SUNSCREEN-CONTAINING LIPSTICKS, LIP BALMS, MAKEUP AND SKIN PREPS ARE DRUGS

SUNSCREEN-CONTAINING LIPSTICKS, LIP BALMS, MAKEUP AND SKIN PREPS ARE DRUGS under FDA's OTC sunscreen tentative final monograph published in the May 12 Federal Register. FDA stated in the TFM that the inclusion of a sunscreen active ingredient in a "nonbeach" product intended to protect the skin from harmful effects of the sun "comes within the definition of a drug" under the FD&C Act. However, the agency makes some exceptions from the warnings required for "beach" sunscreens. FDA noted that "nonbeach" products may "also be regulated, but not solely, as cosmetics." Claims made on labeling or promotional materials that would cause a sunscreen-containing product to be designated a drug include the terms "sunscreen" or "SPF," an SPF value, or claims referring to therapeutic attributes of sunscreen ingredients, the TFM says. These therapeutic claims include "shields from the sun," "blocks out the rays of the sun," "protects from the sun," "protects against UV rays," "prevents freckling," "prevents redness," or "prevents uneven coloration." Other claims that are unacceptable for cosmetic product labeling are: "prevent or protect against wrinkling," "protects against UVA/UVB," "shields the skin against specific factors that accelerate the signs of skin aging," "helps to acquire an even tan," "permits tanning" and "protects against premature aging, skin aging, skin lesions, and skin cancer" with or without stating "due to the sun," according to the TFM. The TFM calls for the following indications on the labeling of "nonbeach" sunscreen-containing products: "(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 or more 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')." Products intended for both drug and cosmetic use are required in the TFM to bear indications for sunscreen drug products but also may be labeled for cosmetic use. Cosmetic claims may not appear within the boxed area designated "APPROVED USES" but may appear elsewhere. The TFM notes that "commingled" drug and cosmetic claims "should be appropriately described so that consumers will more readily be able to differentiate the drug aspects from the cosmetic aspects of such labeling." If the commingled labeling claims are confusing, the TFM states, the product's labeling "could be misleading within the meaning of the [FD&C] act and misbranded under sections . . . of the act." Labeling for all sunscreen-containing products must contain the warning: "Discontinue use if signs of irritation or rash appear. If irritation or rash persists, consult a doctor." Sunscreen-containing drug products that may be used near the eyes will be required to display the warning: "Avoid contact with the eyes. If contact occurs, rinse eyes thoroughly with water." Lip balms containing sunscreens also must bear the warning because they may be used by consumers on other parts of the face such as the nose or near the eyes, according to the TFM. The TFM does not require lip balms and sticks to carry the warning: "For external use only, not to be swallowed" since, FDA noted, some of these products may be inadvertantly swallowed during normal use. Lip balms and skin preparations also must carry the statement: "Adults and children 6 months of age and over: Apply liberally as often as necessary. 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." Product category designation statements, which have been designed by FDA to assist consumers in selecting a product suited to their particular skin type, are optional for both "nonbeach" sunscreen-containing and "beach" sunscreens. Labeling of sunscreen-containing cosmetics may not give an SPF value or use the term "sunscreen" unless it is qualified with a description of the cosmetic benefit related to the sunscreen. For example, acceptable labeling of a hair care product with sunscreen could state that the product "contains a sunscreen to protect the hair from the damaging effects of sunning." If there are other instances where the nontherapeutic use of a sunscreen should be included in labeling, the TFM states, manufacturers should inform FDA in comments to this notice. A suntanning product that does not contain a sunscreen may be designated a cosmetic by FDA under the TFM. However, it must display the following: "Warning -- This product does not contain a sunscreen and does not protect against sunburn." Manufacturers are not permitted to label tanning products that do not contain a sunscreen ingredient with an SPF value of 0 or 1, FDA said, since they could be misleading to consumers. "Sunscreen labeling relating to skin aging caused by the sun that does not clearly link the cause to the effect is unacceptable," the TFM states. The TFM lists a number of examples of unacceptable language related to premature aging of the skin, including: (1) Statements that include only the term "anti-aging"; (2) "Helps prevent lines and wrinkles by guarding against UV damage;" (3) Stops, reverses, or reduces the signs of aging; (4) "Helps to minimize the visible signs of aging" when used in conjunction with a sunscreen ingredient; (5) "Prevent (or reduce) skin aging caused by exposure to ultraviolet rays;" and (6) "Reverses aging of the skin caused by exposure to the sun." The agency is calling for comments on these and related statements that might be used in OTC sunscreen drug product labeling. FDA is proposing in the TFM that the term "anti-aging" not be allowed in labeling or in the product names of OTC sunscreen drug products. Any such claim would be considered Category II under the TFM. Also listed in the TFM are examples of acceptable language regarding premature aging of the skin: (1) "Sunscreen may reduce the chance of skin aging caused by exposure to the sun"; (2) "While biological aging is inevitable, sunscreen may help protect skin from aging caused by exposure to ultraviolet radiation from the sun"; (3) "Skin can age prematurely from exposure to the sun. Sunscreen may help reduce the chance of this type of aging"; and (4) "May help inhibit the signs of skin aging caused by exposure to ultraviolet rays from the sun." Concerning skin cancer-related labeling claims, FDA said such claims should be "especially limited and carefully stated." The agency noted that "it is very important that the labeling of sunscreen drug products not include any phrases or terms that may induce a false sense of security in sunscreen users." FDA pointed to Eclipse Labs' Skin Cancer Garde sunscreen product labeling as misleading because "consumers may be led to believe that use of the product will absolutely prevent cancer, when such is not the case." Acceptable labeling would be: "May reduce the chance of some kinds of skin cancers caused by exposure to the sun that would otherwise appear 20 years from now" and "Regular, everyday use of this product from childhood on, may reduce the chance of some types of skin cancers caused by exposure to the sun."