FDA Approves New Sunscreen Ingredient Bemt After 25-Year Gap
Federal health regulators approved new sunscreen ingredient bemt on Tuesday, clearing bemotrizinol for the US market after more than 25 years without a new active ingredient. The FDA said the ingredient meets standards for protecting against dangerous ultraviolet rays while causing little irritation or absorption into the skin.
That approval gives consumers a new option under the brand name Parsol Shield, which DSM Nutritional Products plans to sell in the United States later in the year. After an 18-month exclusivity period, other manufacturers may use the ingredient as well.
Dr. Mike Davis on FDA access
Dr. Mike Davis, the acting director of the FDA’s drug center, said in a release: “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.” The agency said bemotrizinol is safe for adults and children 6 months and older.
David Andrews, an advocate with the Environmental Working Group, said: “For decades, Americans have used outdated sunscreen tech while the rest of the world moved forward.” He added: “The approval of bemotrizinol will help change that.”
Bemotrizinol in Europe
European authorities authorized bemotrizinol in 1999, and the ingredient was first filed with the FDA for review in 2005. The approval follows a long regulatory path and comes as the FDA has been gradually updating its sunscreen standards.
All sunscreens must protect against UVB rays and UVA rays under FDA rules. In 2011, the FDA banned the term waterproof for sunscreens, and in 2021 it proposed additional measures including capping SPF numbers and requiring stronger UVA protection.
Parsol Shield Launch
Bemotrizinol is expected to fill a practical gap in the US market: protection against both UVA and UVB rays without the white residue associated with mineral-based sunscreens. For consumers, the immediate change is not a shelf switch today, but a new ingredient pathway that starts with Parsol Shield and then opens to other makers after the exclusivity period ends.
That means the first products are likely to come through one brand before broader competition follows. The approval also gives U.S. sunscreen buyers an ingredient already used in Europe and other parts of the world.
