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| Product NDC Code | 79753-046 | ||||
|---|---|---|---|---|---|
| Drug Name | Coola rosilliance mineral tinted face moisturizer spf 30 fresh rose |
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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.Titanium Dioxide - 5.6%
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 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), Water, Oryza Sativa (Rice) Bran Oil (ORGANIC), Dicaprylyl Carbonate, Propanediol, Cocoglycerides, Carthamus Tinctorius (Safflower) Seed Oil (ORGANIC), Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Euterpe Oleracea (Acai) Fruit Oil (ORGANIC), Helianthus Annuus (Sunflower) Seed Oil (ORGANIC), Helianthus Annuus (Sunflower) Seed Extract (ORGANIC), Cucumis Sativus (Cucumber) Fruit Extract (ORGANIC), Rosmarinus Officinalis (Rosemary) Leaf Extract (ORGANIC), Rosa Damascena Leaf Cell Extract, Rosa Gallica Flower Extract, Rosa Centifolia Leaf Cell Extract, Rosa Alba Leaf Cell Extract, Commiphora Myrrha Leaf Cell Extract, Plankton Extract, Glycerin (ORGANIC), Iron Oxides, Caprylyl Glycol, Octyldodecyl Oleate, Aluminum Hydroxide, Hydrolyzed Wheat Protein/PVP Crosspolymer, Xanthan Gum, Trisodium Ethylenediamine Disuccinate, Mica, Caprylhydroxamic Acid, Sodium Citrate, Hydrogen Dimethicone, Flavor
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 Rosilliance Mineral Tinted Face Moisturizer SPF 30 Fresh Rose Titanium Dioxide DICAPRYLYL CARBONATE ROSEMARY XANTHAN GUM ORANGE ROSA X ALBA FLOWER OIL CAPRYLYL GLYCOL SAFFLOWER OIL CAPRYLHYDROXAMIC ACID PROPANEDIOL FERRIC OXIDE YELLOW ROSA CENTIFOLIA WHOLE ACAI OIL SUNFLOWER OIL CUCUMBER POVIDONE, UNSPECIFIED ROSA DAMASCENA FLOWER COCO-GLYCERIDES TRISODIUM ETHYLENEDIAMINE DISUCCINATE RICE BRAN OIL ALUMINUM HYDROXIDE ROSA GALLICA FLOWER FERRIC OXIDE RED FERROSOFERRIC OXIDE WATER HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) MICA HYDROLYZED WHEAT PROTEIN (ENZYMATIC, 3000 MW) GLYCERIN COMMIPHORA MYRRHA WHOLE SUNFLOWER SEED OCTYLDODECYL OLEATE SODIUM CITRATE TITANIUM DIOXIDE TITANIUM DIOXIDE
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.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.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