Otc - Active Ingredient
Drug Facts
Active Ingredients
Avobenzone 3.0%, Homosalate 6.0%, Octisalate 5.0%, Octocrylene 7.0%
Coola Refreshing Water Plumping Gel Serum Spf 30
FDA Label NDC 79753-081
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 Refreshing Water Plumping Gel Serum Spf 30 (NDC 79753-081). 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
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
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 at least every 2 hours
● use a water resistant sunscreen if wimming or sweating
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
Aloe Barbadensis Leaf Juice (ORGANIC), Alcohol Denat (ORGANIC),
Ammonium Acryloyldimethyltaurate/VP Copolymer Butyloctyl
Salicylate, Ethylhexyl Methoxycrylene, Hyaluronic Acid, Cocos Nucifera
(Coconut) Fruit Water (ORGANIC), Alaria Esculenta Extract, Aloe
Barbadensis Flower Extract, Jasminum Sambac (Jasmine) Leaf Cell
Extract, Melia Azadirachta Leaf Extract, Melia Azadirachta Flower Extract,
Corallina Officinalis Extract, Coccinia Indica Fruit Extract, Solanum
Melongena (Eggplant) Fruit Extract, Theobroma Cacao (Cocoa) Seed
Extract, Curcuma Longa (Turmeric) Root Extract, Ocimum Basilicum
(Basil) Flower/Leaf Extract, Ocimum Sanctum Leaf Extract, Schinus
Molle Extract, Caprylic/Capric Triglyceride, Water, Ethyl Ferulate,
Propanediol, Butylene Glycol, 1,2-Hexanediol, Caprylyl Glycol, Triethyl
Citrate*, Tapioca Starch, Glycerin, Gamma-Nonalactone*, Tropolone,
Juniperus Mexicana Oil*, Gamma-Octalactone*, Benzyl Acetate*,
Phenylethyl Alcohol*, Mimosa Tenuiflora Bark Extract*, Vanillin*,
Heliotropine*, Anisaldehyde*, Delta-Decalactone*, Methylbenzyl
Acetate*, Ethyl Butyrate*, Methyl Anthranilate*, Methyl Benzoate*
*Plant derived scent constituent. See coola.com for additional detail.
Other Safety Information
Other information
- protect this product from excessive heat and direct sun
Otc - Questions
Questions or comments? Call 760-940-2125
Coola Refreshing Water Plumping Gel Serum - Labeling
COOLA®
Refreshing Water
Plumping Gel Serum
Sunscreen
Broad Spectrum SPF 30
©2024 COOLA
Manufactured in the USA for
COOLA LLC, located in sunny
San Diego, CA 92009.
All Rights Reserved.
www.coola.com
Carton
Bottle
Tube
Sachet
res
* Please review the disclaimer below.
