[Code of Federal Regulations]
[Title 21, Volume 5]
[Revised as of April 1, 2006]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR352.50]

[Page 291]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 352_SUNSCREEN DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE [STAYED 
INDEFINITELY]--Table of Contents
 
                           Subpart C_Labeling
 
Sec.  352.50  Principal display panel of all sunscreen drug products.


    In addition to the statement of identity required in Sec.  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 Sec.  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 Sec.  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 Sec.  352.76).''
    (c) For products that satisfy the very water resistant sunscreen 
product testing procedures in Sec.  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 Sec.  
352.76).''

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