Otc - Active Ingredient
Drug Facts
Active Ingredients
Zinc Oxide 14.7%
Coola Clear Skin Oil-free Moisturizer Spf 30
FDA Label NDC 79753-080
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Coola Llc for the product Coola Clear Skin Oil-free Moisturizer Spf 30 (NDC 79753-080). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - stop use, otc - keep out of reach of children, dosage & administration, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purpose
Suncreen
Indications & Usage
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
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.
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
● apply liberally 15 minutes before sun exposure.
● reapply at least every 2 hours
● use a water resistant sunscreen if swimming or sweating
● 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 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), Caprylic/Capric
Triglyceride (ORGANIC), Glycerin (ORGANIC), Glyceryl
Stearate Citrate, Niacinamide, Butylene Glycol, Butyloctyl
Salicylate, Ethylhexyl Methoxycrylene, Hydroxyethyl
Acrylate/Sodium Acryloyldimethyl Taurate Copolymer,
Water, Jasminum Sambac (Jasmine) Leaf Cell Extract,
Theobroma Cacao (Cocoa) Seed Extract, Centella Asiatica
Leaf Extract, Tropolone, Schinus Molle Extract, Isostearic
Acid, Citric Acid (ORGANIC), Polyhydroxystearic Acid,
Propanediol, Capryloyl Glycerin/Sebacic Acid Copolymer,
Isoamyl Laurate, 1,2-Hexanediol, Caprylyl Glycol,
Tocopheryl Acetate, Sodium Phytate
Other Safety Information
Other information
- protect this product from excessive heat and direct sun
Other
Questions or comments?
Call 760-940-2125
Coola Clear Skin Oil-Free Moisturizer Spf 30 Label
COOLA
Clear Skin
Oil-Free Moisturizer
Zinc Oxide Sunscreen
Broad Spectrum SPF 30
1.1 FL OZ / 33 mL
© 2024 COOLA
Manufactured in the USA for
COOLA LLC, locatedin sunny
San Diego, CA 92009.
All Rights Reserved.
www.coola.com
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