FDA approves first new sunscreen ingredient in 25 years

Federal health regulators on Tuesday signed off on the first new sunscreen ingredient for the U.S. market in more than 25 years, giving Americans access to a skin-protecting chemical long used in Europe and other parts of the world.

The Food and Drug Administration says the ingredient, bemotrizinol, met the agency's standards for protecting from dangerous ultraviolet rays while causing little irritation or absorption into the skin. The ingredient is safe for adults and children 6 months and older, the agency stated in a release.

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Bemotrizinol will initially be sold in the U.S. by the Dutch manufacturer DSM Nutritional Products under the brand name Parsol Shield, which is expected to launch later in the year. After an 18-month exclusivity period, the ingredient will be available for use by other manufacturers.

Efforts to introduce new sunscreen products have been bogged down for decades by the FDA's bureaucratic system for updating its lists of safe nonprescription drug ingredients. Bemotrizinol is the first ingredient to go through a streamlined process authorized by Congress in 2020.

Experts say bemotrizinol will fill an important niche in the U.S. market: protecting against both ultraviolet A and B rays while not leaving white streaks associated with mineral-based sunscreens.

"For decades, Americans have used outdated sunscreen tech while the rest of the world moved forward," said David Andrews of the Environmental Working Group. "The approval of bemotrizinol will help change that."

Andrews' group has long pushed the FDA to tighten sunscreen standards and allow new ingredients on the market.

Under FDA rules, all sunscreens must protect against UVB rays, which cause most sunburn, as well as UVA rays that pose the greatest risk of skin cancer and wrinkles.

Currently available chemical-blocking ingredients only protect against one or the other. Companies generally mix the chemicals in combination to achieve "broad spectrum protection."

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Mineral-based ingredients, including zinc oxide, block both UVA and UVB but leave a chalky white residue.

Bemotrizinol was authorized by European authorities in 1999 and first filed with the FDA for review in 2005.

"The FDA is committed to ensuring the American consumer has access to the most effective and safe therapies, including over-the-counter products like sunscreens," said Dr. Mike Davis, acting director of FDA's drug center.

The FDA has been gradually updating its standards for sunscreens. In 2011, the agency banned terms like "waterproof," which regulators said was misleading, and required that all sunscreens filter out UVA and UVB rays. Previously some formulas only protected against UVB.

In 2021, the FDA proposed additional measures including capping SPF numbers and requiring stronger UVA protection but those have not been completed.