Source:
64 FR 27687, May 21, 1999, unless otherwise noted.
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.
Subpart B—Active Ingredients
§ 352.10 Sunscreen active ingredients.
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]
§ 352.20 Permitted combinations of active ingredients.
The SPF of any combination product is measured by the testing procedures established in subpart D of this part.
(a) Combinations of sunscreen active ingredients.
(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 multiplied by 2.
(b) Combinations of sunscreen and skin protectant active ingredients. Any single sunscreen active ingredient or any permitted combination of sunscreen active ingredients when used in the concentrations established for each ingredient in § 352.10 may be combined with one or more skin protectant active ingredients identified in § 347.10(a), (d), (e), (g), (h), (i), (k), (l), (m), and (r) of this chapter. The concentration of each sunscreen active ingredient must be sufficient to contribute a minimum SPF of not less that 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, and the product must be labeled according to § 352.60.
(c) [Reserved]
[64 FR 27687, May 21, 1999, as amended at 68 FR 33380, June 4, 2003]
Subpart C—Labeling
§ 352.50 Principal display panel of all sunscreen drug products.
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) For products that do not satisfy the water resistant or very water resistant sunscreen product testing procedures in § 352.76 —
(1) For products with SPF values up to 30. “SPF (insert tested SPF value of the product up to 30).”
(2) For products with SPF values over 30. “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).
(b) For products that satisfy the water resistant sunscreen product testing procedures in § 352.76.
(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).”
(c) For products that satisfy the very water resistant sunscreen product testing procedures in § 352.76.
(1) “Very” (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 very water resistant sunscreen product testing procedures in § 352.76).”
§ 352.52 Labeling of sunscreen drug products.
(a) Statement of identity. The labeling of the product contains the established name of the drug, if any, and identifies the product as a “sunscreen.”
(b) Indications. 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.
(1) For products containing any ingredient in § 352.10.
(i) “[bullet][1] helps prevent sunburn [bullet] higher SPF gives more sunburn protection”.
(ii) For products that satisfy the water resistant testing procedures identified in § 352.76. “[bullet] retains SPF after 40 minutes of” (select one or more of the following: “activity in the water,” “sweating,” or “perspiring”).
(iii) For products that satisfy the very water resistant testing procedures identified in § 352.76. “[bullet] retains SPF after 80 minutes of” (select one or more of the following: “activity in the water,” “sweating,” or “perspiring”).
(2) Additional indications. In addition to the indications provided in paragraph (b)(1) of this section, the following may be used for products containing any ingredient in § 352.10:
(i) For products that provide an SPF of 2 to under 12. Select one or both of the following: [“[bullet]” (select one of the following: “provides minimal,” “provides minimum,” “minimal,” or “minimum”) “protection against” (select one of the following: “sunburn” or “sunburn and tanning”)], or “[bullet] for skin that sunburns minimally”.
(ii) For products that provide an SPF of 12 to under 30. Select one or both of the following: [“[bullet]” (select one of the following: “provides moderate” or “moderate”) “protection against” (select one of the following: “sunburn” or “sunburn and tanning”)], or “[bullet] for skin that sunburns easily”.
(iii) For products that provide an SPF of 30 or above. Select one or both of the following: [“[bullet]” (select one of the following: “provides high” or “high”) “protection against” (select one of the following: “sunburn” or “sunburn and tanning”)], or “[bullet] for skin highly sensitive to sunburn”.
(c) Warnings. The labeling of the product contains the following warnings under the heading “Warnings:”
(1) For products containing any ingredient in § 352.10.
(i) “When using this product [bullet] keep out of eyes. Rinse with water to remove.”
(ii) “Stop use and ask a doctor if [bullet] rash or irritation develops and lasts”.
(2) For products containing any ingredient identified in § 352.10 marketed as a lip protectant or lipstick. The external use only warning in § 201.66(c)(5)(i) of this chapter and the warning in paragraph (c)(1)(i) of this section are not required.
