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9h ago

FDA Adds European Sunscreen Filter Bemotrizinol to U.S. Monograph

The approval could widen UVA and UVB protection and enable lighter, less white‑casting formulas even though broad retail availability will depend on reformulation and an 18‑month exclusivity for DSM.

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Arizona Diamondbacks' Mitch Bratt sprays sunscreen in the team dugout during the second inning of a spring training baseball game against the Los Angeles Dodgers Wednesday, Feb. 25, 2026, in Scottsdale, Ariz.
The US catches up to Europe and Asia with a more effective and safer broad-spectrum chemical filter

Overview

  • This week the FDA designated bemotrizinol (sold as PARSOL Shield) as generally recognized as safe and effective for use in sunscreens for people 6 months and older.
  • The ingredient was cleared for use at concentrations up to 6 percent after a December proposal and a public‑comment period initiated by DSM Nutritional Products.
  • DSM will market the filter as PARSOL Shield and holds 18 months of initial U.S. exclusivity, with DSM and other brands expected to roll out products later in 2026 and after the exclusivity ends.
  • Dermatologists and cosmetic chemists say bemotrizinol is photostable, provides broad UVA/UVB coverage, shows low measured skin absorption, and can help create lighter, less white‑casting sunscreens that may increase daily use.
  • The decision reflects a policy shift to speed U.S. access to UV filters used abroad by using streamlined OTC monograph pathways and broader consideration of foreign safety data.