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| Product NDC Code | 79753-080 | ||||
|---|---|---|---|---|---|
| Drug Name | Coola clear skin oil-free moisturizer spf 30 |
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| Type | Brand | ||||
| Pharm Class | Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE] |
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| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | CREAM | ||||
| Application Number | M020 | ||||
| Labeler Name | COOLA LLC | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Drug Facts Active Ingredients Zinc Oxide 14.7% Purpose Suncreen
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 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
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Aloe Barbadensis Leaf Juice (ORGANIC), Caprylic/Capric Triglyceride (ORGANIC), Glycerin (ORGANIC), Glyceryl Stearate Citrate, Niacinamide, Butylene Glycol, Butyloctyl Salicylate, Ethylhexyl Methoxycrylene, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Water, Jasminum Sambac (Jasmine) Leaf Cell Extract, Theobroma Cacao (Cocoa) Seed Extract, Centella Asiatica Leaf Extract, Tropolone, Schinus Molle Extract, Isostearic Acid, Citric Acid (ORGANIC), Polyhydroxystearic Acid, Propanediol, Capryloyl Glycerin/Sebacic Acid Copolymer, Isoamyl Laurate, 1,2-Hexanediol, Caprylyl Glycol, Tocopheryl Acetate, Sodium Phytate
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 Suncreen
Spl product data elements
Usually a list of ingredients in a drug product.COOLA Clear Skin Oil-Free Moisturizer SPF 30 Zinc Oxide Sunscreen ZINC OXIDE ZINC CATION ALOE VERA LEAF MEDIUM-CHAIN TRIGLYCERIDES GLYCERIN GLYCERYL STEARATE CITRATE NIACINAMIDE BUTYLENE GLYCOL BUTYLOCTYL SALICYLATE ETHYLHEXYL METHOXYCRYLENE HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) WATER JASMINUM SAMBAC FLOWER COCOA CENTELLA ASIATICA LEAF TROPOLONE SCHINUS MOLLE FRUITING TOP ISOSTEARIC ACID CITRIC ACID MONOHYDRATE POLYHYDROXYSTEARIC ACID (2300 MW) PROPANEDIOL CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S) ISOAMYL LAURATE 1,2-HEXANEDIOL CAPRYLYL GLYCOL .ALPHA.-TOCOPHEROL ACETATE PHYTATE SODIUM
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.COOLA Clear Skin Oil-Free Moisturizer SPF 30 Label COOLA Clear Skin Oil-Free Moisturizer Zinc Oxide Sunscreen Broad Spectrum SPF 30 1.1 FL OZ / 33 mL © 2024 COOLA Manufactured in the USA for COOLA LLC, locatedin sunny San Diego, CA 92009. All Rights Reserved. www.coola.com res 79753-080 Box 79753-080 Botl
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Questions or comments? Call 760-940-2125
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 reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other information protect this product from excessive heat and direct sun
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 doctor if skin rash occurs
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 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 doctor if skin rash occurs
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