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| Product NDC Code | 79753-053 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Coola mineral body spf 30 tropical coconut |
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| Type | Brand | ||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||
| Dosage Form | LOTION | ||||||
| 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.Zinc Oxide - 14.2%
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 Shake well 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 Measure : 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 value of 15 or higher and other sun protection measures including: • Limit time in the sun, especially from 10 a.m. to 2 p.m. • Wear long-sleeved shirts, pants, hats, and sun glasses.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Citrus Aurantium Dulcis (Orange) Fruit Water (ORGANIC), Cocos Nucifera (Coconut) Oil (ORGANIC), Butyloctyl Salicylate, Cetearyl Alcohol, Carthamus Tinctorius (Safflower) Seed Oil (ORGANIC), Methyl Dihydroabietate, Sodium Stearoyl Glutamate, Coco-Glucoside, Acacia Senegal Gum (ORGANIC), Caesalpinia Spinosa Gum (ORGANIC), Sodium Hyaluronate, Glycerin, Laminaria Digitata Extract (ORGANIC), Butyrospermum Parkii (Shea) Butter (ORGANIC), Theobroma Cacao (Cocoa) Seed Butter (ORGANIC), Bisabolol (ORGANIC), Rosmarinus Officinalis (Rosemary) Leaf Extract (ORGANIC), Helianthus Annuus (Sunflower) Seed Oil (ORGANIC), Mauritia Flexuosa Fruit Oil (ORGANIC), Limnanthes Alba (Meadowfoam) Seed Oil, Persea Gratissima (Avocado) Oil (ORGANIC), Rubus Idaeus (Raspberry) Seed Oil (ORGANIC), Brassica Campestris (Rapeseed) Seed Oil, Camelina Sativa Seed Oil, Opuntia Ficus-Indica Flower Extract, Carthamus Tinctorius (Safflower) Oleosomes, Caprylhydroxamic Acid, Caprylyl Glycol, Sodium Gluconate, Arachidyl Alcohol, Arachidyl Glucoside, Behenyl Alcohol, Capryloyl Glycerin/Sebacic Acid Copolymer, Water, Citric Acid, Gamma-Nonalactone, Gamma-Octalactone, Caprylic/Capric Triglyceride, Trans-2-hexenal, Vanillin, Maltol, Dimethyl Heptenal
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.Sunscreen
Spl product data elements
Usually a list of ingredients in a drug product.COOLA Mineral Body SPF 30 Tropical Coconut Zinc Oxide CAPRYLYL GLYCOL ACACIA SHEA BUTTER COCOA BUTTER MEDIUM-CHAIN TRIGLYCERIDES VANILLIN OPUNTIA FICUS-INDICA FLOWER CAPRYLHYDROXAMIC ACID ARACHIDYL GLUCOSIDE SODIUM STEAROYL GLUTAMATE COCO GLUCOSIDE BUTYLOCTYL SALICYLATE .GAMMA.-OCTALACTONE CAMELINA SATIVA SEED OIL COCONUT OIL CAESALPINIA SPINOSA RESIN MEADOWFOAM SEED OIL .GAMMA.-NONALACTONE MALTOL CETOSTEARYL ALCOHOL LAMINARIA DIGITATA LEVOMENOL CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S) SAFFLOWER OIL MAURITIA FLEXUOSA FRUIT OIL BRASSICA RAPA SUBSP. OLEIFERA OIL CARTHAMUS TINCTORIUS (SAFFLOWER) OLEOSOMES DOCOSANOL WATER CITRIC ACID MONOHYDRATE ZINC OXIDE ZINC OXIDE ORANGE METHYL DIHYDROABIETATE HYALURONATE SODIUM GLYCERIN RASPBERRY SEED OIL SODIUM GLUCONATE ARACHIDYL ALCOHOL 2-HEXENAL, (2E)- ROSEMARY SUNFLOWER OIL AVOCADO OIL 2,6-DIMETHYL-5-HEPTENAL
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.2 1
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.May stain fabrics 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.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.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 a 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