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
Orange Gel
FDA Label NDC 80641-016
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Vacation Inc. for the product Orange Gel (NDC 80641-016). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding dosage and administration, warnings, indications and usage, keep out of reach of children, purpose, inactives, vacation orange gelee, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
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