Active Ingredients
Avobenzone 3.0%, Homosalate 7.0%, Octisalate 5.0%, Octocrylene 9.0%
Coola Sunblur Primer Spf 50 Lotion
FDA Label NDC 79753-106
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 Sunblur Primer Spf 50 (NDC 79753-106). 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, 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
Purpose
Avobenzone 3.0%, Homosalate 7.0%, Octisalate 5.0%, Octocrylene 9.0% ............ 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
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.
Directions
• Apply liberally 15 minutes before sun exposure
• Reapply:
• Reapply at least every 2 hours
• Use a water-resistant sunscreen if swimming 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 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-sleeve shirts, pants, hats, and sunglasses
• Children under 6 months: Ask a doctor
Other Information
• Protect this product from excessive heat and direct sun
Inactive Ingredients
Isododecane, Dimethicone Crosspolymer, Butyloctyl Salicylate, Vinyl Dimethicone/Methicone Silsesquioxane Crosspolymer, Dimethicone, Carthamus Tinctorius (Safflower) Seed Oil (ORGANIC), Argania Spinosa Kernel Oil (ORGANIC), Rubus Idaeus (Raspberry) Seed Oil (ORGANIC), Tapioca Starch, Dimethicone/Polyglycerin-3 Crosspolymer, Glycerin, Silica, Jasminum Sambac (Jasmine) Leaf Cell Extract, Oryza Sativa (Rice) Bran Extract, Water, Propanediol, Butylene Glycol, Polymethylsilsesquioxane, Helianthus Annuus (Sunflower) Extract, Rosmarinus Officinalis (Rosemary) Leaf Extract, Tocopherol, Mangostin, Theobroma Cacao (Cocoa) Seed Extract, Schinus Molle Extract, Fragrance (Natural)
Questions Or Comments?
Call 760-940-2125
Package Label.Principal Display Panel
COOLA
SPF 50
SunBlur
Primer
Sunscreen
Primes + Protects
Invisible Matte Finish
Featuring
BlueScreen
Digital De-Stress Technology
Broad Spectrum SPF 50
1 FL OZ / 30 mL
COOLA
SPF 50
SunBlur
Primer
Sunscreen
Primes + Protects
Invisible Matte Finish
Featuring
BlueScreen
Broad Spectrum SPF 50
1 FL OZ / 30 mL
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