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Coola bare republic clearscreen spf100 - Medication Information

Product NDC Code 79753-022
Drug Name

Coola bare republic clearscreen spf100

Type Brand
Active Ingredients
Avobenzone 30 mg/ml
Homosalate 150 mg/ml
Octisalate 50 mg/ml
Octocrylene 100 mg/ml
Route TOPICAL
Dosage Form LOTION
Application Number M020
Labeler Name COOLA, LLC
Packages
Package NDC Code Description
79753-022-01 148 ml in 1 tube (79753-022-01)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active ingredients Avobenzone 3.0% Homosalate 15.0% Octisalate 5.0% Octocrylene 10.0%

Dosage and administration

Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.
Directions apply liberally 15 minutes before sun exposure reapply: -after 80 minutes of swimming or sweating -immediately after towel drying -at least every 2 hours 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: -limit time in the sun, especially from 10 a.m.-2 p.m. -wear long-sleeved shirts, pants, hats, and sunglasses

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive Ingredients Water, Butyloctyl Salicylate, Tridecyl Salicylate, Isodecyl Neopentanoate, Acrylates/Dimethicone Copolymer, Diisopropyl Sebacate, Lauryl Lactate, Daucus Carota Sativa (Carrot) Seed Oil, Rubus Idaeus (Raspberry) Seed Seed Oil, Vitis Vinifera (Grape) Seed Oil, Sodium Hyaluronate, Tocopherol, Behenyl Alcohol, Glycerin, Silica, Phenethyl Alcohol, Arachidyl Alcohol, Glyceryl Behenate, Arachidyl Glucoside, Lecithin, Glyceryl Caprylate, Polyurethane-62, Sodium Phytate, Sodium Poluacrylate, Ethylhexyl Stearate, Chlorphenesin, Ammonium Acryloyldimethyltaurate/VP Copolymer, Trideceth-6, Fragrance (Natural)

Indications and usage

A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.
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

Purpose

Information about the drug product’s indications for use.
Purpose Sunscreen

Spl product data elements

Usually a list of ingredients in a drug product.
COOLA BARE REPUBLIC CLEARSCREEN SPF100 Avobenzone, Homosalate, Octisalate, Octocrylene WATER RASPBERRY SEED OIL CHLORPHENESIN HYALURONATE SODIUM CARROT SEED OIL .ALPHA.-TOCOPHEROL, DL- GRAPE SEED OIL ARACHIDYL ALCOHOL GLYCERIN BUTYLOCTYL SALICYLATE HOMOSALATE HOMOSALATE AVOBENZONE AVOBENZONE OCTOCRYLENE OCTOCRYLENE OCTISALATE OCTISALATE TRIDECYL SALICYLATE DOCOSANOL GLYCERYL MONOBEHENATE PHYTATE SODIUM POLYURETHANE-62 LAURYL LACTATE LECITHIN, SOYBEAN ARACHIDYL GLUCOSIDE SILICON DIOXIDE AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER ISODECYL NEOPENTANOATE DIISOPROPYL SEBACATE 2-ETHYLHEXYL ACRYLATE, METHACRYLATE, METHYL METHACRYLATE, OR BUTYL METHACRYLATE/HYDROXYPROPYL DIMETHICONE COPOLYMER (30000-300000 MW) SODIUM POLYACRYLATE (2500000 MW) ETHYLHEXYL STEARATE TRIDECETH-6 GLYCERYL CAPRYLATE PHENYLETHYL ALCOHOL

Package label principal display panel

The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.
Label BR10224_v02

Do not use

Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.
Do not use on damaged or broken skin.

Keep out of reach of children

Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.
Keep out of the reach of children If swallowed, get medical help or contact a Poison Control Center right away.

Stop use

Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.
Stop use and ask a doctor if rash occurs.

When using

Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.
When using this product keep out of eyes. Rinse with water to remove.

Storage and handling

Information about safe storage and handling of the drug product.
Other information protect this product from excessive heat and direct sun may stain or damage some fabrics, materials or surfaces

Warnings

Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.
Warnings For external use only

Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API