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Product NDC Code | 72113-102 | ||||
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Drug Name | Evereden premium mineral sunscreen spf 30 |
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Type | Brand | ||||
Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | LOTION | ||||
Application Number | part352 | ||||
Labeler Name | Eden Brands Inc | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.ACTIVE INGREDIENT: Zinc Oxide, 18.8%
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.INACTIVE INGREDIENTS: Water (Aqua), Coco-Caprylate/Caprate, Glycerin, Steareth-2, Octyldodecanol, Steareth-21, Propanediol, Cetearyl Alcohol, Polyhydroxystearic Acid, Cucumis Sativus (Cucumber) Fruit Extract, Zingiber Officinale (Ginger) Root Extract, Helianthus Annuus (Sunflower) Seed Oil, Simmondsia Chinensis (Jojoba) Seed Oil, Bisabolol, Cetyl Glyceryl Ether, Sodium Stearoyl Glutamate, Xanthan Gum, Tetrasodium Glutamate Diacetate, Caprylhydroxamic Acid, Sodium Hydroxide
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.Evereden Premium Mineral Sunscreen SPF 30 Zinc Oxide OCTYLDODECANOL POLYHYDROXYSTEARIC ACID (2300 MW) CUCUMIS SATIVUS WHOLE ZINGIBER OFFICINALE WHOLE XANTHAN GUM TETRASODIUM GLUTAMATE DIACETATE CAPRYLHYDROXAMIC ACID WATER ZINC OXIDE ZINC OXIDE COCO-CAPRYLATE/CAPRATE STEARETH-2 STEARETH-21 PROPANEDIOL SODIUM HYDROXIDE GLYCERIN HELIANTHUS ANNUUS WHOLE SIMMONDSIA CHINENSIS SEED CETYL GLYCERYL ETHER SODIUM STEAROYL GLUTAMATE
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.Secondary
Instructions for use
Information about safe handling and use of the drug product.DIRECTIONS: - Apply liberally 15 minutes before sun exposure - Reapply at least every 2 hours - Use a water resistant sunscreen if swimming or sweating - Children under 6 months of age: 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 your time in the sun, especially from 10am-2pm -wear long-sleeved shirts, pants, hats, and sungalsses.
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 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