Otc - Active Ingredient
Drug Facts
Active Ingredients
Avobenzone 2.0%. Homosalate 10.0%
Octisalate 5.0%, Octocrylene 5.5%
Coola Refreshing Water Mist Spf 18 Spray
FDA Label NDC 54111-148
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 Refreshing Water Mist Spf 18 (NDC 54111-148). 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 - keep out of reach of children, dosage & administration, inactive ingredient, other safety information, 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 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
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-sleeved shirts, pants, hats, and sunglasses
• children under 6 months: Ask a doctor
Inactive Ingredient
Inactive Ingredients
Aloe Barbadensis Leaf Extract (ORGANIC), Undecane,
Tridecane, Water, Cocos Nucifera (Coconut) Water
(ORGANIC), Sodium Hyaluronate, Jasminum Sambac
(Jasmine) Leaf Cell Extract, Theobroma Cacao (Cocoa)
Seed Extract, Schinus Molle Extract, Heliotropine*,
Juniperus Mexicana*, Propanediol, Butylene Glycol,
Methlypropanediol, Caprylic/Capric Triglyceride, Caprylyl
Glycol, Polyquaternium-80, Sodium Phytate,
Didecyldimonium Chloride, Anisaldehyde*, Benzyl
acetate*, Delta-Decalactone*, Gamma-Nonalactone*,
Gamma Octalactone*, Methyl benzoate*, Nerolidol*, Ethyl
Butyrate*, Triethyl citrate*, Vanillin
* Plant-derived scent constituent.
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
COOLA®
Refreshing Water Mist
Sunscreen
SPF 18
Alcohol-Free
Broad Spectrum SPF 18
1.7 FL OZ / 50 mL
Distributed by: COOLA LLC, located in
Sunny & Cool San Diego, CA 92009
www.coola.com
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* Please review the disclaimer below.
