SouthernWorldwide.com – The U.S. Food and Drug Administration (FDA) is set to update its list of approved sunscreen ingredients, marking the first change in over 25 years. This move will provide Americans with access to a sunscreen component that has been widely used internationally for decades.
The federal health agency officially approved the inclusion of bemotrizinol on Tuesday. This decision comes after the ingredient met the FDA’s stringent standards for effectively protecting against harmful ultraviolet rays while causing minimal skin irritation or absorption.
Bemotrizinol has a long history of use in Europe and other global markets. Its approval in the U.S. means American consumers will soon have a new, proven option for sun protection.
The ingredient will initially be available in the U.S. under the brand name Parsol Shield, produced by the Dutch company DSM Nutritional Products. The launch is anticipated in late 2026. Following an 18-month exclusivity period, other manufacturers will also be able to utilize bemotrizinol in their products.
DSM Nutritional Products had previously submitted a formal request to the FDA for the approval of bemotrizinol as a new sunscreen ingredient. The proposed use allows for concentrations of up to 6% in over-the-counter sunscreen formulations.
In a December press release, the FDA indicated that bemotrizinol is considered “generally recognized” as safe and effective. This designation applies to both adults and children aged 6 months and older.
FDA Commissioner Marty Makary, MD, MPH, acknowledged that the agency has historically been slow to act in this area. He stated that this pace has resulted in Americans having fewer choices compared to consumers in other parts of the world.
“We are continuing to modernize the regulation of sunscreen and other over-the-counter drug products,” Makary commented in the release. He emphasized that Americans deserve prompt access to the most effective, safe, and user-friendly products available on the market.
Karen Murry, MD, acting director of the Office of Nonprescription Drugs, echoed this sentiment. She noted that bemotrizinol would be a valuable addition to the existing range of effective sunscreen ingredients available to consumers in the United States.
“We look forward to collaborating with other companies to bring products containing new active ingredients to market for a wide array of conditions in multiple therapeutic areas, in a much more timely fashion than was possible in the past,” Murry added.
The FDA maintains its commitment to regulating sunscreen products to ensure they meet rigorous safety and effectiveness standards. Concurrently, the agency continues to advocate for the adoption of comprehensive sun protection measures by the public.
These recommended measures include the consistent use of broad-spectrum sunscreens with an SPF of 15 or higher. Such usage is crucial for reducing the risk of skin cancer and mitigating the signs of premature aging. Additionally, wearing protective clothing and limiting direct sun exposure during peak hours are vital components of effective sun safety.
