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| Product NDC Code | 53634-128 | ||||
|---|---|---|---|---|---|
| Drug Name | Spf 30 mineral sunscreen |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | CREAM | ||||
| Application Number | M020 | ||||
| Labeler Name | Malin and Goetz Inc | ||||
| 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 Ingredient Purpose Titanium Dioxide 3.71% Sunscreen Zinc Oxide 2.71% 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 liberally and evenly 15 minutes before sun exposure Children under 6 months of age: ask a doctor 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 your time in the sun, especially from 10a.m. – 2 p.m. wear long-sleeved shirts, pants, hats, and sunglasses reapply after 40 minutes of swimming or sweating Immediately after towel drying At least every 2 hours
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Water/Aqua/Eau, Glycerin, Caprylic/Capric Triglyceride, Butyrospermum Parkii (Shea) Butter, Niacinamide, Coconut Alkanes, Alumina, Glycogen, Isohexadecane, Polysorbate 60, Sorbitan Isostearate, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Sodium Hyaluronate, Diethylhexyl Syringlidenemalonate, Triethoxycaprylylsilane, Ursolic Acid, Stearic Acid, Polyhydroxystearic Acid, hydrogenated Lecithin, Benzyl Alcohol, Phenoxyethanol, Tocopheryl Acetate, Coco-Caprylate/Caprate, Aminomethyl Propanol, Xanthan Gum, Citric Acid.
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.spf 30 mineral Sunscreen Titanium Dioxide, Zinc Oxide DIETHYLHEXYL SYRINGYLIDENEMALONATE BENZYL ALCOHOL PHENOXYETHANOL TITANIUM DIOXIDE TITANIUM DIOXIDE SHEA BUTTER POLYSORBATE 60 SORBITAN ISOSTEARATE URSOLIC ACID STEARIC ACID HYDROGENATED SOYBEAN LECITHIN GLYCERIN COCONUT ALKANES XANTHAN GUM CITRIC ACID MONOHYDRATE ISOHEXADECANE ZINC OXIDE ZINC OXIDE WATER ALUMINUM OXIDE HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) HYALURONATE SODIUM POLYHYDROXYSTEARIC ACID (2300 MW) .ALPHA.-TOCOPHEROL ACETATE COCO-CAPRYLATE/CAPRATE AMINOMETHYLPROPANOL MEDIUM-CHAIN TRIGLYCERIDES NIACINAMIDE GLYCOGEN TRIETHOXYCAPRYLYLSILANE
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.(Malin+Goetz) spf 30 mineral sunscreen Broad Spectrum Water-Resistant 40 minutes 1.7 fl.oz./50 ml carton spf 30 mineral sunscreen Tube spf 30 mineral
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
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