FDA Product

Orange Gel

Product approved by U.S. Food and Drug Administration (US)

Basic Information

Product Name

Orange Gel

FDA Product Code

80641-016

Regulatory Information

NDC Product Code

80641-016

Application Number

M020

Marketing Category

C200263

Effective Date

April 18, 2025

Territorial Authority

USA

FDA Title

Vacation Orange Gelee

Labeling Type

HUMAN OTC DRUG LABEL

Version Number

3

Company Information

ManufacturerVacation Inc.

DUNS Number

117644631

Active Ingredients

Quantity: 2.9 g in 100 g

Code: G63QQF2NOX

Class Code: ACTIB

Quantity: 6.9 g in 100 g

Code: V06SV4M95S

Class Code: ACTIB

BUTYLOCTYL SALICYLATE

Code: 2EH13UN8D3

Class Code: IACT

Quantity: 4.9 g in 100 g

Code: 4X49Y0596W

Class Code: ACTIB

Quantity: 9.5 g in 100 g

Code: 5A68WGF6WM

Class Code: ACTIB

Active Moieties

AVOBENZONE

Code: G63QQF2NOX

HOMOSALATE

Code: V06SV4M95S

OCTISALATE

Code: 4X49Y0596W

OCTOCRYLENE

Code: 5A68WGF6WM

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