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| Product NDC Code | 54111-145 | ||||||||
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| Drug Name | Coola classic body sunscreen fragrance-free spf 50 |
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| Type | Brand | ||||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||||
| Dosage Form | LOTION | ||||||||
| 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.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 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), 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, Decyl Glucoside, Dimethicone, Glycerin (ORGANIC), 1,2-Hexanediol, Limnanthes Alba (Meadowfoam) Seed Oil, Mauritia Flexuosa (Buriti) Fruit Oil, Methyl Dihydroabietate, Opuntia Ficus-Indica Flower Extract, Polyacrylate Crosspolymer-6, Polysilicone-11, Rubus Idaeus (Raspberry) Seed Oil, Silica, Sodium Hydroxide, Sodium Phytate, Sorbitan Oleate, Sorbitan Palmitate, 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 Body Sunscreen Fragrance-Free SPF 50 AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE AVOBENZONE AVOBENZONE HOMOSALATE HOMOSALATE OCTISALATE OCTISALATE OCTOCRYLENE OCTOCRYLENE ALOE VERA LEAF BRASSICA RAPA SUBSP. OLEIFERA OIL BUTYLENE GLYCOL CAMELINA SATIVA SEED OIL CAPRYLYL GLYCOL CARTHAMUS TINCTORIUS SEED OLEOSOMES SAFFLOWER OIL CETOSTEARYL ALCOHOL CETYL PALMITATE DECYL GLUCOSIDE DIMETHICONE GLYCERIN 1,2-HEXANEDIOL MEADOWFOAM SEED OIL MAURITIA FLEXUOSA FRUIT OIL METHYL DIHYDROABIETATE 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 SODIUM HYDROXIDE DISODIUM PHTHALATE SORBITAN MONOOLEATE SORBITAN MONOPALMITATE 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 SPF 50 70% + Organic COOLA ® Classic Body Sunscreen Fragrance-Free Ultra Lightweight Hydrates & Nourishes +Plant Protection ® Broad Spectrum SPF 50 Water Resistant (80 Minutes) 5 FL OZ / 148 mL *Hawaii Reef Friendly Sunscreen Oxybenzone & Octinoxate Free 2020 COOLA. Distributed by: COOLA LLC, located in Sunny & Cool San Diego, CA 92010. BIORUS / EU: 7170 Manage, Belgium / UK: London WC2H 9JQ. All Rights Reserved. www.coola.com Box Tube res COOLA 145-51 Box COOLA 145-51 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