US Code

Public Law 119-73 (01/23/2026)

21 U.S.C. § 360fff–4

Guidance; other provisions

(a)

Guidance

(1)

In general

(A)

Draft guidance

Not later than 1 year after , the Secretary shall issue draft guidance on the implementation of, and compliance with, the requirements with respect to sunscreen under this part, including guidance on—
(i)
section 360fff–1 of this title the format and content of information submitted by a sponsor in support of a request under or a pending request;
(ii)
the data required to meet the safety and efficacy standard for determining whether a nonprescription sunscreen active ingredient or combination of nonprescription sunscreen active ingredients is GRASE and is not misbranded;
(iii)
section 360fff–1 of this title the process by which a request under or a pending request is withdrawn; and
(iv)
section 360fff–3(c) of this titlesection 360fff–1 of this title the process by which the Secretary will carry out , including with respect to how the Secretary will address the total number of requests received under and pending requests.
(B)

Final guidance

The Secretary shall finalize the guidance described in subparagraph (A) not later than 2 years after .

(C)

Inapplicability of Paperwork Reduction Act

Chapter 35 of title 44 shall not apply to collections of information made for purposes of guidance under this subsection.

(2)

Submissions pending issuance of final guidance

Irrespective of whether final guidance under paragraph (1) has been issued—
(A)
persons may, beginning on , make submissions under this part; and
(B)
the Secretary shall review and act upon such submissions in accordance with this part.
(b)

Rules of construction

(1)

Currently marketed sunscreens

Nothing in this part shall be construed to affect the marketing of sunscreens that are marketed in interstate commerce on or before , except as otherwise provided in this part.

(2)

Ensuring safety and effectiveness

section 360fff–3(e) of this titleNothing in this part shall be construed to alter the authority of the Secretary with respect to prohibiting the marketing of a sunscreen that is not safe and effective or is misbranded, or with respect to imposing restrictions on the marketing of a sunscreen to ensure safety and effectiveness, except as otherwise provided in this part, including .

(3)

Other drugs

section 360fff–6 of this title42 U.S.C. 201Except as otherwise provided in , nothing in this part shall be construed to affect the authority of the Secretary under this chapter or the Public Health Service Act ( et seq.) with respect to a drug other than a nonprescription sunscreen.

(4)

Effect on drugs otherwise approved

section 355 of this title42 U.S.C. 262Nothing in this part shall affect the marketing of a drug approved under or section 351 of the Public Health Service Act [].

(c)

Timelines

section 360fff–3(a) of this titlesection 360fff–1 of this titleThe timelines for the processes and procedures under paragraphs (1), (2), (5), and (6) of shall not apply to any requests submitted to the Secretary under after the date that is 6 years after .

June 25, 1938, ch. 675, § 586DPub. L. 113–195, § 2(a)128 Stat. 2044(, as added , , .)

Editorial Notes

References in Text

act July 1, 1944, ch. 37358 Stat. 682section 201 of Title 42The Public Health Service Act, referred to in subsec. (b)(3), is , , which is classified generally to chapter 6A (§ 201 et seq.) of Title 42, The Public Health and Welfare. For complete classification of this Act to the Code, see Short Title note set out under and Tables.