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| Product NDC Code | 83531-497 | ||||
|---|---|---|---|---|---|
| Drug Name | Kovr all-natural spf-30 moisturizing sunscreen for men |
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| Type | Brand | ||||
| Pharm Class | Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE] |
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| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | CREAM | ||||
| Application Number | M020 | ||||
| Labeler Name | ACTIVE LIFE INC | ||||
| 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 6% Zinc Oxide 6% Purpose Sunscreen
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 and evenly prior to sun exposure. Reapply after towel drying, or prolonged swimming or sweating. 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 of 15 or higher and other sun protection measures including limiting time in the sun, especially between 10 a.m. - 2 p.m., and wearing long-sleeve shirts, pants, hats and sunglasses. For use on children under 6: consult a physician. Sun Protection Measures:
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients: Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Camellia Sinensis (Green Tea) Extract, Daucus Carota Sativa (Carrot) Extract, Ethylhexylglycerin, Ethylhexyl Palmitate, Glycerin, Glycine Soja (Soybean) Oil, Helianthus Annuus (Sunflower) Oil, Lecithin, Phenoxyethanol, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Sesamum Indicum (Sesame) Seed Oil, Sodium Laurylglucosides Hydroxypropylsulfonate, Theobroma Cocao (Cocoa) Butter, Tocopherol (Vitamin E), Xanthan Gum.
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: Our SPF formulas provide both UVA and UVB protection, and are infused with antioxidants and nutrients to help prevent sun damage while keeping the skin well-hydrated.
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.KOVR All-Natural SPF-30 Moisturizing Sunscreen for Men TITANIUM DIOXIDE, ZINC OXIDE ALOE VERA LEAF WATER GREEN TEA LEAF CARROT ETHYLHEXYLGLYCERIN ETHYLHEXYL PALMITATE GLYCERIN SOYBEAN OIL HELIANTHUS ANNUUS FLOWERING TOP PHENOXYETHANOL ALMOND OIL SESAME OIL SODIUM LAURYLGLUCOSIDES HYDROXYPROPYLSULFONATE COCOA TOCOPHEROL XANTHAN GUM TITANIUM DIOXIDE TITANIUM DIOXIDE ZINC OXIDE ZINC CATION
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.Package Labeling: Label
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Drug Facts
Other Information: Protect product from excessive heat and direct sun
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 reach of children. If product is swallowed, seek immediate medical attention or contact a Poison Control Center right away.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? Visit www.TheActiveLifeCompany.com or call 800-410-6154
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 using and ask a doctor if irritation or rash develops or persists.
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 avoid contact with eyes. If contact with eyes occurs, flush with water to remove.
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. When using this product avoid contact with eyes. If contact with eyes occurs, flush with water to remove. Stop using and ask a doctor if irritation or rash develops or persists. Keep out of reach of children. If product is swallowed, seek immediate medical attention 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