COMPLEXION CORRECTOR SPF20- titanium dioxide and zinc oxide cream

Complexion Corrector SPF20 by

Drug Labeling and Warnings

Complexion Corrector 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 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.

SPL UNCLASSIFIED SECTION

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

INGREDIENTS AND APPEARANCE

COMPLEXION CORRECTOR SPF20 
titanium dioxide and zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41442-149
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	28 mg  in 1 mL
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	70 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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)
Ascorbyl Tetraisopalmitate (UNII: 47143LT58A)
Isononyl Isononanoate (UNII: S4V5BS6GCX)
Edetate Disodium (UNII: 7FLD91C86K)
Niacinamide (UNII: 25X51I8RD4)
Apple (UNII: B423VGH5S9)
Isopropyl Myristate (UNII: 0RE8K4LNJS)
Zinc Pidolate (UNII: C32PQ86DH4)
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)
Isopropyl Titanium Triisostearate (UNII: 949E3KBJ1I)
Xanthan Gum (UNII: TTV12P4NEE)
Pectin (UNII: 89NA02M4RX)
Linalool, (+)- (UNII: F4VNO44C09)
Nasturtium Officinale Flowering Top (UNII: W1N2U8I64G)
Propylene Carbonate (UNII: 8D08K3S51E)

Product Characteristics
Color	BROWN	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41442-149-01	1 in 1 BOX
1		30 mL in 1 BOTTLE, GLASS
2	NDC: 41442-149-02	50 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	01/25/2013

Labeler - Omorovicza Kozmetikai Kft. (525432105)

Establishment
Name	Address	ID/FEI	Business Operations
Omorovicza Kozmetikai Kft.		525432105	LABEL(41442-149) , MANUFACTURE(41442-149)