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| Product NDC Code | 75936-281 | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Drug Name | Mineral mattescreen spf 40 |
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| Type | Brand | ||||||||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||||||||
| Dosage Form | CREAM | ||||||||||||
| Application Number | M020 | ||||||||||||
| Labeler Name | Supergoop, 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.Active Ingredients Purpose Titanium Dioxide 1.3% Sunscreen Zinc Oxide 17.4% Sunscreen
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 generously and evenly 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 sunscreen with a Broad-Spectrum SPF value of 15 or higher and other sunprotection measures including: • limit your time in the sun, especially from 10a.m. – 2 p.m. • wear long-sleeved shirts, pants, hats, and sunglasses Children under 6 months of age: ask a doctor.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Dimethicone, Dimethicone Copolymer, Caprylic/Capric Triglyceride, Methyl Dihydroabietate, Polyhydroxystearic Acid, C9-12 Alkane, Glycerin, Iron Oxides (CI 77492), Ethylhexylglycerin, Water (Aqua), Coco-Caprylate/Caprate, Silica, Stearic Acid, Iron Oxides (CI 77491), Iron Oxides (CI 77499), Hedychium Coronarium Root Extract, Lactobacillus/Arundinaria Gigantea Leaf Ferment Filtrate, Leuconostoc/Radish Root Ferment Filtrate, Titanium Dioxide (CI 77891)
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.Stop use and ask a doctor if rash occurs.
Purpose
Information about the drug product’s indications for 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.
Spl product data elements
Usually a list of ingredients in a drug product.Mineral Mattescreen SPF 40 Titanium Dioxide, Zinc Oxide GLYCERIN SILICON DIOXIDE METHYL DIHYDROABIETATE POLYHYDROXYSTEARIC ACID (2300 MW) COCO-CAPRYLATE/CAPRATE FERRIC OXIDE YELLOW STEARIC ACID FERRIC OXIDE RED FERROSOFERRIC OXIDE HEDYCHIUM CORONARIUM ROOT LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE DIMETHICONE DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) MEDIUM-CHAIN TRIGLYCERIDES ETHYLHEXYLGLYCERIN WATER TITANIUM DIOXIDE TITANIUM DIOXIDE ZINC OXIDE ZINC 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.Mineral Mattescreen SPF 40 100% Mineral Broad Spectrum Sunscreen SPF 40 PA +++ 1.5 fl. oz./45 ml 20 ml packaging 15 ml packaging 10 ml packaging 1.5 ml packette Carton Tube Carton Tube Tube Back Label Tube packette
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
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. 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