 1988.

The cosmetics company says the molecule, ecamsule, is the only photo-stable filter approved in the U.S. for protection against short UV-A waves (320-340 nm). It will be used in a broad-spectrum formula that also contains avobenzone and octocrylene, two previously approved filters.

L'Oreal says the formula will protect users from both UV-A, the wavelengths that can cause skin cancer, and UV-B, the rays that cause skin to burn. L'Oreal plans to offer the new formula, Anthelios SX, only in its own products, the first of which will be a daily moisturizing cream to be introduced in the fall.

Consultant Nadim A. Shaath of Alpha Research & Development says, "The addition of a new ingredient is great, but this one is limited in scope and only favors L'Oreal." David Steinberg, who heads an eponymous consulting firm, says one drawback of ecamsule is that it is water soluble and thus not useful at the beach.

FDA approved avobenzone 18 years ago. Since then, ingredient makers have eagerly sought U.S. approval of a new generation of improved organic molecules for sun protection. European Union regulators permit formulators to use 28 sunscreens, compared with the 17 now allowed in the U.S.

Many sunscreen-ingredient suppliers contend that FDA has been dragging its feet. L'Oreal's ecamsule, for instance, was approved in Europe in 1991. And both Shaath and Steinberg point out that other ingredients already accepted in Europe still await approval in the U.S.

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