Label: COMPLEXION PERFECTOR BB SPF20 MEDIUM- titanium dioxide and zinc oxide cream
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Contains inactivated NDC Code(s)
NDC Code(s): 41442-150-01, 41442-150-02 - 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 March 13, 2013
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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, Isononyl Isononanoate, Stearyl Heptanoate, Cetearyl Olivate, Ethylhexyldodecanol, Cetearyl Ethylhexanoate, Corundum (Pro Ruby Crystal), Sorbitan Olivate, Cetearyl Alcohol, Phenoxyethanol, Mica, Isopropyl Myristate, Saccharomyces (Hungarian Thermal Water) Ferment Extract, Ascorbyl Tetraisopalmitate, Polyhydroxystearic Acid, Sucrose Palmitate, Disodium EDTA, Glyceryl Linoleate, Isopropyl Titanium Triisostearate, Pyrus Malus (Apple) Fruit Extract, Tocopheryl Acetate, Sodium Hyaluronate, Geraniol, Stearalkonium Hectorite, Prunus Armeniaca (Apricot) Kernel Oil , Tocopherol, Ethylhexylglycerin, Lactic Acid, Isostearic Acid, Citronellol, Parfum (Fragrance), Xanthan Gum, Propylene Carbonate, Chlorella Vulgaris/Lupinus Albus Protein Ferment, Pectin, Phospholipids, Linalool, Potassium Sorbate, CI 77492/CI 77491/CI 77499 (Iron Oxide).
- PRINCIPAL DISPLAY PANEL - 50ml Bottle Box
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INGREDIENTS AND APPEARANCE
COMPLEXION PERFECTOR BB SPF20 MEDIUM
titanium dioxide and zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:41442-150 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide 62 mg in 1 mL Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide 74 mg in 1 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) Cetearyl Ethylhexanoate (UNII: 9M64UO4C25) Aluminum Oxide (UNII: LMI26O6933) Sucrose Palmitate (UNII: 3OSQ643ZK5) Sorbitan Olivate (UNII: MDL271E3GR) Cetostearyl Alcohol (UNII: 2DMT128M1S) Phenoxyethanol (UNII: HIE492ZZ3T) Mica (UNII: V8A1AW0880) Ascorbyl Tetraisopalmitate (UNII: 47143LT58A) Isononyl Isononanoate (UNII: S4V5BS6GCX) Polyhydroxystearic Acid (2300 MW) (UNII: YXH47AOU0F) Edetate Disodium (UNII: 7FLD91C86K) Glyceryl Monolinoleate (UNII: 4763AXI84L) Apple (UNII: B423VGH5S9) Isopropyl Myristate (UNII: 0RE8K4LNJS) .Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0) 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) Chlorella Vulgaris (UNII: RYQ4R60M02) Pectin (UNII: 89NA02M4RX) Omega-3 Fatty Acids (UNII: 71M78END5S) Linalool, (+)- (UNII: F4VNO44C09) Potassium Sorbate (UNII: 1VPU26JZZ4) Stearalkonium Hectorite (UNII: OLX698AH5P) Propylene Carbonate (UNII: 8D08K3S51E) Ferric Oxide Red (UNII: 1K09F3G675) Product Characteristics Color BROWN Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:41442-150-01 1 in 1 BOX 1 50 mL in 1 BOTTLE, GLASS 2 NDC:41442-150-02 125 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 03/18/2013 Labeler - Omorovicza Kozmetikai Kft. (525432105) Establishment Name Address ID/FEI Business Operations Omorovicza Kozmetikai Kft. 525432105 LABEL(41442-150) , MANUFACTURE(41442-150)
