Title 21 CFR reference

(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.

The active ingredient of the product consists of any of the following, within the concentration specified for each ingredient, and the finished product provides a minimum SPF value of not less than 2 as measured by the testing procedures established in subpart D of this part: (a) Aminobenzoic acid (PABA) up to 15 percent. (b) Avobenzone up to 3 percent. (c) Cinoxate up to 3 percent. (d) [Reserved] (e) Dioxybenzone up to 3 percent. (f) Homosalate up to 15 percent. (g) [Reserved] (h) Menthyl anthranilate up to 5 percent. (i) Octocrylene up to 10 percent. (j) Octyl methoxycinnamate up to 7.5 percent. (k) Octyl salicylate up to 5 percent. (l) Oxybenzone up to 6 percent. (m) Padimate O up to 8 percent. (n) Phenylbenzimidazole sulfonic acid up to 4 percent. (o) Sulisobenzone up to 10 percent. (p) Titanium dioxide up to 25 percent. (q) Trolamine salicylate up to 12 percent. (r) Zinc oxide up to 25 percent. [64 FR 27687, May 21, 1999] At 67 FR 41823, June 20, 2002, § 352.10 was amended by revising paragraphs (f) through (n), effective Sept. 1, 2002. This amendment could not be incorporated because at 66 FR 67485, Dec. 31, 2001, the effective date was stayed until…

The SPF of any combination product is measured by the testing procedures established in subpart D of this part. Combinations of sunscreen active ingredients.(a) (1) Two or more sunscreen active ingredients identified in § 352.10(a), (c), (e), (f), and (h) through (r) may be combined with each other in a single product when used in the concentrations established for each ingredient in § 352.10. 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 § 352.10(b), (c), (e), (f), (i) through (l), (o), and (q) may be combined with each other in a single product when used in the concentrations established for each ingredient in § 352.10. 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…

As used in this part: Minimal erythema dose (MED).(a) The quantity of erythema-effective energy (expressed as Joules per square meter) required to produce the first perceptible, redness reaction with clearly defined borders. Product category designation (PCD).(b) 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. Minimal sun protection product.(1) A sunscreen product that provides a sun protection factor (SPF) value of 2 to under 12. Moderate sun protection product.(2) A sunscreen product that provides an SPF value of 12 to under 30. High sun protection product.(3) A sunscreen product that provides an SPF value of 30 or above. Sunscreen active ingredient.(c) An active ingredient listed in § 352.10 that absorbs, reflects, or scatters radiation in the UV range at wavelengths from 290 to 400 nanometers. Sun protection factor (SPF) value.i.e.(d) 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…

In addition to the statement of identity required in § 352.52, the following labeling statements shall be prominently placed on the principal display panel: For products that do not satisfy the water resistant or very water resistant sunscreen product testing procedures in § 352.76For products with SPF values up to 30.(a) —(1) “SPF (insert tested SPF value of the product up to 30).” For products with SPF values over 30.(2) “SPF 30” (select one of the following: “plus” or “ + ”). Any statement accompanying the marketed product that states a specific SPF value above 30 or similar language indicating a person can stay in the sun more than 30 times longer than without sunscreen will cause the product to be misbranded under section 502 of the Federal Food, Drug, and Cosmetic Act (the act). For products that satisfy the water resistant sunscreen product testing procedures in § 352.76.(b) (1) (Select one of the following: “Water,” “Water/Sweat,” or “Water/Perspiration”) “Resistant.” (2) “SPF (insert SPF value of the product, as stated in paragraph (a)(1) or (a)(2) of this section, after it has been tested using the water resistant sunscreen product testing procedures in § 352.76).”…

Statement of identity.(a) The labeling of the product contains the established name of the drug, if any, and identifies the product as a “sunscreen.” Indications.(b) The labeling of the product states, under the heading “Uses,” all of the phrases listed in paragraph (b)(1) of this section that are applicable to the product and may contain any of the additional phrases listed in paragraph (b)(2) of this section, as appropriate. Other truthful and nonmisleading statements, describing only the uses that have been established and listed in this paragraph (b), may also be used, as provided in § 330.1(c)(2) of this chapter, subject to the provisions of section 502 of the act relating to misbranding and the prohibition in section 301(d) of the act against the introduction or delivery for introduction into interstate commerce of unapproved new drugs in violation of section 505(a) of the act. For products containing any ingredient in § 352.10.1(1) (i) “[bullet] helps prevent sunburn [bullet] higher SPF gives more sunburn protection”. For products that satisfy the water resistant testing procedures identified in § 352.76.(ii) “[bullet] retains SPF after 40 minutes of” (select one or more…

Statements of identity, indications, warnings, and directions for use, respectively, applicable to each ingredient in the product may be combined to eliminate duplicative words or phrases so that the resulting information is clear and understandable. Statement of identity.(a) For a combination drug product that has an established name, the labeling of the product states the established name of the combination drug product, followed by the statement of identity for each ingredient in the combination, as established in the statement of identity sections of the applicable OTC drug monographs. For a combination drug product that does not have an established name, the labeling of the product states the statement of identity for each ingredient in the combination, as established in the statement of identity sections of the applicable OTC drug monographs. Indications.(b) The labeling of the product states, under the heading “Uses,” the indication(s) for each ingredient in the combination as established in the indications sections of the applicable OTC drug monographs, unless otherwise stated in this paragraph. Other truthful and nonmisleading statements, describing only the indications…

