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- May stain or damage some fabrics or surfaces.
Croc Bloc Broad Spectrum Spf 50 Fps Ecran Solaire
FDA Label NDC 58331-050
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Degil Safety Products (1989) Inc. for the product Croc Bloc Broad Spectrum Spf 50 Fps Ecran Solaire (NDC 58331-050). 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 - keep out of reach of children, when using this product, stop use and ask doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
| Active | Ingredients | Purposes |
|---|---|---|
| Homosalate | 13.0 % w/w | Sunscreen |
| Octocrylene | 7.0 % w/w | Sunscreen |
| Octisalate | 5.0 % w/w | Sunscreen |
| Oxybenzone | 4.0 % w/w | Sunscreen |
| Avobenzone | 3.0 % w/w | Sunscreen |
Uses
- Helps prevent sunburn
Warnings
For external use only.
Otc - Do Not Use
Do not use on damaged or broken skin.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children
When Using This Product
- Avoid contact with eyes. Rinse with water to remove.
Stop Use And Ask Doctor If
- Rash or irritation develops and lasts
Directions
- Apply liberally and evenly to dry skin 15 minutes before exposure to the sun. Reapply every 2 hours to insure adequate UV protection or 80 minutes after swimming, perspiring heavily, or immediately after washing and towel drying.
- For children under 6 months of age: Ask a doctor
Other Information
- Protect the product from excessive heat and direct sun
Inactive Ingredients
Aqua, Sorbitol, Aluminum Starch Octenylsuccinate VP/Eicosene Copolymer, Stearic Acid, Triethanolamine, Sorbitan Isostearate, Benzyl Alcohol, Dimethicone, Tocopherol, Polyglyceryl-3 Distearate, Methylparaben, Carbomer, Propylparaben, Disodium EDTA.
Principal Display Panel - 120 Ml Bottle Label
BROAD SPECTRUM
UVA / UVB PROTECTION
Dermatologist Tested • Gentle Formula • Unscented
Water Resistant (80 Minutes)
Net Contents : 4 fl. oz. (120 mL)
DIN 02401436
Sunscreen
SPF 50
Distributed by:
Croc Bloc Products Inc.
200 Zenway Blvd., Unit 1 Vaughan, Ontario, Canada
1-800-332-1810
E-mail: [email protected]
Website: www.degilsafety.com
* Please review the disclaimer below.