(d) Directions. The labeling of the product contains the following statements, as appropriate, under the heading “Directions.” More detailed directions applicable to a particular product formulation (e.g., cream, gel, lotion, oil, spray, etc.) may also be included.
(1) For products containing any ingredient in § 352.10.
(i) “[bullet] apply” (select one or more of the following, as applicable: “liberally,” “generously,” “smoothly,” or “evenly”) “(insert appropriate time interval, if a waiting period is needed) before sun exposure and as needed”.
(ii) “[bullet] children under 6 months of age: ask a doctor”.
(2) In addition to the directions provided in § 352.52(d)(1), the following may be used for products containing any ingredient in § 352.10. “[bullet] reapply as needed or after towel drying, swimming, or” (select one of the following: “sweating” or “perspiring”).
(3) If the additional directions provided in § 352.52(d)(2) are used, the phrase “and as needed” in § 352.52(d)(1) is not required.
(4) For products marketed as a lip protectant or lipstick. The directions in paragraphs (d)(1) and (d)(2) of this section are not required.
(e) Statement on product performance —
(1) For products containing any ingredient identified in § 352.10, the following PCD labeling claims may be used under the heading “Other information” or anywhere outside of the “Drug Facts” box or enclosure.
(i) For products containing active ingredient(s) that provide an SPF value of 2 to under 12. (Select one of the following: “minimal” or “minimum”) “sun protection product.”
(ii) For products containing active ingredient(s) that provide an SPF value of 12 to under 30. “moderate sun protection product.”
(iii) For products containing active ingredient(s) that provide an SPF value of 30 or above. “high sun protection product.”
(2) For products containing any ingredient identified in § 352.10, the following labeling statement may be used under the heading “Other information” or anywhere outside of the “Drug Facts” box or enclosure. “Sun alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risks of skin aging, skin cancer, and other harmful effects of the sun.” Any variation of this statement will cause the product to be misbranded under section 502 of the act.
(f) Products labeled for use only on specific small areas of the face (e.g., lips, nose, ears, and/or around eyes) and that meet the criteria established in § 201.66(d)(10) of this chapter. The title, headings, subheadings, and information described in § 201.66(c) of this chapter shall be printed in accordance with the following specifications:
(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.
[64 FR 27687, May 21, 1999, as amended at 68 FR 33380, June 4, 2003]
§ 352.60 Labeling of permitted combinations of active ingredients.
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) Statement of identity. 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.
(b) Indications. 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 for use that have been established in the applicable OTC drug monographs or listed in this paragraph (b), may also be used, as provided by § 330.1(c)(2) of this chapter, subject to the provisions of section 502 of the Federal Food, Drug, and Cosmetic Act (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.
(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) Warnings. The labeling of the product states, under the heading “Warnings,” the warning(s) for each ingredient in the combination, as established in the warnings section of the applicable OTC drug monographs, except that the warning for skin protectants in § 347.50(c)(3) of this chapter is not required for permitted combinations containing a sunscreen and a skin protectant identified in § 352.20(b). For products marketed as a lip protectant or lipstick, § 352.52(f)(1)(iii), (f)(1)(iv) (except “Keep out of eyes,” which may be omitted), and (f)(1)(vi) apply.
(d) Directions. The labeling of the product states, under the heading “directions,” directions that conform to the directions established for each ingredient in the directions sections of the applicable OTC drug monographs, unless otherwise stated in this paragraph. When the time intervals or age limitations for administration of the individual ingredients differ, the directions for the combination product may not contain any dosage that exceeds those established for any individual ingredient in the applicable OTC drug monograph(s), and may not provide for use by any age group lower than the highest minimum age limit established for any individual ingredient. For permitted combinations containing a sunscreen and a skin protectant identified in § 352.20(b), the directions for sunscreens in § 352.52(d) should be used. For products marketed as a lip protectant or lipstick, § 352.52(d)(4) applies.
[64 FR 27687, May 21, 1999, as amended at 68 FR 33380, June 4, 2003]
Subpart D—Testing Procedures
§ 352.70 Standard sunscreen.
(a) Laboratory validation. 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
