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| Product NDC Code | 79753-040 | ||||||||
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| Drug Name | Coola 70 percent plus organic mineral body sunscreen spf50 |
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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.Active ingredients Titanium Dioxide 3.5%, Zinc Oxide 7.25%
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 value 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-sleeved shirts, pants, hats, and sunglasses children under 6 months of age: 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, Blue-Green (Algae) Extract (ORGANIC), Butyloctyl Salicylate, C30-38 Olefin/Isopropyl Maleate/MA Copolymer, Cananga Odorata Flower Oil, Caprylic/Capric Triglyceride, Carthamus Tinctorius (Safflower) Oleosomes (ORGANIC), Chlorphenesin, Citrus Paradisi (Grapefruit) Peel Oil, Cocos Nucifera (Coconut) Oil (ORGANIC), Ethylhexylglycerin, Glycerin (ORGANIC), Glyceryl Stearate, Limnanthes Alba (Meadowfoam) Seed Oil, Magnesium Sulfate, Mauritia Flexuosa (Buriti) Fruit Oil (ORGANIC), Neopentyl Glycol Diheptanoate, Olive Oil Polyglyceryl-6 Esters, Opuntia Ficus-Indica Flower Extract, Pelargonium Graveolens Flower Oil, Polyglyceryl-6 Pentaoleate, Polymethyl Methacrylate, Rubus Idaeus (Raspberry) Seed Oil, Silica, Simmondsia Chinensis (Jojoba) Seed Oil (ORGANIC), Stearyl/Octyldodecyl Citrate Crosspolymer, Tocopherol, Triethyl Citrate, VP/Hexadecene Copolymer., Water
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 70 PERCENT PLUS ORGANIC MINERAL BODY SUNSCREEN SPF50 Titanium Dioxide, Zinc Oxide OLIVE OIL POLYGLYCERYL-6 ESTERS POLY(METHYL METHACRYLATE; 450000 MW) COCONUT OIL AMYRIS BALSAMIFERA OIL PELARGONIUM GRAVEOLENS FLOWER OIL GRAPEFRUIT OIL NEOPENTYL GLYCOL DIHEPTANOATE CANANGA OIL CHLORPHENESIN APHANIZOMENON FLOSAQUAE TRIETHYL CITRATE TITANIUM DIOXIDE TITANIUM DIOXIDE ALOE VERA LEAF WATER RASPBERRY SEED OIL JOJOBA OIL VINYLPYRROLIDONE/HEXADECENE COPOLYMER GLYCERYL 1-STEARATE .ALPHA.-TOCOPHEROL, DL- MAGNESIUM SULFATE HEPTAHYDRATE GLYCERIN STEARYL/OCTYLDODECYL CITRATE CROSSPOLYMER SAFFLOWER OIL SILICON DIOXIDE MAURITIA FLEXUOSA FRUIT OIL BUTYLOCTYL SALICYLATE ZINC OXIDE ZINC OXIDE MEDIUM-CHAIN TRIGLYCERIDES ETHYLHEXYLGLYCERIN MEADOWFOAM SEED OIL OPUNTIA TUNA FLOWERING TOP
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.Label CA52372 tube CA00792 carton CA00792 tube CA00889 carton CA00889 tube
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 the reach of children If swallowed, get medical help or contact a Poison Control Center right away.
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 a 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.
Storage and handling
Information about safe storage and handling of the drug product.Other information protect this product from excessive heat and direct sun may stain or damage some fabrics, materials or surfaces
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