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| Product NDC Code | 58892-602 | ||||
|---|---|---|---|---|---|
| Drug Name | Cotz pure botanicals |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | CREAM | ||||
| 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 3.0% 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: Apply liberally 15 minutes before sun exposure. Reapply: - After 80 minutes of swimming or sweating - Immediately after towel drying - At least every two 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: Butyrospermum Parkii (Shea) Butter (Shea Tree Extract), C 12-15 Alkyl Benzoate (from Cranberries & Coconut), Camellia Sinensis (Green Tea) Leaf Extract, Capric/Caprylic Triglyceride (From Coconut), Glyceryl Caprylate (From Coconut), Glyceryl Undecylenate (From Castor Bean & Coconut), Iron Oxides (Natural Mineral), Melissa Officinalis (Balm Mint) Extract (Natural Herb), Olive Oil Polyglyceryl-6 Esters (From Glycerin & Olive Oil), Polyglyceryl-6 Oleate (From Glycerin & Olive Oil), Polyhydroxystearic Acid (From Castor Plant), Propanediol (From Corn), Rosemarinus Officinalis (Rosemary) Extract (Natural Herb), Salvia Officinalis (Sage) Leaf Extract (Natural Herb), Sclerocarya Birrea (Marula) Seed Oil (Tree Fruit Extract), Simmondsia Chinensis (Jojoba) Esters (From Natural Plant), Sodium Chloride (Natural Mineral), Sodium Stearoyl Glutamate (From Coconut & Amino Acid), Tetradecane (Derived from Vegetable Oil), Tocopherol (From Mixed Fruit & Seed Extracts), Tocopheryl Acetate (From Mixed Fruit & Seed Extracts), 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 Pure Botanicals Titanium Dioxide, Zinc Oxide Titanium Dioxide Titanium Dioxide Zinc Oxide Zinc Oxide SHEA BUTTER ALKYL (C12-15) BENZOATE CAMELLIA OLEIFERA LEAF MEDIUM-CHAIN TRIGLYCERIDES GLYCERYL MONOCAPRYLATE GLYCERYL 1-UNDECYLENATE FERRIC OXIDE RED FERRIC OXIDE YELLOW FERROSOFERRIC OXIDE MELISSA OFFICINALIS POLYGLYCERYL-6 STEARATE POLYHYDROXYSTEARIC ACID (2300 MW) PROPANEDIOL ROSEMARY OIL SAGE SIMMONDSIA CHINENSIS SEED WAX SCLEROCARYA BIRREA SEED OIL SODIUM CHLORIDE SODIUM STEAROYL GLUTAMATE 1-TETRADECENE TOCOPHEROL .ALPHA.-TOCOPHEROL ACETATE 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 SUNCREEN ® Pure Botanicals Lightly Tinted SPF 45 Plant Based Mineral Sunscreen BODY Broad Spectrum SPF 45 Water Resistant (80 Minutes) Net Wt. 3 oz/85 g Principal Display Panel – Carton Label
Principal Display Panel – Tube Label CoTZ ® the HEALTHIER SUNCREEN ® Pure Botanicals Lightly Tinted SPF 45 Plant Based Mineral Sunscreen Body Broad Spectrum SPF 45 Water Resistant (80 Minutes) Net Wt. 3 oz/85 g Principal Display Panel – Tube 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. May stain some fabrics. Manufactured Exclusively For: CōTZ ® 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