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Product NDC Code | 78518-001 | ||||
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Drug Name | Monat sun veil sunscreen broad spectrum spf 30 |
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Type | Brand | ||||
Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | LOTION | ||||
Application Number | part352 | ||||
Labeler Name | Monat Global Corp. | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient[s] Zinc Oxide 15%
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: at least every 2 hours Use a water resistant sunscreen if swimming or sweating. 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 of 15 or higher and other sun protection measures including: limiting time in the sun, especially from 10 a.m. - 2 p.m. wearing long-sleeve shirts, pants, hats, and sunglasses. children under 6 months: Ask a doctor.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Water, Coco-Caprylate, Glycerin, Coco-Caprylate/Caprate, C12-15 Alkyl Benzoate, Coco-Glucoside, Cetearyl Olivate, Soibitan Olivate, Coconut Alcohol, Xylitylgucoside, Anhydroxylitol, Jojoba Esters, Zinc Sulfate, Jasminum Officinale (Jasmine) Extract, Arnica Montana (Arnica) Rower Extract, Hypnea Musciformis (Red Algae) Extract, Niacinamide, Marrubium Vulgare Extract, Hydrogenated Olive Oil Unsaponifiables, Hyaluronic Acid, Salvia Hispanica Seed Extract, Galactoarabinan, Xylitol, Sorbitol, Leuconostoc/Rad- ish Root Ferment Filtrate, Glucose, Caprylyl Glycol, CaprylhydroxamicAcid, Glyceryl Caprylate, Trehalose, Sodium Phytate, Xanthan Gum, Polyhydroxystearic Add, Benzyl Alcohol, Sodium Phosphate, 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.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.Monat Sun Veil Sunscreen Broad Spectrum SPF 30 Zinc Oxide GLYCERIN HOREHOUND HYALURONIC ACID CHIA SEED XANTHAN GUM BENZYL ALCOHOL LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE COCO-CAPRYLATE/CAPRATE ALKYL (C12-15) BENZOATE CETEARYL OLIVATE COCONUT ALCOHOL XYLITYLGLUCOSIDE ANHYDROXYLITOL COCO-CAPRYLATE JOJOBA OIL, RANDOMIZED COCO GLUCOSIDE ARNICA MONTANA FLOWER TREHALOSE SORBITAN OLIVATE XYLITOL SORBITOL ANHYDROUS DEXTROSE CAPRYLYL GLYCOL CAPRYLHYDROXAMIC ACID GLYCERYL CAPRYLATE PHYTATE SODIUM POLYHYDROXYSTEARIC ACID (2300 MW) WATER ZINC SULFATE JASMINUM OFFICINALE FLOWER HYPNEA MUSCIFORMIS NIACINAMIDE HYDROGENATED OLIVE OIL UNSAPONIFIABLES GALACTOARABINAN SODIUM PHOSPHATE ZINC OXIDE ZINC OXIDE
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.Product Packaging MONAT SUN VEIL Sunscreen Daily Mineral High Protection Broad Spectrum SPF 30 ALL SKIN TYPES 50 ml 1.7 fl. oz. sun veil
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
Company Information PRODUCT OF U.S.A. Manufactured for MONAT Global Corp, Doral, FL 33122, USA. www.monatglobal.com
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, get medical help or contact a Poison Control Center right away.
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. Report serious adverse effect to: 1-800-878-1978.
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? Call toll free: 1-888-867 9987 (US)
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 use and ask a doctor if rash occurs
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 keep out of eyes. Rinse 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 keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if rash occurs Keep out of reach of children. If product is 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