[USC02] 21 USC 360fff-5: Sunscreen monograph
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21 USC 360fff-5: Sunscreen monograph Text contains those laws in effect on February 19, 2020
From Title 21-FOOD AND DRUGSCHAPTER 9-FEDERAL FOOD, DRUG, AND COSMETIC ACTSUBCHAPTER V-DRUGS AND DEVICESPart I-Nonprescription Sunscreen and Other Active Ingredients
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§360fff–5. Sunscreen monograph

(a) In general

Not later than 5 years after November 26, 2014, the Secretary shall amend and finalize regulations under part 352 of title 21, Code of Federal Regulations concerning nonprescription sunscreen that are effective not later than 5 years after November 26, 2014. The Secretary shall publish such regulations not less than 30 calendar days before the effective date of such regulations.

(b) Reports

If the regulations promulgated under subsection (a) do not include provisions related to the effectiveness of various sun protection factor levels, and do not address all dosage forms known to the Secretary to be used in sunscreens marketed in the United States without a new drug approval under section 355 of this title, the Secretary shall submit a report to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives on the rationale for such provisions not being included in such regulations, and a plan and timeline to compile any information necessary to address such provisions through final regulations.

(June 25, 1938, ch. 675, §586E, as added Pub. L. 113–195, §2(a), Nov. 26, 2014, 128 Stat. 2045 .)