[Code of Federal Regulations]
[Title 21, Volume 5]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR352.20]

[Page 276-277]
 
                        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--Table of Contents
 
                      Subpart B--Active Ingredients
 
Sec. 352.20  Permitted combinations of active ingredients.

    The SPF of any combination product is measured by the testing 
procedures established in subpart D of this part.
    (a) Combinations of sunscreen active ingredients. (1) Two or more 
sunscreen active ingredients identified in Sec. 352.10(a), (c), (e), 
(f), and (h) through (r) may be combined with each other in a single 
product when used in the concentrations established for each ingredient 
in Sec. 352.10. The concentration of each active ingredient must be 
sufficient to contribute a minimum SPF of not less

[[Page 277]]

than 2 to the finished product. The finished product must have a minimum 
SPF of not less than the number of sunscreen active ingredients used in 
the combination multiplied by 2.
    (2) Two or more sunscreen active ingredients identified in 
Sec. 352.10(b), (c), (e), (f), (i) through (l), (o), and (q) may be 
combined with each other in a single product when used in the 
concentrations established for each ingredient in Sec. 352.10. The 
concentration of each active ingredient must be sufficient to contribute 
a minimum SPF of not less than 2 to the finished product. The finished 
product must have a minimum SPF of not less than the number of sunscreen 
active ingredients used in the combination multiplied by 2.
    (b)-(c) [Reserved]