Food and Drug Administration, HHS § 352.20
Subpart A—General Provisions tected skin, i.e., skin to which no sun- screen product has been applied. In ef- § 352.1 Scope. fect, the SPF value is the reciprocal of (a) An over-the-counter sunscreen the effective transmission of the prod- drug product in a form suitable for top- uct viewed as a UV radiation filter. ical administration is generally recog- nized as safe and effective and is not Subpart B—Active Ingredients misbranded if it meets each condition in this part and each general condition § 352.10 Sunscreen active ingredients. established in § 330.1 of this chapter. The active ingredient of the product (b) References in this part to regu- consists of any of the following, within latory sections of the Code of Federal the concentration specified for each in- Regulations are to Chapter I of Title 21 gredient, and the finished product pro- unless otherwise noted. vides a minimum SPF value of not less than 2 as measured by the testing pro- § 352.3 Definitions. cedures established in subpart D of this As used in this part: part: (a) Minimal erythema dose (MED). The (a) Aminobenzoic acid (PABA) up to quantity of erythema-effective energy 15 percent. (expressed as Joules per square meter) (b) Avobenzone up to 3 percent. required to produce the first percep- (c) Cinoxate up to 3 percent. tible, redness reaction with clearly de- (d) [Reserved] fined borders. (e) Dioxybenzone up to 3 percent. (b) Product category designation (PCD). (f) Homosalate up to 15 percent. A labeling designation for sunscreen (g) [Reserved] drug products to aid in selecting the (h) Menthyl anthranilate up to 5 per- type of product best suited to an indi- cent. vidual’s complexion (pigmentation) (i) Octocrylene up to 10 percent. and desired response to ultraviolet (j) Octyl methoxycinnamate up to 7.5 (UV) radiation. percent. (1) Minimal sun protection product. A (k) Octyl salicylate up to 5 percent. sunscreen product that provides a sun (l) Oxybenzone up to 6 percent. protection factor (SPF) value of 2 to (m) Padimate O up to 8 percent. under 12. (n) Phenylbenzimidazole sulfonic (2) Moderate sun protection product. A acid up to 4 percent. sunscreen product that provides an (o) Sulisobenzone up to 10 percent. SPF value of 12 to under 30. (p) Titanium dioxide up to 25 percent. (3) High sun protection product. A sun- (q) Trolamine salicylate up to 12 per- screen product that provides an SPF cent. value of 30 or above. (r) Zinc oxide up to 25 percent. (c) Sunscreen active ingredient. An ac- tive ingredient listed in § 352.10 that ab- § 352.20 Permitted combinations of ac- sorbs, reflects, or scatters radiation in tive ingredients. the UV range at wavelengths from 290 The SPF of any combination product to 400 nanometers. is measured by the testing procedures (d) Sun protection factor (SPF) value. established in subpart D of this part. The UV energy required to produce an (a) Combinations of sunscreen active in- MED on protected skin divided by the gredients. (1) Two or more sunscreen ac- UV energy required to produce an MED tive ingredients identified in § 352.10(a), on unprotected skin, which may also be (c), (e), (f), and (h) through (r) may be defined by the following ratio: SPF combined with each other in a single value = MED (protected skin (PS))/ product when used in the concentra- MED (unprotected skin (US)), where tions established for each ingredient in MED (PS) is the minimal erythema § 352.10. The concentration of each ac- dose for protected skin after applica- tive ingredient must be sufficient to tion of 2 milligrams per square centi- contribute a minimum SPF of not less meter of the final formulation of the than 2 to the finished product. The fin- sunscreen product, and MED (US) is ished product must have a minimum the minimal erythema dose for unpro- SPF of not less than the number of
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