TIZO SHEERFOAM - TINTED- titanium dioxide, zinc oxide aerosol, foam 
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 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.

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:

Shake well before using. Use caution during first application. Apply liberally 15 minutes before sun exposure.

Inactive ingredients:

Bismuth Oxychloride, Butyloctyl Salicylate, 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, Isododecane, Isohexadecane, Methyl Methacrylate Crosspolymer, Mica. Macrocrystalline Cellulose, Octyldodecyl Erucate, Octyldodecyl Neopentanoate, Poly C10-30 Alkyl Acrylate, Polyhydroxystearic Acid. Polysorbate 80, Trans-1,3,3,3- Tetrafluoropropene, Triacontanyl PVP, Triethoxycaprylylsilane, Water

Other Information:

Principal Display Panel – 1 Can Carton Label

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 – 1 Can Carton Label

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

Principal Display Panel – 100g Can Label
TIZO SHEERFOAM - TINTED 
titanium dioxide, zinc oxide aerosol, foam
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58892-230
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide30 mg  in 1 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide100 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)  
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
GLYCERETH-26 (UNII: NNE56F2N14)  
GLYCERIN (UNII: PDC6A3C0OX)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
ISODODECANE (UNII: A8289P68Y2)  
METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EG97988M5Q)  
Mica (UNII: V8A1AW0880)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
OCTYLDODECYL ERUCATE (UNII: D4N66T98C2)  
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)  
BEHENYL ACRYLATE POLYMER (UNII: D64PM5UT4U)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
1,3,3,3-TETRAFLUOROPROPENE, (1E)- (UNII: 5I2481UOO8)  
TRICONTANYL POVIDONE (UNII: N0SS3Q238D)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58892-230-011 in 1 CARTON12/01/2022
1100 g in 1 CAN; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35204/20/2012
Labeler - Fallien Cosmeceuticals, LTD (958388357)
Establishment
NameAddressID/FEIBusiness Operations
Custom Analytics LLC144949372ANALYSIS(58892-230)
Establishment
NameAddressID/FEIBusiness Operations
Tri-Pac Inc020844956MANUFACTURE(58892-230)

Revised: 12/2022
Document Id: 15e1f0ba-c6e7-4bbe-ac6f-0107472fbac8
Set id: ddd4ea96-e305-4d66-9341-739663f381b5
Version: 4
Effective Time: 20221229
 
Fallien Cosmeceuticals, LTD