COMPLEXION PERFECTOR BB SPF20- titanium dioxide and zinc oxide cream

Complexion Perfector BB SPF20 by

Drug Labeling and Warnings

Complexion Perfector BB SPF20 by is a Otc medication manufactured, distributed, or labeled by Omorovicza Kozmetikai Kft.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

DRUG FACTS

ACTIVE INGREDIENT

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

INGREDIENTS AND APPEARANCE

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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

Inactive Ingredients
Ingredient Name	Strength
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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
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 Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	02/27/2012

Labeler - Omorovicza Kozmetikai Kft. (525432105)

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