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| Product NDC Code | 63712-001 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Zelens daily defence mineral sunscreen spf 30 |
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| Type | Brand | ||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||
| Dosage Form | CREAM | ||||||
| Application Number | M020 | ||||||
| Labeler Name | Zelens Limited | ||||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredients Zinc Oxide 20%
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: limit time in the sun, especially from 10 a.m. - 2 p.m. wear 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 Aqua (Water), Caprylic/Capric Triglyceride, Propylheptyl Caprylate, Glycerin, Butyloctyl Salicylate, Lauryl Lactate, Propanediol, Lauryl Glucoside, Polyglyceryl-2 Dipolyhydroxystearate, Cetearyl Alcohol, Hydrogenated Vegetable Oil, Alpha-glucan Oligosaccharide, Lactobacillus, Lecithin, Dimethicone, Acetyl Hexapeptide-1 Perilla Frutescens Leaf Extract, Camellia Sinensis Leaf Extract, Centella Asiatica Leaf Extract, Malpighia Glabra (Acerola) Fruit Extract, Ginkgo Biloba Leaf Extract, Punica Granatum Fruit Extract, Haematococcus Pluvialis Extract, Pongamia Pinnata Seed Extract, Dunliella Salina Extract, Pongamia Glabra Seed Oil, Diisopropyl Sebacate, Benzyl Alcohol, Isopropyl Palmitate, Xanthan Gum, Propylene Glycol Dicaprylate/dicaprate, Tocopherol, Sodium Stearoyl Glutamate, C12-15 Alkyl Benzoate, Diisopropyl Adipate, Dehydroacetic Acid, Sodium Dehydroacetate, Polymnia Sonchifolia Root Juice, Maltodextrin, Sorbitol, Citric Acid, Sodium Benzoate, Potassium Sorbate.
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.Zelens Daily Defence Mineral Sunscreen SPF 30 Zinc Oxide BUTYLOCTYL SALICYLATE PONGAMIA PINNATA SEED LAURYL LACTATE DUNALIELLA SALINA MALPIGHIA GLABRA FRUIT SODIUM STEAROYL GLUTAMATE ACETYL HEXAPEPTIDE-1 POMEGRANATE BENZYL ALCOHOL MEDIUM-CHAIN TRIGLYCERIDES DIISOPROPYL SEBACATE CENTELLA ASIATICA LEAF GINKGO XANTHAN GUM PROPYLENE GLYCOL DICAPRYLATE/DICAPRATE PROPYLHEPTYL CAPRYLATE DIMETHICONE DIISOPROPYL ADIPATE .ALPHA.-GLUCAN OLIGOSACCHARIDE LECITHIN, SOYBEAN PROPANEDIOL POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE GLYCERIN GREEN TEA LEAF MALTODEXTRIN SORBITOL CITRIC ACID MONOHYDRATE ZINC OXIDE ZINC OXIDE TOCOPHEROL SODIUM DEHYDROACETATE SODIUM BENZOATE DEHYDROACETIC ACID WATER LAURYL GLUCOSIDE CETOSTEARYL ALCOHOL POTASSIUM SORBATE PERILLA FRUTESCENS LEAF HAEMATOCOCCUS PLUVIALIS KARUM SEED OIL ISOPROPYL PALMITATE ALKYL (C12-15) BENZOATE SMALLANTHUS SONCHIFOLIUS ROOT JUICE
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 dailydefense
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 ZELENS LIMITED LONDON SW1V 3JL, UK www.zelens.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 you may report a serious adverse reaction to this product to: Report Reaction, LLC PO Box 611 Pompton Plains, NJ 07444
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.Wen 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 Wen 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