COMPLEXION ENHANCER SPF15- titanium dioxide and zinc oxide cream

Complexion Enhancer SPF15 by

Drug Labeling and Warnings

Complexion Enhancer SPF15 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 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

INGREDIENTS AND APPEARANCE

COMPLEXION ENHANCER SPF15 
titanium dioxide and zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41442-110
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium dioxide (UNII: 15FIX9V2JP) (Titanium dioxide - UNII:15FIX9V2JP)	Titanium dioxide	0.75 mL  in 50 mL
Zinc oxide (UNII: SOI2LOH54Z) (Zinc oxide - UNII:SOI2LOH54Z)	Zinc oxide	1.6 mL  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
Caprylic/Capric Mono/Diglycerides (UNII: U72Q2I8C85)
Squalane (UNII: GW89575KF9)
Cetearyl Ethylhexanoate (UNII: 9M64UO4C25)
Glycerin (UNII: PDC6A3C0OX)
Aluminum Oxide (UNII: LMI26O6933)
Stearyl Heptanoate (UNII: 2M4UGL1NCN)
Cetostearyl Alcohol (UNII: 2DMT128M1S)
Cetearyl Olivate (UNII: 58B69Q84JO)
Sorbitan Olivate (UNII: MDL271E3GR)
Shea Butter (UNII: K49155WL9Y)
Apricot Seed Oil (UNII: 54JB35T06A)
Phenoxyethanol (UNII: HIE492ZZ3T)
Ethylhexylglycerin (UNII: 147D247K3P)
Lactic Acid (UNII: 33X04XA5AT)
Apple (UNII: B423VGH5S9)
Pectin (UNII: 89NA02M4RX)
Geraniol (UNII: L837108USY)
.BETA.-CITRONELLOL, (+/-)- (UNII: 565OK72VNF)
LINALOOL, (+)- (UNII: F4VNO44C09)
Acerola (UNII: XDD2WEC9L5)
Zinc Gluconate (UNII: U6WSN5SQ1Z)
Magnesium Aspartate (UNII: R17X820ROL)
Copper Gluconate (UNII: RV823G6G67)
Mannitol (UNII: 3OWL53L36A)
Yeast (UNII: 3NY3SM6B8U)
Soy Protein (UNII: R44IWB3RN5)
Mica (UNII: V8A1AW0880)
Silicon Dioxide (UNII: ETJ7Z6XBU4)
Xanthan Gum (UNII: TTV12P4NEE)
Alpha-Tocopherol (UNII: H4N855PNZ1)
Edetate Disodium (UNII: 7FLD91C86K)
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: 41442-110-01	1 in 1 BOX
1		50 mL in 1 BOTTLE, GLASS
2	NDC: 41442-110-02	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	03/01/2011

Labeler - Omorovicza Kozmetikai Kft. (525432105)

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