Otc - Active Ingredient
Active Ingredients
AVOBENZONE 3.0%, OCTISALATE 4.0%, OCTOCRYLENE 8.0%
Coola Anti-aging Sun Silk Drops Sunscreen Liquid
FDA Label NDC 79753-084
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 Anti-aging Sun Silk Drops Sunscreen (NDC 79753-084). 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 - 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 risk of
skin cancer and early aging caused by the sun
Warnings
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 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
● 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-sleve shirts, pants, hats, and sunglasses
● Children under 6 months: Ask a doctor
Inactive Ingredient
Inactive Ingredients
Aloe Barbadensis Leaf Juice (ORGANIC), Butyloctyl
Salicylate, Polyglyceryl-6 Stearate, Glycerin
(ORGANIC), Carthamus Tinctorius (Safflower) Seed
Oil (ORGANIC), Rubus Idaeus (Raspberry) Seed Oil
(ORGANIC), Simmondsia Chinensis (Jojoba) Seed
Oil (ORGANIC), Theobroma Cacao (Cocoa) Seed
Extract, Schinus Molle Extract, Spilanthes Acmella
Flower/Leaf/Stem Extrqact, Jasminum Sambac
(Jasmine) Leaf Cell Extract, Sodium Hyaluronate,
Ethyl Ferulate, Water, Butylene Glycol,
1,2-Hexanediol, Caprylyl Glycol, Glyceryl Stearate,
Hydroxyacetophenone, Polyglyceryl-6 Behenate,
Acrylates/C10-30 Alkyl Acrylate Crosspolymer,
Sodium Phytate, Tocopheryl Acetate, Astragalus
Membranaceus Root Extract, Sodium Hydroxide,
Ubiquinone, Propanediol, Fragrance* (Natural)
Other Safety Information
Other Information
● Protect this product from excessive heat and direct sun
Otc - Questions
Questions or comments? Call 760-940-2125
Product Labeling: Coola Anti-Aging Sun Silk Drops Sunscreen Spf 30
COOLA
Anti-Aging
Sun Silk Drops
Sunscreen
30
1.0 FL OZ / 30 mL
©2024 COOLA. Manufactured in the USA for COOLA LLC,
located in Sunny San Diego, CA 92009.
All Rights Reserved.
www.coola.com
CARTON
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