USA: A 17th UV filter set to be authorised

By approving bemotrizinol, the FDA could bring an end to more than two decades of stagnation in the United States. This potential landmark advance is driven by DSM Nutritional Products LLC (DSM-Firmenich), which has requested its addition as an active protective ingredient at concentrations of up to 6%. The FDA recognises its safe toxicological profile, with low skin absorption and very rare cases of irritation. The federal agency has now opened a public consultation period prior to its final decision on the inclusion of this broad-spectrum UV filter in the OTC monograph M020 and on the GRASE (Generally Recognised as Safe and Effective) list. This request falls under the CARES Act of 2020: a set of measures aimed at streamlining the regulatory process for OTC medicines by simplifying administrative steps. If approved, this decision would be a significant turning point for brands, offering greater freedom to formulators and expanding consumer choice.