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| Product NDC Code | 79753-081 | ||||||||
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| Drug Name | Coola refreshing water plumping gel serum spf 30 |
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| Type | Brand | ||||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||||
| Dosage Form | GEL | ||||||||
| 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 6.0%, Octisalate 5.0%, Octocrylene 7.0% 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 at least every 2 hours ● use a water resistant sunscreen if wimming 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 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 Aloe Barbadensis Leaf Juice (ORGANIC), Alcohol Denat (ORGANIC), Ammonium Acryloyldimethyltaurate/VP Copolymer Butyloctyl Salicylate, Ethylhexyl Methoxycrylene, Hyaluronic Acid, Cocos Nucifera (Coconut) Fruit Water (ORGANIC), Alaria Esculenta Extract, Aloe Barbadensis Flower Extract, Jasminum Sambac (Jasmine) Leaf Cell Extract, Melia Azadirachta Leaf Extract, Melia Azadirachta Flower Extract, Corallina Officinalis Extract, Coccinia Indica Fruit Extract, Solanum Melongena (Eggplant) Fruit Extract, Theobroma Cacao (Cocoa) Seed Extract, Curcuma Longa (Turmeric) Root Extract, Ocimum Basilicum (Basil) Flower/Leaf Extract, Ocimum Sanctum Leaf Extract, Schinus Molle Extract, Caprylic/Capric Triglyceride, Water, Ethyl Ferulate, Propanediol, Butylene Glycol, 1,2-Hexanediol, Caprylyl Glycol, Triethyl Citrate*, Tapioca Starch, Glycerin, Gamma-Nonalactone*, Tropolone, Juniperus Mexicana Oil*, Gamma-Octalactone*, Benzyl Acetate*, Phenylethyl Alcohol*, Mimosa Tenuiflora Bark Extract*, Vanillin*, Heliotropine*, Anisaldehyde*, Delta-Decalactone*, Methylbenzyl Acetate*, Ethyl Butyrate*, Methyl Anthranilate*, Methyl Benzoate* *Plant derived scent constituent. See coola.com for additional detail.
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 Refreshing Water Plumping Gel Serum SPF 30 Avobenzone, Homosalate, Octisalate, Octocrylene AVOBENZONE AVOBENZONE HOMOSALATE HOMOSALATE OCTISALATE OCTISALATE OCTOCRYLENE OCTOCRYLENE ALOE VERA LEAF ALCOHOL AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER BUTYLOCTYL SALICYLATE ETHYLHEXYL METHOXYCRYLENE HYALURONIC ACID COCONUT WATER ALARIA ESCULENTA ALOE VERA FLOWER JASMINUM OFFICINALE LEAF AZADIRACHTA INDICA LEAF AZADIRACHTA INDICA FLOWER CORALLINA OFFICINALIS COCCINIA GRANDIS FRUIT EGGPLANT COCOA TURMERIC HOLY BASIL LEAF OCIMUM BASILICUM FLOWERING TOP SCHINUS MOLLE FRUITING TOP MEDIUM-CHAIN TRIGLYCERIDES WATER ETHYL FERULATE PROPANEDIOL BUTYLENE GLYCOL 1,2-HEXANEDIOL CAPRYLYL GLYCOL TRIETHYL CITRATE STARCH, TAPIOCA GLYCERIN .GAMMA.-NONALACTONE TROPOLONE JUNIPERUS DEPPEANA WOOD OIL .GAMMA.-OCTALACTONE BENZYL ACETATE PHENYLETHYL ALCOHOL MIMOSA TENUIFLORA BARK VANILLIN PIPERONAL P-ANISALDEHYDE .DELTA.-DECALACTONE METHYLBENZYL ACETATE ETHYL BUTYRATE METHYL ANTHRANILATE METHYL BENZOATE
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 Refreshing Water Plumping Gel Serum - Labeling COOLA® Refreshing Water Plumping Gel Serum Sunscreen Broad Spectrum SPF 30 ©2024 COOLA Manufactured in the USA for COOLA LLC, located in sunny San Diego, CA 92009. All Rights Reserved. www.coola.com Carton Bottle Tube Sachet res 79753-081 Box 79753-081 Botl 081-03 Packet 081-02 Tube
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