FDA trimmed the proposed sun protection categories to minimum, moderate, or high and did away with obsolete or misleading terms such as "sunblock," "waterproof," "all-day protection," and "visible and/or infrared light protection." It also added a new SPF (sun protection factor) of "30 plus" (or "30+"). Sunscreen labels also must contain a "Sun Alert" statement reflecting the important role of sunscreens in a total program to reduce the harmful effects of the sun. The statement reads: "Sun alert: Limiting sun exposure, wearing protective clothing and using sunscreens may reduce the risks of skin aging, skin cancer and other harmful effects of the sun." Tanning preparations that do not contain sunscreen ingredients must display a specifically worded warning to that effect. Sunscreen manufacturers have 24 months to comply with the new labeling regulations, while those making cosmetic tanning products that do not contain a sunscreen must add the required warning within 12 months. FDA is still evaluating claims related to ultraviolet protection.
Sunscreen labeling changes
New regulations on sun protection products are designed to better inform consumers. The regulations call for uniform, streamlined labeling on all OTC sunscreen products, including sunscreen-cosmetic combinations.
Jun 30, 1999
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