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Alumier md sheer hydration tinted moisturizing sunscreen - Medication Information

Product NDC Code 69473-010
Drug Name

Alumier md sheer hydration tinted moisturizing sunscreen

Type Brand
Active Ingredients
Titanium dioxide 70 mg/ml
Zinc oxide 62.8 mg/ml
Route TOPICAL
Dosage Form LOTION
Application Number part352
Labeler Name Alumier Labs
Packages
Package NDC Code Description
69473-010-01 1 tube in 1 carton (69473-010-01) / 60 ml in 1 tube
69473-010-02 8 ml in 1 tube (69473-010-02)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active Ingredients Titanium Dioxide 7% Zinc Oxide 6.28%

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, Propanediol, Butyloctyl Salicylate, Glycerin, Cetearyl Alcohol, Aluminium Stearate, Glyceryl Stearate, PEG-100 Stearate, Synthetic Fluorphlogopite, Lecithin (Syn. Phosphatidycholine), Vitis Vinifera Seed Extract, Resveratrol, Glutathione, Tocopheryl Acetate, Magnesium Ascorbyl Phosphate, Acacia Senegal Gum, Synthetic Wax, Polyhydroxystearic Acid, Ceteareth-20, Alumina, Microcrystalline Cellulose, Triethoxycaprylylsilane, Xanthan Gum, Cellulose Gum, C20-40 Pareth-10, Hydroxyethyl Behenamidopropyl Dimonium Chloride, Polyquatemium-67, Disodium EDTA, Ammonium Polyacrylate, Iron Oxides (CI 77491), Iron Oxides (CI 77492), Iron Oxides (CI 77499), 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 Sheer Hydration Tinted Moisturizing Sunscreen Titanium Dioxide, Zinc Oxide FERRIC OXIDE RED FERRIC OXIDE YELLOW LECITHIN, SOYBEAN 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 EDETATE DISODIUM EDETIC ACID CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM C20-40 PARETH-10 ETHYLHEXYLGLYCERIN PHENOXYETHANOL BUTYLOCTYL SALICYLATE GLYCERIN VITIS VINIFERA SEED RESVERATROL .ALPHA.-TOCOPHEROL ACETATE POLYHYDROXYSTEARIC ACID (2300 MW) FERROSOFERRIC 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 - 60 mL Alumier MD Sheer Hydration Broad Spectrum SPF 40 TINTED MOISTURIZING SUNSCREEN LOTION VERSATILE TINT NPN 80065824 60 mL/2 fl oz sh tint 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