Home
gpo.gov
govinfo.gov

e-CFR Navigation Aids

Browse

Simple Search

Advanced Search

 — Boolean

 — Proximity

 

Search History

Search Tips

Corrections

Latest Updates

User Info

FAQs

Agency List

Incorporation By Reference

eCFR logo

Related Resources

Electronic Code of Federal Regulations

We invite you to try out our new beta eCFR site at https://ecfr.federalregister.gov. We have made big changes to make the eCFR easier to use. Be sure to leave feedback using the Feedback button on the bottom right of each page!

e-CFR data is current as of March 2, 2021

Title 21Chapter ISubchapter DPart 352 → Subpart B


Title 21: Food and Drugs
PART 352—SUNSCREEN DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE [STAYED INDEFINITELY]


Subpart B—Active Ingredients


Contents
§352.10   Sunscreen active ingredients.
§352.20   Permitted combinations of active ingredients.

return arrow Back to Top

§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, §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 revised text is set forth as follows:

§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.

*   *   *   *   *

return arrow Back to Top

§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 §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 §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 §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 §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) 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 §352.10 may be combined with one or more skin protectant active ingredients identified in §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 §352.60.

(c) [Reserved]

[64 FR 27687, May 21, 1999, as amended at 68 FR 33380, June 4, 2003]

Effective Date Note: At 67 FR 41823, June 20, 2002, §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:

§352.20   Permitted combinations of active ingredients.

*   *   *   *   *

(a) Combinations of sunscreen active ingredients. (1) Two or more sunscreen active ingredients identified in §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 §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 §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 §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.

*   *   *   *   *

return arrow Back to Top

Need assistance?