Otc - Active Ingredient
Drug Facts
Active Ingredients
Avobenzone 3%, Octisalate 4%, Octocrylene 8%
Coola Sun Silk Drops Spf 30
FDA Label NDC 79753-038
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 Sun Silk Drops Spf 30 (NDC 79753-038). 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
● shake well ● apply liberally 15 minutes before sun
exposure • reapply: ● after 80 minutes of 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 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),
Butyloctyl Salicylate, Glycerin (ORGANIC),
Polyglyceryl-6 Stearate, Carthamus Tinctorius
(Safflower) Seed Oil (ORGANIC), Olea Europaea
(Olive) Fruit Oil (ORGANIC), Simmondsia Chinensis
(Jojoba) Seed Oil (ORGANIC), Theobroma Cacao
(Cocoa) Seed Extract, Jasminum Sambac
(Jasmine) Leaf Cell Extract, Schinus Molle Extract,
Sodium Hyaluronate, Sodium Hydroxide, Plankton
Extract, Water, Ethyl Ferulate, Propanediol,
Butylene Glycol, 1,2-Hexanedipol, Caprylyl Glycol,
Glyceryl Stearate, Hydroxyacetophenone,
Polyglyceryl-6 Behenate, Acrylates/10-30 Alkyl
Acrylate Crosspolymer, Sodium Phylae,
Tocopheryl Acetate, 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
Coola Label
SPF
30
70%+
Organic
COOLA®
Sun Silk Drops
Sunscreen
1.0 FL OZ / 30 mL
*SPF value may decrease if blended.
For detailed instructions, see insert.
©2021 COOLA. Distributed by: COOLA LLC,
located in Sunny & Cool San Diego, CA 92010.
All Rights Reserved.
www.coola.com
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