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Executive Summary

ESTEE LAUDER SUNSCREEN PRODUCTS ARE UNAPPROVED NEW DRUGS that are either not generally recognized as safe and effective for their labeled uses or misbranded in that their labeling fails to bear adequate directions for use, FDA Drugs & Biologics Office of Compliance Director Daniel Michels asserted in a Sept. 5 regulatory letter to the firm. The products cited by the agency include Estee Lauder Sun Golden Sun Tanning Milk, Golden Sunning Lotion, Ultra Screening Creme, Golden Sun Pre-Tanning Accelerator, Apres Tan Maintainer for Body, and Prescriptives Hand Smoother. Michels stated that the Estee Lauder products are regarded as drugs under the FD&C Act "because of statements in the labeling. . .which represent and suggest that the articles are intended for use in the prevention of sunburn or serious damage to the skin caused by sun exposure, prevention of premature aging and wrinkles, acceleration of the production of melanin, and similar claims." With regard to products that claim to help speed up the skin's production of melanin and thus contribute to greater protection from the sun, Michels declared: "We are not aware of any OTC drug product. . .with ingredients for the acceleration of the production of melanin either alone or in combination with sunscreen ingredients ultimately for the protection from the harmful effects of the sun. Neither are we aware of any substantial scientific evidence which establishes that these formulations are generally recognized as safe and effective for these uses." The agency further noted that all Estee Lauder sun products except "Golden Sun Pre-Tan Accelerator" contain the sunscreen ingredients butyl methoxydibenzoylmethane, and/or propyl methoxycinnamate, which FDA said "have not been marketed in the U.S. prior to Dec. 4, 1975 as sunscreen agents, nor to our knowledge is there any substantial scientific evidence that they are recognized as safe and effective for their intended uses." FDA also asserted that Estee Lauder may not use SPF designations higher than 15. Michels said FDA's OTC advisory review panel "made no recommendation for an SPF number higher than 15 to appear in the labeling of sunscreen drug products." Estee Lauder products bear designations of SPF 23 and SPF 19.

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