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| Product NDC Code | 58892-330 | ||||
|---|---|---|---|---|---|
| Drug Name | Cotz silky foam non-tinted |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | AEROSOL, FOAM | ||||
| Application Number | part352 | ||||
| Labeler Name | Fallien Cosmeceuticals, LTD | ||||
| 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% Zinc Oxide 10%
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 before using. Push nozzle up to release. Apply liberally 15 minutes before sun exposure. Reapply: After 40 minutes of swimming or sweating Immediately after towel drying At least every 2 hours Children under 6 months: Ask a doctor 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
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients: Butyloctyl Salicylate, C8-22 Alkyl Acrylates/Methacrylic Acid Crosspolymer, C12-15 Alkyl Benzoate, Caprylhydroxamic Acid, Caprylyl Glycol, Cellulose Gum. Ceteareth-20, Cetearyl Alcohol, Citric Acid, Disodium EDTA, Glycereth-26, Glycerin, Glyceryl Stearate, Methyl Methacrylate Crosspolymer, Microcrystalline Cellulose, Octyldodecyl Neopentanoate, Polyhydroxystearic Acid, Polymethyl Methacrylate, Polysorbate 80, Trans-1,3,3,3-Tetrafluoropropene, Triacontanyl PVP, Triethoxycaprylylsilane, 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 Sunscreen
Spl product data elements
Usually a list of ingredients in a drug product.CoTZ Silky Foam Non-Tinted Titanium Dioxide, Zinc Oxide Titanium Dioxide Titanium Dioxide Zinc Oxide Zinc Oxide BUTYLOCTYL SALICYLATE ALKYL (C12-15) BENZOATE CAPRYLHYDROXAMIC ACID CAPRYLYL GLYCOL CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM POLYOXYL 20 CETOSTEARYL ETHER CETOSTEARYL ALCOHOL CITRIC ACID MONOHYDRATE EDETATE DISODIUM ANHYDROUS GLYCERETH-26 GLYCERIN GLYCERYL MONOSTEARATE METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER MICROCRYSTALLINE CELLULOSE OCTYLDODECYL NEOPENTANOATE POLYHYDROXYSTEARIC ACID (2300 MW) POLY(METHYL METHACRYLATE; 450000 MW) POLYSORBATE 80 1,3,3,3-TETRAFLUOROPROPENE, (1E)- TRICONTANYL POVIDONE TRIETHOXYCAPRYLYLSILANE WATER
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.Principal Display Panel – Carton Label CoTZ ® the HEALTHIER SUNSCREEN ® Silky Foam Non-Tinted SPF 30 Vanishing Zinc Oxide MINERAL SUNCREEN BODY Broad Spectrum SPF 30 Water Resistant (40 Minutes) Net Wt. 3.5 oz/100 g Principal Display Panel – Carton Label
Principal Display Panel – Can Label CoTZ ® the HEALTHIER SUNSCREEN ® Silky Foam Non-Tinted SPF 30 Foaming MINERAL SUNSCREEN BODY Broad Spectrum SPF 30 Water Resistant (40 Minutes) Net Wt. 3.5 oz/100 g Principal Display Panel – Can Label
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 Store between 68° to 104°F (20° to 40° C) DO not store at temperature above 120° F Manufactured Exclusively For: CoTZ ® Skincare Norristown, PA 19403 www.cotzskincare.com
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. Do not use on damaged or broken skin. Stop use and ask a doctor if rash occurs. When using this product, keep out of eyes. Rinse with water to remove. Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
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