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| Product NDC Code | 67226-2232 | ||||
|---|---|---|---|---|---|
| Drug Name | Sheet spf 30 mineral |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | LOTION | ||||
| 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.Medicinal ingredients 10% Titanium Dioxide 8% Zinc Oxide 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 Adults and children over 6 months of age: Apply liberally and evenly 15 minutes before sun exposure. Reapply at least every 2 hours. Sun Protection Measures: Spending time in the sun increase 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: - limits time in the sun, especially from 10 a.m.–2 p.m. ; and wear long-sleeved shirts, pants, hats, and sunglasses.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Non-medicinal ingredients Alumina, Ammonium Acryloyldimethyltaurate/VP Copolymer, Bis-PEG/PPG-16/16 PEG/PPG-16/16 Dimethicone, Butylparaben, C12-15 Alkyl Benzoate, Caprylic/Capric Triglyceride, Ceteareth-20, Cetearyl Alcohol, Cetyl Dimethicone, Citrus Aurantium Dulcis (Orange) Peel Extract, Citrus Limon (Lemon) Peel Extract, Cyclohexasiloxane, Cyclopentasiloxane, Dimethicone, Dipropylene Glycol Dibenzoate, DL-alpha Tocopheryl Acetate, Ethylparaben, Glycerin, Glyceryl Stearate, Green Tea Extract, Iron Oxides CI 77491, Iron Oxides CI 77492, Iron Oxides CI 77499, Isopropyl Titanium Triisostearate, Methylparaben, Phenoxyethanol, Phytic Acid, Polyhydroxystearic Acid, Polysorbate 20, PPG-15 Stearyl Ether Benzoate, Propylene Glycol, Propylparaben, Pyrus Malus (Apple) Fruit Extract, Saccharum Officinarum (Sugar Cane) Extract, Sodium Ascorbyl Phosphate, Sodium Hydroxide, t-Butyl Alcohol, Triethoxycaprylylsilane, VP/Eicosene Copolymer, 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. Broad Spectrum. • 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.Sheet SPF 30 Mineral TITANIUM DIOXIDE, ZINC OXIDE SODIUM ASCORBYL PHOSPHATE SODIUM HYDROXIDE ALUMINUM OXIDE AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER BIS-PEG/PPG-16/16 PEG/PPG-16/16 DIMETHICONE BUTYLPARABEN ALKYL (C12-15) BENZOATE MEDIUM-CHAIN TRIGLYCERIDES POLYOXYL 20 CETOSTEARYL ETHER CETOSTEARYL ALCOHOL ORANGE PEEL LEMON PEEL CYCLOMETHICONE 6 CYCLOMETHICONE 5 DIPROPYLENE GLYCOL DIBENZOATE .ALPHA.-TOCOPHEROL ACETATE, DL- ETHYLPARABEN GLYCERIN GLYCERYL MONOSTEARATE GREEN TEA LEAF FERRIC OXIDE RED FERRIC OXIDE YELLOW FERROSOFERRIC OXIDE ISOPROPYL TITANIUM TRIISOSTEARATE METHYLPARABEN PHENOXYETHANOL FYTIC ACID POLYSORBATE 20 PPG-15 STEARYL ETHER BENZOATE PROPYLENE GLYCOL PROPYLPARABEN APPLE SUGARCANE TERT-BUTYL ALCOHOL TRIETHOXYCAPRYLYLSILANE WATER XANTHAN GUM 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.Package Labeling: Label Label2
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.Product Facts
Other information Store at room temperature (15-30°C / 59-86°F).
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.Do not use on damaged or broken skin.
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? Call 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 occurs.
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.
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 avoid contact with eyes. If contact occurs, rinse thoroughly with water. Stop use and ask a doctor if rash occurs. Other warnings Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging. 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