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| Product NDC Code | 79753-073 | ||||||||
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| Drug Name | Coola classic face sunscreen cucumber broad spectrum 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.Active Ingredients Avobenzone 1.75% Homosalate 2.5% Octisalate 1.5% Octocrylene 3.75%
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 40 minutes of 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 spectrum SPF of 15 or higher and after 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), Amyris Balsamifera Bark Oil*, Brassica Campestris (Rapeseed) Seed Oil, Butylene Glycol, Camelina Sativa Seed Oil, Caprylyl Glycol, Carthamus Tinctorius (Safflower) Oleosomes, Carthamus Tinctorius (Safflower) Seed Oil (ORGANIC), Cetearyl Alcohol, Cetyl Palmitate, Citric Acid, Citronellyl Acetate*, Citrus Aurantium Dulcis (Orange) Peel Oil*, Decanal*, Decyl Glucoside, Dimethicone, Dimethyl Heptenal*, Glycerin (ORGANIC), 1,2-Hexanediol, 3-Hexenol*, Hexenyl Acetate*, Hexyl Acetate*, Hydrolyzed Jojoba Esters, Jojoba Esters, Limnanthes Alba (Meadowfoam) Seed Oil, Linalyl Acetate*, Mauritia Flexuosa (Buriti) Fruit Oil, Methyl Dihydroabietate, Nerol*, Opuntia Ficus-Indica Flower Extract, Polyacrylate, Crosspolymer-6, Polysilicone-11, Rubus Idaeus (Raspberry) Seed Oil, Silica, Sodium Phytate, Sorbitan Oleate, Sorbitan Palmitate, Squalane, Triethyl Citrate*, Tropolone, 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 Sunscreen
Spl product data elements
Usually a list of ingredients in a drug product.COOLA CLASSIC FACE SUNSCREEN Cucumber Broad Spectrum SPF 30 AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE AVOBENZONE AVOBENZONE HOMOSALATE HOMOSALATE OCTISALATE OCTISALATE OCTOCRYLENE OCTOCRYLENE ALOE VERA LEAF AMYRIS BALSAMIFERA OIL BRASSICA RAPA SUBSP. OLEIFERA OIL BUTYLENE GLYCOL CAMELINA SATIVA SEED OIL CAPRYLYL GLYCOL CARTHAMUS TINCTORIUS SEED OLEOSOMES SAFFLOWER OIL CETOSTEARYL ALCOHOL CETYL PALMITATE CITRIC ACID MONOHYDRATE CITRONELLYL ACETATE ORANGE OIL DECANAL DECYL GLUCOSIDE DIMETHICONE 2,6-DIMETHYL-5-HEPTENAL GLYCERIN 1,2-HEXANEDIOL 3-HEXEN-1-OL, (3Z)- HEXENYL ACETATE, (2Z)- HEXYL ACETATE HYDROLYZED JOJOBA ESTERS (ACID FORM) JOJOBA OIL, RANDOMIZED MEADOWFOAM SEED OIL LINALYL ACETATE MAURITIA FLEXUOSA FRUIT OIL METHYL DIHYDROABIETATE NEROL OPUNTIA FICUS-INDICA WHOLE AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) RASPBERRY SEED OIL SILICON DIOXIDE DISODIUM PHTHALATE SORBITAN MONOOLEATE SORBITAN MONOPALMITATE SQUALANE TRIETHYL CITRATE TROPOLONE 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.Package Label - COOLA CLASSIC FACE SUNSCREEN Cucumber Broad Spectrum SPF 30 NEEDS OUTER BOX LABELING INSERTED SPF 30 70% + Organic COOLA ® Classic Face Sunscreen Cucumbar Non-Greasy Ultralight Hydration +Plant Protection ® Broad Spectrum SPF 30 Water Resistant (40 Minutes) .85 FL OZ / 25 mL 2021 COOLA. Distributed by: COOLA LLC, located in Sunny & Cool San Diego, CA 92010. , All Rights Reserved. www.coola.com Box TO DELETE OLD!!!!!! Tube res 073-02 25mL Tube
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.DRUG FACTS
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.Do not use on damaged or broken skin.
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 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.
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.
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