FDA Approves Bemotrizinol as New Sunscreen Ingredient

The FDA approved bemotrizinol as a new sunscreen ingredient for the United States. The chemical compound protects against both UVA and UVB rays and has been sold in Europe since 1999 under the name Parsol Shield. The filter was first submitted for approval in 2005 and received final clearance after nearly 20 years of review.

It became the first ingredient reviewed under a streamlined process Congress created in 2020. The product containing bemotrizinol is scheduled to reach store shelves later in 2026, after which an 18-month exclusivity period ends and other manufacturers may use it. The ingredient passed safety tests for adults and children six months and older.

Two-year animal studies showed no evidence of cancer, and multigenerational reproductive tests showed no evidence of reproductive harm. Separate skin tests found bemotrizinol non-irritating, and FDA scientists determined that the compound is not readily absorbed through the skin. A senior health official stated that the ingredient changes the calculus of sun care.

David Andrews, chief science officer at the Environmental Working Group, said the filter provides meaningful UVA coverage. In its 2026 report, the group listed 550 recommended sunscreens, 497 of which rely primarily on mineral ingredients. "For decades Americans have used outdated sunscreen tech while the rest of the world moved forward," Andrews said.

The approval follows earlier 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. In 2011 the FDA banned the term "waterproof" on sunscreen labels and required protection against both UVA and UVB rays.