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| Product NDC Code | 67226-2231 | ||||
|---|---|---|---|---|---|
| Drug Name | Triple protection sunscreen broad spectrum spf 30 |
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| Type | Brand | ||||
| Pharm Class | Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE] |
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| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | CREAM | ||||
| Application Number | M020 | ||||
| Labeler Name | Vivier Pharma 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 INGREDIENTS Titanium Dioxide 10.0% Zinc Oxide 8.0% 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.DIRECTIONS Apply daily to face, neck and chest. Apply liberally and evenly 15 minutes before sun exposure. Reapply at least every 2 hours or as needed after towel drying, perspiring heavily or washing. For use on children less than 6 months of age, consult a healthcare practitioner. Use a water resistant sunscreen if swimming or sweating.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.INACTIVE INGREDIENTS: ALUMINA, AMMONIUM ACRYLOYLDIMETHYLTAURATE, BIS PEG/PPG-16-16 PEG/PPG16/16 DIMETHICONE, BUTYLPARABEN, C12-15 ALKYL BENZOATE, CAMELIA SINENSIS (GREEN TEA) EXTRACT, CAPRYLIC/- CAPRIC TRIGLYCERIDE, CETEARETH 20, CETEARYL ALCOHOL, CETYL DIMETHICONE, CITRUS MEDICA LIMONUM (LEMON BIOFLAVANOIDS) PEEL EXTRACT, CYCLOMETHICONE, DIMETHICONE, DIPROPYLENE GLYCOL DIBENZOATE, EICOSENE COPOLYMER, ETHYLPARABEN, GLYCERIN, GLYCERYL STEARATE, ISOPROPYL TITANIUM TRIISOSTEARATE, METHYLPARABEN, PHENOXYETHANOL, POLYHYDROXYSTEARIC ACID, POLYSORBATE 20, PPG-15 STEARYL ETHER BENZOATE, PROPYLPARABEN, PYRUS MALUS (APPLE) FRUIT EXTRACT, SACCHARUM OFFICINARUM (SUGAR CANE) EXTRACT, SODIUM ASCORBYL PHOSPHATE, TOCOPHERYL ACETATE, TRIETHOXYCAPRYLYLSILANE, WATER/EAU, XANTHAN GUM.
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 and provides a sun protection factor of 30. Ideal for daily use; can be applied under makeup.
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.Triple Protection Sunscreen Broad Spectrum SPF 30 TITANIUM DIOXIDE, ZINC OXIDE ALUMINUM OXIDE AMMONIUM ACRYLOYLDIMETHYLTAURATE BUTYLPARABEN GREEN TEA LEAF POLYOXYL 20 CETOSTEARYL ETHER CETOSTEARYL ALCOHOL LEMON PEEL CYCLOMETHICONE DIMETHICONE DIPROPYLENE GLYCOL DIBENZOATE ETHYLPARABEN GLYCERIN GLYCERYL MONOSTEARATE ISOPROPYL TITANIUM TRIISOSTEARATE METHYLPARABEN PHENOXYETHANOL POLYSORBATE 20 PPG-15 STEARYL ETHER BENZOATE PROPYLPARABEN APPLE SUGARCANE SODIUM ASCORBYL PHOSPHATE .ALPHA.-TOCOPHEROL ACETATE TRIETHOXYCAPRYLYLSILANE WATER XANTHAN GUM TITANIUM DIOXIDE TITANIUM DIOXIDE ZINC OXIDE ZINC CATION
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.Package Labeling: outer updated 60mL inner packaging
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 If swallowed, get medical help or contact a Poison Control Center right away.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? 450 455 9779 1 877 484 8437
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 Rash or irritation develops and lasts.
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 Avoid contact with eyes. If contact occurs, rinse thoroughly with water. Do not use on damaged or broken skin.
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 The sun may cause sunburn, premature aging of the skin and skin cancer. Avoiding the sun, wearing protective clothing and regular use of sunscreens over the years may reduce the chance of these harmful effects. When using this product Avoid contact with eyes. If contact occurs, rinse thoroughly with water. Do not use on damaged or broken skin. Stop use and ask a doctor if Rash or irritation develops and lasts. Keep out of reach of children If swallowed, get medical help or contact a Poison Control Center 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