Orange Gel

Manufacturer
Vacation Inc.
Effective date
2026-01-28
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:35:43

Label at a glance#

ProductOrange Gel
Active ingredientAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE
Label structure8 sections

Indications and uses

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

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

Label contents#

Full prescribing information#

Dosage and Administration

DOSAGE & ADMINISTRATION SECTION

Apply liberally 15 minutes before sun exposure

Reapply at least every 2 hours

Use a water resistant sunscreen if swimming or sweating

Warnings

WARNINGS SECTION

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

INDICATIONS & USAGE SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

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

Purpose

OTC - PURPOSE SECTION

Sunscreen

Inactives

INACTIVE INGREDIENT SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Orange GeleeOrange Gelee

PRINCIPAL DISPLAY PANEL - 88 G Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SPF
30

VACATION® BRAND

ORANGE
gelee

SUNSCREEN GEL

BROAD SPECTRUM
SPF 30 SUNSCREEN GEL
WATER RESISTANT (80 MINUTES)

Vacation®

NET WT 3.12 OZ / 88 G

PRINCIPAL DISPLAY PANEL - PRINCIPAL DISPLAY PANEL - 88 G Tube Carton
PRINCIPAL DISPLAY PANEL - PRINCIPAL DISPLAY PANEL - 88 G Tube Carton

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80641-016-02Orange Gel2 in 1 CARTONGEL24
80641-016-30Orange Gel88 g in 1 TUBEGEL884

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
80641-01680641-016-30, 80641-016-02

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Orange GelAVOBENZONE OCTISALATE OCTOCRYLENE HOMOSALATEVacation Inc.132896ef-d6c6-4ec7-e063-6294a90a103b2026-01-28WarningsExact identifier
ndc (package): 80641-016-30
ndc (package): 80641-016-02
ndc (product): 80641-016
ndc11 (package): 80641001630
ndc11 (package): 80641001602
spl id: b99c06a3-7b97-4257-bd0c-8a9f3f6297de
spl set id: 132896ef-d6c6-4ec7-e063-6294a90a103b

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.