Tizo Sheerfoam - Tinted
FDA Label NDC 58892-230

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Fallien Cosmeceuticals, Ltd for the product Tizo Sheerfoam - Tinted (NDC 58892-230). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, active ingredients:, purpose:, uses:, warnings:, otc - do not use, otc - stop use, otc - when using, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

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DRUG FACTS

Active Ingredients:

Titanium Dioxide 3%

Zinc Oxide 10%

Purpose:

Sunscreen

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.

Warnings:

For external use only.

Otc - Do Not Use

Do not use on damaged or broken skin.

Otc - Stop Use

Stop use and ask a doctor if rash occurs.

Otc - When Using

When using this product, keep out of eyes. Rinse with water to remove.

Otc - Keep Out Of Reach Of Children

Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions:

  • Shake well before using.
  • Push nozzle up to release.
  • 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 10:00 a.m.-2:00 p.m.
    • Wear long-sleeved shirts, pants, hats, and sunglasses

Inactive Ingredients:

Bismuth Oxychloride, Butyloctyl Salicylate, C8-22 Alkyl Acrylates/Methacrylic Acid Crosspolymer, C12-15 Alkyl Benzoate, Caprylhydroxamic Acid, Caprylyl Glycol, Cellulose Gum, Ceteareth-20, Cetearyl Alcohol, Citric Acid, Disodium EDTA, Glycereth-26, Glycerin, Glyceryl Stearate, Iron Oxides, Methyl Methacrylate Crosspolymer, Mica, Microcrystalline Cellulose, Octyldodecyl Neopentanoate, Polyhydroxystearic Acid, Polysorbate 80, Trans-1,3,3,3-Tetrafluoropropene, Triacontanyl PVP, Triethoxycaprylylsilane, Water

Other Information:

  • Protect this product from excessive heat and direct sun.
  • May stain some fabrics.
  • Store between 68° to 104° F (20° to 40° C)
  • Do not store at temperatures above 120° F

    • Fallien Cosmeceuticals Ltd.
    Eagleville, PA
    19403
    Made in USA

    @tizoskin
    www.tizofusion.com

    PATENTED Covered by one or more of the follwoing patents: 10,154,946;9,561,159;8,911,754;8,795,696

Principal Display Panel – 1 Can Carton Label

MINERAL
PROTECTION

TIZO®
SHEERFOAM™

TINTED
SPF 30

Mineral Sunscreen
For Body & Face

Titanium & Zinc Oxides

Weightless

Spreads Easily

Broad Spectrum SPF 30

Water Resistant (40 minutes)

Net Wt. 3.5 oz/100 g

Principal Display Panel – 100G Can Label

MINERAL
PROTECTION

TIZO®
SHEERFOAM™

TINTED
SPF 30

Mineral Sunscreen
For Body & Face

Titanium & Zinc Oxides

Weightless

Spreads Easily

Broad Spectrum SPF 30

Water Resistant (40 minutes)

Net Wt. 3.5 oz/100 g

* Please review the disclaimer below.