Your browser does not support JavaScript! COMPLEXION CORRECTOR SPF20 (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [OMOROVICZA KOZMETIKAI KFT.]
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COMPLEXION CORRECTOR SPF20 (titanium dioxide and zinc oxide) cream
[Omorovicza Kozmetikai Kft.]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph not final
NOTE: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.
Drug Label Sections

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 DRUG LABELItem Code (Source)NDC:41442-149
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Titanium Dioxide (Titanium Dioxide) Titanium Dioxide28 mg  in 1 mL
Zinc Oxide (Zinc Oxide) Zinc Oxide70 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Caprylic/Capric Mono/Diglycerides 
Glycerin 
Squalane 
Stearyl Heptanoate 
Cetearyl Olivate 
Octyldodecanol 
Cetearyl Ethylhexanoate 
Aluminum Oxide 
Sorbitan Olivate 
Cetostearyl Alcohol 
Phenoxyethanol 
Mica 
Ascorbyl Tetraisopalmitate 
Isononyl Isononanoate 
Edetate Disodium 
Niacinamide 
Apple 
Isopropyl Myristate 
Zinc Pidolate 
Hyaluronate Sodium 
Geraniol 
Ethylhexylglycerin 
Apricot Kernel Oil 
Tocopherol 
Lactic Acid 
Glyceryl Isostearate 
.Beta.-Citronellol, (+/-)- 
Isopropyl Titanium Triisostearate 
Xanthan Gum 
Pectin 
Linalool, (+)- 
Nasturtium Officinale Flowering Top 
Propylene Carbonate 
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
 
Omorovicza Kozmetikai Kft.

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