URBAN DEFENSE- octocrylene and octinoxate emulsion

Urban Defense by

Drug Labeling and Warnings

Urban Defense by is a Otc medication manufactured, distributed, or labeled by Urban Decay Cosmetics, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active Ingredient	Purpose
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

• rinse with water to remove

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 BULLETPROOF 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 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 HALO Carton

ud
URBAN DECAY

URBAN DEFENSE

TINTED MOISTURIZER
PARABEN FREE
SPF 20

50 ml e 1.69 US OZ

INGREDIENTS AND APPEARANCE

URBAN DEFENSE 
octocrylene and octinoxate emulsion

Product 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 emulsion

Product 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 emulsion

Product 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 emulsion

Product 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)