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ATLANTA — The Food and Drug Administration on Tuesday said it added bemotrizinol to its list of permitted active ingredients, marking the first new UV filter to be cleared for over-the-counter sunscreens since the late 1990s.
Bemotrizinol helps protect against both ultraviolet A and B rays and has low levels of absorption through the skin into the body, the FDA said.
The agency said the ingredient is considered safe and effective for use by adults and children aged six months and older.
"Bemotrizinol has been used safely in Europe for decades, and FDA' action will increase competition and consumer confidence in sunscreen products," said Health and Human Services Secretary Robert F. Kennedy Jr.
The FDA finalized the decision within seven months of issuing its proposed order.
DSM Nutritional Products LLC had submitted an OTC monograph order request to add bemotrizinol, at concentrations up to 6%, as a new active ingredient in the OTC monograph for sunscreens.
An OTC monograph drug, such as a sunscreen product, can enter the market without an approved drug application if it meets certain requirements.
