Complexion Brightener SPF20

Dosage form: cream
Ingredients: Titanium dioxide 0.84mL in 30mL, Zinc oxide 2.1mL in 30mL
Labeler: Omorovicza Kozmetikai Kft.
NDC Code: 41442-123

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

COMPLEXION BRIGHTENER SPF20 
titanium dioxide and zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41442-123
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Titanium dioxide (Titanium dioxide) Titanium dioxide0.84 mL  in 30 mL
Zinc oxide (Zinc oxide) Zinc oxide2.1 mL  in 30 mL
Inactive Ingredients
Ingredient NameStrength
Caprylic/Capric Mono/Diglycerides 
Glycerin 
Squalane 
Cetearyl Ethylhexanoate 
Cetearyl Olivate 
Sorbitan Olivate 
Stearyl Heptanoate 
Alcohol 
Mica 
Phenoxyethanol 
Cetostearyl Alcohol 
Niacinamide 
Polyhydroxystearic Acid (2300 MW) 
Isostearic Acid 
Zinc Pidolate 
Geraniol 
.BETA.-CITRONELLOL, (+/-)- 
LINALOOL, (+)- 
Rorippa Nasturtium-Aquaticum Flowering Top 
Acerola 
Apple 
Pectin 
Apricot Seed Oil 
Alpha-Tocopherol 
Edetate Disodium 
Xanthan Gum 
Ethylhexylglycerin 
Lactic Acid 
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:41442-123-011 BOTTLE, GLASS (BOTTLE) 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/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.

Hide
(web4)