§352.10. Sunscreen active ingredients.
21 C.F.R. § 352.10
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:
Aminobenzoic acid (PABA) up to 15 percent.
Avobenzone up to 3 percent.
Cinoxate up to 3 percent.
[Reserved]
Dioxybenzone up to 3 percent.
Homosalate up to 15 percent.
[Reserved]
Menthyl anthranilate up to 5 percent.
Octocrylene up to 10 percent.
Octyl methoxycinnamate up to 7.5 percent.
Octyl salicylate up to 5 percent.
Oxybenzone up to 6 percent.
Padimate O up to 8 percent.
Phenylbenzimidazole sulfonic acid up to 4 percent.
Sulisobenzone up to 10 percent.
Titanium dioxide up to 25 percent.
Trolamine salicylate up to 12 percent.
Zinc oxide up to 25 percent.
Notes, amendments, and revision history
Amendments
[64 FR 27687, May 21, 1999]
Authority
Authority: 21 U.S.C. 321, 351, 352, 353, 355, 360, 371.
Source
Source: 64 FR 27687, May 21, 1999, unless otherwise noted.
Amendments
[64 FR 27687, May 21, 1999]