Food and Drug Administration, HHS § 352.20 (c) Cinoxate up to 3 percent. than 2 to the finished product. The fin- (d) [Reserved] ished product must have a minimum (e) Dioxybenzone up to 3 percent. SPF of not less than the number of (f) Homosalate up to 15 percent. sunscreen active ingredients used in (g) [Reserved] the combination multiplied by 2. (h) Menthyl anthranilate up to 5 per- (2) Two or more sunscreen active in- cent. gredients identified in § 352.10(b), (c), (i) Octocrylene up to 10 percent. (e), (f), (i) through (l), (o), and (q) may (j) Octyl methoxycinnamate up to 7.5 be combined with each other in a single percent. product when used in the concentra- (k) Octyl salicylate up to 5 percent. tions established for each ingredient in (l) Oxybenzone up to 6 percent. § 352.10. The concentration of each ac- (m) Padimate O up to 8 percent. tive ingredient must be sufficient to (n) Phenylbenzimidazole sulfonic contribute a minimum SPF of not less acid up to 4 percent. than 2 to the finished product. The fin- (o) Sulisobenzone up to 10 percent. ished product must have a minimum (p) Titanium dioxide up to 25 percent. SPF of not less than the number of (q) Trolamine salicylate up to 12 per- sunscreen active ingredients used in cent. the combination multiplied by 2. (r) Zinc oxide up to 25 percent. (b) Combinations of sunscreen and skin [64 FR 27687, May 21, 1999] protectant active ingredients. Any single sunscreen active ingredient or any per- EFFECTIVE DATE NOTE: At 67 FR 41823, June mitted combination of sunscreen ac- 20, 2002, § 352.10 was amended by revising tive ingredients when used in the con- paragraphs (f) through (n), effective Sept. 1, 2002. This amendment could not be incor- centrations established for each ingre- porated because at 66 FR 67485, Dec. 31, 2001 dient in § 352.10 may be combined with the effective date was stayed until further one or more skin protectant active in- notice. For the convenience of the user, the gredients identified in § 347.10(a), (d), revised text is set forth as follows: (e), (g), (h), (i), (k), (l), (m), and (r) of this chapter. The concentration of each § 352.10 Sunscreen active ingredients. sunscreen active ingredient must be sufficient to contribute a minimum * * * * * SPF of not less that 2 to the finished (f) Ensulizole up to 4 percent. product. The finished product must (g) Homosalate up to 15 percent. have a minimum SPF of not less than (h) [Reserved] the number of sunscreen active ingredi- (i) Meradimate up to 5 percent. ents used in the combination multi- (j) Octinoxate up to 7.5 percent. (k) Octisalate up to 5 percent. plied by 2, and the product must be la- (l) Octocrylene up to 10 percent. beled according to § 352.60. (m) Oxybenzone up to 6 percent. (c) [Reserved] (n) Padimate O up to 8 percent. [64 FR 27687, May 21, 1999, as amended at 68 FR 33380, June 4, 2003] * * * * * EFFECTIVE DATE NOTE: At 67 FR 41823, June 20, 2002, § 352.20 was amended by revising § 352.20 Permitted combinations of ac- paragraphs (a)(1) through (a)(2), effective tive ingredients. Sept. 1, 2002. This amendment could not be The SPF of any combination product incorporated because at 66 FR 67485, Dec. 31, is measured by the testing procedures 2001 the effective date was stayed until fur- established in subpart D of this part. ther notice. For the convenience of the user, (a) Combinations of sunscreen active in- the text is set forth as follows: gredients. (1) Two or more sunscreen ac- § 352.20 Permitted combinations of active tive ingredients identified in § 352.10(a), ingredients. (c), (e), (f), and (h) through (r) may be combined with each other in a single * * * * * product when used in the concentra- (a) Combinations of sunscreen active ingredi- tions established for each ingredient in ents. (1) Two or more sunscreen active ingre- § 352.10. The concentration of each ac- dients identified in § 352.10(a), (c), (e), (f), (g), tive ingredient must be sufficient to and (i) through (r) may be combined with contribute a minimum SPF of not less each other in a single product when used in 297 VerDate Mar<15>2010 13:06 May 27, 2010 Jkt 220069 PO 00000 Frm 00307 Fmt 8010 Sfmt 8003 Y:\SGML\220069.XXX 220069 wwoods2 on DSK1DXX6B1PROD with CFR § 352.50 21 CFR Ch. I (4–1–10 Edition) the concentrations established for each in- sunscreen product testing procedures gredient in § 352.10. The concentration of in § 352.76).’’ each active ingredient must be sufficient to (c) For products that satisfy the very contribute a minimum SPF of not less than water resistant sunscreen product testing 2 to the finished product. The finished prod- procedures in § 352.76. (1) ‘‘Very’’ (select uct must have a minimum SPF of not less than the number of sunscreen active ingredi- one of the following: ‘‘Water,’’ ‘‘Water/ ents used in the combination multiplied by 2. Sweat,’’ or ‘‘Water/Perspiration’’) ‘‘Re- (2) Two or more sunscreen active ingredi- sistant.’’ ents identified in § 352.10(b), (c), (e), (g), (j) (2) ‘‘SPF (insert SPF value of the through (m), (o), and (q) may be combined product, as stated in paragraph (a)(1) with each other in a single product when or (a)(2) of this section, after it has used in the concentrations established for been tested using the very water resist- each ingredient in § 352.10. The concentration ant sunscreen product testing proce- of each active ingredient must be sufficient dures in § 352.76).’’ to contribute a minimum SPF of not less than 2 to the finished product. The finished § 352.52 Labeling of sunscreen drug product must have a minimum SPF of not products. less than the number of sunscreen active in- gredients used in the combination multiplied (a) Statement of identity. The labeling by 2. 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 Subpart C—Labeling ‘‘Uses,’’ all of the phrases listed in paragraph (b)(1) of this section that are § 352.50 Principal display panel of all sunscreen drug products. applicable to the product and may con- tain any of the additional phrases list- In addition to the statement of iden- ed in paragraph (b)(2) of this section, as tity required in § 352.52, the following appropriate. Other truthful and non- labeling statements shall be promi- misleading statements, describing only nently placed on the principal display the uses that have been established and panel: listed in this paragraph (b), may also (a) For products that do not satisfy the be used, as provided in § 330.1(c)(2) of water resistant or very water resistant this chapter, subject to the provisions sunscreen product testing procedures in of section 502 of the act relating to § 352.76—(1) For products with SPF values misbranding and the prohibition in sec- up to 30. ‘‘SPF (insert tested SPF value tion 301(d) of the act against the intro- of the product up to 30).’’ duction or delivery for introduction (2) For products with SPF values over into interstate commerce of unap- 30. ‘‘SPF 30’’ (select one of the fol- proved new drugs in violation of sec- lowing: ‘‘plus’’ or ‘‘+’’). Any statement tion 505(a) of the act. accompanying the marketed product (1) For products containing any ingre- that states a specific SPF value above dient in § 352.10. (i) ‘‘[bullet] 1 helps pre- 30 or similar language indicating a per- vent sunburn [bullet] higher SPF gives son can stay in the sun more than 30 more sunburn protection’’. times longer than without sunscreen (ii) For products that satisfy the water will cause the product to be mis- resistant testing procedures identified in branded under section 502 of the Fed- § 352.76. ‘‘[bullet] retains SPF after 40 eral Food, Drug, and Cosmetic Act (the minutes of’’ (select one or more of the act). following: ‘‘activity in the water,’’ (b) For products that satisfy the water ‘‘sweating,’’ or ‘‘perspiring’’). resistant sunscreen product testing proce- (iii) For products that satisfy the very dures in § 352.76. (1) (Select one of the water resistant testing procedures identi- following: ‘‘Water,’’ ‘‘Water/Sweat,’’ or fied in § 352.76. ‘‘[bullet] retains SPF ‘‘Water/Perspiration’’) ‘‘Resistant.’’ after 80 minutes of’’ (select one or more (2) ‘‘SPF (insert SPF value of the of the following: ‘‘activity in the product, as stated in paragraph (a)(1) water,’’ ‘‘sweating,’’ or ‘‘perspiring’’). or (a)(2) of this section, after it has been tested using the water resistant 1 See § 201.66(b)(4) of this chapter. 298 VerDate Mar<15>2010 13:06 May 27, 2010 Jkt 220069 PO 00000 Frm 00308 Fmt 8010 Sfmt 8010 Y:\SGML\220069.XXX 220069 wwoods2 on DSK1DXX6B1PROD with CFR.