Drug Facts
Active ingredients
Zinc Oxide 15%
Coola Mineral Sun Silk Creme Sunscreen
FDA Label NDC 21839-550
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Gordon Laboratories,inc for the product Coola Mineral Sun Silk Creme Sunscreen (NDC 21839-550). 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 drug facts, otc - purpose, indications & usage, warnings and precautions, 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
Purpose
Sunscreen
Indications & Usage
Uses
* helps prevent sunburn
* if used as directed with other sun protection measures (see Directions), decreases the rise of skin cancer and early skin aging caused by the sun
Warnings And Precautions
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 doctor if skin rash occurs
Keep out of reach of children. If prodcut is swallowed, get medical help or contact Poison Control Center right away.
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 doctor if skin rash occurs
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.
Dosage & Administration
Directions
* shake well * apply liberally 15 minutes before sun exposure
* reapply: * after swimming or sweating * immediately after towel drying * at least every 2 hours
* Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF 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-sleeve shirts, pants, hats, and sunglasses
* children under 6 months: Ask a doctor
Inactive Ingredient
Inactive ingredients
Aloe Barbadensis Leaf Juice (ORGANIC), Butylene Glycol, Caprylyl Glycol, Caprylic/Capric Triglyceride, Cetearyl Alcohol, Didecyldimonium Chloride, Dimethicone, Glyceryl Caprylate, Glyceryl Stearate Citrate, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Jasminum Sambac Leaf Cell Extract, Methylpropanediol, Niacinamide, PEG-7 Trimethylolpropane Coconut Ether, Polyhydroxystearic Acid, Polyisobutene, Polyquaternium-80, Propanediol, Schinus Molle Extract, Theobroma Cacao (Cocoa) Seed Extract.
Other Safety Information
Other information
* protect this product from excessive heat and direct sun
Otc - Questions
Questions or comments? Call 760-940-2125
Instructions For Use
How to use:
Apply daily to cleansed skin,
15 minutes before sun exposure.
Dispense into palm of hand and
apply evenly across face and
neck using upward strokes,
Package Label.Principal Display Panel
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