FDA Approves Bemotrizinol, New US Sunscreen Ingredient
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- FDA approved bemotrizinol on Tuesday, marking the first new sunscreen ingredient for the U.S. market in over 25 years.
- FDA said bemotrizinol meets standards for UV protection, causes little skin irritation or absorption, and is safe for adults and children six months and older.
- DSM Nutritional Products will launch bemotrizinol in the U.S. under the brand Parsol Shield later this year, with an 18‑month exclusivity before other manufacturers can use the ingredient.
- Congress authorized a streamlined review process for sunscreen ingredients in 2020, and bemotrizinol is the first ingredient to use that pathway.
- David Andrews of the Environmental Working Group said bemotrizinol fills a niche by providing broad‑spectrum UVA and UVB protection without the white residue typical of mineral sunscreens.
- European authorities authorized bemotrizinol in 1999, and the ingredient was first filed with the FDA for review in 2005.
Why it matters: American consumers and sunscreen makers gain a modern, broad‑spectrum UV filter that avoids the chalky residue of mineral sunscreens, closing a 25‑year gap with Europe; the FDA’s use of the 2020 streamlined review also shows a path to faster ingredient approvals.
