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 INGREDIENTS PURPOSE
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 Type HUMAN OTC DRUG Item Code (Source) NDC:41442-149
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide 28 mg  in 1 mL
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide 70 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
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
Color BROWN Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:41442-149-01 1 in 1 BOX
1 30 mL in 1 BOTTLE, GLASS
2 NDC:41442-149-02 50 mL in 1 BOTTLE, PUMP
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part352 01/25/2013
Labeler - Omorovicza Kozmetikai Kft. (525432105)
Establishment
Name Address ID/FEI Business Operations
Omorovicza Kozmetikai Kft. 525432105 LABEL(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.