Food and Drug Administration, HHS § 201.327 (2) At least as large as the size of the the same font style, size, and color ‘‘Drug Facts’’ title, as required in with the same background color. § 201.66(d)(2). The new warnings infor- (ii) For sunscreen products that do not mation statement must remain on the pass the broad spectrum test in paragraph PDP of the drug product for at least 1 (j) of this section. The labeling states year from the date the product is ini- ‘‘SPF [insert numerical SPF value re- tially introduced into interstate com- sulting from testing under paragraph merce. (i) of this section]’’. The entire text (c) Requirements to supplement ap- shall appear in the same font style, proved application. Holders of approved size, and color with the same back- applications for OTC drug products ground color. that contain internal analgesic/anti- (2) Water resistance statements—(i) For pyretic active ingredients that are sub- products that provide 40 minutes of water ject to the requirements of paragraph resistance according to the test in para- (a) of this section must submit supple- graph (i)(7)(i) of this section. The label- ments under § 314.70(c) of this chapter ing states ‘‘Water Resistant (40 min- to include the required information in utes)’’. the product’s labeling. Such labeling (ii) For products that provide 80 min- may be put into use without advance utes of water resistance according to the approval of FDA provided it includes at test in paragraph (i)(7)(ii) of this section. least the exact information included in The labeling states ‘‘Water Resistant paragraph (a) of this section. (80 minutes)’’. (b) Statement of identity. The labeling [74 FR 19407, Apr. 29, 2009, as amended at 74 of the product contains the established FR 31180, June 30, 2009; 74 FR 61514, Nov. 25, name of the drug, if any, and identifies 2009] the drug as a ‘‘sunscreen.’’ (c) Indications. The labeling of the § 201.327 Over-the-counter sunscreen product states, under the heading drug products; required labeling based on effectiveness testing. ‘‘Uses,’’ the phrases listed in this para- graph (c), as appropriate. Other truth- The following provisions apply to ful and nonmisleading statements, de- sunscreen products containing amino- scribing only the uses that have been benzoic acid, avobenzone, cinoxate, established and listed in this paragraph dioxybenzone, ensulizole, homosalate, (c), may also be used, as provided in meradimate, octinoxate, octisalate, § 330.1(c)(2) of this chapter, subject to octocrylene, oxybenzone, padimate O, the provisions of section 502 of the Fed- sulisobenzone, titanium dioxide, eral Food, Drug, and Cosmetic Act (the trolamine salicylate, or zinc oxide, FD&C Act) relating to misbranding and alone or in combination. The provi- the prohibition in section 301(d) of the sions do not apply to sunscreen prod- FD&C Act against the introduction or ucts marketed under approved new delivery for introduction into inter- drug applications or abbreviated new state commerce of unapproved new drug applications. drugs in violation of section 505(a) of (a) Principal display panel. In addition the FD&C Act. to the statement of identity in para- (1) For all sunscreen products, the graph (b) of this section, the following following indication statement must be labeling shall be prominently placed on included under the heading ‘‘Uses’’: the principal display panel: ‘‘[Bullet] helps prevent sunburn’’. See (1) Effectiveness claim—(i) For products § 201.66(b)(4) of this chapter for defini- that pass the broad spectrum test in para- tion of bullet. graph (j) of this section. (A) The labeling (2) For sunscreen products with a states ‘‘Broad Spectrum SPF [insert Broad Spectrum SPF value of 15 or numerical SPF value resulting from higher according to the tests in para- testing under paragraph (i) of this sec- graphs (i) and (j) of this section, the la- tion]’’. beling may include the following state- (B) Prominence. The Broad Spectrum ment in addition to the indication in SPF statement shall appear as contin- § 201.327(c)(1): ‘‘[Bullet] if used as di- uous text with no intervening text or rected with other sun protection meas- graphic. The entire text shall appear in ures (see Directions [in bold italic 95 VerDate Mar<15>2010 10:14 May 21, 2013 Jkt 229071 PO 00000 Frm 00105 Fmt 8010 Sfmt 8010 Y:\SGML\229071.XXX 229071 erowe on DSK2VPTVN1PROD with CFR § 201.327 21 CFR Ch. I (4–1–13 Edition) font]), decreases the risk of skin cancer (j) of this section. The labeling states and early skin aging caused by the ‘‘[bullet] Sun Protection Measures. [in sun’’. bold font] Spending time in the sun in- (3) Any labeling or promotional ma- creases your risk of skin cancer and terials that suggest or imply that the early skin aging. To decrease this risk, use, alone, of any sunscreen reduces regularly use a sunscreen with a Broad the risk of or prevents skin cancer or Spectrum SPF value of 15 or higher early skin aging will cause the product and other sun protection measures in- to be misbranded under section 502 of cluding: [Bullet] limit time in the sun, the FD&C Act (21 U.S.C. 352). especially from 10 a.m.