COMPLEXION CORRECTOR SPF20- titanium dioxide and zinc oxide cream 
Omorovicza Kozmetikai Kft.

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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Complexion Corrector SPF20

DRUG FACTS

ACTIVE INGREDIENTSPURPOSE
Titanium Dioxide 2.8%Sunscreen
Zinc Oxide 7%Sunscreen

USES

Protects from UVA/B sunrays.

WARNING

For external use only; do not swallow.

Stop use if rash or irritation occurs.

DIRECTIONS

Appy evenly to face and neck.

INGREDIENTS

Aqua (Hungarian Thermal Water), Caprylic/Capric Triglyceride, Glycerin, Squalane, Stearyl Heptanoate, Cetearyl Olivate, Octyldodecanol, Corundum (Pro Ruby Crystal), Cetearyl Ethylhexanoate, Sorbitan Olivate, Alcohol Denat., Cetearyl Alcohol, Phenoxyethanol, Mica, Isononyl Isononanoate, Isostearic Acid, Ascorbyl Tetraisopalmitate, Niacinamide, Saccharomyces (Hungarian Thermal Water) Ferment Extract, Polyhydroxystearic Acid, Isopropyl Myristate, Zinc PCA, Disodium EDTA, Pyrus Malus (Apple) Fruit Extract, Geraniol, Sodium Hyaluronate, Prunus Armeniaca (Apricot) Kernel Oil, Tocopherol, Ethylhexylglycerin, Lactic Acid, Chlorella Vulgaris/Lupinus Albus Protein Ferment, Citronellol, Parfum (Fragrance), Isopropyl Titanium Triisostearate, Nasturtium Officinale Flower/Leaf Extract, Xanthan Gum, Stearalkonium Hectorite, Pectin, Phospholipids, Linalool, Propylene Carbonate.

Product of Hungary
www.omorovicza.com
Omorovicza Kft, 2 Andrassy Ut, 1061 Budapest

PRINCIPAL DISPLAY PANEL - 30 ml Pump Bottle Carton

COMPLEXION CORRECTOR

SPF 20

Omorovicza

BUDAPEST

e 1.0 fl oz 30ml

Principal Display Panel - 30 ml Pump Bottle Carton
COMPLEXION CORRECTOR SPF20 
titanium dioxide and zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41442-149
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide28 mg  in 1 mL
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide70 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Caprylic/Capric Mono/Diglycerides (UNII: U72Q2I8C85)  
Glycerin (UNII: PDC6A3C0OX)  
Squalane (UNII: GW89575KF9)  
Stearyl Heptanoate (UNII: 2M4UGL1NCN)  
Cetearyl Olivate (UNII: 58B69Q84JO)  
Octyldodecanol (UNII: 461N1O614Y)  
Cetearyl Ethylhexanoate (UNII: 9M64UO4C25)  
Aluminum Oxide (UNII: LMI26O6933)  
Sorbitan Olivate (UNII: MDL271E3GR)  
Cetostearyl Alcohol (UNII: 2DMT128M1S)  
Phenoxyethanol (UNII: HIE492ZZ3T)  
Mica (UNII: V8A1AW0880)  
Ascorbyl Tetraisopalmitate (UNII: 47143LT58A)  
Isononyl Isononanoate (UNII: S4V5BS6GCX)  
Edetate Disodium (UNII: 7FLD91C86K)  
Niacinamide (UNII: 25X51I8RD4)  
Apple (UNII: B423VGH5S9)  
Isopropyl Myristate (UNII: 0RE8K4LNJS)  
Zinc Pidolate (UNII: C32PQ86DH4)  
Hyaluronate Sodium (UNII: YSE9PPT4TH)  
Geraniol (UNII: L837108USY)  
Ethylhexylglycerin (UNII: 147D247K3P)  
Apricot Kernel Oil (UNII: 54JB35T06A)  
Tocopherol (UNII: R0ZB2556P8)  
Lactic Acid (UNII: 33X04XA5AT)  
Glyceryl Isostearate (UNII: HYE7O27HAO)  
.Beta.-Citronellol, (+/-)- (UNII: 565OK72VNF)  
Isopropyl Titanium Triisostearate (UNII: 949E3KBJ1I)  
Xanthan Gum (UNII: TTV12P4NEE)  
Pectin (UNII: 89NA02M4RX)  
Linalool, (+)- (UNII: F4VNO44C09)  
Nasturtium Officinale Flowering Top (UNII: W1N2U8I64G)  
Propylene Carbonate (UNII: 8D08K3S51E)  
Product Characteristics
ColorBROWNScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:41442-149-011 in 1 BOX
130 mL in 1 BOTTLE, GLASS
2NDC:41442-149-0250 mL in 1 BOTTLE, PUMP
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35201/25/2013
Labeler - Omorovicza Kozmetikai Kft. (525432105)
Establishment
NameAddressID/FEIBusiness Operations
Omorovicza Kozmetikai Kft.525432105LABEL(41442-149) , MANUFACTURE(41442-149)

Revised: 1/2013
Document Id: 78efc956-0494-456a-ba69-3941dd949e91
Set id: ed5cdce2-a6eb-46fd-a9b0-19987705a96e
Version: 1
Effective Time: 20130125
 
Omorovicza Kozmetikai Kft.