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  1. Cosmetics Labeling Regulations

Required Warning Statement for Tanning Products Without Sunscreen

The warning statement that FDA requires on tanning products that do not contain sunscreen is important for both consumers and manufacturers.

All suntanning preparations that do not contain sunscreen ingredients are required to carry the following warning statement on the label:

"Warning--This product does not contain a sunscreen and does not protect against sunburn. Repeated exposure of unprotected skin while tanning may increase the risk of skin aging, skin cancer, and other harmful effects to the skin even if you do not burn." (Title 21 of the Code of Federal Regulations, Section 740.19)

FDA is requiring this warning statement so that consumers are fully informed that such products do not provide protection from the sun.

The term "suntanning preparations" includes gels, creams, liquids, and other topical products that are intended to provide cosmetic effects on the skin while tanning through exposure to ultraviolet (UV) radiation (such as moisturizing or conditioning products) or to give the appearance of a tan by imparting color to the skin through the application of approved color additives, such as dihydroxyacetone, without the need for exposure to UV radiation.

Because such products include those sold for use at the beach or for use in tanning salons, consumers are strongly encouraged to read carefully the labeling of all tanning products to determine whether or not they provide protection against the harmful effects of UV radiation.

This required warning was published in the rulemaking for over-the-counter sunscreen drug products in the Federal Register May 21, 1999. The regulation became effective May 22, 2000.

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