COMPLEXION BRIGHTENER 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.

----------

Complexion Brightener 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

Apply evenly to face and neck.

INGREDIENTS

Aqua (Hungarian Thermal Water), Caprylic/Capric Triglyceride, Zinc Oxide, Glycerin, Squalane, Titanium Dioxide, Cetearyl Ethylhexanoate, Cetearyl Olivate, Corundum (Pro Ruby Crystal), Sorbitan Olivate, Stearyl Heptanoate, Saccharomyces Ferment Extract, Alcohol Denat., Mica, Phenoxyethanol, Cetearyl Alcohol, Niacinamide, Polyhydroxystearic Acid, Isostearic Acid, Zinc PCA, Parfum (Fragrance), Geraniol, Citronellol, Linalool, Chlorella Vulgaris/Lupinus Albus Protein Ferment, Nasturtium Officinale Flower/Leaf Extract, Malpighia Punicifolia (Acerola) Fruit Extract, Pyrus Malus (Apple) Fruit Extract, Pectin, Prunus Armeniaca (Apricot) Kernel Oil, Phospholipids, Tocopherol, Disodium EDTA, Xanthan Gum, Ethylhexylglycerin, Lactic Acid

PRINCIPAL DISPLAY PANEL - 30ml Bottle Carton

COMPLEXION BRIGHTENER
SPF 20
ARCTÓNUS VILÁGOSÍTÓ

Omorovicza
BUDAPEST

e 1.0 fl oz    30ml

Principal Display Panel - 30ml Bottle Carton
COMPLEXION BRIGHTENER SPF20 
titanium dioxide and zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41442-123
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Titanium dioxide (UNII: 15FIX9V2JP) (Titanium dioxide - UNII:15FIX9V2JP) Titanium dioxide0.84 mL  in 30 mL
Zinc oxide (UNII: SOI2LOH54Z) (Zinc oxide - UNII:SOI2LOH54Z) Zinc oxide2.1 mL  in 30 mL
Inactive Ingredients
Ingredient NameStrength
Caprylic/Capric Mono/Diglycerides (UNII: U72Q2I8C85)  
Glycerin (UNII: PDC6A3C0OX)  
Squalane (UNII: GW89575KF9)  
Cetearyl Ethylhexanoate (UNII: 9M64UO4C25)  
Cetearyl Olivate (UNII: 58B69Q84JO)  
Sorbitan Olivate (UNII: MDL271E3GR)  
Stearyl Heptanoate (UNII: 2M4UGL1NCN)  
Alcohol (UNII: 3K9958V90M)  
Mica (UNII: V8A1AW0880)  
Phenoxyethanol (UNII: HIE492ZZ3T)  
Cetostearyl Alcohol (UNII: 2DMT128M1S)  
Niacinamide (UNII: 25X51I8RD4)  
Polyhydroxystearic Acid (2300 MW) (UNII: YXH47AOU0F)  
Isostearic Acid (UNII: X33R8U0062)  
Zinc Pidolate (UNII: C32PQ86DH4)  
Geraniol (UNII: L837108USY)  
.BETA.-CITRONELLOL, (+/-)- (UNII: 565OK72VNF)  
LINALOOL, (+)- (UNII: F4VNO44C09)  
Rorippa Nasturtium-Aquaticum Flowering Top (UNII: W1N2U8I64G)  
Acerola (UNII: XDD2WEC9L5)  
Apple (UNII: B423VGH5S9)  
Pectin (UNII: 89NA02M4RX)  
Apricot Seed Oil (UNII: 54JB35T06A)  
Alpha-Tocopherol (UNII: H4N855PNZ1)  
Edetate Disodium (UNII: 7FLD91C86K)  
Xanthan Gum (UNII: TTV12P4NEE)  
Ethylhexylglycerin (UNII: 147D247K3P)  
Lactic Acid (UNII: 33X04XA5AT)  
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:41442-123-011 in 1 BOX
130 mL in 1 BOTTLE, GLASS
2NDC:41442-123-0250 mL in 1 BOTTLE, PUMP
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35203/01/2011
Labeler - Omorovicza Kozmetikai Kft. (525432105)
Establishment
NameAddressID/FEIBusiness Operations
Omorovicza Kozmetikai Kft.525432105LABEL, MANUFACTURE

Revised: 3/2011
Document Id: 8967b214-754c-4655-adf8-c51b95e94253
Set id: 30cc9de4-a153-4dae-a528-1314b6ec9be8
Version: 1
Effective Time: 20110301
 
Omorovicza Kozmetikai Kft.