Federal health officials announced Tuesday they have approved the first new sunscreen ingredient for American consumers in over 25 years, opening access to a protective compound that has been available in Europe and other regions for decades.
The Food and Drug Administration determined that bemotrizinol meets agency requirements for shielding skin from harmful ultraviolet radiation while producing minimal irritation or penetration into the skin. Officials stated the compound is safe for use by adults and children six months of age and older.
The ingredient will debut in American stores through Dutch company DSM Nutritional Products, marketed as Parsol Shield with an anticipated release later this year. Following an 18-month exclusive period, other manufacturers will gain access to use the ingredient in their products.
The introduction of new sunscreen formulations has faced significant delays for years due to the FDA’s complex administrative process for updating approved nonprescription drug ingredient lists. Bemotrizinol represents the first compound to navigate a faster approval pathway that Congress established in 2020.
Industry specialists indicate bemotrizinol addresses a significant gap in the American sunscreen market by defending against both ultraviolet A and B radiation without creating the white residue typical of mineral-based products.
“For decades, Americans have used outdated sunscreen tech while the rest of the world moved forward,” said David Andrews of the Environmental Working Group. “The approval of bemotrizinol will help change that.”
Andrews’ organization has consistently advocated for the FDA to strengthen sunscreen regulations and approve additional ingredients for consumer use.
According to FDA regulations, all sunscreen products must defend against UVB radiation, which creates most sunburn damage, plus UVA radiation that presents the highest risk for skin cancer and aging effects.
Chemical-blocking compounds currently on the market typically protect against only one type of radiation. Manufacturers usually combine multiple chemicals to create “broad spectrum protection.”
Mineral-based compounds, such as zinc oxide, block both UVA and UVB radiation but create a white, chalky appearance on skin.
European regulators approved bemotrizinol in 1999, and the compound was initially submitted to the FDA for evaluation in 2005.
“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 FDA’s drug center.
The FDA has been progressively revising its sunscreen regulations. In 2011, officials prohibited misleading terms such as “waterproof” and mandated that all products filter both UVA and UVB radiation. Previously, some formulations protected only against UVB rays.
In 2021, the FDA suggested additional changes including limits on SPF ratings and enhanced UVA protection requirements, though these proposals remain incomplete.
