Active Ingredients
Avobenzone 3.0%
Homosalate 15.0%
Octisalate 5.0%
Octocrylene 10.0%
Coola Bare Republic Clearscreen Spf100 Lotion
FDA Label NDC 79753-021
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 Bare Republic Clearscreen Spf100 (NDC 79753-021). 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
Water, Butyloctyl Salicylate, Tridecyl Salicylate, Isodecyl Neopentanoate, Acrylates/Dimethicone Copolymer, Behenyl Alcohol, Diisopropyl Sebacate, Lauryl Lactate, Glyceryl Behenatae,Vitis Vinifera (Grape) Seed Extract, Daucus Carota Sativa (Carrot) Extract, Rubus Idaeus (Raspberry) Seed Extract, Sodium Hyaluronate, Glycerin, Ethylhexylglycerin, Chlorphenesin, Polyurethane-62, Silica, Ammonium Acryloyldimethyltaurate/VP Copolymer, Trideceth-6, Tocopherol, Arachidyl Alcohol, Arachidyl Glucoside, Lecithin, Sodium Phytate
Label
Br10223_v03 (Br10223 V03)
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