[Code of Federal Regulations] [Title 21, Volume 5] [Revised as of April 1, 2006] From the U.S. Government Printing Office via GPO Access [CITE: 21CFR352.52] [Page 292-293] TITLE 21--FOOD AND DRUGS CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) PART 352_SUNSCREEN DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE [STAYED INDEFINITELY]--Table of Contents Subpart C_Labeling Sec. 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 Sec. 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 Sec. 352.10. (i) ``[bullet]\1\ helps prevent sunburn [bullet] higher SPF gives more sunburn protection''. --------------------------------------------------------------------------- \1\ See Sec. 201.66(b)(4) of this chapter. --------------------------------------------------------------------------- (ii) For products that satisfy the water resistant testing procedures identified in Sec. 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 Sec. 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 Sec. 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 Sec. 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 Sec. 352.10 marketed as a lip protectant or lipstick. The external use only warning in Sec. 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 Sec. 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 Sec. 352.52(d)(1), the following may be used for products containing any ingredient in Sec. 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 Sec. 352.52(d)(2) are used, the phrase ``and [[Page 293]] as needed'' in Sec. 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 Sec. 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 Sec. 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 Sec. 201.66(d)(10) of this chapter. The title, headings, subheadings, and information described in Sec. 201.66(c) of this chapter shall be printed in accordance with the following specifications: (1) The labeling shall meet the requirements of Sec. 201.66(c) of this chapter except that the title, headings, and information described in Sec. 201.66(c)(1), (c)(3), and (c)(7) may be omitted, and the headings, subheadings, and information described in Sec. 201.66(c)(2), (c)(4), (c)(5), and (c)(6) may be presented as follows:- (i) The active ingredients (Sec. 201.66(c)(2) of this chapter) shall be listed in alphabetical order. (ii) The heading and the indication required by Sec. 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 Sec. 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 Sec. 201.66(c)(5)(i) of this chapter may be omitted. (iv) The subheadings in Sec. 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 Sec. 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 Sec. 352.52(f)(1)(iv) and ``Keep out of reach of children'' in Sec. 352.52(f)(1)(v) and the directions in Sec. 352.52(d) may be omitted. (2) The labeling shall be printed in accordance with the requirements of Sec. 201.66(d) of this chapter except that any requirements related to Sec. 201.66(c)(1), (c)(3), and (c)(7), and the horizontal barlines and hairlines described in Sec. 201.66(d)(8), may be omitted. [64 FR 27687, May 21, 1999, as amended at 68 FR 33380, June 4, 2003]