FDA finalizes action on bemotrizinol, first new active sunscreen ingredient in 20 years

Purpose-built for physicians

The FDA has added bemotrizinol to the over-the-counter sunscreen monograph, making it the first new active sunscreen ingredient permitted in the United States since 1999, according to an agency press release.

The final order allows bemotrizinol to be added as an active ingredient to sunscreen formulations at concentrations up to 6%, the FDA reported. The decision comes within 7 months of the agency’s previously issued proposed order in December 2025.

“As promised in the Trump Administration’s MAHA Strategy Report, HHS is advancing innovation by bringing a new sunscreen ingredient to the U.S. market for the first time in 20 years,” HHS Secretary Robert F. Kennedy Jr said in the release. “Bemotrizinol has been used safely in Europe for decades, and FDA’s action will increase competition and consumer confidence in sunscreen products.”

Bemotrizinol, marketed by dsm-firmenich as PARSOL Shield, is a broad-spectrum ultraviolet filter that protects against both UVA and UVB light, . Unlike other chemical ingredients, it has low levels of absorption through the skin. (Editor’s note: Read Healio’s past coverage of bemotrizinol here.)