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| Product NDC Code | 51326-130 | ||||
|---|---|---|---|---|---|
| Drug Name | Topix mineral mattifying tinted sunscreen spf 30 |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | CREAM | ||||
| Application Number | part352 | ||||
| Labeler Name | Topiderm, 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 Zinc Oxide 16.5% Sunscreen Titanium Dioxide 3.2% Sunscreen
| Zinc Oxide 16.5% | Sunscreen |
| Titanium Dioxide 3.2% | 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 spread evenly by hand 15 minutes before sun exposure Re-apply after swimming, excessive perspiring, or anytime after towel drying Use a water resistant sunscreen if swimming or sweating Use on children under 6 months of age: consult a doctor.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Alumina, Ascorbic Acid, Biotin, Butylene Glycol, Butyrospermum Parkii (Shea) Butter, Camellia Sinensis Leaf (Green Tea) Polyphenols, Caprylic/Capric Triglyceride, Centella Asiatica Extract, Ceramide NS, Cyclopentasiloxane, Cyclotetrasiloxane, Dimethicone Crosspolymer, Dimethicone, Hexyl Laurate, Iron Oxides, Isodoecane, Methyl Trimethicone, PEG/PPG-18/18 Dimethicone, PEG-10 Dimethicone, PEG-8 Methyl Ether Triethoxysilane, Phospholipids, Phyllanthus Emblica Fruit Extract, Polyglyceryl-4 Isostearate, Polyhydroxystearic Acid, Polymethylsilsesquiloxane, Polysilicone-11, Purified Water, Resveratrol, Silica Dimethyl Silylate, Silica, Stearic Acid, Tocopherol, Ubiquinone (Co-Enzyme Q10).
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.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.
Purpose
Information about the drug product’s indications for use.Active ingredient Purpose Zinc Oxide 16.5% Sunscreen Titanium Dioxide 3.2% Sunscreen
| Zinc Oxide 16.5% | Sunscreen |
| Titanium Dioxide 3.2% | Sunscreen |
Spl product data elements
Usually a list of ingredients in a drug product.Topix Mineral Mattifying Tinted Sunscreen SPF 30 Zinc Oxide ZINC OXIDE ZINC OXIDE TITANIUM DIOXIDE TITANIUM DIOXIDE ALUMINUM OXIDE ASCORBIC ACID BIOTIN BUTYLENE GLYCOL SHEA BUTTER GREEN TEA LEAF MEDIUM-CHAIN TRIGLYCERIDES CENTELLA ASIATICA WHOLE CERAMIDE NG CYCLOMETHICONE 5 CYCLOMETHICONE 4 DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) DIMETHICONE HEXYL LAURATE FERROUS OXIDE ISODODECANE METHYL TRIMETHICONE PEG/PPG-18/18 DIMETHICONE PEG-10 DIMETHICONE (220 CST) OMEGA-3 FATTY ACIDS PHYLLANTHUS EMBLICA FRUIT POLYGLYCERYL-4 ISOSTEARATE POLYHYDROXYSTEARIC ACID (2300 MW) POLYMETHYLSILSESQUIOXANE (11 MICRONS) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) WATER RESVERATROL SILICA DIMETHYL SILYLATE SILICON DIOXIDE STEARIC ACID .ALPHA.-TOCOPHEROL COENZYME Q10, (2Z)-
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.PRINCIPAL DISPLAY PANEL - 54 g Bottle Label COMPLIMENTS OF TOPIX PHARMACEUTICALS, INC MULTI-TASKING Mineral Mattifying Tinted Sunscreen SPF 30 Broad Spectrum SPF 30 Net wt. 1.9 oz. (54 g) Available Custom Branded 800.445.2595 [email protected] Principal Display Panel - 54 g Bottle Label
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
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.
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 if signs of irritation or rash appear. If irritation or rash persists consult a doctor.
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 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 keep out of eyes, rinse with water to remove. Stop use if signs of irritation or rash appear. If irritation or rash persists consult a doctor. Keep out of reach of children. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately. 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 of 15 or higher and other sunscreen measures including: limit time in the sun, especially from 10a.m.-2 p.m. wear long-sleeve shirts, pants, hats, and sunglasses
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