COMPLEXION PERFECTOR BB 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.

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Complexion Perfector BB SPF20

DRUG FACTS

ACTIVE INGREDIENTS	PURPOSE
Titanium Dioxide 4.4%	Sunscreen
Zinc Oxide 7.4%	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, Zinc Oxide, Titanium Dioxide, Glycerin, Squalane, Stearyl Heptanoate, Cetearyl Olivate, Octyldodecanol, Cetearyl Ethylhexanoate, Corundum (Pro Ruby Crystal), Simmondsia Chinensis (Jojoba) Seed Oil, Sorbitan Olivate, Cetearyl Alcohol, Phenoxyethanol, Mica, Ascorbyl Tetraisopalmitate, Saccharomyces (Hungarian Thermal Water) Ferment Extract, Sucrose Palmitate, Polyhydroxystearic Acid, Disodium EDTA, Glyceryl Linoleate, Pyrus Malus (Apple) Fruit Extract, Tocopherol Acidate, Galactoarabinan, Sodium Hyaluronate, Geraniol, Ethylhexylglycerin, Prunus Armeniaca (Apricot) Kernel Oil, Tocopherol, Lactic Acid, Isostearic Acid, Citronellol, Parfum (Fragrance), Xanthan Gum, Chlorella Vulgaris / Lupinus Albus Protein Ferment, Pectin, Phospholipids, Linalool, Potassium Sorbate, CI 77492/ CI 77491/ CI 77499 (Iron Oxides).

PRINCIPAL DISPLAY PANEL - 50 ml Carton

COMPLEXION PERFECTOR

BB SPF 20

Omorovicza
BUDAPEST

e 1.7 fl oz 50ml

COMPLEXION PERFECTOR BB SPF20
titanium dioxide and zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:41442-143
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	2.2 mL in 50 mL
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	3.7 mL in 50 mL

Ingredient Name	Strength
Inactive Ingredients
Water (UNII: 059QF0KO0R)
Caprylic/Capric Mono/Diglycerides (UNII: U72Q2I8C85)
Glycerin (UNII: PDC6A3C0OX)
Squalane (UNII: GW89575KF9)
Stearyl Heptanoate (UNII: 2M4UGL1NCN)
Cetearyl Olivate (UNII: 58B69Q84JO)
Octyldodecanol (UNII: 461N1O614Y)
Cetearyl Ethylhexanoate (UNII: 9M64UO4C25)
Aluminum Oxide (UNII: LMI26O6933)
Sorbitan Olivate (UNII: MDL271E3GR)
Cetostearyl Alcohol (UNII: 2DMT128M1S)
Phenoxyethanol (UNII: HIE492ZZ3T)
Mica (UNII: V8A1AW0880)
Sucrose Palmitate (UNII: 3OSQ643ZK5)
Edetate Disodium (UNII: 7FLD91C86K)
Glyceryl Monolinoleate (UNII: 4763AXI84L)
Apple (UNII: B423VGH5S9)
Hyaluronate Sodium (UNII: YSE9PPT4TH)
Geraniol (UNII: L837108USY)
Ethylhexylglycerin (UNII: 147D247K3P)
Apricot Kernel Oil (UNII: 54JB35T06A)
Tocopherol (UNII: R0ZB2556P8)
Lactic Acid (UNII: 33X04XA5AT)
Glyceryl Isostearate (UNII: HYE7O27HAO)
.Beta.-Citronellol, (+/-)- (UNII: 565OK72VNF)
Xanthan Gum (UNII: TTV12P4NEE)
Pectin (UNII: 89NA02M4RX)
Linalool, (+)- (UNII: F4VNO44C09)
Potassium Sorbate (UNII: 1VPU26JZZ4)
Ferrosoferric Oxide (UNII: XM0M87F357)

Product Characteristics
Color	BROWN	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description
Packaging
1	NDC:41442-143-01	1 in 1 BOX
1		50 mL in 1 BOTTLE, GLASS
2	NDC:41442-143-02	125 mL in 1 BOTTLE, PUMP

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part352	02/27/2012

Labeler - Omorovicza Kozmetikai Kft. (525432105)

Name	Address	ID/FEI	Business Operations
Establishment
Omorovicza Kozmetikai Kft.		525432105	LABEL, MANUFACTURE