URBAN DEFENSE- octocrylene and octinoxate emulsion 
Urban Decay Cosmetics, LLC

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.

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URBAN DECAY
URBAN DEFENSE

Drug Facts

Active IngredientPurpose
Octocrylene (8.0 %)Sunscreen
Octinoxate (7.5%)Sunscreen

Uses

Helps prevent sunburn. Higher SPF provides more sunburn protection.

Warnings

For external use only

Keep out of eyes

Stop use and ask doctor if

  • rash or irritation occurs

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control center right away.

Directions

Smooth liberally on face, neck and other exposed areas. Reapply if excess perspiration or product wear occurs.

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

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URBAN DECAY

URBAN DEFENSE

TINTED MOISTURIZER
PARABEN FREE
SPF 20

50 ml e 1.69 US OZ

Principal Display Panel - 50 ml BODYGUARD Carton

PRINCIPAL DISPLAY PANEL - 50 ml BULLETPROOF Carton

ud
URBAN DECAY

URBAN DEFENSE

TINTED MOISTURIZER
PARABEN FREE
SPF 20

50 ml e 1.69 US OZ

Principal Display Panel - 50 ml BULLETPROOF Carton

PRINCIPAL DISPLAY PANEL - 50 ml FORCEFIELD Carton

ud
URBAN DECAY

URBAN DEFENSE

TINTED MOISTURIZER
PARABEN FREE
SPF 20

50 ml e 1.69 US OZ

Principal Display Panel - 50 ml FORCEFIELD Carton

PRINCIPAL DISPLAY PANEL - 50 ml HALO Carton

ud
URBAN DECAY

URBAN DEFENSE

TINTED MOISTURIZER
PARABEN FREE
SPF 20

50 ml e 1.69 US OZ

Principal Display Panel - 50 ml HALO Carton
URBAN DEFENSE 
octocrylene and octinoxate emulsion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51727-0631
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM) Octocrylene4 mL  in 50 mL
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate3.75 mL  in 50 mL
Inactive Ingredients
Ingredient NameStrength
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
ColorBROWN (Halo) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51727-0631-11 in 1 CARTON
150 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35207/16/2012
URBAN DEFENSE 
octocrylene and octinoxate emulsion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51727-0632
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM) Octocrylene4 mL  in 50 mL
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate3.75 mL  in 50 mL
Inactive Ingredients
Ingredient NameStrength
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
ColorBROWN (Bodyguard) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51727-0632-11 in 1 CARTON
150 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35207/16/2012
URBAN DEFENSE 
octocrylene and octinoxate emulsion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51727-0633
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM) Octocrylene4 mL  in 50 mL
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate3.75 mL  in 50 mL
Inactive Ingredients
Ingredient NameStrength
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
ColorBROWN (Bulletproof) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51727-0633-11 in 1 CARTON
150 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35207/16/2012
URBAN DEFENSE 
octocrylene and octinoxate emulsion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51727-0634
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM) Octocrylene4 mL  in 50 mL
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate3.75 mL  in 50 mL
Inactive Ingredients
Ingredient NameStrength
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
ColorBROWN (Forcefield) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51727-0634-11 in 1 CARTON
150 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35207/16/2012
Labeler - Urban Decay Cosmetics, LLC (833155315)

Revised: 7/2012
Document Id: 92c06df6-f2e8-458a-b19f-5dd28daa52e4
Set id: a9e0c9ed-fb28-468c-b15b-a33f553bf628
Version: 1
Effective Time: 20120702
 
Urban Decay Cosmetics, LLC