FDA Approves Bemotrizinol, First New Sunscreen Ingredient in Over 20 Years, as Stronger UVA Rules Remain Unfinalized
The agency approved bemotrizinol for broad-spectrum UVA and UVB protection. Products are expected on U.S. shelves later in 2026.
Abc NewsU.S. use in 20 years. The agency determined that the filter meets its standards for safety and broad-spectrum protection against both UVA and UVB rays.
The compound has been sold in Europe since 1999 under the brand name Parsol Shield by DSM Nutritional Products. It was first submitted to the FDA in 2005 and became the first ingredient reviewed under a streamlined process Congress created in 2020. The product is scheduled to reach store shelves later in 2026, after which an 18-month exclusivity period ends and other manufacturers may use it.
The FDA stated that bemotrizinol is safe for adults and children six months and older. Two-year animal studies and multigenerational reproductive tests found no evidence of cancer or reproductive harm, and separate skin tests showed the ingredient is non-irritating. Agency scientists also determined that the filter is not readily absorbed through the skin.
U.S. Health and Human Services Secretary Robert F. Kennedy said in a statement that bemotrizinol changes the calculus of sun care. Alexa Friedman, senior scientist at the Environmental Working Group, said the ingredient provides meaningful UVA coverage.
In its 2026 report, the group listed 550 recommended sunscreens, 497 of which rely primarily on mineral ingredients. The approval follows earlier FDA findings that six common sunscreen chemicals, including homosalate and oxybenzone, entered the bloodstream above safety thresholds after a single day of use and remained detectable for more than two weeks.
David Andrews, chief science officer at the Environmental Working Group, said that for decades Americans have used outdated sunscreen tech while the rest of the world moved forward.
Dr. Mike Davis, acting director of the FDA’s drug center, said the agency remains committed to giving consumers access to effective and safe over-the-counter products. In 2011 the FDA banned the term “waterproof” on sunscreen labels and required protection against both UVA and UVB rays.
Proposed 2021 rules that would have capped SPF values and strengthened UVA requirements have not been finalized.
