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| Product NDC Code | 79753-070 | ||||
|---|---|---|---|---|---|
| Drug Name | Coola mineral sun silk creme sunscreen spf 30 |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | LOTION | ||||
| Application Number | part352 | ||||
| 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 15.8%
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 * shake well * apply liberally 15 minutes before sun exposure * reapply: * after swimming or sweating * immediately after towel drying * at least every 2 hours * Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early 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 Water, Caprylic/Capric Triglyceride, Dimethicone, Polyhydroxystearic Acid, Aloe Barbadensis Leaf Juice Powder, Jasminum Sambac (Jasmine) Leaf Cell Extract, Theobroma Cacao (Cocoa) Seed Extract, Schinus Molle Extract, Niacinamide, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Propanediol, Butylene Glycol, Polyisobutene, Methylpropanediol, Cetearyl Alcohol, Glyceryl Stearate Citrate, PEG-7 Trimethylolpropane Coconut Ether, Caprylyl Glycol, Sorbitan Isostearate, Polyquaternium-80, Glyceryl Caprylate, Didecyldimonium Chloride
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 Mineral Sun Silk Creme Sunscreen SPF 30 ZINC OXIDE WATER COCOA SCHINUS MOLLE FRUITING TOP POLYISOBUTYLENE (1000 MW) POLYHYDROXYSTEARIC ACID (2300 MW) NIACINAMIDE ZINC OXIDE ZINC OXIDE METHYLPROPANEDIOL JASMINUM SAMBAC FLOWER MEDIUM-CHAIN TRIGLYCERIDES BUTYLENE GLYCOL SORBITAN ISOSTEARATE PROPANEDIOL DIDECYLDIMONIUM CHLORIDE ALOE VERA LEAF HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) DIMETHICONE CAPRYLYL GLYCOL CETOSTEARYL ALCOHOL GLYCERYL CAPRYLATE GLYCERYL STEARATE CITRATE PEG-7 TRIMETHYLOLPROPANE COCONUT ETHER POLYQUATERNIUM-80
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.Package Labeling SPF 30 COOLA MINERAL SUN SILK CREME SUNSCREEN SPF 30 1.5 FL OZ /44 mL ©2021 COOLA. Distributed by: COOLA LLC, located in Sunny & Cool San Diego, CA 92010. All Rights Reserved. res 070-01 1.5Oz Box 070-01 1.5Oz Botle
Instructions for use
Information about safe handling and use of the drug product.How to use: Apply daily to cleansed skin, 15 minutes before sun exposure. Dispense into palm of hand and apply evenly across face and neck using upward strokes,
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
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions or comments? Call 760-940-2125
Questionsor Comments? Call 760-940-2125
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
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
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