Laboratory validation.i.e.(a) A standard sunscreen shall be used concomitantly in the testing procedures for determining the SPF value of a sunscreen drug product to ensure the uniform evaluation of sunscreen drug products. The standard sunscreen shall be an 8-percent homosalate preparation with a mean SPF value of 4.47 (standard deviation = 1.279). In order for the SPF determination of a test product to be considered valid, the SPF of the standard sunscreen must fall within the standard deviation range of the expected SPF (, 4.47 ±1.279) and the 95-percent confidence interval for the mean SPF must contain the value 4. Preparation of the standard homosalate sunscreen.(b) (1) The standard homosalate sunscreen is prepared from two different preparations (preparation A and preparation B) with the following compositions: (2) Preparation A and preparation B are heated separately to 77 to 82 °C, with constant stirring, until the contents of each part are solubilized. Add preparation A slowly to preparation B while stirring. Continue stirring until the emulsion formed is cooled to room temperature (15 to 30 °C). Add sufficient purified water to obtain 100 grams of standard sunscreen…

A solar simulator used for determining the SPF of a sunscreen drug product should be filtered so that it provides a continuous emission spectrum from 290 to 400 nanometers similar to sunlight at sea level from the sun at a zenith angle of 10° it has less than 1 percent of its total energy output contributed by nonsolar wavelengths shorter than 290 nanometers; and it has not more than 5 percent of its total energy output contributed by wavelengths longer than 400 nanometers. In addition, a solar simulator should have no significant time-related fluctuations in radiation emissions after an appropriate warmup time, and it should have good beam uniformity (within 10 percent) in the exposure plane. To ensure that the solar simulator delivers the appropriate spectrum of UV radiation, it must be measured periodically with an accurately-calibrated spectroradiometer system or equivalent instrument.

Selection of test subjects (male and female).(a) (1) Only fair-skin subjects with skin types I, II, and III using the following guidelines shall be selected: (2) A medical history shall be obtained from all subjects with emphasis on the effects of sunlight on their skin. Ascertain the general health of the individual, the individual's skin type (I, II, or III), whether the individual is taking medication (topical or systemic) that is known to produce abnormal sunlight responses, and whether the individual is subject to any abnormal responses to sunlight, such as a phototoxic or photoallergic response. Test site inspection.(b) The physical examination shall determine the presence of sunburn, suntan, scars, active dermal lesions, and uneven skin tones on the areas of the back to be tested. The presence of nevi, blemishes, or moles will be acceptable if in the physician's judgment they will not interfere with the study results. Excess hair on the back is acceptable if the hair is clipped or shaved. Informed consent.(c) Legally effective written informed consent must be obtained from all individuals. Test site delineationTest site area.(d) —(1) A test site area serves as an area…

(a)(1) The following erythema action spectrum shall be used to calculate the erythema effective exposure of a solar simulator: (2) The data contained in this action spectrum are to be used as spectral weighting factors to calculate the erythema effective exposure of a solar simulator as follows: Determination of MED of the unprotected skin.n(b) A series of UV radiation exposures expressed as Joules per square meter (adjusted to the erythema action spectrum calculated according to § 352.73(a)) is administered to the subsite areas on each subject with an accurately calibrated solar simulator. A series of five exposures shall be administered to the untreated, unprotected skin to determine the subject's inherent MED. The doses selected shall be a geometric series represented by (1.25 ), wherein each exposure time interval is 25 percent greater than the previous time to maintain the same relative uncertainty (expressed as a constant percentage), independent of the subject's sensitivity to UV radiation, regardless of whether the subject has a high or low MED. Usually, the MED of a person's unprotected skin is determined the day prior to testing a product. This MED(US) shall be used in…

The general testing procedures in § 352.72 shall be used as part of the following tests, except where modified in this section. An indoor fresh water pool, whirlpool, and/or jacuzzi maintained at 23 to 32 °C shall be used in these testing procedures. Fresh water is clean drinking water that meets the standards in 40 CFR part 141. The pool and air temperature and the relative humidity shall be recorded. Procedure for testing the water resistance of a sunscreen product.(a) For sunscreen products making the claim of “water resistant,” the label SPF shall be the label SPF value determined after 40 minutes of water immersion using the following procedure for the water resistance test: (1) Apply sunscreen product (followed by the waiting period after application of the sunscreen product indicated on the product labeling). (2) 20 minutes moderate activity in water. (3) 20-minute rest period (do not towel test sites). (4) 20 minutes moderate activity in water. (5) Conclude water test (air dry test sites without toweling). (6) Begin solar simulator exposure to test site areas as described in § 352.73. Procedure for testing a very water resistant sunscreen product.(b) For sunscreen…

The formulation or mode of administration of certain products may require modification of the testing procedures in this subpart. In addition, alternative methods (including automated or in vitro procedures) employing the same basic procedures as those described in this subpart may be used. Any proposed modification or alternative procedure shall be submitted as a petition in accord with § 10.30 of this chapter. The petition should contain data to support the modification or data demonstrating that an alternative procedure provides results of equivalent accuracy. All information submitted will be subject to the disclosure rules in part 20 of this chapter.