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| Product NDC Code | 54111-183 | ||||
|---|---|---|---|---|---|
| Drug Name | Mineral sunscreen |
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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 | Bentley Laboratories 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.Drug Facts Active ingredient Zinc Oxide 12.025%
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 evenly to the face as the last step of your skin care routine and 15 minutes before sun exposure. Can be used under makeup. Reapply at least every two hours, especially after swimming or sweating. • Children under 6 months: 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 time in the sun, especially from 10 a.m. – 2 p.m. • Wear long-sleeved shirts, pants, hats, and sunglasses.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Aqua (Water, Eau), Isododecane, Caprylyl Methicone, Propanediol, Coco-Caprylate / Caprate, Glycerin, Cetyl PEG / PPG-10 / 1 Dimethicone, Methyl Dihydroabietate, Polyglyceryl-4 Diisostearate/Polyhydroxystearate/Sebacate, Zea Mays (Corn) Starch, Dimethicone, Sodium Chloride, Physalis Pubescens Fruit Juice, Yeast Extract, Hyaluronic Acid, Lycium Chinense Fruit Extract, Vaccinium Angustifolium (Blueberry) Fruit Extract, Vaccinium Macrocarpon (Cranberry) Fruit Extract, Tocopherol, Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocinnamate, Polyglyceryl-3 Polyricinoleate, Phenoxyethanol, Disteardimonium Hectorite, Zinc Stearate, 1,2-Hexanediol, Caprylyl Glycol, Caprylic/Capric Triglyceride, Isostearic Acid, Propylene Carbonate, Sodium Gluconate
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 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.Mineral Sunscreen Zinc Oxide Sunscreen ZINC OXIDE ZINC CATION WATER ISODODECANE CAPRYLYL TRISILOXANE PROPANEDIOL COCO-CAPRYLATE/CAPRATE GLYCERIN CETYL PEG/PPG-10/1 DIMETHICONE (HLB 4) METHYL DIHYDROABIETATE POLYGLYCERYL-4 DIISOSTEARATE/POLYHYDROXYSTEARATE/SEBACATE STARCH, CORN DIMETHICONE SODIUM CHLORIDE PHYSALIS PUBESCENS FRUIT JUICE YEAST, UNSPECIFIED HYALURONIC ACID LYCIUM CHINENSE FRUIT LOWBUSH BLUEBERRY CRANBERRY TOCOPHEROL PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) POLYGLYCERYL-3 PENTARICINOLEATE PHENOXYETHANOL DISTEARDIMONIUM HECTORITE ZINC STEARATE 1,2-HEXANEDIOL CAPRYLYL GLYCOL MEDIUM-CHAIN TRIGLYCERIDES ISOSTEARIC ACID PROPYLENE CARBONATE SODIUM GLUCONATE
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.Mario Badescu Mineral Sunscreen SPF 30 product label MARIO BADESCU SKIN CARE Since 1967 MB MINERAL SUNSCREEN BROAD SPECTRUM SPF 30 SUNSCREEN Store in a cool, dry place. 0001 Manufactured in the US with globally-sourced ingredients. Mario Badescu Skin Care, New York, NY • (800) BADESCU Leceur, Bulevardi 21, 00180 Helsinki FI / Plaza 1, Salford M50 3UB, UK order online at mariobadescu.com res 54111-183 Crtn 54111-183 Inner
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.
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 1-800-223-3728 M – F 9 a.m. – 5 p.m. EST or visit mariobadescu.com
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.
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