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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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The information on this page is current as of April 1 2016.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 5]
[Revised as of April 1, 2016]
[CITE: 21CFR352.50]



TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER D--DRUGS FOR HUMAN USE

PART 352 -- SUNSCREEN DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE [STAYED INDEFINITELY]

Subpart C--Labeling

Sec. 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)."

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