A Popular Sunscreen Ingredient Can Finally Be Sold in the United States
The ingredient is safe for adults and children 6 months and older and will initially be sold by DSM Nutritional Products as Parsol Shield.
- On June 10, the Food and Drug Administration approved bemotrizinol, the first new sunscreen ingredient cleared for the U.S. market in more than 25 years. This chemical filter provides broad-spectrum protection against UVA and UVB rays.
- Because the U.S. regulates sunscreen as a drug, new ingredients historically faced lengthy approval processes that kept the ingredient list largely unchanged for two decades. Bemotrizinol utilized a streamlined authorization process Congress established in 2020.
- Dermatologists note bemotrizinol offers superior protection against UVA1 rays, which penetrate deeply and cause photoaging, while providing a 'much more cosmetically elegant' finish than mineral alternatives. The ingredient is safe for adults and children 6 months and older.
- Dutch manufacturer DSM-Firmenich holds an 18-month exclusivity agreement for the ingredient, with the FDA's final order becoming effective on August 9, 2026. Marketing activities can then officially launch.
- Experts anticipate leading brands like Neutrogena will integrate new formulations with the filter later this year. Pricing will depend on brand-specific strategies, though the approval represents a major step toward modernizing American sunscreen options.
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16 Articles
The FDA Just Approved the First New Ingredient in Sunscreen in 20 Years—but Founders Have Been Preparing for This Moment for Years
For decades, American brands have lost customers to foreign competitors. Yet, a historic regulatory breakthrough is about to completely change the U.S. market.
FDA’s 25-Year Sunscreen Stall Exposed
The real story is not just that the Food and Drug Administration approved a new sunscreen ingredient. It is that Americans waited more than 25 years for a filter many other countries had long already used. Story Snapshot Bemotrizinol is now approved for United States sunscreen products.[6][7] The ingredient protects against both UVA and UVB...
FDA OKs first new sunscreen ingredient in more than 25 years
WASHINGTON (AP) — Federal health regulators on Tuesday signed off on 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 says the ingredient, bemotrizinol, met the agency’s standards for protecting from dangerous ultraviolet rays while causing little irritation or absorption into the sk…
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