"WATERPROOF" CLAIM IN SUNSCREENS NOT ALLOWED UNDER TFM

"WATERPROOF" CLAIM IN SUNSCREENS NOT ALLOWED UNDER TFM because it "could be easily misconstrued by consumers" to mean that a product is resistant to water regardless of how much time is spent in the water, FDA decided in the OTC sunscreen tentative final monograph. Instead, FDA is proposing the terms "water resistant" for sunscreens that retain the same product category designation (PCD) after 40 minutes of water immersion and "very water resistant" for products that retain the same PCD after 80 minutes in the water. The TFM calls for the use of two SPF numbers on each "water resistant" and "very water resistant" product to indicate the initial SPF value after application and the SPF after immersion in water for either 40 or 80 minutes, depending upon the product claims. The SPF values should appear on the principal display panel of the product labeling, FDA said. The principal display panel for all "very water resistant" sunscreens, according to the TFM, should state "SPF = (insert SPF value before very water resistant testing) before" (select one of the following: 'sweating' or 'perspiring') "or going into the water," followed by "SPF = (insert SPF value resulting from very water resistant testing) after 80 minutes of" (select one of the following: 'sweating' or 'perspiring') "or activity in the water." Also, the statement "retains its sun protection for at least 80 minutes in the water" may be used on the principal display panel of "very water resistant" products. A "water resistant" sunscreen should state on the principal display panel the same information substituting 40 for 80. Products meeting the criteria for either "water resistant" or "very water resistant" are permitted to use the terms "sweat resistant" or "resists removal by sweating." In addition, the TFM allows the terms "perspiration" and "perspiring" to be substituted for "sweat" and "sweating." "Water resistant" or "very water resistant" products are required to bear the directions: "Adults and children 6 months of age and over: Apply" (select one or more of the following, as applicable: "liberally," "generously," "smoothly," or "evenly") (insert appropriate time interval, if a waiting period is needed) "before sun or water exposure. Reapply after" (select one of the following: "40 minutes" [if water resistant] or "80 minutes" [if very water resistant]) "of swimming or excessive" (select one of the following: "sweating" or "perspiring") "or anytime after towel drying. Children under 2 years of age should use sunscreen products with a minimum SPF of 4. Children under 6 months of age: consult a doctor." Sunscreens that make no claims pertaining to water resistance should bear the same statement omitting the appropriate time interval for a waiting period and the "40 minutes" or "80 minutes" after which a consumer should reapply. To test the water resistance of a sunscreen product, the TFM states that after applying the sunscreen, the waiting period indicated on the label must pass, followed by alternating 20 minute intervals of moderate activity in water and a rest period. The alternating intervals should continue for a total of either 40 or 80 minutes of water activity, depending on the claims. After completing the intervals, the test sites should air dry before beginning solar simulator exposure to the areas.