OTC SUNSCREEN LABELING MUST DISPLAY "SUN ALERT" WARNING

OTC SUNSCREEN LABELING MUST DISPLAY "SUN ALERT" WARNING in a product's principal display panel, the OTC sunscreen tentative final monograph says. Any variation of the alert that does not point out the relationship between skin aging or skin cancer and sun exposure will cause FDA to classify the product as "misbranded," the agency said. The proposed warning reads: "SUN ALERT: The sun causes skin damage. Regular use of sunscreens over the years may reduce the chance of skin damage, some types of skin cancer, and other harmful effects due to the sun." Until the final rule for OTC sunscreen drug products is published, sunscreen manufacturers may use either the "SUN ALERT" warning or the statement recommended by FDA's topical analgesic panel in its 1978 report, which reads: "Regular use over the years of this product may help prevent premature aging of the skin and skin cancer, due to long-term overexposure of the sun." Product Category Designation (PCD) labeling, which groups products into five categories by their SPF values, is optional under the TFM. "Although PCD labeling may provide useful information to the consumer, it is not necessary for the safe and/or effective use of the product provided an SPF value is included in the products labeling," FDA explained. Products with active ingredients that provide SPF 2 to under 4 can bear the PCD for a "Minimal Sun Protection Product"; products with SPFs from 4 to under 8 can be labeled "Moderate Sun Protection Product"; and SPF 8 to under 12 is a "High Sun Protection Product." A "Very High Sun Protection Product" has an SPF of 12 to under 20 and an "Ultra High Sun Protection Product" has an SPF between 20 and 30. Products containing any of the active ingredients mentioned in the monograph must be labeled "sunscreen." Other possible labeling includes: (Select one of the following: "Filters" or "Screens") "out the sun's" (Select one of the following: "burning" or "harsh and often harmful") "rays to prevent sunburn"; "Allows you to stay in the sun up to (insert SPF up to 30) times longer than without sunscreen protection"; "Provides up to (insert SPF up to 30) times your natural protection from sunburn"; (Select one of the following: "Filters" or "Screens") "out the" (Select one of the following: "sun's rays," "sun's harsh rays," or "sun's harmful rays") "to help prevent" (Select one of the following: "lip damage," "skin damage," "freckling," or "uneven coloration"); and (Select one of the following: "Protects from" or "Shields from") (Select one of the following: "the harmful rays of the sun" or "the sun") "to help prevent" (Select one or more of the following: "lip damage," "skin damage," "freckling," or "uneven coloration"). The Recommended Sunscreen Product Guide also should be listed on the principal display panel of sunscreen products. The guide recommends SPF values for specific skin types based on their reaction to the sun. All sunscreen products must bear the warnings: "For external use only, not to be swallowed"; "Avoid contact with the eyes. If contact occurs, rinse eyes thoroughly with water"; "Discontinue use if signs of irritation or rash appear. If irritation or rash persists, consult a doctor." All sunscreen labels regardless of SPF additionally are required to state that children under two years of age use sunscreen products with a minimum SPF of 4 and that a doctor be consulted for children under 6 months. Additional indications may be used that correspond to the five PCDs. Products in the five categories can be said to provide minimal, moderate, high, very high or the most protection against sunburn, depending on their SPFs. The three lowest ranges of protection can state, "Prolongs exposure time before sunburn occurs" and "Permits" (select one of the following: "tanning" or "suntanning") "and" (select one of the following: "reduces chance of" or "minimizes") "sunburning." The SPF 12 to under 20 category can state, "Prevents sunburn and limits tanning," and the highest protection category may say "Prevents tanning and sunburn." Other additional indications for the lowest SPF range are "Helps to protect skin against sunburn while permitting tanning" and "Helps prevent sunburn on limited exposure of untanned skin." The SPF 4 to under 8 category can use the same statement substituting the word "moderate" for "limited." SPF 8 to under 12 products can state "Helps prevent sunburn" and both SPF 8 to under 12 and SPF 12 to under 20 can claim "For sunsensitive skin." The SPF 20 to 30 category can state "For highly sunsensitive skin." Claims of degree of protection also vary depending on the PCD. "High protection," "Very high protection" and "The most protection" against "sunburn for blondes, redheads and fairskinned persons" can appear on the labeling of products with SPFs 8 and above. The "ultra" PCD category is allowed to say "Provides the highest degree of" (select one of the following: "sunburn" or "sunscreen") "protection and permits no tanning" on labeling. Products with SPFs 12 to 30 that contain up to 25% of the active sunscreen ingredient titanium dioxide may be labeled a "sunblock" and may state: "Reflects the burning rays of the sun." FDA is requiring in the TFM that suntanning preparations that do not contain a sunscreen must state on the label: "Warning -- This product does not contain a sunscreen and does not protect against sunburn." The warning also applies to sunless tanning products, which have been classified as drugs by FDA in warning letters to a number of manufacturers. Labeling for permitted combinations of active ingredients should include a statement of identity, indications, warnings and directions for use for each active ingredient. These may be combined to eliminate repeated words or phrases so that the resulting information is clear. Combination products containing lawsone up to .25% with dihydroxyacetone up to 3% must state on the label, "This product consists of two solutions. Do not mix the contents of the two solutions. Use both solutions; one alone will not provide protection," the TFM says. These products also must state "Use only on skin free of rash and abrasions" and "May stain clothing when freshly applied." Addressing the ingredient aminobenzoic acid (PABA), the agency noted that some consumers experience adverse reactions, mostly dermal, to the ingredient. However, products containing the ingredient do not have to carry any special labeling. The commonly used abbreviation PABA should not be substituted for the ingredient's full name, the TFM directs. FDA is seeking comments on what should appear on labeling concerning vitamin D[3] suppression associated with sunscreen use. The agency said it does not support a warning statement because it may deter the use of sunscreens in children.