FDA adds bemotrizinol, first new sunscreen ingredient in 20 years

The U.S. Food and Drug Administration has approved bemotrizinol as a new active ingredient for over‑the‑counter sunscreens, marking the first addition to the sunscreen monograph since the late 1990s.

HHS Secretary Robert F. Kennedy, Jr. highlighted that the ingredient has been used safely in Europe for decades and that its approval should boost competition and consumer confidence in U.S. sunscreen products.

The agency completed the rulemaking within seven months of issuing a proposed order, emphasizing a modernized, science‑based regulatory approach.

Bemotrizinol offers protection against both UVA and UVB radiation and is noted for its low skin absorption, aligning with the FDA's goal of providing effective and safe OTC therapies.