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| Product NDC Code | 69473-014 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Alumier md moisture matte broad spectrum spf 40 sunscreen amber |
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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 Amber Shade: Titanium Dioxide 8.3% Zinc Oxide 9% Ivory and Sand Shades: Titanium Dioxide 7.8% Zinc Oxide 9%
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 Cyclopentasiloxane, Water/Aqua/Eau, Squalane, PEG-10 Dimethicone, Cetyl PEG/PPG-10/1 Dimethicone, Glycerin, Argania Spinosa Kernel Oil, Butylene Glycol, Disteardimonium Hectorite, Tocopheryl Acetate, Hexyl Laurate, Polymethylsilsesquioxane, Polyglyceryl-4 Isostearate, Caffeine, Sodium Chloride, Polygonum Aviculare Extract, Sodium Hyaluronate, Lecithin (Syn. Phosphatidylcholine), Silybin, Bisabolol, Phenethyl Alcohol, Stearic Acid, Alumina, Mica, Polyester-1, Silica Dimethyl Silylate, 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 Moisture Matte Broad Spectrum SPF 40 Sunscreen Amber ZINC OXIDE, TITANIUM DIOXIDE ZINC OXIDE ZINC OXIDE WATER SQUALANE DISTEARDIMONIUM HECTORITE .ALPHA.-TOCOPHEROL ACETATE HEXYL LAURATE TITANIUM DIOXIDE TITANIUM DIOXIDE POLYGLYCERYL-4 ISOSTEARATE POLYGONUM AVICULARE TOP PEG-10 DIMETHICONE (600 CST) ARGAN OIL FERRIC OXIDE YELLOW FERROSOFERRIC OXIDE CYCLOMETHICONE 5 GLYCERIN BUTYLENE GLYCOL POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) LECITHIN, SOYBEAN PHENYLETHYL ALCOHOL STEARIC ACID SILICA DIMETHYL SILYLATE SODIUM CHLORIDE HYALURONATE SODIUM SILIBININ LEVOMENOL PHENOXYETHANOL CAFFEINE CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) ALUMINUM OXIDE MICA FERRIC OXIDE RED ETHYLHEXYLGLYCERIN Alumier MD Moisture Matte Broad Spectrum SPF 40 Sunscreen Sand ZINC OXIDE, TITANIUM DIOXIDE ZINC OXIDE ZINC OXIDE WATER SQUALANE DISTEARDIMONIUM HECTORITE .ALPHA.-TOCOPHEROL ACETATE HEXYL LAURATE TITANIUM DIOXIDE TITANIUM DIOXIDE POLYGLYCERYL-4 ISOSTEARATE POLYGONUM AVICULARE TOP PEG-10 DIMETHICONE (600 CST) ARGAN OIL FERRIC OXIDE YELLOW FERROSOFERRIC OXIDE CYCLOMETHICONE 5 GLYCERIN BUTYLENE GLYCOL POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) LECITHIN, SOYBEAN PHENYLETHYL ALCOHOL STEARIC ACID SILICA DIMETHYL SILYLATE SODIUM CHLORIDE HYALURONATE SODIUM SILIBININ LEVOMENOL PHENOXYETHANOL CAFFEINE CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) ALUMINUM OXIDE MICA FERRIC OXIDE RED ETHYLHEXYLGLYCERIN Alumier MD Moisture Matte Broad Spectrum SPF 40 Sunscreen Ivory ZINC OXIDE, TITANIUM DIOXIDE ZINC OXIDE ZINC OXIDE WATER SQUALANE DISTEARDIMONIUM HECTORITE .ALPHA.-TOCOPHEROL ACETATE HEXYL LAURATE TITANIUM DIOXIDE TITANIUM DIOXIDE POLYGLYCERYL-4 ISOSTEARATE POLYGONUM AVICULARE TOP PEG-10 DIMETHICONE (600 CST) ARGAN OIL FERRIC OXIDE YELLOW FERROSOFERRIC OXIDE CYCLOMETHICONE 5 GLYCERIN BUTYLENE GLYCOL POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) LECITHIN, SOYBEAN PHENYLETHYL ALCOHOL STEARIC ACID SILICA DIMETHYL SILYLATE SODIUM CHLORIDE HYALURONATE SODIUM SILIBININ LEVOMENOL PHENOXYETHANOL CAFFEINE CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) ALUMINUM OXIDE MICA FERRIC OXIDE RED ETHYLHEXYLGLYCERIN
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 - Amber amber
Product Packaging - Ivory ivory rev
Product Packaging - Sand sand 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 Distributed in the USA by Alumier Labs Inc., 550 Cochituate Road, Suite 25 Framingham, MA 01701
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 Center 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 Center 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