The FDA has approved bemotrizinol as a new sunscreen ingredient, marking the first addition to the list of permissible sunscreen components in over 25 years.
The U.S. Food and Drug Administration (FDA) has made a significant update to its list of approved sunscreen ingredients for the first time in more than 25 years. On Tuesday, the agency announced its approval of bemotrizinol, a chemical that has been widely used in other countries for decades.
This new ingredient will enhance the protection offered by sunscreen products, as it meets the FDA’s stringent standards for safeguarding against harmful ultraviolet rays while causing minimal irritation or absorption into the skin. The approval opens the door for American consumers to access a skin-protecting agent that has long been available in Europe and various other regions.
Bemotrizinol will initially be marketed in the United States under the name Parsol Shield, produced by DSM Nutritional Products, a Dutch company. The product is anticipated to launch in late 2026, following an 18-month exclusivity period during which only DSM can sell sunscreens containing bemotrizinol. After this period, other manufacturers will be permitted to incorporate the ingredient into their products.
In December, DSM submitted a formal request to the FDA for the approval of bemotrizinol as a new sunscreen ingredient, allowing its use in over-the-counter sunscreens at concentrations of up to 6%. The FDA has classified bemotrizinol as “generally recognized” as safe and effective for use by adults and children aged six months and older.
FDA Commissioner Dr. Marty Makary expressed the agency’s commitment to modernizing sunscreen regulations, noting that the FDA has historically been slow to approve new ingredients, which has limited options for American consumers compared to those in other countries. “Americans deserve timely access to the best safe, effective, and consumer-friendly over-the-counter products available,” he stated.
Dr. Karen Murry, acting director of the Office of Nonprescription Drugs, emphasized the importance of bemotrizinol as a valuable addition to the existing range of effective sunscreen ingredients available to consumers in the U.S. She expressed optimism about collaborating with other companies to expedite the introduction of new active ingredients for various health conditions.
The FDA continues to regulate sunscreen products to ensure they meet safety and effectiveness standards. The agency encourages the public to adopt a comprehensive approach to sun protection, which includes using broad-spectrum sunscreens with an SPF of 15 or higher, wearing protective clothing, and limiting sun exposure.
As the launch of bemotrizinol approaches, consumers can look forward to enhanced options for sun protection, aligning U.S. standards more closely with those already established in other parts of the world, according to the Associated Press.