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DRUG FACTS
Coola Classic Body Sunscreen Fragrance-free Lotion
FDA Label NDC 54111-145
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Bentley Laboratories, Llc for the product Coola Classic Body Sunscreen Fragrance-free (NDC 54111-145). 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 other, otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Active Ingredient
Active Ingredients
Avobenzone 1.75% Homosalate 5.0%
Octisalate 2.0% Octocrylene 5.0%
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 skin 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 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:
• 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 after 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), Brassica
Campestris (Rapeseed) Seed Oil, Butylene Glycol,
Camelina Sativa Seed Oil, Caprylyl Glycol, Carthamus
Tinctorius (Safflower) Oleosomes, Carthamus Tinctorius
(Safflower) Seed Oil (ORGANIC), Cetearyl Alcohol, Cetyl
Palmitate, Decyl Glucoside, Dimethicone, Glycerin
(ORGANIC), 1,2-Hexanediol, Limnanthes Alba
(Meadowfoam) Seed Oil, Mauritia Flexuosa (Buriti) Fruit Oil,
Methyl Dihydroabietate, Opuntia Ficus-Indica Flower
Extract, Polyacrylate Crosspolymer-6, Polysilicone-11,
Rubus Idaeus (Raspberry) Seed Oil, Silica, Sodium
Hydroxide, Sodium Phytate, Sorbitan Oleate, Sorbitan
Palmitate, Tropolone, Water, Xanthan Gum
Other Safety Information
Other Information
- protect this product from excessive heat and direct sun
Otc - Questions
Questions or Comments? Call 760-940-2125
Package Label
SPF
50
70% +
Organic
COOLA®
Classic
Body Sunscreen
Fragrance-Free
Ultra Lightweight
Hydrates & Nourishes
+Plant Protection®
Broad Spectrum SPF 50
Water Resistant (80 Minutes)
5 FL OZ / 148 mL
*Hawaii Reef Friendly Sunscreen Oxybenzone & Octinoxate Free
2020 COOLA. Distributed by: COOLA LLC, located in Sunny
& Cool San Diego, CA 92010. BIORUS / EU: 7170 Manage,
Belgium / UK: London WC2H 9JQ. All Rights Reserved.
www.coola.com
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