Key facts
- The FDA approved bemotrizinol, a new sunscreen ingredient, marking the first such approval in over 25 years.
- Bemotrizinol provides protection against both UVA and UVB rays.
- The ingredient is deemed safe for individuals aged 6 months and older.
- DSM Nutritional Products will initially market the ingredient as Parsol Shield.
- A streamlined process authorized by Congress in 2020 facilitated this approval.
The U.S. Food and Drug Administration has approved bemotrizinol, the first new sunscreen ingredient to enter the American market in over a quarter-century. This approval marks a significant update to the nation's sunscreen offerings, which have long relied on older formulations.
Bemotrizinol has met the FDA's stringent standards for safety and efficacy, demonstrating protection against dangerous ultraviolet rays with minimal skin irritation or absorption. The ingredient is deemed safe for use by both adults and children aged six months and older. Experts note that bemotrizinol will fill a crucial gap by providing broad-spectrum protection against both UVA and UVB rays without the white residue often associated with mineral-based sunscreens.
Initially, the Dutch manufacturer DSM Nutritional Products will market the ingredient in the U.S. under the brand name Parsol Shield, with a launch expected later this year. Following an 18-month exclusivity period, the ingredient will become available for use by other manufacturers, potentially leading to a wider array of advanced sunscreen products.
For decades, the introduction of new sunscreen ingredients in the U.S. has been hindered by the FDA's complex regulatory system. Bemotrizinol's approval comes via a more streamlined process authorized by Congress in 2020, signaling a potential shift in how such products are evaluated. David Andrews of the Environmental Working Group highlighted the long-standing disparity, stating, "For decades, Americans have used outdated sunscreen tech while the rest of the world moved forward." The FDA has been progressively updating its sunscreen regulations, including banning misleading terms like "waterproof" in 2011 and requiring broad-spectrum protection.