FDA Set to Classify All Sunscreen Products as Drugs

By McCann, Jean | Drug Topics, January 25, 1993 | Go to article overview

FDA Set to Classify All Sunscreen Products as Drugs


McCann, Jean, Drug Topics


Expect a new look soon in the Eisunscreen section.

Having revolutionized the labeling on food products, the Food & Drug Administration is now moving toward a similar comprehensive labeling for sunscreens or any products, such as self-tanning agnts or lip balm, that promote themselves as being protective against the sun.

Under a new proposal expected to be out in March, products used at the beach will also have to carry a "Sun Alert" warning detailing the hazards of sun exposure and the fact that use of a sunscreen may protect the skin. Nonbeach products, such as hair spray containing sunscreen, will have to indicate that they are not for protection against the sun.

There will be some other changes, too, according to William Gilbertson, M.D., director of the FDA monograph review staff:

* Labels will have to spell out in detail who should use what product for what type of skin.

* SPFs, or sun protection factors, will be capped at 30 under the proposal, although there is some argument that higher numbers--up to 50--may be required for Type I Celtic skin.

* Sunscreens will not be allowed for children under 6 months of age without a doctor's prescription, "althouh," said Gilbertson, "I know there are baby sunscreens out there."

* The SPF for children from 6 months to 2 years of age will be required to be at least 4.

* No SPFs of 0 or 1 will be allowed.

* Products such as cocoa butter that are used to keep skin from drying after sun exposure will have to carry a new warning: "Does not contain a sunscreen."

Not allowed under the proposed labeling will be such claims as, "antiaging," "antiwrinkling," "water-proof," or "protects against skin cancer."

"We're not going to allow absolute terms like this," added Gilbertson. And while a manufacturer won't be able to say a product is "water-proof," it will be able to label a product "water resistant." It would also be all right to include a statement such as, "This product may prevent the harmful effects of the sun such as premature aging of the skin" instead of specific antiaging claims.

In comments made during the annual meeting of the American Academy of Dermatology in San Francisco, Gilbertson said that he expected new regulations to come down probably not before 1994, after public coents on the proposal are received and after various government agencies have their say. …

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