---
kind: "section"
citation: "21 U.S.C. § 360fff"
title: "21"
title_heading: "Food and Drugs"
number: "360fff"
heading: "Definitions"
release: "119-102"
date: "2026-07-12"
url: "https://uscodex.org/usc/21/360fff"
units:
  - "Chapter 9 — Federal Food, Drug, and Cosmetic Act"
  - "Subchapter V — Drugs and Devices"
  - "Part I — Nonprescription Sunscreen and Other Active Ingredients"
---

# §360fff. Definitions


In this part—

- (1) the term “Advisory Committee” means the [Nonprescription](#5) [Drug](/usc/21/321.md?p=g-1) Advisory Committee of the [Food](/usc/21/321.md?p=f) and [Drug](/usc/21/321.md?p=g-1) Administration or any successor to such Committee;
- (2) the term “final sunscreen order” means an order published by the [Secretary](/usc/21/321.md?p=d) in the Federal Register containing information stating that a [nonprescription](#5) [sunscreen active ingredient](#10) or combination of [nonprescription](#5) [sunscreen active ingredients](#10)—
  - (A) is [GRASE](#3) and is not misbranded if marketed in accordance with such order; or
  - (B) is not [GRASE](#3) and is misbranded;
- (3) the term “GRASE” means generally recognized, among experts qualified by scientific training and experience to evaluate the safety and effectiveness of [drugs](/usc/21/321.md?p=g-1), as [safe](/usc/21/321.md?p=u) and effective for use under the conditions prescribed, recommended, or suggested in the [labeling](/usc/21/321.md?p=m) of a [drug](/usc/21/321.md?p=g-1) as described in [section 321(p) of this title](/usc/21/321.md?p=p);
- (4) the term “GRASE determination” means, with respect to a [nonprescription](#5) active ingredient or a combination of [nonprescription](#5) active ingredients, a determination of whether such ingredient or combination of ingredients is [GRASE](#3);
- (5) the term “nonprescription” means not subject to [section 353(b)(1) of this title](/usc/21/353.md?p=b-1);
- (6) the term “pending request” means each request with respect to a [nonprescription](#5) [sunscreen active ingredient](#10) submitted under section 330.14 of title 21, Code of Federal Regulations (as in effect on November 26, 2014) for consideration for inclusion in the over-the-counter [drug](/usc/21/321.md?p=g-1) monograph system—
  - (A) that was determined to be eligible for such review by publication of a notice of eligibility in the Federal Register prior to November 26, 2014; and
  - (B) for which safety and effectiveness data have been submitted to the [Secretary](/usc/21/321.md?p=d) prior to November 26, 2014;
- (7) the term “proposed sunscreen order” means an order containing a tentative determination published by the [Secretary](/usc/21/321.md?p=d) in the Federal Register containing information proposing that a [nonprescription](#5) [sunscreen active ingredient](#10) or combination of [nonprescription](#5) [sunscreen active ingredients](#10)—
  - (A) is [GRASE](#3) and is not misbranded if marketed in accordance with such order;
  - (B) is not [GRASE](#3) and is misbranded; or
  - (C) is not [GRASE](#3) and is misbranded because the data are insufficient to classify such ingredient or combination of ingredients as [GRASE](#3) and not misbranded and additional information is necessary to allow the [Secretary](/usc/21/321.md?p=d) to determine otherwise;
- (8) the term “sponsor” means the [person](/usc/21/321.md?p=e) that submitted—
  - (A) a request under [section 360fff–1 of this title](/usc/21/360fff–1.md);
  - (B) a [pending request](#6); or
  - (C) any other application subject to this part;
- (9) the term “sunscreen” means a [drug](/usc/21/321.md?p=g-1) containing one or more [sunscreen active ingredients](#10); and
- (10) the term “sunscreen active ingredient” means an active ingredient that is intended for application to the skin of humans for purposes of absorbing, reflecting, or scattering ultraviolet radiation.

## Source credit

(June 25, 1938, ch. 675, § 586, as added Pub. L. 113–195, § 2(a), Nov. 26, 2014, 128 Stat. 2035.)

## Notes

### Statutory Notes and Related Subsidiaries

### Construction

Pub. L. 113–195, § 2(b), Nov. 26, 2014, 128 Stat. 2045, provided that: “Nothing in the amendment made by this section [enacting this section and sections 360fff–1 to [former] 360fff–5 of this title] shall be construed to— limit the right of a sponsor (as defined in section 586(8) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 360fff(8)], as added by subsection (a)) to request that the Secretary of Health and Human Services convene an advisory committee; or limit the authority of the Secretary of Health and Human Services to meet with a sponsor (as defined in section 586(8) of the Federal Food, Drug, and Cosmetic Act, as added by subsection (a)).”