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| Product NDC Code | 79753-020 | ||||||||
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| Drug Name | Coola full spectrum 360 refreshing water cream spf 50 |
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| Type | Brand | ||||||||
| 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 Avobenzone 3.0%, Homosalate 5.0%, Octisalate 3.0%, Octocrylene 5.0% 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: ● 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 skin aging. To decrease this risk, regularly use a sunscreen with a broad spection 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 Adipic Acid/Diglycol Crosspolymer, Aloe Barbadensis Flower Extract, Aloe Barbadensis Leaf Juice, (ORGANIC) Anisaldehyde*, Argania Spinosa Kernel Oil, Benzyl Acetate*, Bisabolol, Butylene Glycol, Caprylhydroxamic Acid, Carthamus Tinctorius (Safflower) Oleosomes (ORGANIC), Citric Acid, Coccinia Indica Fruit Extract, Cocos Nucifera (Coconut) Water (ORGANIC), Corallina Officinalis Extract, Curcuma Longa (Turmeric) Root Extract, Delta-Decalactone*, Ethyl Butyrate*, Gamma-Nonalactone*, Gamma-Octalactone*, Gluconolactone, Glycerin (ORGANIC), Glyceryl Caprylate, Glyceryl Stearate, Heliotropine*, Hyaluronic Acid, Isododecane, Jasminum Sambac (Jasmine) Leaf Cell Extract, Juniperus Mexicana, Lecithin, Leuconostoc/Radish Root Ferment Filtrate, Leuconostoc Ferment Filtrate, Melia Azadirachta Flower Extract, Melia Azadirachta Leaf Extract, Methyl Anthranilate*, Methyl Benzoate*, Methyl Benzyl Acetate*, Mimosa Tenuiflora Bark Extract, Neopentyl Glycol Diheptanoate, Nerolidol, Ocimum Basilicum (Basil) Flower/Leaf Extract, Ocimum Sanctum Leaf Extract, Phenethyl Alcohol*, Propanediol, Schinus Molle Extract, Sodium Acrylates Copolymer, Sodium Benzoate, Sodium Hydroxide, Sodium Stearoyl Glutamate, Solanum Melongena (Eggplant) Fruit Extract, Theobroma Cacao (Cocoa) Seed Extract, Tocopheryl Acetate, Triethyl Citrate*, Vanillin, Water, Xanthan Gum
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 Full Spectrum 360 Refreshing Water Cream SPF 50 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE AVOBENZONE AVOBENZONE HOMOSALATE HOMOSALATE OCTISALATE OCTISALATE OCTOCRYLENE OCTOCRYLENE ADIPIC ACID/DIGLYCOL CROSSPOLYMER (20000 MPA.S) ALOE VERA FLOWER ALOE VERA LEAF P-ANISALDEHYDE ARGAN OIL BENZYL ACETATE LEVOMENOL BUTYLENE GLYCOL CAPRYLHYDROXAMIC ACID CARTHAMUS TINCTORIUS (SAFFLOWER) OLEOSOMES CITRIC ACID MONOHYDRATE COCCINIA GRANDIS LEAF COCONUT WATER CORALLINA OFFICINALIS TURMERIC .DELTA.-DECALACTONE ETHYL BUTYRATE .GAMMA.-NONALACTONE .GAMMA.-OCTALACTONE GLUCONOLACTONE GLYCERIN GLYCERYL CAPRYLATE GLYCERYL MONOSTEARATE PIPERONAL HYALURONIC ACID ISODODECANE JASMINUM SAMBAC FLOWER JUNIPERUS DEPPEANA WOOD OIL LECITHIN, SOYBEAN LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE AZADIRACHTA INDICA FLOWER AZADIRACHTA INDICA LEAF METHYL ANTHRANILATE METHYL BENZOATE METHYLBENZYL ACETATE MIMOSA TENUIFLORA BARK NEOPENTYL GLYCOL DIHEPTANOATE NEROLIDOL OCIMUM BASILICUM FLOWERING TOP HOLY BASIL LEAF PHENYLETHYL ALCOHOL PROPANEDIOL SCHINUS MOLLE FRUITING TOP SODIUM ACRYLATE/STYRENE SULFONATE COPOLYMER (11000 MW) SODIUM BENZOATE SODIUM HYDROXIDE SODIUM STEAROYL GLUTAMATE EGGPLANT COCOA .ALPHA.-TOCOPHEROL ACETATE TRIETHYL CITRATE VANILLIN WATER XANTHAN GUM
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 SPF 50 70%+ Organic COOLA ® Refreshing Water Cream Sunscreen 1.5 FL OZ / 44 mL Broad Spectrum SPF 70 Water Resistant (80 Minutes) 5.0 FL OZ / 148 mL ©2021 COOLA. Distributed by: COOLA LLC, located in Sunny & Cool San Diego, CA 92010. All Rights Reserved. †Hawaii Reef Friendly Sunscreen Oxybenzone & Octinoxate Free *Plant-derived scent constituent. See coola.com for additional detail. Carton Bottle res 020 Box 1.5 OZ 020 Box 1.5 OZ
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
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