TIZO3- titanium dioxide, zinc oxide cream 
Fallien Cosmeceuticals, LTD

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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DRUG FACTS

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 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:

Inactive Ingredients:

Alumina, Cyclohexasiloxane, Cyclopentasiloxane, Dimethicone, Dimethicone Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Dimethiconol, Iron Oxide (Cl 77491), Lauryl PEG/ PPG-18/18 Methicone, Hydrogen Dimethicone, PEG-10 Dimethicone, Tetrahexyldecyl Ascorbate, Tocopheryl Acetate

Other Information:

- Protect this product from excessive heat and direct sun - May stain some fabrics

Principal Display Panel - 50 g Carton Label

TiZO®3

PRIMER/
SUNSCREEN

Tinted

SPF
40

PA+++

FACIAL
MINERAL SUNSCREEN

Titanium & Zinc Oxides

Antioxidants C & E

Sheer Matte Finish

Broad Spectrum SPF 40

Water Resistant (80 Minutes)

Net Wt. 1.75 Oz./50 g

Principal Display Panel - 50 g Carton Label

Principal Display Panel - 50 g Tube Label

TiZO®3

PRIMER/
SUNSCREEN

Tinted

SPF
40

PA+++

FACIAL
MINERAL SUNSCREEN

With Antioxidants C & E

Broad Spectrum SPF 40

Water Resistant (80 Minutes)

Net Wt. 1.75 Oz./50 g

Principal Display Panel - 50 g Tube Label
TIZO3 
titanium dioxide, zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58892-326
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide85.4 mg  in 1 mL
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide40.7 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58892-326-501 in 1 CARTON03/25/2015
144.4 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35205/21/2007
Labeler - Fallien Cosmeceuticals, LTD (958388357)
Establishment
NameAddressID/FEIBusiness Operations
Custom Analytics LLC144949372ANALYSIS(58892-326)
Establishment
NameAddressID/FEIBusiness Operations
Fragrance Manufacturing Inc. (FMI)793406000MANUFACTURE(58892-326) , PACK(58892-326)

Revised: 10/2019
Document Id: 0845e94c-5521-4488-9211-5c460d7aed19
Set id: 2e53defe-98a3-4689-8763-35d76b5701c3
Version: 3
Effective Time: 20191011
 
Fallien Cosmeceuticals, LTD