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| Product NDC Code | 83325-008 | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Drug Name | Mineral sunscreen spf 50 |
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| Type | Generic | ||||||||
| 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 | LOTION | ||||||||
| Application Number | M020 | ||||||||
| Labeler Name | Volans Epic 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.Active Ingredients Purpose Niacinamide 0.01%, Vitamin E Acetate 0.50%, Titanium Di Oxide 0.01%, Zinc Oxide 0.01% ................. Sun protection
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 sunscreen evenly, 15 minutes before stepping out.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive lngredlents Aqua, Octocrylene, Methylene Bis-Benzotriazolyl Tetramethylbutylphenol (and) Aqua (and) Decyl Glucoslde (and) Propylene Glycol (and) Xanthan Gum, Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine, Ethylhexyl Salicylate, Cetyl Alcohol, PEG 100 Stearate & Glyceryl Stearate, C12-15 Alkyl Benzoate, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Glycerin, Phenoxyethanol, Fragrance.
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.No White Cast UVA/UVB Protection With PA++++ Weightless & Non-Greasy Niacinamide & Vitamin E Suitable For Sensitive Skin
Purpose
Information about the drug product’s indications for use.Use For Sun protection
Spl product data elements
Usually a list of ingredients in a drug product.MINERAL SUNSCREEN SPF 50 MINERAL SUNSCREEN SPF 50 WATER OCTOCRYLENE BISOCTRIZOLE DECYL GLUCOSIDE PROPYLENE GLYCOL XANTHAN GUM BEMOTRIZINOL OCTISALATE CETYL ALCOHOL PEG-100 STEARATE GLYCERYL MONOSTEARATE ALKYL (C12-15) BENZOATE HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) GLYCERIN PHENOXYETHANOL FRAGRANCE 13576 NIACINAMIDE NIACINAMIDE .ALPHA.-TOCOPHEROL ACETATE .ALPHA.-TOCOPHEROL 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.PRINCIPAL DISPLAY PANEL image description
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.Other lnformation Store in a cool & dry place. Keep away from direct sunlight.
DISTRIBUTED BY & DOMESTIC REPRESENTATIVE ADDRESS: Volans Epic LLC Corporation Trust Center, 1209 Orange Street, Wilmington, Delaware 19801, Country of New Castle MANUFACTURED BY: Pontika Aerotech Limited Village Johron, PO Puruwala, Nahan Road, Paonta Sahib District Sirmour, Himachal Pradesh-173001, India Mfg.Lic.No.: N-COS/18/47 Made in India
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 or children. If swallowed, get medical help. Patch Test Recommended.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions or Comments? For any customer feedback or queries, write to us at: [email protected] or call us on +1 530-464-6426
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 occurs, flush thoroughly with water
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.
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