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Proceuticals private label by tizo tinted mineral sunscreen stick - Medication Information

Product NDC Code 58892-220
Drug Name

Proceuticals private label by tizo tinted mineral sunscreen stick

Type Brand
Active Ingredients
Titanium dioxide 40 mg/g
Zinc oxide 55 mg/g
Route TOPICAL
Dosage Form STICK
Application Number M020
Labeler Name Fallien Cosmeceuticals, Ltd
Packages
Package NDC Code Description
58892-220-30 30 g in 1 cylinder (58892-220-30)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
ACTIVE INGREDIENTS: Titanium Dioxide 4.0% Zinc Oxide 5.5%

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 befor sun exposure.

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
INACTIVE INGREDIENTS: Alumina, Aluminum Hydroxide, Aluminum Stearate, Ascorbic Acid, Ascorbyl Palmitate, C12-15 Alkyl Benzoate, Cetearyl Isononanoate, Cetyl PEG/PPG-15/15 Butyl Ether Dimethicone, Citric Acid, Ethylene Brassylate, Ethylhexyl Palmitate, Helianthus Annuus (Sunflower) Wax, Hexyldecanol, Hexyldecyl Laurate, Iron Oxide, Lecithin, Ozokerite, PEG-8, Polyglyceryl-3 Diisostearate, Polyhydroxystearic Acid, Propylene Glycol Dicaprylate/Dicaprate, Stearic Acid, Tocopherol, Tocopheryl Acetate, Zingiber Officinale (Ginger) Root Oil

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:DIRECTIONS: Apply liberally 15 minutes before sun exposure. Reapply: • After 80 mintues of swimming or sweating • Immediately after towel drying • 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 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.
Proceuticals Private Label by TiZO tinted mineral sunscreen stick Titanium Dioxide, Zinc Oxide ALKYL (C12-15) BENZOATE HELIANTHUS ANNUUS SEED WAX CERESIN TOCOPHEROL HEXYLDECANOL POLYETHYLENE GLYCOL 400 CETYL PEG/PPG-10/1 DIMETHICONE (HLB 4) ETHYLHEXYL PALMITATE POLYGLYCERYL-3 DIISOSTEARATE POLYHYDROXYSTEARIC ACID (2300 MW) ASCORBYL PALMITATE ETHYLENE BRASSYLATE .ALPHA.-TOCOPHEROL ACETATE HEXYL LAURATE ASCORBIC ACID CETEARYL ISONONANOATE ALUMINUM STEARATE CITRIC ACID MONOHYDRATE DIPROPYLENE GLYCOL CAPRYLATE TITANIUM DIOXIDE TITANIUM DIOXIDE ZINC OXIDE ZINC OXIDE GINGER OIL ALUMINUM OXIDE ALUMINUM HYDROXIDE LECITHIN, SUNFLOWER STEARIC ACID FERRIC OXIDE RED

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 – 30g Cylinder Label PROCEUTICALS PRIVATE LABEL by TiZO tinted mineral sunscreen stick broad spectrum spf 45 water resistant (80 minutes) Net Wt. 1 oz. /30 g Graphic-Untitled Reference 58892-220-30 tinted mineral sunscreen stick proceuticals NDC-01

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