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| Product NDC Code | 69473-011 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Alumier md clear shield broad spectrum spf 42 sunscreen |
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| Type | Brand | ||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||
| Dosage Form | LOTION | ||||||
| Application Number | part352 | ||||||
| Labeler Name | Alumier Labs | ||||||
| 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 7% Zinc Oxide 6.18%
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/generously (and evenly) 15 minutes before sun exposure reapply at least every 2 hours for use on children less than 6 months of age, consult a health care practitioner 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 use a water resistant sunscreen if swimming or sweating
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Water/Aqua/Eau, C12-15 Alkyl Benzoate, Caprylic/Capric Triglyceride, Cyclopentasiloxane, Niacinamide, Propanediol, Butyloctyl Salicylate, Cetearyl Alcohol, Aluminium Stearate, Glycerin, Glyceryl Stearate, PEG-100 Stearate, Vitis Vinifera Seed Extract, Sodium Hyaluronate, Resveratrol, Lecithin, Magnesium Ascorbyl Phosphate, Tocopheryl Acetate, Glutathione, Acacia Senegal Gum, Cellulose Gum, Microcrystalline Cellulose, Polysilicone-11, Triethoxycaprylylsilane, Ceteareth-20, Polyhydroxystearic Acid, Synthetic Wax, C20-40 Pareth-10, Hydroxyethyl Behenamidopropyl Dimonium Chloride, Polyquatemium-67, Xanthan Gum, Disodium EDTA, Alumina, Ethylhexylglycerin, Phenoxyethanol.
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.Use helps prevent sunburn
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.Alumier MD Clear Shield Broad Spectrum SPF 42 Sunscreen Titanium Dioxide, Zinc Oxide NIACINAMIDE DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) ZINC OXIDE ZINC OXIDE MEDIUM-CHAIN TRIGLYCERIDES ALUMINUM MONOSTEARATE TRIETHOXYCAPRYLYLSILANE TITANIUM DIOXIDE TITANIUM DIOXIDE WATER CETOSTEARYL ALCOHOL GLYCERYL MONOSTEARATE PEG-100 STEARATE ACACIA POLYOXYL 20 CETOSTEARYL ETHER ALUMINUM OXIDE XANTHAN GUM HYDROXYETHYL BEHENAMIDOPROPYL DIMONIUM CHLORIDE ALKYL (C12-15) BENZOATE PROPANEDIOL GLUTATHIONE MAGNESIUM ASCORBYL PHOSPHATE ASCORBIC ACID MICROCRYSTALLINE CELLULOSE PHENOXYETHANOL LECITHIN, SOYBEAN EDETATE DISODIUM EDETIC ACID C20-40 PARETH-10 ETHYLHEXYLGLYCERIN BUTYLOCTYL SALICYLATE GLYCERIN VITIS VINIFERA SEED POLYHYDROXYSTEARIC ACID (2300 MW) RESVERATROL .ALPHA.-TOCOPHEROL ACETATE CYCLOMETHICONE 5 HYALURONATE SODIUM CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM
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 - 60 mL Alumier MD Clear Shield Broad Spectrum SPF 42 OIL FREE SUNSCREEN LOTION NPN 80064930 60 mL/2 fl oz clear shield rev
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 Alumier MD ALUMIER EUROPE LTD. 5 ST. FREDERICK STREET VALLETTA VLT 1470, MALTA WWW.ALUMIERMD.COM EUROPE • UNITED STATES • CANADA UNITED KINGDOM DISTRIBUTED IN CANADA BY ALUMIER LABS INC., 436 LIMESTONE CRESCENT TORONTO, ON, M3J 2S4 DISTRIBUTED IN THE USA BY ALUMIER LABS INC., 550 COCHITUATE ROAD, SUITE 25 FRAMINGHAM, MA 01701 MANUFACTURED IN CANADA UNDER LICENSE FROM ALUMIER EUROPE LTD.
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 swallowed, call a Poison Control Centre or get medical help 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 Do not use if security seal is broken or missing. You may report a serious adverse reaction event from using this product to: Alumier Labs Inc., 550 Cochituate Road, Suite 25, Framingham, MA 01701
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 you develop severe irritation, burning or itching of the skin, hives, swelling of eyes and mouth, blistering or difficulty breathing.
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 do not use on damaged or broken skin 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. When using this product do not use on damaged or broken skin keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if you develop severe irritation, burning or itching of the skin, hives, swelling of eyes and mouth, blistering or difficulty breathing. Keep out of reach of children. If swallowed, call a Poison Control Centre or get medical help 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