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13h ago

FDA Adds Bemotrizinol to U.S. Sunscreen Ingredients, First New Filter in Over 20 Years

The agency declared the filter generally recognized as safe and effective for people six months and older, clearing a path for DSM’s PARSOL Shield and limited initial market exclusivity.

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Mellissa Brown makes sure her son has sunscreen on his face before heading into the pool. A new type of sunscreen ingredient is coming to the U.S. after decades in Europe and Australia. 
Going outside? Make sure to use at least a shot glass full of sunscreen all over your body and cover your head with a wide-brimmed hat.

Overview

  • The FDA has added bemotrizinol (also called BEMT or PARSOL Shield) to the over‑the‑counter sunscreen ingredient list, marking the first new active approved in more than two decades.
  • The agency classified the ingredient as GRASE for use at specified conditions and ages six months and older after reviewing safety data showing broad UVA and UVB coverage, strong photostability, and low systemic absorption.
  • Regulatory changes that allow non‑U.S. studies and a streamlined OTC monograph process helped speed the review and made bemotrizinol eligible for U.S. approval.
  • DSM Nutritional Products will market the ingredient as PARSOL Shield and is reported to hold an initial exclusivity window of about 18 months before other manufacturers can use the filter.
  • Dermatologists and formulators say bemotrizinol can enable lighter, less whitening formulas that may increase daily sunscreen use, which could boost protection against UV‑linked skin cancers as new products roll out later in 2026.