Otc - Active Ingredient
Active Ingredients
AVOBENZONE 3%, HOMOSALATE 5%, OCTISALATE 5%, OCTOCRYLENE 10%
Coola Firming Face Serum Sunscreen Oil
FDA Label NDC 79753-083
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 Firming Face Serum Sunscreen (NDC 79753-083). 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 - do not use, otc - when using, otc - stop use, otc - keep out of reach of children, 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 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 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 especially if swimming or sweating
● 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-sleve shirts, pants, hats, and sunglasses
● Children under 6 months: Ask a doctor
Inactive Ingredient
Inactive Ingredients
Caprylic/Capric Triglyceride(ORGANIC), Helianthus Annuus
(Sunflower) Seed Oil (ORGANIC), Ethylhexyl Methoxycrylene,
Maleated Soybean Oil Glyceryl/Octyldodecanol Esters
(ORGANIC), Tetrahexyldecyl Ascorbate, Bakuchiol, Moringa
Oleifera Seed Oil (ORGANIC), Simmondsia Chinensis
(Jojoba) Seed Oil (ORGANIC), Carthamus Tinctorius
(Safflower) Seed Oil, Hippophae Rhamnoides Fruit Oil, Alaria
Esculenta Extract, Rosmarinus Officinalis (Rosemary) Leaf
Extract, Citrullus Lanatus (Watermelon) Seed Oil, Tagetes
Erecta Flower Extract, 1,2-Hexanediol, Tocopheryl Acetate,
Terpineol, 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
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Product Labeling - COOLA Firming Face Oil Sunscreen SPF 30
COOLA Firming Face Oil
Sunscreen
Broad Spectrum SPF 30
1.1 FL OZ / 33 mL
2024 COOLA.
Manufactured in the USA for
COOLA LLC, located in Sunny
San Diego, CA 92009.
All Rights Reserved.
www.coola.com
33 mL Carton
33 mLBottle
5 mL Sample Card
5 mL Sample Bottle
res
* Please review the disclaimer below.
