For the first time since the late 1990s, the FDA has approved a new active ingredient for sunscreens.
Approved as an over-the-counter (OTC) product for use by adults and children, bemotrizinol is a non-mineral broad-spectrum ultraviolet filter that blocks UVA and UVB. The agent has been used in sunscreens available in Europe since 1999 and meets FDA standards for products generally recognized as safe.
“Bemotrizinol has been used safely in Europe for decades, and the FDA’s action will increase competition and consumer confidence in sunscreen products,” said HHS Secretary Robert F. Kennedy Jr., in a statement.
Bemotrizinol was approved as an addition to the FDA OTC monograph on sunscreen products. OTC monographs establish technical and legal requirements that allow products to enter the market without submission of a new drug application. DSM Nutritional Products submitted an OTC monograph order request to add bemotrizinol at concentrations up to 6% as a sunscreen active ingredient, and the FDA issued a proposed order last December.
According to the Environmental Working Group (EWG), which has advocated for bemotrizinol since 2019, consumers often prefer sunscreen products with non-mineral active ingredients, which do not leave a white cast on the skin.
“For decades, Americans have used outdated sunscreen tech while the rest of the world moved forward,” EWG Chief Science Officer David Andrews, PhD, said in a statement. “The approval of bemotrizinol will help change that. The FDA’s go-ahead will bring more effective, safer sun protection to American store shelves.”
According to the EWG, data reviewed by the FDA included a 2-year animal study that showed no evidence of carcinogenesis when bemotrizinol was applied to skin. Skin irritation studies showed no irritations at permitted concentrations. The results mirror those of the European Union’s Scientific Committee on Consumer Safety. A multi-generational reproductive study showed no harmful effects of the UV filter on birth, survival, or offspring development.
Following the approval, DSM will have 18 months of exclusive marketing rights for Parsol Shield, a proprietary bemotrizinol formulation already available in Europe. After that, other manufacturers may use the ingredient in their own sunscreen products.
