Active Ingredients
Avobenzone 3%
Homosalate 10%
Octisalate 5%
Octocrylene 7%
Jafra Royal Revitalize 4 Tube Set Kit
FDA Label NDC 68828-522
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Distribuidora Comercial Jafra, S.a. De C.v. for the product Jafra Royal Revitalize 4 Tube Set (NDC 68828-522). 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 active ingredients, purpose, uses, warnings, otc - keep out of reach of children, directions, inactive ingredients, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Sunscreen
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.
Warnings
For external use only
Do not use on damaged or broken skin
When using this productkeep out of eyes. Rinse with water to remove.
Stop use and ask a doctor if rash occurs
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away.
Directions
- apply liberally 15 minutes before sun exposure
- use a water resistant sunscreen if swimming or sweating
- reapply at least every 2 hours.
- children under 6 months of age: Ask a doctor
- Sun Protection Measures.Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad-Spectrum SPF value of 15 or higher and other sun protection measures including:
• limit your time in the sun, especially from 10 a.m. – 2 p.m.
• wear long-sleeved shirts, pants, hats, and sunglasses
Inactive Ingredients
Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Acrylates/Dimethicone Copolymer, Actinidia Chinensis (Kiwi) Fruit Water, Alcohol, Allantoin,
Aluminum Starch Octenylsuccinate, Arachidyl Alcohol, Arachidyl Glucoside, Arginine, Behenyl Alcohol, Benzyl Alcohol, Bisabolol, Butylene Glycol,
Butyrospermum Parkii (Shea) Butter, Chlorphenesin, Cocos Nucifera Fruit Extract, Cyclopentasiloxane, Dipropylene Glycol, Disodium EDTA,
Ethylhexylglycerin, Fragrance/Parfum, Glycerin, Glyceryl Stearate, Hydrogenated Lecithin, Lauroyl Lysine, Lecithin, Maltodextrin, Moringa Oleifera
Leaf Extract, PEG-100 Stearate, Phenethyl Alcohol, Polygonum Aviculare Extract, Royal Jelly,
Sodium Ascorbyl Phosphate, Sophora Flavescens Root Extract, Styrene/Acrylates Copolymer, Tetrapeptide-45, Water/Aqua
Other Information
- protect this product from excessive heat and direct sun
Product Label
Image Description (Updated Image)
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