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Drug Facts
Revive Fermitif Hand Renewal
FDA Label NDC 58411-415
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 Fermitif Hand Renewal (NDC 58411-415). 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 3.0% | Sunscreen |
| Octinoxate 7.5% | Sunscreen |
| Octisalate 2.0% | 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
Water, Butylene Glycol, Glycerin, C12-15 Alkyl Benzoate, Mangifera Indica (Mango) Seed Butter, Octyldodecyl Neopentanoate, Cetyl Alcohol, Glyceryl Stearate, PEG-100 Stearate, Potassium Cetyl Phosphate, Aluminum Starch Octenylsuccinate, Hydrogenated Palm Glycerides, Dimethicone, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Decapeptide-4, Palmitoyl Tripeptide-1, Palmitoyl Tetrapeptide-7, Sodium Coco PG-Dimonium Chloride Phosphate, Caprylyl Methicone, Squalane, Camellia Sinensis Seed Oil, Caprylyl Glycol, Fragrance, Glyceryl Laurate, Polysilicone-11, Isohexadecane, Carrageenan, Glucose, Polyethylene, Tocopheryl Acetate, Polysorbate 60, Butyrospermum Parkii (Shea) Butter, Jojoba Alcohol, Phenylethyl Resorcinol, Potassium Jojobate, Potassium Sorbate, Propanediol, Simmondsia Chinensis (Jojoba) Butter, Maltodextrin, Disodium EDTA, Pentylene Glycol, Carbomer, Rhodiola Rosea Root Extract, Polysorbate 20, Sodium Hyaluronate, Subtilisin, Citronellol, Geraniol. May Contain (+/-): Red 4, Red 33.
Questions Or Comments?
Call 1-888-704-3440, M – F 8am – 5pm CST.
Principal Display Panel - 100 G Tube Carton
FERMITIF™
HAND RENEWAL CREAM
RéVive
Broad Spectrum
SPF 15 Sunscreen
100 g / net wt. 3.4 oz.
Principal Display Panel (100 g Tube Carton)
* Please review the disclaimer below.
