Tizo Ultra Zinc Spf 40 (non-tinted) Cream
FDA Label NDC 58892-317

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 Ultra Zinc Spf 40 (non-tinted) (NDC 58892-317). 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 active ingredients:, purpose:, uses:, warnings:, directions:, inactive ingredients:, other information:, principal display panel - 100 g carton label, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients:

Zinc Oxide 20%

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.

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.

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 10:00 a.m.-2:00 p.m.
      • Wear long-sleeved shirts, pants, hats, and sunglasses

Inactive Ingredients:

C12-15 Alkyl Benzoate, Caprylhydroxamic Acid, Caprylyl Glycol, Cety, PEG/PPG 10/1 Dimethicone, Cyclohexasiloxane, Cyclopentasiloxane, Dimethicone, Dimethicone Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Dimethiconol, Disodium EDTA, Glycerin, Hydrogen Dimethicone, Microcrystalline Wax, PEG-10 Dimethicone, PEG-30 Dipolyhydroxystearate, Polyglyceryl-4 Isostearate, Polyhydroxystearic Acid, Polysorbate 20, Sodium Chloride, Stearyl Dimethicone, Tetrahexyldecyl Ascorbate, Tocopheryl Acetate, Triethanolamine, Triethoxycaprylylsilane, Water

Other Information:

  • Protect this product from excessive heat and direct sun.
  • Cleanse thoroughly at nighttime.

Principal Display Panel - 100 G Carton Label

MINERAL
PROTECTION

TIZO®

ULTRA ZINC

NON TINTED
SPF 40

Mineral Sunscreen
For Body & Face

20% Zinc Oxide
Antioxidants C & E
Moisturizing

Broad Spectrum SPF 40

Water Resistant (40 minutes)

Net Wt. 3.5 oz/100 g

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