21 CFR § 333.310
Acne active ingredients
June 25, 2020
The active ingredient of the product consists of any of the following:
(a) Benzoyl peroxide, 2.5 to 10 percent.
(b) Resorcinol, 2 percent, when combined with sulfur in accordance with §333.320(a).
(c) Resorcinol monoacetate, 3 percent, when combined with sulfur in accordance with §333.320(b).
(d) Salicylic acid, 0.5 to 2 percent.
(e) Sulfur, 3 to 10 percent.
(f) Sulfur, 3 to 8 percent, when combined with resorcinol or resorcinol monoacetate in accordance with §333.320.
[75 FR 9776, Mar. 4, 2010]