FDA Approves New Sunscreen Ingredient After 25 Years
In a significant update for sunscreen users, the Food and Drug Administration (FDA) has announced a new ingredient that will enhance sun protection options for Americans. This marks the first change in permitted sunscreen components in over 25 years.
On Tuesday, the FDA confirmed that it will allow bemotrizinol to be included in sunscreen products. This ingredient has proven effective in shielding the skin from harmful ultraviolet (UV) rays while being gentle on the skin and not absorbing deeply, according to the Associated Press.
Bemotrizinol has been in use internationally, particularly in Europe, and now Americans can look forward to its benefits as well. The ingredient will debut in the U.S. under the name Parsol Shield, produced by the Dutch company DSM Nutritional Products, with an expected release in 2026. After an initial 18-month exclusive period, other manufacturers will also be able to use bemotrizinol in their products.
DSM has submitted a request to the FDA, allowing bemotrizinol’s use in over-the-counter sunscreens at concentrations up to 6%. The FDA has deemed this ingredient safe and effective for both adults and children aged six months and older.
Dr. Marty Makary, the FDA Commissioner, acknowledged the agency’s slow pace in regulating sunscreen. He emphasized the importance of providing Americans with more choices that align with what consumers in other countries already enjoy.
In the announcement, Dr. Karen Murry, acting director of the Office of Nonprescription Drugs, expressed optimism about bemotrizinol being a positive addition to existing sunscreen ingredients available in the U.S. She mentioned the agency’s commitment to collaborating with various companies to introduce more new active ingredients efficiently.
The FDA remains dedicated to ensuring that sunscreen products meet safety and effectiveness standards while promoting multiple protective measures for sun exposure. This includes recommending the use of broad-spectrum sunscreens with an SPF of 15 or higher to help lower the risks of skin cancer and premature aging, alongside wearing protective clothing and limiting sun exposure whenever possible.
