§ M020.20 Permitted combinations of active ingredients

Law · OTC Monograph M020.20 · posted 24 Sep 2021 · checked 30 Sep 2026 · Official source: accessdata.fda.gov

The SPF of any combination product is measured by the testing procedures established in § M020.80.

(a) Combinations of sunscreen active ingredients.

(1) Two or more sunscreen active ingredients identified in §§ M020.10(a), (c), (d), (e), (f), and (g) through (p) may be combined with each other in a single product when used in the concentrations established for each ingredient in § M020.10. The concentration of each active ingredient must be sufficient to contribute a minimum SPF of not less than 2 to the finished product. The finished product must have a minimum SPF of not less than the number of sunscreen active ingredients used in the combination multiplied by 2.

(2) Two or more sunscreen active ingredients identified in §§ M020.10(b), (c), (d), (f), (h) through (k), (m), and (o) may be combined with each other in a single product when used in the concentrations established for each ingredient in § M020.10. The concentration of each active ingredient must be sufficient to contribute a minimum SPF of not less than 2 to the finished product. The finished product must have a minimum SPF of not less than the number of sunscreen active ingredients used in the combination multiplied by 2.