---
kind: "section"
citation: "21 C.F.R. § 333.310"
title: "21"
number: "333.310"
heading: "Acne active ingredients."
url: "https://uscodex.org/cfr/21/333.310"
---

# §333.310. Acne active ingredients.


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)](/cfr/21/333.320.md?p=a).
- (c) Resorcinol monoacetate, 3 percent, when combined with sulfur in accordance with [§ 333.320(b)](/cfr/21/333.320.md?p=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](/cfr/21/333.320.md).

## Notes

### Amendments

[75 FR 9776, Mar. 4, 2010]

### Source

Source: 56 FR 41019, Aug. 16, 1991, unless otherwise noted.

### Authority

Authority: 21 U.S.C. 321, 351, 352, 353, 355, 360, 371.

### Source

Source: 52 FR 47322, Dec. 11, 1987, unless otherwise noted.

### Amendments

[75 FR 9776, Mar. 4, 2010]