[Code of Federal Regulations]
[Title 21 Volume 5]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR352.76]

[Page 283-284]
 
                        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 D--Testing Procedures
 
Sec. 352.76  Determination if a product is water resistant or very water resistant.

    The general testing procedures in Sec. 352.72 shall be used as part 
of the following tests, except where modified in this section. An indoor 
fresh water pool, whirlpool, and/or jacuzzi maintained at 23 to 32 
deg.C shall be used in these testing procedures. Fresh water is clean 
drinking water that meets the standards in 40 CFR part 141. The pool and 
air temperature and the relative humidity shall be recorded.
    (a) Procedure for testing the water resistance of a sunscreen 
product. For sunscreen products making the claim of ``water resistant,'' 
the label SPF shall be the label SPF value determined

[[Page 284]]

after 40 minutes of water immersion using the following procedure for 
the water resistance test:
    (1) Apply sunscreen product (followed by the waiting period after 
application of the sunscreen product indicated on the product labeling).
    (2) 20 minutes moderate activity in water.
    (3) 20-minute rest period (do not towel test sites).
    (4) 20 minutes moderate activity in water.
    (5) Conclude water test (air dry test sites without toweling).
    (6) Begin solar simulator exposure to test site areas as described 
in Sec. 352.73.
    (b) Procedure for testing a very water resistant sunscreen product. 
For sunscreen products making the claim of ``very water resistant,'' the 
label SPF shall be the label SPF value determined after 80 minutes of 
water immersion using the following procedure for the very water 
resistant test:
    (1) Apply sunscreen product (followed by the waiting period after 
application of the sunscreen product indicated on the product labeling).
    (2) 20 minutes moderate activity in water.
    (3) 20-minute rest period (do not towel test sites).
    (4) 20 minutes moderate activity in water.
    (5) 20-minute rest period (do not towel test sites).
    (6) 20 minutes moderate activity in water.
    (7) 20-minute rest period (do not towel test sites).
    (8) 20 minutes moderate activity in water.
    (9) Conclude water test (air dry test sites without toweling).
    (10) Begin solar simulator exposure to test site areas as described 
in Sec. 352.73.