Warnings.
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”.
(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 paragraph (i) of this section or that do not pass the broad spectrum test in paragraph (j) of this section. 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 paragraphs (i) and (j) of this section. 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 paragraph (i)(7) of this section. 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 paragraph (i)(7) of this section. 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”.
(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 (21 U.S.C. 352).
(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 § 347.50(e) of this chapter shall not apply to these products.
(i) SPF test procedure -
(1) UV source (solar simulator).
(i) Emission spectrum. A single port or multiport solar simulator should be filtered so that it provides a continuous emission spectrum from 290 to 400 nanometers (nm) with a limit of 1,500 Watts per square meter (W/m 2) on total irradiance for all wavelengths between 250 and 1,400 nm.
(A) The solar simulator should have the following percentage of erythema-effective radiation in each specified range of wavelengths:
(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”.
(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 paragraph (i) of this section or that do not pass the broad spectrum test in paragraph (j) of this section. 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 paragraphs (i) and (j) of this section. 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 paragraph (i)(7) of this section. 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 paragraph (i)(7) of this section. 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”.
(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 (21 U.S.C. 352).
(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 § 347.50(e) of this chapter shall not apply to these products.
(i) SPF test procedure -
(1) UV source (solar simulator).
(i) Emission spectrum. A single port or multiport solar simulator should be filtered so that it provides a continuous emission spectrum from 290 to 400 nanometers (nm) with a limit of 1,500 Watts per square meter (W/m
2) on total irradiance for all wavelengths between 250 and 1,400 nm.
(A) The solar simulator should have the following percentage of erythema-effective radiation in each specified range of wavelengths: