21 CFR §74.2333

1. (a)Identity and specifications. The color additive D&C Red No. 33 shall conform in identity and specifications to the requirements of § 74.1333(a) (1) and (b).
2. (b)Uses and restrictions. The color additive D&C Red No. 33 may be safely used for coloring cosmetic lip products in amounts not to exceed 3 percent total color by weight of the finished cosmetic products. D&C Red No. 33 may be safely used for coloring mouthwashes (including breath fresheners), dentifrices, and externally applied cosmetics in amounts consistent with current good manufacturing practice.
3. (c)Labeling requirements. The label of the color additive and any mixtures prepared therefrom intended solely or in part for coloring purposes shall conform to the requirements of § 70.25 of this chapter.
4. (d)Certification. All batches of D&C Red No. 33 shall be certified in accordance with regulations in part 80 of this chapter.