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| Product NDC Code | 58892-258 | ||||
|---|---|---|---|---|---|
| Drug Name | Proceuticals private label by tizo daily defense tinted mineral sunscreen |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | CREAM | ||||
| Application Number | M020 | ||||
| Labeler Name | Fallien Cosmeceuticals, LTD | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.ACTIVE INGREDIENTS: Titanium Dioxide 10% Zinc Oxide 3%
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.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. Apply liberally 15 minutes before sun exposure.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.INACTIVE INGREDIENTS: Bismuth Oxychloride, Capric/Caprylic Triglyceride, Caprylhydroxamic Acid, Caprylyl Glycol, Ceteareth-20, Cyclohexasiloxane, Cyclopentasiloxane, Dimethicone, Disodium EDTA, Ethylhexyl Hydroxystearate Benzoate, Glycerin, Iron Oxides, Isododecane, Isohexadecane, Melissa Officinalis (Balm Mint) Extract, Mica, Microcrystalline Wax, Octyldodecyl Neopentanoate, PEG-30 Dipolyhydroxystearate, Sodium Chloride, Tetrahexyldecyl Ascorbate, Tocopheryl Acetate, Tocopherol, Triethanolamine, Triethoxycaprylylsilane, Water
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.DIRECTIONS: • Apply liberally 15 minutes before sun exposure. • Reapply: • After 40 minutes of swimming or sweating • Immediately after towel drying • At least every 2 hours • Children under 6 months: 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 time in the sun, especially from 10 am-2 pm • Wear long-sleeved shirts, pants, hats, and sunglasses
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.PROCEUTICALS PRIVATE LABEL by TiZO daily defense tinted mineral sunscreen Titanium Dioxide, Zinc Oxide FERRIC OXIDE YELLOW BISMUTH OXYCHLORIDE CAPRYLHYDROXAMIC ACID CAPRYLYL GLYCOL ETHYLHEXYL HYDROXYSTEARATE BENZOATE CYCLOMETHICONE 6 CYCLOMETHICONE 5 MELISSA OFFICINALIS WHOLE WATER POLYOXYL 20 CETOSTEARYL ETHER GLYCERIN ISOHEXADECANE MICROCRYSTALLINE WAX SODIUM CHLORIDE TETRAHEXYLDECYL ASCORBATE FERRIC OXIDE RED OCTYLDODECYL NEOPENTANOATE .ALPHA.-TOCOPHEROL ACETATE ZINC OXIDE ZINC OXIDE EDETATE DISODIUM ANHYDROUS TITANIUM DIOXIDE TITANIUM DIOXIDE MEDIUM-CHAIN TRIGLYCERIDES DIMETHICONE FERROSOFERRIC OXIDE PEG-30 DIPOLYHYDROXYSTEARATE (4000 MW) TRIETHOXYCAPRYLYLSILANE ISODODECANE MICA TOCOPHEROL TROLAMINE
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 – 53 g Bottle Label Proceuticals PRIVATE LABEL by TiZO daily defense tinted mineral sunscreen broad spectrum spf 50 water resistant (40 minutes) net wt. 1.8 oz / 53 g Graphic-Untitled 58892-258-50 proceuticals reference
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 the reach of children.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.OTHER INFORMATION: • Protect this product from excessive heat and direct sun • May stain some fabrics
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. Stop use and ask a doctor if rash occurs. When using this product, keep out of eyes. Rinse with water to remove. Keep out of the 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