§352.52. Labeling of sunscreen drug products. — Inbound Citations

In addition to the statement of identity required in § 352.52, the following labeling statements shall be prominently placed on the principal display panel:

(2) For permitted combinations containing a sunscreen and a skin protectant identified in § 352.20(b), any or all of the applicable indications for sunscreens in § 352.52(b) and the indication for skin protectants in § 347.50(b)(2)(i) of this chapter should be used. For products marketed as a lip protectant, the indication in § 352.52(f)(1)(ii) should be used.

(vi) For a lip protectant product or lipstick, the warnings “Keep out of eyes” in § 352.52(f)(1)(iv) and “Keep out of reach of children” in § 352.52(f)(1)(v) and the directions in § 352.52(d) may be omitted.

(d) The labeling of the product states, under the heading “directions,” directions that conform to the directions established for each ingredient in the directions sections of the applicable OTC drug monographs, unless otherwise stated in this paragraph. When the time intervals or age limitations for administration of the individual ingredients differ, the directions for the combination product may not contain any dosage that exceeds those established for any individual ingredient in the applicable OTC drug monograph(s), and may not provide for use by any age group lower than the highest minimum age limit established for any individual ingredient. For permitted combinations containing a sunscreen and a skin protectant identified in § 352.20(b), the directions for sunscreens in § 352.52(d) should be used. For products marketed as a lip protectant or lipstick, § 352.52(d)(4) applies.

(d) The labeling of the product states, under the heading “directions,” directions that conform to the directions established for each ingredient in the directions sections of the applicable OTC drug monographs, unless otherwise stated in this paragraph. When the time intervals or age limitations for administration of the individual ingredients differ, the directions for the combination product may not contain any dosage that exceeds those established for any individual ingredient in the applicable OTC drug monograph(s), and may not provide for use by any age group lower than the highest minimum age limit established for any individual ingredient. For permitted combinations containing a sunscreen and a skin protectant identified in § 352.20(b), the directions for sunscreens in § 352.52(d) should be used. For products marketed as a lip protectant or lipstick, § 352.52(d)(4) applies.

(2) For permitted combinations containing a sunscreen and a skin protectant identified in § 352.20(b), any or all of the applicable indications for sunscreens in § 352.52(b) and the indication for skin protectants in § 347.50(b)(2)(i) of this chapter should be used. For products marketed as a lip protectant, the indication in § 352.52(f)(1)(ii) should be used.

(c) The labeling of the product states, under the heading “Warnings,” the warning(s) for each ingredient in the combination, as established in the warnings section of the applicable OTC drug monographs, except that the warning for skin protectants in § 347.50(c)(3) of this chapter is not required for permitted combinations containing a sunscreen and a skin protectant identified in § 352.20(b). For products marketed as a lip protectant or lipstick, § 352.52(f)(1)(iii), (f)(1)(iv) (except “Keep out of eyes,” which may be omitted), and (f)(1)(vi) apply.

(vi) For a lip protectant product or lipstick, the warnings “Keep out of eyes” in § 352.52(f)(1)(iv) and “Keep out of reach of children” in § 352.52(f)(1)(v) and the directions in § 352.52(d) may be omitted.

(c) The labeling of the product states, under the heading “Warnings,” the warning(s) for each ingredient in the combination, as established in the warnings section of the applicable OTC drug monographs, except that the warning for skin protectants in § 347.50(c)(3) of this chapter is not required for permitted combinations containing a sunscreen and a skin protectant identified in § 352.20(b). For products marketed as a lip protectant or lipstick, § 352.52(f)(1)(iii), (f)(1)(iv) (except “Keep out of eyes,” which may be omitted), and (f)(1)(vi) apply.

(vi) For a lip protectant product or lipstick, the warnings “Keep out of eyes” in § 352.52(f)(1)(iv) and “Keep out of reach of children” in § 352.52(f)(1)(v) and the directions in § 352.52(d) may be omitted.