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Title 21

Displaying title 21, up to date as of 9/16/2021. Title 21 was last amended 9/13/2021.

Title 21

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Subpart A - General Provisions
§ 352.1 Scope.

(a) An over-the-counter sunscreen drug product in a form suitable for topical administration is generally recognized as safe and effective and is not misbranded if it meets each condition in this part and each general condition established in § 330.1 of this chapter.

(b) References in this part to regulatory sections of the Code of Federal Regulations are to Chapter I of Title 21 unless otherwise noted.

§ 352.3 Definitions.

As used in this part:

(a) Minimal erythema dose (MED). The quantity of erythema-effective energy (expressed as Joules per square meter) required to produce the first perceptible, redness reaction with clearly defined borders.

(b) Product category designation (PCD). A labeling designation for sunscreen drug products to aid in selecting the type of product best suited to an individual's complexion (pigmentation) and desired response to ultraviolet (UV) radiation.

(1) Minimal sun protection product. A sunscreen product that provides a sun protection factor (SPF) value of 2 to under 12.

(2) Moderate sun protection product. A sunscreen product that provides an SPF value of 12 to under 30.

(3) High sun protection product. A sunscreen product that provides an SPF value of 30 or above.

(c) Sunscreen active ingredient. An active ingredient listed in § 352.10 that absorbs, reflects, or scatters radiation in the UV range at wavelengths from 290 to 400 nanometers.

(d) Sun protection factor (SPF) value. The UV energy required to produce an MED on protected skin divided by the UV energy required to produce an MED on unprotected skin, which may also be defined by the following ratio: SPF value = MED (protected skin (PS))/MED (unprotected skin (US)), where MED (PS) is the minimal erythema dose for protected skin after application of 2 milligrams per square centimeter of the final formulation of the sunscreen product, and MED (US) is the minimal erythema dose for unprotected skin, i.e., skin to which no sunscreen product has been applied. In effect, the SPF value is the reciprocal of the effective transmission of the product viewed as a UV radiation filter.