The US Food and Drug Administration (FDA) has added bemotrizinol to the list of permitted sunscreen active ingredients, the first update in 20 years.
It is the first new ingredient added to the over-the-counter sunscreen segment since the late 1990s, and was finalised within seven months of the proposed order being issued.
Bemotrizinol, abbreviated as BEMT, has been marketed as a sunscreen ingredient in Europe and other countries for several years.
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The ingredient, which is being released as part of fragrance and flavour maker DSM-Firmenich’s Parsol Shield’s sunscreen, is said to protect against both ultraviolet A and B rays, and has low levels of absorption through the skin into the body.
The FDA stated that it considers bemotrizinol to be ‘Generally Recognised as Safe and Effective’ (GRASE) for use in sunscreens by adults and children six months of age and older.
“This is exactly the kind of progress we can achieve when we modernise our processes and apply sound science to regulatory decisions,” said Mike Davis, Acting Director of the FDA Center for Drug Evaluation and Research (CDER).
“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.”
The addition of bemotrizinol also aligns with the Make America Healthy Again (MAHA) Strategy Report initiative.
This is focused on the FDA promoting innovation in the sunscreen market and improving “regulatory processes for over-the-counter sunscreen, which has fallen behind other countries”.
Karen Murry, Director of the Office of Nonprescription Drugs in CDER, added: “The FDA’s rigorous standards ensure consumers can be confident in the sunscreens and other non-prescription drugs they use.
“Now, through the best available science and updated regulatory framework, we can work with companies to get innovative products to market in a more efficient manner than ever before.”
What does the FDA’s decision mean for the beauty industry?
The US FDA is notoriously conservative when it comes to sunscreen actives’ approval, so the update “marks an important step in the effort to provide better sun safety for US consumers”, Julia Wray, a Freelance Beauty Editor who specialises in packaging, ingredients and formulation, told Cosmetics Business.
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