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| Product NDC Code | 54111-148 | ||||||||
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| Drug Name | Coola refreshing water mist spf 18 |
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| Type | Brand | ||||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||||
| Dosage Form | SPRAY | ||||||||
| Application Number | M020 | ||||||||
| Labeler Name | Bentley Laboratories, 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 Avobenzone 2.0%. Homosalate 10.0% Octisalate 5.0%, Octocrylene 5.5% Purpose Sunscreen
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-sleeved 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 Extract (ORGANIC), Undecane, Tridecane, Water, Cocos Nucifera (Coconut) Water (ORGANIC), Sodium Hyaluronate, Jasminum Sambac (Jasmine) Leaf Cell Extract, Theobroma Cacao (Cocoa) Seed Extract, Schinus Molle Extract, Heliotropine*, Juniperus Mexicana*, Propanediol, Butylene Glycol, Methlypropanediol, Caprylic/Capric Triglyceride, Caprylyl Glycol, Polyquaternium-80, Sodium Phytate, Didecyldimonium Chloride, Anisaldehyde*, Benzyl acetate*, Delta-Decalactone*, Gamma-Nonalactone*, Gamma Octalactone*, Methyl benzoate*, Nerolidol*, Ethyl Butyrate*, Triethyl citrate*, Vanillin * Plant-derived scent constituent.
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 Refreshing Water Mist SPF 18 Avobenzone, Homosalate, Octisalate, Octocrylene AVOBENZONE AVOBENZONE HOMOSALATE HOMOSALATE OCTISALATE OCTISALATE OCTOCRYLENE OCTOCRYLENE ALOE VERA LEAF UNDECANE TRIDECANE WATER COCONUT WATER HYALURONATE SODIUM JASMINUM OFFICINALE LEAF COCOA SCHINUS MOLLE FRUITING TOP PIPERONAL JUNIPERUS DEPPEANA WOOD OIL PROPANEDIOL BUTYLENE GLYCOL METHYLPROPANEDIOL MEDIUM-CHAIN TRIGLYCERIDES CAPRYLYL GLYCOL POLYQUATERNIUM-80 PHYTATE SODIUM DIDECYLDIMONIUM CHLORIDE P-ANISALDEHYDE BENZYL ACETATE .DELTA.-DECALACTONE .GAMMA.-NONALACTONE .GAMMA.-OCTALACTONE METHYL BENZOATE NEROLIDOL ETHYL BUTYRATE TRIETHYL CITRATE VANILLIN
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 Label COOLA ® Refreshing Water Mist Sunscreen SPF 18 Alcohol-Free Broad Spectrum SPF 18 1.7 FL OZ / 50 mL Distributed by: COOLA LLC, located in Sunny & Cool San Diego, CA 92009 www.coola.com res 54111-148 Box 148 jar
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
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