Key facts
- The FDA approved bemotrizinol, a new sunscreen ingredient, for the U.S. market.
- This is the first new sunscreen ingredient approved in over 25 years.
- Bemotrizinol provides protection against both UVA and UVB rays.
- The ingredient is considered safe for adults and children aged 6 months and older.
- DSM Nutritional Products will initially sell the ingredient under the brand name Parsol Shield.
- Bemotrizinol was approved via a streamlined process established by Congress in 2020.
The U.S. Food and Drug Administration has approved bemotrizinol, a new sunscreen ingredient, marking the first such approval in over 25 years. The ingredient, already in use in Europe, meets FDA standards for protecting against dangerous ultraviolet rays with minimal skin irritation or absorption. It is deemed safe for individuals aged six months and older.
Initially, bemotrizinol will be available in the U.S. under the brand name Parsol Shield, sold by Dutch manufacturer DSM Nutritional Products, with wider availability expected after an 18-month exclusivity period. This approval utilized a streamlined process authorized by Congress in 2020, addressing long-standing delays in updating the FDA's list of safe nonprescription drug ingredients.
Experts note that bemotrizinol fills a market gap by offering protection against both UVA and UVB rays without the white residue associated with mineral-based sunscreens. David Andrews of the Environmental Working Group stated that this approval helps modernize American sunscreen technology. The FDA has been updating sunscreen regulations since 2011, when it banned terms like 'waterproof' and mandated broad-spectrum protection.