WASHINGTON – Federal health regulators on Tuesday approved the approval of 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 ingredient, bemotriginol, is minimally irritating to or absorbed by the skin, and meets the Food and Drug Administration’s standards for protection from dangerous ultraviolet rays, according to the Food and Drug Administration. The ingredient is safe for adults and children over 6 months of age, the agency said in a release.
Bemotriginol will initially be sold in the United States by Dutch manufacturer DSM Nutritional Products under the brand name Parsol Shield, and is expected to be released later this year. After an 18-month exclusivity period, the ingredient will be made available to other manufacturers.
Efforts to introduce new sunscreen products have been stalled for decades by the FDA’s bureaucratic system for updating the list of safe over-the-counter drug ingredients. Bemotriginol is the first ingredient to go through the streamlined process approved by Congress in 2020.
Experts say bemotriginol will fill an important niche in the U.S. market, protecting against both UV A and B rays without leaving the white streaks common with mineral-based sunscreens.
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“While the rest of the world has made progress, Americans have been using outdated sunscreen technology for decades,” said David Andrews of the Environmental Working Group. “The approval of bemotriginol will help change this situation.”
Andrews’ group has long urged the FDA to tighten standards for sunscreens and allow new ingredients to market.
FDA regulations require that all sunscreens protect not only from UVB rays, which cause most sunburns, but also from UVA rays, which pose the greatest risk for skin cancer and wrinkles.
Currently available chemical blocking ingredients protect only one or the other. Companies typically mix and match chemicals to achieve “broad spectrum protection.”
Mineral-based ingredients, such as zinc oxide, block both UVA and UVB rays, but leave behind a chalky white residue.
Bemotriginol was approved by European authorities in 1999 and first submitted to the FDA for review in 2005.
“FDA is committed to ensuring that U.S. consumers have access to the most effective and safest treatments, including over-the-counter products such as sunscreen,” said Dr. Mike Davis, acting director of the FDA Center for Drugs.
The FDA is gradually updating its standards for sunscreens. In 2011, regulators banned terms such as “waterproof” as misleading and required all sunscreens to block UVA and UVB rays. Previously, some formulas only protected against UVB.
In 2021, the FDA proposed additional measures, such as setting SPF caps and mandating stronger UVA protection, but they have not yet been completed.
— Matthew Perrone
