The US Food and Drug Administration (FDA) has permitted another ingredient in non-prescription sunscreens: bemotrizinol, a filter used to protect skin from ultraviolet radiation. Its order of 10 June 2026 allows concentrations of up to 6%, subject to conditions on the finished product and who may market it. U.S. Food and Drug Administration (source, opens in new tab)U.S. Food and Drug AdministrationFinal Administrative Order OTC000039: Amending Over-the-Counter Monograph M020: Sunscreen Drug Products for Over-the-Counter Human UseOpen source (opens in new tab) OTC Monographs@FDA (source, opens in new tab)OTC Monographs@FDAOrder Number OTC000039Open source (opens in new tab)
The decision adds bemotrizinol to the FDA’s sunscreen monograph—the rules that allow qualifying products to be sold without a separately approved drug application for each one. This gives manufacturers another permitted ingredient to work with when developing sunscreens for the US market. Products must still meet testing and labelling requirements. The FDA records reviewed do not establish whether compliant sunscreens have reached US shops or when consumers will be able to buy them.
The requirements apply to the complete sunscreen formulation. A product containing bemotrizinol must achieve a tested sun protection factor (SPF) of at least 2—a rating of protection against sunburn-causing ultraviolet radiation. SPF 2 is the minimum required under this order, not the rating of every sunscreen that might use the ingredient. The 6% limit concerns the amount of bemotrizinol allowed; it is not a protection rating for the finished sunscreen.
The permitted product forms include lotions, creams, gels and sticks. Sprays are allowed only when the propellant—the gas used to dispense the product—is kept separate from the sunscreen formulation. Powders are not covered by this permission. Neither are aerosol sprays that mix the propellant with the formulation.
Combinations with other sunscreen active ingredients are also restricted. The order excludes combinations with PABA or trolamine salicylate; other combinations must meet its specified conditions.
The order sets 9 August 2026 as its effective date, subject to the legal provisions governing disputed orders. It also grants DSM Nutritional Products LLC, the company named as the exclusivity holder, and qualifying licensees, assignees or successors 18 months of exclusive marketing rights under the order. That period begins when DSM may lawfully market under it. Other manufacturers therefore cannot assume that the ingredient’s addition immediately allows them to sell sunscreens relying on the change.
- U.S. Food and Drug Administration · Regulatory recordFinal Administrative Order OTC000039: Amending Over-the-Counter Monograph M020: Sunscreen Drug Products for Over-the-Counter Human Useaccessdata.fda.gov · opens in new tab
