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| Product NDC Code | 79753-074 | ||||||||
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| Drug Name | Coola classic face sunscreen fragrance-free spf 50 |
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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 5.0%, OCTISALATE 2.0%, OCTOCRYLENE 5.0%
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 80 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 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-sleve 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), Carthamus Tinctorius (Safflower) Oleosomes, Water, Carthamus Tinctorius (Safflower) Seed Oil (ORGANIC), Glycerin (ORGANIC), Polyacrylate Crosspolymer-6, Limnanthes Alba (Meadowfoam) Seed Oil, Mauritia Flexuosa (Buriti) Fruit Oil, Rubus Idaeus (Raspberry) Seed Oil, Squalane, Brassica Campestris (Rapeseed) Seed Oil, Opuntia Ficus-Indica Flower Extract, Camelina Sativa Seed Oil, Tropolone, Cetyl Palmitate, Sodium Hydroxide, Citric Acid, Cetearyl Alcohol, Caprylyl Glycol, 1,2-Hexanediol, Sorbitan Palmitate, Methyl Dihydroabietate, Xanthan Gum, Dimethicone, Sorbitan Oleate, Gluconolactone, Silica, Sodium Phytate, Sodium Benzoate, Polysilicone-11, Butylene Glycol, Decyl Glucoside
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 rise 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 Fragrance-Free SPF 50 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE OCTISALATE OCTISALATE OCTOCRYLENE OCTOCRYLENE HOMOSALATE HOMOSALATE SODIUM HYDROXIDE XANTHAN GUM WATER TROPOLONE PHYTATE SODIUM ALOE VERA LEAF DECYL GLUCOSIDE CITRIC ACID MONOHYDRATE BUTYLENE GLYCOL 1,2-HEXANEDIOL SQUALANE BRASSICA RAPA SUBSP. OLEIFERA OIL CETOSTEARYL ALCOHOL SORBITAN MONOPALMITATE SORBITAN MONOOLEATE METHYL DIHYDROABIETATE SODIUM BENZOATE RASPBERRY SEED OIL DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) SILICON DIOXIDE AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) OPUNTIA FICUS-INDICA GLUCONOLACTONE CARTHAMUS TINCTORIUS SEEDCAKE DIMETHICONE MEADOWFOAM SEED OIL GLYCERIN SAFFLOWER OIL CAPRYLYL GLYCOL CAMELINA SATIVA SEED OIL AVOBENZONE AVOBENZONE
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.Product Labeling - COOLA Classic Face Sunscreen Fragrance-Free SPF 50 SPF 50 70% + Organic COOLA Classic Face Sunscreen FragranceiFree Broad Spectrum SPF 50 Water Resistant (80 Minutes) 1.7 FL OZ / 50 mL 2022 COOLA. Manufactured in the USA forDistributed by: COOLA LLC, COOLA LLC, located in Sunny& Cool San Diego, CA 92009. All Rights Reserved. ww.coola.com Carton Tube 074-01 Tube 50mL 074-01-Box
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 * may stain fabrics
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
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