Complexion Enhancer SPF15

Dosage form: cream
Ingredients: Titanium dioxide 0.75mL in 50mL, Zinc oxide 1.6mL in 50mL
Labeler: Omorovicza Kozmetikai Kft.
NDC Code: 41442-110

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 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

COMPLEXION ENHANCER SPF15 
titanium dioxide and zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41442-110
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Titanium dioxide (Titanium dioxide) Titanium dioxide0.75 mL  in 50 mL
Zinc oxide (Zinc oxide) Zinc oxide1.6 mL  in 50 mL
Inactive Ingredients
Ingredient NameStrength
Caprylic/Capric Mono/Diglycerides 
Squalane 
Cetearyl Ethylhexanoate 
Glycerin 
Aluminum Oxide 
Stearyl Heptanoate 
Cetostearyl Alcohol 
Cetearyl Olivate 
Sorbitan Olivate 
Shea Butter 
Apricot Seed Oil 
Phenoxyethanol 
Ethylhexylglycerin 
Lactic Acid 
Apple 
Pectin 
Geraniol 
.BETA.-CITRONELLOL, (+/-)- 
LINALOOL, (+)- 
Acerola 
Zinc Gluconate 
Magnesium Aspartate 
Copper Gluconate 
Mannitol 
Yeast 
Soy Protein 
Mica 
Silicon Dioxide 
Xanthan Gum 
Alpha-Tocopherol 
Edetate Disodium 
Ferrosoferric Oxide 
Product Characteristics
ColorBROWNScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:41442-110-011 BOTTLE, GLASS (BOTTLE) 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/FEIOperations
Omorovicza Kozmetikai Kft.525432105LABEL, MANUFACTURE

Revised: 03/2011
 
Omorovicza Kozmetikai Kft.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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