[Code of Federal Regulations]
[Title 21, Volume 5]
[Revised as of April 1, 2004]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR352.20]

[Page 292-293]
 
                        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 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 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]

[64 FR 27687, May 21, 1999]

    Effective Date Note: At 67 FR 41823, June 20, 2002, Sec. 352.20 was 
amended by revising paragraphs (a)(1) through (a)(2), effective Sept. 1, 
2002. This amendment could not be incorporated because at 66 FR 67485, 
Dec. 31, 2001 the effective date was stayed until further notice. For 
the convenience of the user, the text is set forth as follows:

Sec. 352.20  Permitted combinations of active ingredients.

                                * * * * *

    (a) Combinations of sunscreen active ingredients. (1) Two or more 
sunscreen active ingredients identified in Sec. 352.10(a), (c), (e), 
(f), (g), and (i) 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 than 2 to the 
finished product. The finished product must have a minimum SPF of not 
less

[[Page 293]]

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), (g), (j) through (m), (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.

                                * * * * *

    Effective Date Note: At 68 FR 33380, June 4, 2003, Sec. 352.20 was 
amended by adding paragraph (b), effective June 4, 2004. For the 
convenience of the user, the added text is set forth as follows:

Sec. 352.20  Permitted combinations of active ingredients.

                                * * * * *

    (b) Combinations of sunscreen and skin protectant active 
ingredients. Any single sunscreen active ingredient or any permitted 
combination of sunscreen active ingredients when used in the 
concentrations established for each ingredient in Sec. 352.10 may be 
combined with one or more skin protectant active ingredients identified 
in Sec. 347.10(a), (d), (e), (g), (h), (i), (k), (l), (m), and (r) of 
this chapter. The concentration of each sunscreen active ingredient must 
be sufficient to contribute a minimum SPF of not less that 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, and the product must be labeled according 
to Sec. 352.60.