Drug Facts
Active ingredients
Zinc Oxide 13.5%
Mineral Sun Silk Moisturizer Sunscreen
FDA Label NDC 79753-078
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 Mineral Sun Silk Moisturizer Sunscreen (NDC 79753-078). 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, warnings, otc - when using, 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
Sunscreen
Warnings
Warnings
For external use only
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), Cocos Nucifera (Coconut) Oil (ORGANIC), Simmondsia Chinensis
(Jojoba) Seed Oil (ORGANIC), Caprylic/Capric Triglyceride, Water/Aqua/Eau, Olive Oil Polyglyceryl-6 Esters,
Polyhydroxystearic Acid, Cetearyl Alcohol, Jasminum Sambac (Jasmine) Leaf Cell Extract, Theobroma Cacao
(Cocoa) Seed Extract, Schinus Molle Extract, Nymphaea Caerulea Flower Extract, Paeonia Lactiflora Leaf Cell
Extract, Nelumbo Nucifera Flower Extract, Polyurethane-79, Polyacrylate Crosspolymer-6, Polyglyceryl-6
Pentaoleate, Propanediol, Glycerin, Butylene Glycol, Citric Acid, Polymethylsilsesquioxane, Xanthan Gum,
Methylpropanediol, Caprylyl Glycol, Polyquaternium-80, Didecyldimonium Chloride, Fragrance (Natural)
Other Safety Information
Other information
* protect this product from excessive heat and direct sun
Otc - Questions
Questionsor Comments? Call 760-940-2125
Package Labeling - Coola Mineral Sun Silk Moisturizer Sunscreen Spf 30
SPF
30
70% +
Organic
COOLA
Mineral Sun Silk Moisturizer
Sunscreen
Ultra-Rich Priming Cream
Broad Spectrum SPF 30
1.5 FL OZ / 44 mL
2020 COOLA. Distributed by:
COOLA LLC, located in Sunny &
Cool San Diego, CA 92009.
All Rights Reserved. www.coola.com
Carton
Jar
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