Active Ingredients
Avobenzone 3.0%
Homosalate 10.0%
Octisalate 4.5%
Octocrylene 8.0%
Coola Classic Sunscreen Fragrance Free Lotion
FDA Label NDC 79753-045
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 Classic Sunscreen Fragrance Free (NDC 79753-045). 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, do not use, when using this product, stop use and ask a doctor if, keep out of the reach of children, 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
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 A Doctor If
- rash occurs.
Keep Out Of The Reach Of Children
If swallowed, get medical help or contact a Poison Control Center right away.
Directions
- apply liberally 15 minutes before sun exposure
- reapply:
- children under 6 months of age: ask a doctor
- 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 value of 15 or higher and other sun protection measures including:
-after 80 minutes of swimming or sweating
-immediately after towel drying
-at least every 2 hours
-limit time in the sun, especially from 10 a.m.-2 p.m.
-wear long-sleeved shirts, pants, hats, and sunglasses
Other Information
- protect this product from excessive heat and direct sun
- may stain or damage some fabrics, materials or surfaces
Inactive Ingredients
Alkyl Heptoate, Behenyl Alcohol, Butylated PVP, Butylene Glycol, Butyloctyl Salicylate, Caprylic/Capric Triglyceride, Cellulose Gum, Cetyl Alcohol, Citrus Aurantium Bergamia (Bergamot) Leaf Extract, Disodium EDTA, Ethylhexylglycerin, Gamma-Decalactone, Gamma-Nonalactone, Glycerin, Glyceryl Stearate, Heliotropine, Lauryl Alcohol, Lecithin, Linum Usitatissimum (Linseed) Seed Oil, Lycium Barbarum Fruit Extract, Microcrystalline Cellulose, Myristyl Alcohol, Palmitic Acid, Phenoxyethanol, Propylene Glycol, Raspberry Ketone, Rubus Idaeus (Raspberry) Seed Extract, Sodium Ascorbyl Phosphate, Stearic Acid, Tocopherol, Triethyl Citrate, Vanillin, Water (Aqua)
Label
Ca61410 (Ca61410)
Ca00770 (Ca00770)
Ca00761 (Ca00761)
* Please review the disclaimer below.
