Label: COMPLEXION PERFECTOR BB SPF20- titanium dioxide and zinc oxide cream
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Contains inactivated NDC Code(s)
NDC Code(s): 41442-143-01, 41442-143-02 - Packager: Omorovicza Kozmetikai Kft.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated February 16, 2012
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- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- USES
- WARNING
- DIRECTIONS
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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
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INGREDIENTS AND APPEARANCE
COMPLEXION PERFECTOR BB SPF20
titanium dioxide and zinc oxide creamProduct 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
