COMPLEXION ENHANCER SPF15- 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 Enhancer SPF15

DRUG FACTS

ACTIVE INGREDIENTSPURPOSE
Titanium Dioxide 1.5%Sunscreen
Zinc Oxide 3.2%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, Squalane, Cetearyl Ethylhexanoate, Glycerin, Corundum (Pro Ruby Crystal), Stearyl Heptanoate, Cetearyl Alcohol, Cetearyl Olivate, Sorbitan Olivate, Titanium Dioxide, Butyrospermum Parkii (Shea) Butter, Prunus Armeniaca (Apricot) Kernel Oil, Phenoxyethanol, Ethylhexylglycerin, Galactoarabinan, Lactic Acid, Pyrus Malus, Pectin, Chlorella Vulgaris/Lupinus Albus Protein Ferment, Parfum (Fragrance), Geraniol, Citronellol, Linalool, Malpighia Punicifolia (Acerola) Fruit Extract, Zinc gluconate, Magnesium aspartate, Copper gluconate, Mannitol, Yeast Extract, Hydrolyzed Soy Protein, Mica, Silica, Xanthan Gum, Tocopherol (Vitamin E), Disodium EDTA, CI 77492/ CI 77491/ CI 77499 (Iron Oxides)

PRINCIPAL DISPLAY PANEL - 50ml Bottle Carton

COMPLEXION ENHANCER
SPF 15
ARCTÓNUS JAVITÓ

Omorovicza
BUDAPEST

e 1.7 fl oz    50ml

Principal Display Panel - 50ml Bottle Carton
COMPLEXION ENHANCER SPF15 
titanium dioxide and zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41442-110
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Titanium dioxide (UNII: 15FIX9V2JP) (Titanium dioxide - UNII:15FIX9V2JP) Titanium dioxide0.75 mL  in 50 mL
Zinc oxide (UNII: SOI2LOH54Z) (Zinc oxide - UNII:SOI2LOH54Z) Zinc oxide1.6 mL  in 50 mL
Inactive Ingredients
Ingredient NameStrength
Caprylic/Capric Mono/Diglycerides (UNII: U72Q2I8C85)  
Squalane (UNII: GW89575KF9)  
Cetearyl Ethylhexanoate (UNII: 9M64UO4C25)  
Glycerin (UNII: PDC6A3C0OX)  
Aluminum Oxide (UNII: LMI26O6933)  
Stearyl Heptanoate (UNII: 2M4UGL1NCN)  
Cetostearyl Alcohol (UNII: 2DMT128M1S)  
Cetearyl Olivate (UNII: 58B69Q84JO)  
Sorbitan Olivate (UNII: MDL271E3GR)  
Shea Butter (UNII: K49155WL9Y)  
Apricot Seed Oil (UNII: 54JB35T06A)  
Phenoxyethanol (UNII: HIE492ZZ3T)  
Ethylhexylglycerin (UNII: 147D247K3P)  
Lactic Acid (UNII: 33X04XA5AT)  
Apple (UNII: B423VGH5S9)  
Pectin (UNII: 89NA02M4RX)  
Geraniol (UNII: L837108USY)  
.BETA.-CITRONELLOL, (+/-)- (UNII: 565OK72VNF)  
LINALOOL, (+)- (UNII: F4VNO44C09)  
Acerola (UNII: XDD2WEC9L5)  
Zinc Gluconate (UNII: U6WSN5SQ1Z)  
Magnesium Aspartate (UNII: R17X820ROL)  
Copper Gluconate (UNII: RV823G6G67)  
Mannitol (UNII: 3OWL53L36A)  
Yeast (UNII: 3NY3SM6B8U)  
Soy Protein (UNII: R44IWB3RN5)  
Mica (UNII: V8A1AW0880)  
Silicon Dioxide (UNII: ETJ7Z6XBU4)  
Xanthan Gum (UNII: TTV12P4NEE)  
Alpha-Tocopherol (UNII: H4N855PNZ1)  
Edetate Disodium (UNII: 7FLD91C86K)  
Ferrosoferric Oxide (UNII: XM0M87F357)  
Product Characteristics
ColorBROWNScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:41442-110-011 in 1 BOX
150 mL in 1 BOTTLE, GLASS
2NDC:41442-110-02125 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: 33b6c804-5246-4826-8e76-6d9b636948c3
Set id: 2a7edfb9-4d01-4d37-a5e1-99acbba68a44
Version: 1
Effective Time: 20110301
 
Omorovicza Kozmetikai Kft.