–2 p.m. [bullet] (d) Warnings. The labeling of the wear long-sleeved shirts, pants, hats, product contains the following warn- and sunglasses’’. ings under the heading ‘‘Warnings’’. (3) For products that satisfy the water (1) For all sunscreen products. (i) The resistance test in paragraph (i)(7) of this labeling states ‘‘Do not use [bullet] on section. The labeling states ‘‘[bullet] re- damaged or broken skin’’. apply: [Bullet] after [select one of the (ii) The labeling states ‘‘When using following determined by water resist- this product [bullet] keep out of eyes. ance test: ‘40 minutes of’ or ‘80 minutes Rinse with water to remove.’’ of’] swimming or sweating [bullet] im- (iii) The labeling states ‘‘Stop use mediately after towel drying [bullet] at and ask a doctor if [bullet] rash oc- least every 2 hours’’. curs’’. (4) For products that do not satisfy the (2) For sunscreen products that are water resistance test in paragraph (i)(7) of broad spectrum with SPF values of at this section. The labeling states ‘‘[bul- least 2 but less than 15 according to the let] reapply at least every 2 hours [bul- SPF test in paragraph (i) of this section or let] use a water resistant sunscreen if that do not pass the broad spectrum test swimming or sweating’’. in paragraph (j) of this section. The first (f) Other information. The labeling of statement under the heading ‘‘Warn- the product contains the following ings’’ states ‘‘Skin Cancer/Skin Aging statement under the heading ‘‘Other Alert [in bold font]; Spending time in information:’’ ‘‘[bullet] protect the the sun increases your risk of skin can- product in this container from exces- cer and early skin aging. This product sive heat and direct sun’’. has been shown only to help prevent (g) False and misleading claims. There sunburn, not [in bold font] skin cancer are claims that would be false and/or or early skin aging.’’ misleading on sunscreen products. (e) Directions. The labeling of the These claims include but are not lim- product contains the following state- ited to the following: ‘‘Sunblock,’’ ments, as appropriate, under the head- ‘‘sweatproof,’’ and ‘‘waterproof.’’ These ing ‘‘Directions.’’ More detailed direc- or similar claims will cause the prod- tions applicable to a particular product uct to be misbranded under section 502 formulation may also be included. of the FD&C Act (21 U.S.C. 352). (1) For all sunscreen products. (i) As an (h) Labeling of products containing a option, the labeling may state ‘‘For combination of sunscreen and skin pro- sunscreen use:’’. tectant active ingredients. Statements of (ii) The labeling states ‘‘[bullet] identity, indications, warnings, and di- apply [select one of the following: ‘Lib- rections for use, respectively, applica- erally’ or ‘generously’] [and, as an op- ble to each ingredient in the product tion: ‘And evenly’] 15 minutes before may be combined to eliminate duplica- sun exposure’’. tive words or phrases so that the re- (iii) As an option, the labeling may sulting information is clear and under- state ‘‘[bullet] apply to all skin ex- standable. Labeling provisions in posed to the sun’’. § 347.50(e) of this chapter shall not (iv) The labeling states ‘‘[bullet] chil- apply to these products. dren under 6 months of age: Ask a doc- (i) SPF test procedure—(1) UV source tor’’. (solar simulator). (i) Emission spectrum. A (2) For sunscreen products with a Broad single port or multiport solar simu- Spectrum SPF value of 15 or higher ac- lator should be filtered so that it pro- cording to the tests in paragraphs (i) and vides a continuous emission spectrum 96 VerDate Mar<15>2010 10:14 May 21, 2013 Jkt 229071 PO 00000 Frm 00106 Fmt 8010 Sfmt 8010 Y:\SGML\229071.XXX 229071 erowe on DSK2VPTVN1PROD with CFR Food and Drug Administration, HHS § 201.327 from 290 to 400 nanometers (nm) with a in accordance with 5 U.S.C. 552(a) and 1 limit of 1,500 Watts per square meter CFR part 51. You may obtain a copy (W/m2) on total irradiance for all wave- from the ISO Copyright Office, Case lengths between 250 and 1,400 nm. Postale 56, CH–1211, Geneva 20, Switzer- (A) The solar simulator should have land, telephone +41–22–749–01–11 or fax the following percentage of erythema- +41–22–74 -09–47. http://www.iso.org.