After a decades-long wait, U.S. consumers are finally set to gain access to an advanced sunscreen active ingredient that has been widely used across Europe and much of the world for years. On Tuesday, U.S. Food and Drug Administration (FDA) federal health regulators officially approved bemotrizinol for the American market, marking the first addition of a new sunscreen ingredient to the approved U.S. list in more than 25 years.
In an official public statement, the FDA confirmed that bemotrizinol meets all the agency’s strict safety and efficacy requirements for ultraviolet (UV) radiation protection. Testing data shows the chemical provides robust protection from dangerous UV rays, causes minimal skin irritation, and has very low absorption into human skin. The agency also cleared the ingredient for use on all populations, including adults and children six months of age and older.
Initially, the Dutch manufacturer DSM Nutritional Products will distribute bemotrizinol to U.S. sunscreen brands under the registered brand name Parsol Shield, with a full commercial launch planned for later this year. Per FDA regulations, DSM will hold an 18-month exclusivity period for the newly approved ingredient, after which other cosmetic and pharmaceutical manufacturers will be permitted to incorporate bemotrizinol into their own sunscreen products.
For decades, the process to update the FDA’s list of safe over-the-counter (nonprescription) sunscreen ingredients has been stalled by long-standing bureaucratic bottlenecks. This approval marks the first time a new sunscreen ingredient has been reviewed and cleared through the streamlined approval pathway authorized by federal Congress in 2020, a change designed to cut through years of regulatory backlog.
Public health and industry experts note that bemotrizinol fills a critical gap in the current U.S. sunscreen market. Unlike existing options, the new ingredient provides built-in broad-spectrum protection against both UVA and UVB rays on its own — a benefit that current chemical sunscreen ingredients cannot match, as existing single ingredients only block one type of UV radiation, requiring brands to blend multiple chemical components to achieve full broad-spectrum protection.
It also solves a common consumer complaint about mineral-based sunscreens, which use active ingredients like zinc oxide to block both UVA and UVB rays but often leave an unsightly chalky white residue on the skin. Bemotrizinol does not leave this characteristic white streaking, making it a more aesthetically appealing option for many consumers.
“For decades, Americans have relied on outdated sunscreen technology while the rest of the world adopted newer, more effective options,” said David Andrews, a senior scientist with the Environmental Working Group (EWG), a non-profit advocacy organization that has spent years pushing the FDA to update its sunscreen regulations and open the market to new ingredients. “The approval of bemotrizinol will help change that disparity for American consumers.”
FDA regulations currently require all commercially sold sunscreens marketed for daily use to provide protection against both forms of harmful UV radiation: UVB rays, which are the primary cause of sunburn and contribute to skin cancer development, and UVA rays, which penetrate deeper into the skin and are the leading cause of premature wrinkles and the highest risk of invasive skin cancer.
First authorized for commercial use by European regulatory authorities all the way back in 1999, bemotrizinol was first submitted to the FDA for regulatory review in 2005, meaning it took 18 years to navigate the agency’s prior outdated approval process to reach final approval.
“The FDA is committed to ensuring the American consumer has access to the most effective and safe therapies, including over-the-counter products like sunscreens,” said Dr. Mike Davis, acting director of the FDA’s Center for Drug Evaluation and Research, in a statement accompanying the approval.
The approval of bemotrizinol is part of the agency’s gradual, ongoing process to update U.S. sunscreen safety and efficacy standards. In 2011, the agency implemented a landmark update that banned misleading marketing terms such as “waterproof,” which regulators found overstated product performance, and mandated that all commercially sold sunscreens provide protection against both UVA and UVB rays — a requirement that did not exist before, when many products only blocked UVB radiation. In 2021, the FDA proposed a further round of updates, including capping maximum labeled SPF numbers and enforcing stricter minimum UVA protection requirements, but those rule changes are still pending finalization.
This reporting from The Associated Press Health and Science Department is supported by the Howard Hughes Medical Institute’s Science and Educational Media Group and the Robert Wood Johnson Foundation; the AP retains full editorial control over all content.