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Proceuticals private label by tizo non-tinted replenishing daily protection - Medication Information

Product NDC Code 58892-226
Drug Name

Proceuticals private label by tizo non-tinted replenishing daily protection

Type Brand
Active Ingredients
Zinc oxide 160 mg/g
Route TOPICAL
Dosage Form CREAM
Application Number M020
Labeler Name Fallien Cosmeceuticals, Ltd
Packages
Package NDC Code Description
58892-226-50 50 g in 1 bottle, pump (58892-226-50)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
ACTIVE INGREDIENTS: Zinc Oxide 16%

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: Capric/Caprylic Triglyceride, Ceramide 3, Cyclohexasiloxane, Cyclopentasiloxane, Dimethicone, Dimethicone Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Dimethiconol, Hydrogen Dimethicone, PEG-10 Dimethicone, Polyhydroxystearic Acid, Tetrahexyldecyl Ascorbate, Tocopheryl Acetate, Vinyl Dimethicone/Methicone Silsesquioxane Crosspolymer

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 • Use a water resistant product if swimming or sweating. • Reapply 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 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 non-tinted replenishing daily protection Zinc Oxide PEG-10 DIMETHICONE (600 CST) MEDIUM-CHAIN TRIGLYCERIDES CYCLOMETHICONE 6 VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER POLYHYDROXYSTEARIC ACID (2300 MW) CYCLOMETHICONE 5 TETRAHEXYLDECYL ASCORBATE .ALPHA.-TOCOPHEROL ACETATE ZINC OXIDE ZINC OXIDE DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) HYDROGEN DIMETHICONE (20 CST) CERAMIDE NP DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) DIMETHICONE 20 DIMETHICONOL (2000 CST)

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 – 50g Bottle Label PROCEUTICALS PRIVATE LABEL by TiZO non-tinted replenishing daily protection broad spectrum spf 40 with ceramides, zinc oxide & antioxidants C & E net wt. 1.75 oz / 50 g Graphic-Untitled Reference 58892-226-50 Replenish NT 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 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