Otc - Active Ingredient
Active Ingredients
Avobenzone 2.9%, Homosalate 4.0%, Octisalate 4.9%, Octocrylene 9.5%
Coola Clear California Summers Spray
FDA Label NDC 79753-104
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 Clear California Summers (NDC 79753-104). 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, otc - when using, otc - stop use, otc - do not use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purpose
Sunscreeen
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
Flammable: Contents under pressure. Do not puncture or incinerate. Do not store at temperatures about 120°F. Do not use in the presence of a flame or spark, or while smoking.
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.
Otc - When Using
When using this product keep away from face to avoid breaking. Keep out of eyes. Rinse with water to remove. Apply outdoors. Avoid overspray as it could cause surface to become slippery. Do not apply in windy conditions. Use in a well-venitilated area.
Otc - Stop Use
Stop use and ask doctor if skin rash occurs.
Otc - Do Not Use
Do not use on damaged or broken skin.
Dosage & Administration
Shake Well. Apply liberally 15 minutes before sun exposure. Hold container 4 to 6 inches from skin to apply. Rub in. Do not spray directly on face. Spray onto hands and apply to face. -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 specturm SPF of 15 or higher and other sun protection measures including: -Limit time in the sun, especially from: 10am - 2pm. -Wear long sleeve shirt, pants, hat and sunglasses -Children under 6 months; Ask a doctor
Otc - Questions
Questions or comments? Call 760-940-2125
Inactive Ingredient
Alcohol (ORGANIC), Butyloctyl Salicylate, VA/Butyl Maleate/Isobornyl Acrylate Copolymer, Limnanthes Alba (Meadowfoam) Seed Oil, Mauritia Flexuose (Buriti) Fruit Oil (ORGANIC), Rubus Idaeus (Raspberry) Seed Oil (ORGANIC), Brassica Campestris (Rapeseed) Seed Oil, Carthamus Tinctorius (Safflower) Seed Oil (ORGANIC), Opuntia Ficus-Indica Flower Extract, Camelina Sativa Seed Oil, Ethyl Ferulate, Fragrance (Natural)
Other Safety Information
Other Information -May stain fabrics -Protect this product from excessive heat and direct sun
Package Label.Principal Display Panel
1 (Coola Voluspa Spf50 Spray 6oz V2.2p)
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