FDA Label for Tizo3

View Indications, Usage & Precautions

Tizo3 Product Label

The following document was submitted to the FDA by the labeler of this product Fallien Cosmeceuticals, Ltd. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Active Ingredients:



Titanium Dioxide 8%

Zinc Oxide 3.8%


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. 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.


Directions:



Apply liberally 15 minutes before sun exposure.

  •   Reapply:
    • - After 80 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 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:



Alumina, Cyclohexasiloxane, Cyclopentrasiloxane, Dimethicone, Dimethicone Crosspolymer, Dimethiconol, Iron Oxide (Cl77491), Lauryl PEG/PPG-18/18-Hydrogen Dimethicone, Hydrogen Dimethicone, PEG-10 Dimethicone, Tetrahexyldecyl Ascorbate, Tocopheryl Acetate


Other Information:



  • Protect this product from excessive heat and direct sun
  • May stain some fabrics
  • Cleanse thoroughly at nightttime

Principal Display Panel - Box Label



MINERAL
PROTECTION

TIZO®3

PRIMER/SUNSCREEN

TINTED

SPF 40

PA+++

Titanium & Zinc Oxides

Mineral Sunscreen

Facial Primer

Sheer Tint

Antioxidants C & E

Broad Spectrum SPF 40

Water Resistant (80 minutes)

Net Wt. 1.75 oz/50 g


Principal Display Panel - Tube Label



MINERAL
PROTECTION

TIZO®3

PRIMER/SUNSCREEN

TINTED

SPF 40

PA+++

Titanium & Zinc Oxides

Mineral Sunscreen

Facial Primer

Sheer Tint

Antioxidants C & E

Broad Spectrum SPF 40

Water Resistant (80 minutes)

Net Wt. 1.75 oz/50 g


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