TIZO3- titanium dioxide, zinc oxide cream

TiZO3 by

Drug Labeling and Warnings

TiZO3 by is a Otc medication manufactured, distributed, or labeled by Fallien Cosmeceuticals, LTD, Custom Analytics LLC, Fragrance Manufacturing Inc. (FMI). Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

TIZO3 
titanium dioxide, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58892-326
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	85.4 mg  in 1 mL
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	40.7 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Aluminum Hydroxide (UNII: 5QB0T2IUN0)
Cyclomethicone 6 (UNII: XHK3U310BA)
Cyclomethicone 5 (UNII: 0THT5PCI0R)
Dimethicone 20 (UNII: H8YMB5QY0D)
Dimethicone Crosspolymer (450000 MPA.S AT 12% in Cyclopentasiloxane) (UNII: UF7620L1W6)
Dimethicone/Vinyl Dimethicone Crosspolymer (Soft Particle) (UNII: 9E4CO0W6C5)
Dimethiconol (2000 CST) (UNII: T74O12AN6Y)
Brown Iron Oxide (UNII: 1N032N7MFO)
Lauryl PEG/PPG-18/18 Methicone (UNII: ZJ5S27D9NX)
Hydrogen Dimethicone (20 CST) (UNII: 12Z59IF64N)
PEG-10 Dimethicone (600 CST) (UNII: 8PR7V1SVM0)
Tetrahexyldecyl Ascorbate (UNII: 9LBV3F07AZ)
.Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58892-326-50	1 in 1 CARTON	03/25/2015
1		44.4 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	05/21/2007

Labeler - Fallien Cosmeceuticals, LTD (958388357)

Establishment
Name	Address	ID/FEI	Business Operations
Custom Analytics LLC		144949372	ANALYSIS(58892-326)

Establishment
Name	Address	ID/FEI	Business Operations
Fragrance Manufacturing Inc. (FMI)		793406000	MANUFACTURE(58892-326) , PACK(58892-326)