Otc - Active Ingredient
Drug Facts
Active Ingredients
Avobenzone 2.0%, Homosalate 2.0%, Octisalate 3.0%, Octocrylene 5.0%
Coola Full Spectrum 360 Day Eye Cream Spf 30
FDA Label NDC 79753-017
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 Full Spectrum 360 Day Eye Cream Spf 30 (NDC 79753-017). 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, dosage & administration, inactive ingredient, other safety information, otc - questions, 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. • Stop use and ask doctor if
skin rash occurs • 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: ● 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 spection 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 1,2-HEXANEDIOL, Aloe Barbadensis Flower Extract, Aloe Barbadensis Leaf Juice
(ORGANIC), Amino Esters-1(JPN), Butylene Glycol, C12-15 Alkyl Benzoate, Caprylyl Glycol, Carthamus Tinctorius
(Safflower) Oleosomes, Cetearyl Alcohol , Cetyl Palmitate, Coccinia Indica Fruit Extract, Corallina Officinalis Extract,
Corallina Officinalis Powder, Curcuma Longa (Turmeric) Root Extract, Dimethicone, Dimethicone Crosspolymer,
Glycerin (ORGANIC), Isododecane, Jasminum Sambac (Jasmine) Leaf Cell Extract, Melia Azadirachta Flower Extract,
Melia Azadirachta Leaf Extract, Neopentyl Glycol Diheptanoate, Ocimum Basilicum (Basil) Flower/Leaf Extract,
Ocimum Sanctum Leaf Extract, Parfum, Polyacrylate Crosspolymer-6, Propanediol, Schinus Molle Extract, Silica,
Sodium Hydroxide, Sodium Phytate, Sodium Polyacrylate, Sodium Melongena (Eggplant) Fruit Extract, Sorbitan
Oleate, Sorbitan Palmitate, Tetrahexyldecyl Ascorbate, Theobroma Cacao (Cocoa) Seed Extract, Tropolone, Water
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®
Day SPF 30 & Night
Eye Cream Duo
Full 360° Spectrum
With Vitamin C & Resveratrol
Stress from Blue Light, Pollution & Fatigue
Broad Spectrum SPF 30
0.8 FL OZ / 24 mL
©2021 COOLA. Distributed by: COOLA LLC, located in Sunny &
Cool San Diego, CA 92010. All Rights Reserved. www.coola.com
*Hawaii Reef Friendly Sunscreen Oxybenzone & Octinoxate Free
res
* Please review the disclaimer below.
