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| Product NDC Code | 75936-169 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | (re) setting 100% mineral powder translucent broad spectrum sunscreen spf 35 |
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| Type | Brand | ||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||
| Dosage Form | POWDER | ||||||
| Application Number | part352 | ||||||
| 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.Zinc Oxide 24.7% Purpose 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.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 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 sunglassess Children under 6 months: Ask a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Calcium Aluminum Borosilicate, Silica, Trimethylsiloxysilicate, Calcium Sodium Borosilicate, Polymethyl Methacrylate, Lauroyl Lysine, Polyglyceryl-10 Pentaisostearate, Boron Nitride, Triethoxycaprylysilane, Ethylhexylglycerin, Nylon-6/12, Sodium Dehydroacetate, Olive Glycerides, Ascorbyl Palmitate, Ceramide 3, Iron Oxides (CI 77492, 77491, 77499)
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.Sunscreen 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.(RE) Setting 100% Mineral Powder Translucent Broad Spectrum Sunscreen SPF 35 Zinc Oxide CALCIUM ALUMINUM BOROSILICATE ETHYLHEXYLGLYCERIN SODIUM DEHYDROACETATE FERRIC OXIDE YELLOW LAUROYL LYSINE BORON NITRIDE TRIETHOXYCAPRYLYLSILANE ASCORBYL PALMITATE FERRIC OXIDE RED FERROSOFERRIC OXIDE SILICON DIOXIDE TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) POLY(METHYL METHACRYLATE; 450000 MW) CERAMIDE 3 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.Supergoop! (RE) SETTING 100% Mineral Powder SPF 35 Translucent Broad Spectrum Sunscreen SPF 35 PA+++ 0.15 oz./4.25 g re setting 100 mineral powder 35 translucnet carton
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, 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.For external use only. Do not use on damaged or broken skin. When using this products 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