Label: URBAN DEFENSE- octocrylene and octinoxate emulsion
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Contains inactivated NDC Code(s)
NDC Code(s): 51727-0631-1, 51727-0632-1, 51727-0633-1, 51727-0634-1 - Packager: Urban Decay Cosmetics, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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 July 2, 2012
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- Uses
- Warnings
- Directions
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Inactive Ingredients
Aqua, Cetearyl Alcohol, Glyceryl Stearate, PEG-40 Castor Oil, Glycerin, Silica, Dimethicone, Dicaprylyl Carbonate, Ginkgo Biloba Leaf Extract, Chamomilla Recutita Flower Extract, Panax Ginseng Root Extract, Litchi Chinensis Pericarp Extract, Tocopheryl Acetate, Tetrahexyldecyl Ascorbate, Montmorillonite, Butylene Glycol, Xanthan Gum, Disodium EDTA, Caprylyl Glycol, Phenoxyethanol. All shades may contain (Toutes les couleurs peuvent contenir): CI77891, CI77491 / 77492 /77499 (Iron Oxides).
- PRINCIPAL DISPLAY PANEL - 50 ml BODYGUARD Carton
- PRINCIPAL DISPLAY PANEL - 50 ml BULLETPROOF Carton
- PRINCIPAL DISPLAY PANEL - 50 ml FORCEFIELD Carton
- PRINCIPAL DISPLAY PANEL - 50 ml HALO Carton
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INGREDIENTS AND APPEARANCE
URBAN DEFENSE
octocrylene and octinoxate emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51727-0631 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM) Octocrylene 4 mL in 50 mL Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 3.75 mL in 50 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) POLYOXYL 40 CASTOR OIL (UNII: 4ERD2076EF) GLYCERIN (UNII: PDC6A3C0OX) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) DIMETHICONE (UNII: 92RU3N3Y1O) DICAPRYLYL CARBONATE (UNII: 609A3V1SUA) GINKGO (UNII: 19FUJ2C58T) MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) ASIAN GINSENG (UNII: CUQ3A77YXI) LITCHI FRUIT (UNII: Y5P61KP51E) ACETATE ION (UNII: 569DQM74SC) TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ) MONTMORILLONITE (UNII: A585MN1H2L) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) XANTHAN GUM (UNII: TTV12P4NEE) EDETATE DISODIUM (UNII: 7FLD91C86K) CAPRYLYL GLYCOL (UNII: 00YIU5438U) PHENOXYETHANOL (UNII: HIE492ZZ3T) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FERRIC OXIDE RED (UNII: 1K09F3G675) Product Characteristics Color BROWN (Halo) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51727-0631-1 1 in 1 CARTON 1 50 mL in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 07/16/2012 URBAN DEFENSE
octocrylene and octinoxate emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51727-0632 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM) Octocrylene 4 mL in 50 mL Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 3.75 mL in 50 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) POLYOXYL 40 CASTOR OIL (UNII: 4ERD2076EF) GLYCERIN (UNII: PDC6A3C0OX) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) DIMETHICONE (UNII: 92RU3N3Y1O) DICAPRYLYL CARBONATE (UNII: 609A3V1SUA) GINKGO (UNII: 19FUJ2C58T) MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) ASIAN GINSENG (UNII: CUQ3A77YXI) LITCHI FRUIT (UNII: Y5P61KP51E) ACETATE ION (UNII: 569DQM74SC) TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ) MONTMORILLONITE (UNII: A585MN1H2L) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) XANTHAN GUM (UNII: TTV12P4NEE) EDETATE DISODIUM (UNII: 7FLD91C86K) CAPRYLYL GLYCOL (UNII: 00YIU5438U) PHENOXYETHANOL (UNII: HIE492ZZ3T) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FERRIC OXIDE RED (UNII: 1K09F3G675) Product Characteristics Color BROWN (Bodyguard) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51727-0632-1 1 in 1 CARTON 1 50 mL in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 07/16/2012 URBAN DEFENSE
octocrylene and octinoxate emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51727-0633 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM) Octocrylene 4 mL in 50 mL Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 3.75 mL in 50 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) POLYOXYL 40 CASTOR OIL (UNII: 4ERD2076EF) GLYCERIN (UNII: PDC6A3C0OX) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) DIMETHICONE (UNII: 92RU3N3Y1O) DICAPRYLYL CARBONATE (UNII: 609A3V1SUA) GINKGO (UNII: 19FUJ2C58T) MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) ASIAN GINSENG (UNII: CUQ3A77YXI) LITCHI FRUIT (UNII: Y5P61KP51E) ACETATE ION (UNII: 569DQM74SC) TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ) MONTMORILLONITE (UNII: A585MN1H2L) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) XANTHAN GUM (UNII: TTV12P4NEE) EDETATE DISODIUM (UNII: 7FLD91C86K) CAPRYLYL GLYCOL (UNII: 00YIU5438U) PHENOXYETHANOL (UNII: HIE492ZZ3T) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FERRIC OXIDE RED (UNII: 1K09F3G675) Product Characteristics Color BROWN (Bulletproof) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51727-0633-1 1 in 1 CARTON 1 50 mL in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 07/16/2012 URBAN DEFENSE
octocrylene and octinoxate emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51727-0634 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM) Octocrylene 4 mL in 50 mL Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 3.75 mL in 50 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) POLYOXYL 40 CASTOR OIL (UNII: 4ERD2076EF) GLYCERIN (UNII: PDC6A3C0OX) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) DIMETHICONE (UNII: 92RU3N3Y1O) DICAPRYLYL CARBONATE (UNII: 609A3V1SUA) GINKGO (UNII: 19FUJ2C58T) MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) ASIAN GINSENG (UNII: CUQ3A77YXI) LITCHI FRUIT (UNII: Y5P61KP51E) ACETATE ION (UNII: 569DQM74SC) TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ) MONTMORILLONITE (UNII: A585MN1H2L) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) XANTHAN GUM (UNII: TTV12P4NEE) EDETATE DISODIUM (UNII: 7FLD91C86K) CAPRYLYL GLYCOL (UNII: 00YIU5438U) PHENOXYETHANOL (UNII: HIE492ZZ3T) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FERRIC OXIDE RED (UNII: 1K09F3G675) Product Characteristics Color BROWN (Forcefield) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51727-0634-1 1 in 1 CARTON 1 50 mL in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 07/16/2012 Labeler - Urban Decay Cosmetics, LLC (833155315)
