§ 352.50 - Principal display panel of all sunscreen drug products.

§ 352.50 Principal display panel of all sunscreen drug products.

In addition to the statement of identity required in § 352.52, the following labeling statements shall be prominently placed on the principal display panel:

(a) For products that do not satisfy the water resistant or very water resistant sunscreen product testing procedures in § 352.76 -

(1) For products with SPF values up to 30. “SPF (insert tested SPF value of the product up to 30).”

(2) For products with SPF values over 30. “SPF 30” (select one of the following: “plus” or “ + ”). Any statement accompanying the marketed product that states a specific SPF value above 30 or similar language indicating a person can stay in the sun more than 30 times longer than without sunscreen will cause the product to be misbranded under section 502 of the Federal Food, Drug, and Cosmetic Act (the act).

(b) For products that satisfy the water resistant sunscreen product testing procedures in § 352.76.

(1) (Select one of the following: “Water,” “Water/Sweat,” or “Water/Perspiration”) “Resistant.”

(2) “SPF (insert SPF value of the product, as stated in paragraph (a)(1) or (a)(2) of this section, after it has been tested using the water resistant sunscreen product testing procedures in § 352.76).”

(c) For products that satisfy the very water resistant sunscreen product testing procedures in § 352.76.

(1) “Very” (select one of the following: “Water,” “Water/Sweat,” or “Water/Perspiration”) “Resistant.”

(2) “SPF (insert SPF value of the product, as stated in paragraph (a)(1) or (a)(2) of this section, after it has been tested using the very water resistant sunscreen product testing procedures in § 352.76).”