Active Ingredients
Avobenzone 2.9%, Octisalate 4.9%, Octocrylene 9.5%
Coola Spray
FDA Label NDC 79753-033
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 (NDC 79753-033). 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 active ingredients, purpose, uses, warnings, directions, inactive ingredients, other information, questions or comments, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Sunscreen
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
For external use only.
Flammable: Do not store at temperatures above 120 F.
Do not use in the presence of a flame or spark, or while smoking.
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.
Directions
SHAKE WELL before use.
With your eyes completely closed, mist face evenly, holding bottle 10-12 inches away from face.
Wait until dry.
Apply liberally 15 minutes before sun exposure.
Reapply:
-After 80 minutes 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 the risk, regularly use a sunscreen with a broad-spectrum SPF of 15 or higher and other protection measures including:
-Limit time in the sun, especially from 10 a.m. – 2 p.m.
-Wear long sleeves shirts, pants, hats, and sunglasses.
Children under 6 months: Ask a doctor.
Inactive Ingredients
Alcohol (ORGANIC), Butyloctyl Salicylate, Ethylhexyl Methoxycrylene, Polyester-8, Fragrance (Natural), VA/Butyl Maleate/Isobornyl Acrylate Copolymer, Carthamus Tinctorius (Safflower) Seed Oil (ORGANIC), Rubus Idaeus (Raspberry) Seed Oil (ORGANIC), Mauritia Flexuosa (Buriti) Fruit Oil (ORGANIC), Limnanthes Alba (Meadowfoam) Seed Oil, Brassica Campestris (Rapeseed) Seed Oil, Camellia Sinensis Leaf Extract (ORGANIC),Glycyrrhiza Glabra (Licorice) Root Extract (ORGANIC), Opuntia Ficus-Indica Flower Extract, Camelina Sativa Seed Oil, Bisabolol (ORGANIC), Glycerin (ORGANIC), Water, Ethyl Ferulate, Diisooctyl Succinate
Other Information
Protect this product from excessive heat and direct sun
Questions Or Comments
Call 760-940-2125
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