The US Food and Drug Administration approved bemotrizinol, known as BEMT, as a new active sunscreen ingredient for over-the-counter products, the first new UV-filter approved in over 20 years [1, 2, 3, 4]. Bemotrizinol has been widely used in Europe and Asia for over two decades, offering broad-spectrum protection against UVA and UVB rays [1, 2, 3, 4]. It resists degradation under sunlight better than existing ingredients, allowing for smoother, lighter sunscreen formulations with longer-lasting protection [1, 2].
Bemotrizinol will be sold initially in the US under the brand name Parsol Shield by DSM Nutritional Products, with a launch planned for later in 2026 [2, 4]. The ingredient will be allowed at concentrations up to 6% in sunscreen products [4]. DSM Nutritional Products has an 18-month exclusivity period before other manufacturers can include bemotrizinol in their products [2, 4].
US sunscreens have faced slow innovation due to regulatory delays. Unlike many countries where sunscreens are regulated as cosmetics, the FDA classifies sunscreen ingredients as over-the-counter drugs, requiring lengthy approvals [1, 3, 4]. Dr. Adewole Adamson said the US "hasn’t been able to really have any innovation in US-based sunscreens since last millennium" [3].
Dr. Ellen Gendler noted US sunscreens generally provide strong UVB protection but rely mostly on Avobenzone for UVA coverage, which she called "not very stable" [1]. Acting FDA Office of Nonprescription Drugs Director Karen Murry said bemotrizinol "would be a welcome addition to the current array of effective sunscreen active ingredients already available to American consumers" [4].
FDA Commissioner Marty Makary acknowledged the agency’s slow progress in sunscreen ingredient approvals and said it was working to modernize regulation. He stated, "We’re continuing to modernize the regulation of sunscreen and other over-the-counter drug products. Americans deserve timely access to the best safe, effective and consumer-friendly over-the-counter products available" [4].
Congress ordered the FDA to overhaul its sunscreen approval process in 2020. DSM Nutritional Products submitted bemotrizinol for approval in 2024, leading to the recent FDA clearance [3]. Parsol Shield sunscreen with bemotrizinol is scheduled to launch in the US later this year, and the exclusivity period for DSM Nutritional Products ends 18 months after the launch, allowing other companies to use bemotrizinol in their sunscreens [2, 4].