§ M020.50 Labeling of sunscreen drug products

(a) Principal display panel. In addition to the statement of identity in § M020.50(b), the following labeling shall be prominently placed on the principal display panel:

(1) Effectiveness claim

(i) For products that pass the broad spectrum test in § M020.90.

(A) The labeling states "Broad Spectrum SPF [insert numerical SPF value resulting from testing under § M020.80]”.

(B) Prominence. The Broad Spectrum SPF statement shall appear as continuous text with no intervening text or graphic. The entire text shall appear in the same font style, size, and color with the same background color.

(ii) For sunscreen products that do not pass the broad spectrum test in § M020.90. The labeling states "SPF [insert numerical SPF value resulting from testing under § M020.80]". The entire text shall appear in the same font style, size, and color with the same background color.

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(2) Water resistance statements

(i) For products that provide 40 minutes of water resistance according to the test in § M020.80(g)(1). The labeling states "Water Resistant (40 minutes)".

(ii) For products that provide 80 minutes of water resistance according to the test in § M020.80(g)(2). The labeling states "Water Resistant (80 minutes)".

(b) Statement of identity. The labeling of the product contains the established name of the drug, if any, and identifies the drug as a "sunscreen."

(c) Indications. The labeling of the product states, under the heading "Uses," the phrases listed in § M020.50(c), as appropriate. Other truthful and nonmisleading statements, describing only the uses that have been established and listed in § M020.50(c), may also be used, as provided in 21 CFR 330.1(c)(2), subject to the provisions of section 502 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 352) relating to misbranding and the prohibition in section 301(d) of the FD&C Act (21 U.S.C. 331(d)) against the introduction or delivery for introduction into interstate commerce of unapproved new drugs in violation of section 505(a) of the FD&C Act (21 U.S.C. 355(a)).

(1) For all sunscreen products, the following indication statement must be included under the heading "Uses": "[Bullet]⁶ helps prevent sunburn".

(2) For sunscreen products with a Broad Spectrum SPF value of 15 or higher according to the tests in §§ M020.80 and M020.90, the labeling may include the following statement in addition to the indication in § M020.50(c)(1): "[Bullet] if used as directed with other sun protection measures (see Directions [in bold italic font]), decreases the risk of skin cancer and early skin aging caused by the sun".

(3) Any labeling or promotional materials that suggest or imply that the use, alone, of any sunscreen reduces the risk of or prevents skin cancer or early skin aging will cause the product to be misbranded under section 502 of the FD&C Act.

(d) Warnings. The labeling of the product contains the following warnings under the heading "Warnings".

(1) For all sunscreen products.

(i) The labeling states "Do not use [bullet] on damaged or broken skin".

(ii) The labeling states "When using this product [bullet] keep out of eyes. Rinse with water to remove."

(iii) The labeling states "Stop use and ask a doctor if [bullet] rash occurs".

⁶ See 21 CFR 201.66(b)(4).

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(2) For sunscreen products that are broad spectrum with SPF values of at least 2 but less than 15 according to the SPF test in §M020.80 or that do not pass the broad spectrum test in § M020.90. The first statement under the heading "Warnings" states "Skin Cancer/Skin Aging Alert [in bold font]: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not [in bold font] skin cancer or early skin aging."

(e) 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 may also be included.

(1) For all sunscreen products.

(i) As an option, the labeling may state "For sunscreen use:".

(ii) The labeling states "[bullet] apply [select one of the following: `Liberally' or `generously'] [and, as an option: `And evenly'] 15 minutes before sun exposure".

(iii) As an option, the labeling may state "[bullet] apply to all skin exposed to the sun".

(iv) The labeling states "[bullet] children under 6 months of age: Ask a doctor".

(2) For sunscreen products with a Broad Spectrum SPF value of 15 or higher according to the tests in §§ M020.80 and M020.90. The labeling states "[bullet] Sun Protection Measures. [in bold font] Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: [Bullet] limit time in the sun, especially from 10 a.m.-2 p.m. [bullet] wear long-sleeved shirts, pants, hats, and sunglasses".

(3) For products that satisfy the water resistance test in § M020.80(g). The labeling states "[bullet] reapply: [Bullet] after [select one of the following determined by water resistance test: `40 minutes of' or `80 minutes of'] swimming or sweating [bullet] immediately after towel drying [bullet] at least every 2 hours".

(4) For products that do not satisfy the water resistance test in § M020.80(g). The labeling states "[bullet] reapply at least every 2 hours [bullet] use a water resistant sunscreen if swimming or sweating".

(f) Other information. The labeling of the product contains the following statement under the heading "Other information:" "[bullet] protect the product in this container from excessive heat and direct sun".

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(g) False and misleading claims. There are claims that would be false and/or misleading on sunscreen products. These claims include but are not limited to the following: "Sunblock," "sweatproof," and "waterproof." These or similar claims will cause the product to be misbranded under section 502 of the FD&C Act.

(h) Labeling of products containing a combination of sunscreen and skin protectant 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. Labeling provisions in § M016.50(e) of OTC Monograph M016 shall not apply to these products.