WASHINGTON (AP) — Federal health regulators on Tuesday approved the first new sunscreen ingredient for the U.S. market in more than 25 years, giving Americans access to a skin-protecting chemical long used in Europe and other parts of the world.
The Food and Drug Administration (FDA) states that the ingredient bemotrizinol meets the agency's standards for protection against harmful ultraviolet rays while causing minimal irritation and being absorbed into the skin. The agency's statement states that the ingredient is safe for use in adults and children 6 months and older.
Bemotrizinol will initially be sold in the US by Dutch manufacturer DSM Nutritional Products under the brand name Parsol Shield, which is expected to launch later this year. After an 18-month exclusivity period, the ingredient will become available for use by other manufacturers.
For decades, attempts to introduce new sunscreens have been hampered by the FDA's bureaucratic system for updating the safe ingredient lists for over-the-counter medications. Bemotrizinol became the first ingredient to undergo the streamlined process approved by Congress in 2020.
Experts say bemotrizinol will fill an important niche in the U.S. market because it provides protection from both UVA and UVB rays without the white streaks common with mineral-based sunscreens.
«"For decades, Americans have been using outdated sunscreens while the rest of the world has moved forward," said David Andrews of the Environmental Working Group. "The approval of bemotrizinol will help change that.".
Andrews' group has long been pushing the FDA to tighten sunscreen standards and allow new ingredients to be marketed.
According to FDA regulations, all sunscreens must protect against UVB rays, which cause most sunburn, as well as UVA rays, which pose the greatest risk of skin cancer and wrinkles.
Currently available chemical blocking ingredients protect against only one of these factors. Companies typically combine chemicals to achieve "broad-spectrum protection.".
Mineral-based ingredients, including zinc oxide, block both UVA and UVB rays but leave a white, chalky residue.
Bemotrizinol was approved by European regulatory authorities in 1999 and first submitted to the FDA for review in 2005.
«"The U.S. Food and Drug Administration is committed to ensuring American consumers have access to the most effective and safe treatments, including over-the-counter medications like sunscreens," said Dr. Mike Davis, acting director of the FDA's Center for Drug Administration.
The Food and Drug Administration (FDA) is gradually updating its sunscreen standards. In 2011, the agency banned terms like "waterproof," which regulators deemed misleading, and required all sunscreens to filter both UVA and UVB rays. Previously, some formulas only protected against UVB rays.
In 2021, the FDA proposed additional measures, including limiting SPF values and requiring stronger UVA protection, but these were never implemented.
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