[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: 21CFR352.10]

[Page 290]
 
                        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.  352.10  Sunscreen active ingredients.


    The active ingredient of the product consists of any of the 
following, within the concentration specified for each ingredient, and 
the finished product provides a minimum SPF value of not less than 2 as 
measured by the testing procedures established in subpart D of this 
part:
    (a) Aminobenzoic acid (PABA) up to 15 percent.
    (b) Avobenzone up to 3 percent.
    (c) Cinoxate up to 3 percent.
    (d) [Reserved]
    (e) Dioxybenzone up to 3 percent.
    (f) Homosalate up to 15 percent.
    (g) [Reserved]
    (h) Menthyl anthranilate up to 5 percent.
    (i) Octocrylene up to 10 percent.
    (j) Octyl methoxycinnamate up to 7.5 percent.
    (k) Octyl salicylate up to 5 percent.
    (l) Oxybenzone up to 6 percent.
    (m) Padimate O up to 8 percent.
    (n) Phenylbenzimidazole sulfonic acid up to 4 percent.
    (o) Sulisobenzone up to 10 percent.
    (p) Titanium dioxide up to 25 percent.
    (q) Trolamine salicylate up to 12 percent.
    (r) Zinc oxide up to 25 percent.

[64 FR 27687, May 21, 1999]

    Effective Date Note: At 67 FR 41823, June 20, 2002, Sec.  352.10 was 
amended by revising paragraphs (f) through (n), 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.  352.10  Sunscreen active ingredients.

                                * * * * *

    (f) Ensulizole up to 4 percent.
    (g) Homosalate up to 15 percent.
    (h) [Reserved]
    (i) Meradimate up to 5 percent.
    (j) Octinoxate up to 7.5 percent.
    (k) Octisalate up to 5 percent.
    (l) Octocrylene up to 10 percent.
    (m) Oxybenzone up to 6 percent.
    (n) Padimate O up to 8 percent.

                                * * * * *