The US Food and Drug Administration is proposing new regulations on over-the-counter sunscreens in an effort to keep up with the latest scientific and safety information.
The proposal, announced Thursday, is available for public review and comment for the next 90 days and addresses the safety of common sunscreen ingredients, as well their dosage forms, sun protection factor (SPF) and broad-spectrum requirements. It also addresses labeling, aiming to make it easier for consumers to identify key product information.
“Since the initial evaluation of these products, we know much more about the effects of the sun and about sunscreen’s absorption through the skin,” FDA Commissioner Dr. Scott Gottlieb said in a statement.
Over-the-counter sunscreen drug products are regulated by the FDA under the Sunscreen Innovation Act, an expedited process put in place in 2014. Certain ingredients can be marketed without going through the new drug application process because they are generally considered to be safe.
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The proposed regulation would allow for some ingredients and formulations to continue to be marketed without new drug approvals, including zinc oxide, titanium oxide and sunscreens sold as sprays, oils, lotions, creams, gels, butters, pastes, ointment and sticks.
Two ingredients – PABA and trolamine salicylate – would not be on the list of ingredients generally recognized as safe and effective, and any product containing these would be considered a new drug and would have to be approved by the FDA before it is marketed.
For another list of 12 ingredients, the agency said there is insufficient data to decide on safety and appropriate regulation; as such, it has asked the sunscreen industry to conduct additional testing.