ORANGE GEL- avobenzone octisalate octocrylene homosalate gel

Orange Gel by

Drug Labeling and Warnings

Orange Gel by is a Otc medication manufactured, distributed, or labeled by Vacation Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Dosage and Administration

Apply liberally 15 minutes before sun exposure

Reapply at least every 2 hours

Use a water resistant sunscreen if swimming or sweating

Warnings

For external use only

Do not use on damaged or broken skin

When using this product, keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if rash occurs

Indications and Usage

Helps prevent sunburn

If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

Keep out of reach of children

Keep out of reach of children

In case of ingestion, get medical help or contact a Poison Control Center right away

Purpose

Sunscreen

Inactives

Behenyl Behenate, Butyloctyl Salicylate, Butyrospermum Parkii (Shea) Butter, Calophyllum Inophyllum Seed Oil, Cetyl Esters, Citrus Aurantium Bergamia (Bergamot) Peel Oil, Cocos Nucifera (Coconut) Oil, Crocus Sativus Flower Extract, Euphorbia Cerifera (Candelilla) Wax, Fragrance, Glyceryl Stearate, Helianthus Annuus (Sunflower) Seed Oil, Hydrogenated Castor Oil, Isododecane

Vacation Orange Gelee

INGREDIENTS AND APPEARANCE

ORANGE GEL 
avobenzone octisalate octocrylene homosalate gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80641-016
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	2.9 g  in 100 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	6.9 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	4.9 g  in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	9.5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80641-016-30	88 g in 1 TUBE; Type 0: Not a Combination Product	03/08/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	03/08/2024

Labeler - Vacation Inc. (117644631)