COMPLEXION PERFECTOR BB SPF20 MEDIUM- 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 Perfector BB SPF20 Medium

DRUG FACTS

ACTIVE INGREDIENTSPURPOSE
Titanium Dioxide 6.2%Sunscreen
Zinc Oxide 7.4%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, Zinc Oxide, Titanium Dioxide, Glycerin, Squalane, Isononyl Isononanoate, Stearyl Heptanoate, Cetearyl Olivate, Ethylhexyldodecanol, Cetearyl Ethylhexanoate, Corundum (Pro Ruby Crystal), Sorbitan Olivate, Cetearyl Alcohol, Phenoxyethanol, Mica, Isopropyl Myristate, Saccharomyces (Hungarian Thermal Water) Ferment Extract, Ascorbyl Tetraisopalmitate, Polyhydroxystearic Acid, Sucrose Palmitate, Disodium EDTA, Glyceryl Linoleate, Isopropyl Titanium Triisostearate, Pyrus Malus (Apple) Fruit Extract, Tocopheryl Acetate, Sodium Hyaluronate, Geraniol, Stearalkonium Hectorite, Prunus Armeniaca (Apricot) Kernel Oil , Tocopherol, Ethylhexylglycerin, Lactic Acid, Isostearic Acid, Citronellol, Parfum (Fragrance), Xanthan Gum, Propylene Carbonate, Chlorella Vulgaris/Lupinus Albus Protein Ferment, Pectin, Phospholipids, Linalool, Potassium Sorbate, CI 77492/CI 77491/CI 77499 (Iron Oxide).

PRINCIPAL DISPLAY PANEL - 50ml Bottle Box

COMPLEXION PERFECTOR

BB SPF 20 MEDIUM

Omorovicza

BUDAPEST

e 1.7 fl oz 50ml

Principal Display Panel - 50ml Bottle Box
COMPLEXION PERFECTOR BB SPF20 MEDIUM 
titanium dioxide and zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41442-150
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide62 mg  in 1 mL
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide74 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Caprylic/Capric Mono/Diglycerides (UNII: U72Q2I8C85)  
Glycerin (UNII: PDC6A3C0OX)  
Squalane (UNII: GW89575KF9)  
Stearyl Heptanoate (UNII: 2M4UGL1NCN)  
Cetearyl Olivate (UNII: 58B69Q84JO)  
Cetearyl Ethylhexanoate (UNII: 9M64UO4C25)  
Aluminum Oxide (UNII: LMI26O6933)  
Sucrose Palmitate (UNII: 3OSQ643ZK5)  
Sorbitan Olivate (UNII: MDL271E3GR)  
Cetostearyl Alcohol (UNII: 2DMT128M1S)  
Phenoxyethanol (UNII: HIE492ZZ3T)  
Mica (UNII: V8A1AW0880)  
Ascorbyl Tetraisopalmitate (UNII: 47143LT58A)  
Isononyl Isononanoate (UNII: S4V5BS6GCX)  
Polyhydroxystearic Acid (2300 MW) (UNII: YXH47AOU0F)  
Edetate Disodium (UNII: 7FLD91C86K)  
Glyceryl Monolinoleate (UNII: 4763AXI84L)  
Apple (UNII: B423VGH5S9)  
Isopropyl Myristate (UNII: 0RE8K4LNJS)  
.Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0)  
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)  
Chlorella Vulgaris (UNII: RYQ4R60M02)  
Pectin (UNII: 89NA02M4RX)  
Omega-3 Fatty Acids (UNII: 71M78END5S)  
Linalool, (+)- (UNII: F4VNO44C09)  
Potassium Sorbate (UNII: 1VPU26JZZ4)  
Stearalkonium Hectorite (UNII: OLX698AH5P)  
Propylene Carbonate (UNII: 8D08K3S51E)  
Ferric Oxide Red (UNII: 1K09F3G675)  
Product Characteristics
ColorBROWNScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:41442-150-011 in 1 BOX
150 mL in 1 BOTTLE, GLASS
2NDC:41442-150-02125 mL in 1 BOTTLE, PUMP
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph Not Finalpart35203/18/2013
Labeler - Omorovicza Kozmetikai Kft. (525432105)
Establishment
NameAddressID/FEIBusiness Operations
Omorovicza Kozmetikai Kft.525432105LABEL(41442-150) , MANUFACTURE(41442-150)

Revised: 3/2013
Document Id: 496c67cd-cbed-4931-8cd5-04c35c531746
Set id: 307787b6-5fcb-4c2c-9811-dde13836bd46
Version: 1
Effective Time: 20130313
 
Omorovicza Kozmetikai Kft.