21 U.S.C. 321, 351, 352, 353, 355, 360, 371.
At 68 FR 33381, June 4, 2003, part 352 was stayed until further notice, effective June 4, 2004.
(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.
As used in this part:
(a)
(b)
(1)
(2)
(3)
(c)
(d)
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.
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 further notice. For the convenience of the user, the revised text is set forth as follows:
(f) Ensulizole up to 4 percent.
(g) Homosalate up to 15 percent.
(h) [Reserved]
(i) Meradimate up to 5 percent.
(j) Octinoxate up to 7.5 percent.
(k) Octisalate up to 5 percent.
(l) Octocrylene up to 10 percent.
(m) Oxybenzone up to 6 percent.
(n) Padimate O up to 8 percent.
The SPF of any combination product is measured by the testing procedures established in subpart D of this part.
(a)
(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 multiplied by 2.
(b)
(c) [Reserved]
At 67 FR 41823, June 20, 2002, § 352.20 was amended by revising paragraphs (a)(1) through (a)(2), effective Sept. 1, 2002. This amendment could not be incorporated because at 66 FR 67485, Dec. 31, 2001 the effective date was stayed until further notice. For the convenience of the user, the text is set forth as follows:
(a)
(2) Two or more sunscreen active ingredients identified in § 352.10(b), (c), (e), (g), (j) through (m), (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 multiplied by 2.
In addition to the statement of identity required in § 352.52, the following labeling statements shall be prominently placed on the principal display panel:
(a)
(2)
(b)
(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).”
(c)
(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 very water resistant sunscreen product testing procedures in § 352.76).”
(a)
(b)
(1)
(ii)
(iii)
(2)
(i)
(ii)
(iii)
(c)
(1)
(ii) “Stop use and ask a doctor if [bullet] rash or irritation develops and lasts”.
(2)
(d)
(1)
(ii) “[bullet] children under 6 months of age: ask a doctor”.
(2)
(3)
(4)
(e)
(i)
(ii)
(iii)
(2)
(f)
(1) The labeling shall meet the requirements of § 201.66(c) of this chapter except that the title, headings, and information described in § 201.66(c)(1), (c)(3), and (c)(7) may be omitted, and the headings, subheadings, and information described in § 201.66(c)(2), (c)(4), (c)(5), and (c)(6) may be presented as follows:
(i) The active ingredients (§ 201.66(c)(2) of this chapter) shall be listed in alphabetical order.
(ii) The heading and the indication required by § 201.66(c)(4) of this chapter may be limited to: “Use [in bold type] helps protect against sunburn.” For a lip protectant product, the heading and the indication required by § 201.66(c)(4) may be limited to: “Use [in bold type] helps protect against sunburn and chapped lips.”
(iii) The “external use only” warning in § 201.66(c)(5)(i) of this chapter may be omitted.
(iv) The subheadings in § 201.66(c)(5)(iii) through (c)(5)(vii) of this chapter may be omitted, provided the information after the heading “Warnings” states: “Keep out of eyes.” and “Stop use if skin rash occurs.”
(v) The warning in § 201.66(c)(5)(x) of this chapter may be limited to the following: “Keep out of reach of children.”
(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.
(2) The labeling shall be printed in accordance with the requirements of § 201.66(d) of this chapter except that any requirements related to § 201.66(c)(1), (c)(3), and (c)(7), and the horizontal barlines and hairlines described in § 201.66(d)(8), may be omitted.
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.
(a)
(b)
(1) In addition, the labeling of the product may contain any of the “other allowable statements” that are identified in the applicable monographs.
(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)
(d)
(a)
(b)
(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 preparation.
(c)
(1)
(2)
(3)
(4)
(5)
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.
(a)
(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.
(b)
(c)
(d)
(2)
(e)
(f)
(g)
(h)
(i)
(a)(1) The following erythema action spectrum shall be used to calculate the erythema effective exposure of a solar simulator:
V
V
V
(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:
(b)
(c)
SPF value =the ratio of erythema effective exposure (Joules per square meter) (MED(PS)) to the erythema effective exposure (Joules per square meter) (MED(US)).
(d)
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.
(a)
(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.
(b)
(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) 20-minute rest period (do not towel test sites).
(6) 20 minutes moderate activity in water.
(7) 20-minute rest period (do not towel test sites).
(8) 20 minutes moderate activity in water.
(9) Conclude water test (air dry test sites without toweling).
(10) Begin solar simulator exposure to test site areas as described in § 352.73.
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.