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Drug Facts
Revive Soleil Superieur Broad Spectrum
FDA Label NDC 58411-420
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by R�vive Skincare for the product Revive Soleil Superieur Broad Spectrum (NDC 58411-420). 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 other, otc - purpose, uses, warnings, otc - do not use, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
| Active ingredients | Purpose |
|---|---|
| Avobenzone 3.00% | Sunscreen |
| Homosalate 10.00% | Sunscreen |
| Octisalate 5.00% | Sunscreen |
| Octocrylene 2.60% | 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.
Otc - Do Not Use
Do not use on damaged or broken skin.
Otc - When Using
When using this product keep out of eyes. Rinse with water to remove.
Otc - Stop Use
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
- For sunscreen use:
- apply liberally 15 minutes before sun exposure
- use a water resistant sunscreen if swimming or sweating
- reapply at least every 2 hours
- 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 time in the sun, especially from 10 a.m. – 2 p.m.
- wear long-sleeved shirts, pants, hats, and sunglasses
- Children under 6 months of age: Ask a doctor
Other Information
Protect the product in this container from excessive heat and direct sun.
Inactive Ingredients
Aqua/Water/Eau, Caprylyl Methicone, Dipropylene Glycol, Dicaprylyl Carbonate, PEG/PPG-17/6 Copolymer, Potassium Cetyl Phosphate, Thermus Thermophillus Ferment, Glyceryl Stearate, PEG-100 Stearate, Methyl Glucose Sesquistearate, SD Alcohol 40-B, Hydrogenated Palm Glycerides, Oligopeptide-24, Silybin, Carnosine, Adenosine, Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Cetyl Alcohol, Isohexadecane, Phenoxyethanol, Panthenol, Caprylyl Glycol, Polyacrylate-15, PEG-10 Dimethicone, Tocopheryl Acetate, Glycerin, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Disodium EDTA, Lecithin, Polygonum Aviculare Extract, Polyacrylate-17, Polysorbate 80, Potassium Sorbate, Potassium Hydroxide, Hexylene Glycol, C11-15 Pareth-40, C11-15 Pareth-7, Dipotassium Glycyrrhizate, Fragrance (Parfum), Sorbitan Oleate, Sodium Benzoate, Disodium Lauryl Sulfosuccinate, Sodium Laureth-12 Sulfate.
Questions Or Comments?
Call 1-866-986-7083, M – F 8am – 5pm CST.
Principal Display Panel - 50 G Bottle Carton
SOLEIL SUPERIÉUR
RéVive
Broad Spectrum
SPF 50 Sunscreen
PA++++
50 g / net wt. 1.7 oz.
Principal Display Panel (50 g Bottle Carton)
* Please review the disclaimer below.
