MANGO BUTTER LIPSTICK SPF 10- avobenzone and octinoxate lipstick

MANGO BUTTER LIPSTICK by

Drug Labeling and Warnings

MANGO BUTTER LIPSTICK by is a Otc medication manufactured, distributed, or labeled by ART COSMETICS SRL. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Avobenzone (2%)

Octinoxate (6%)

Inactive ingredients

Pentaerythrityl Tetraisostearate, Isostearyl Isostearate, Diisostearyl Malate, Polybutene, Octyldodecanol, Polyethylene, VP/Hexadecene Copolymer, Euphorbia Cerifera (Candelilla) Wax, Calcium Sodium Borosilicate, Microcrystalline Wax, Ozokerite, Calcium Aluminum Borosilicate, Anise Alcohol, Flavor, Ascorbyl Palmitate, Citric Acid, Lecithin, Mangifera Indica (Mango) Fruit Extract, Phenoxyethanol, Silica, Tocopherol, Tocopheryl Acetate. [+/- (May Contain) Mica, Titanium Dioxide, Red 7 Lake, Red 7, Red 6, Iron Oxides, Yellow 6 Lake, Blue 1 Lake, Red 28 Lake, Manganese Violet, Carmine, Yellow 5 Lake, Red 33, Bismuth Oxychloride].

Use

helps prevent sunburn

Directions

Apply as often as necessary. Children under six months old: consult a physician.

Warnings

For external use only. Not to be swallowed. Avoid contact with the eyes. If contact occurs, rinse thoroughly with water.

Stop use

if rash occurs and consult your physician.

Keep out of the reach of children.

SPL UNCLASSIFIED SECTION

You may report a serious adverse reaction to this product to
Report Reaction, LLC, PO Box 22,Plainsboro, NJ 08536-0222

DERMATOLOGICALLY TESTED
MINERAL OIL FREE
SILICONE FREE
PROPYLENE GLYCOL FREE
ETHANOLAMINE FREE

Package/Label Principal Display Panel - Carton Label (13 Natural Pink)

LIPSTICK WITH A SHEER COLOUR
FOR A BRILLIANT HIGH SHINE

MANGO BUTTER LIPSTICK SPF 10

LIPSTICK

KORRES

MANGO BUTTER LIPSTICK
SHEER COLOUR / HIGH SHINE / SPF 10

13 NATURAL PINK

Lipstick with a sheer colour for a brilliant
high shine. With Mango butter which
leaves lips smooth and moisturised.

www.korres.com

K.Μάνου 20-26,
116 33 Αθήνα
20-26 K. Manou St.
116 33, Athens, Greece
T +30 210 756 5800
F +30 210 756 2122
Made in Italy for
Korres Natural Products

Carton Label - Natural Pink

Package/Label Principal Display Panel - Carton Label (33 Nude)

LIPSTICK WITH A SHEER COLOUR
FOR A BRILLIANT HIGH SHINE

MANGO BUTTER LIPSTICK SPF 10

LIPSTICK

KORRES

MANGO BUTTER LIPSTICK
SHEER COLOUR / HIGH SHINE / SPF 10

33 NUDE

Lipstick with a sheer colour for a brilliant
high shine. With Mango butter which
leaves lips smooth and moisturised.

www.korres.com

K.Μάνου 20-26,
116 33 Αθήνα
20-26 K. Manou St.
116 33, Athens, Greece
T +30 210 756 5800
F +30 210 756 2122
Made in Italy for
Korres Natural Products

Carton Label - Nude

Package/Label Principal Display Panel - Carton Label (25 Natural Purple)

LIPSTICK WITH A SHEER COLOUR
FOR A BRILLIANT HIGH SHINE

MANGO BUTTER LIPSTICK SPF 10

LIPSTICK

KORRES

MANGO BUTTER LIPSTICK
SHEER COLOUR / HIGH SHINE / SPF 10

25 NATURAL PURPLE

Lipstick with a sheer colour for a brilliant
high shine. With Mango butter which
leaves lips smooth and moisturised.

www.korres.com

K.Μάνου 20-26,
116 33 Αθήνα
20-26 K. Manou St.
116 33, Athens, Greece
T +30 210 756 5800
F +30 210 756 2122
Made in Italy for
Korres Natural Products

Carton Label - Natural Purple

Package/Label Principal Display Panel - Carton Label (47 Orange Brown)

LIPSTICK WITH A SHEER COLOUR
FOR A BRILLIANT HIGH SHINE

MANGO BUTTER LIPSTICK SPF 10

LIPSTICK

KORRES

MANGO BUTTER LIPSTICK
SHEER COLOUR / HIGH SHINE / SPF 10

47 ORANGE BROWN

Lipstick with a sheer colour for a brilliant
high shine. With Mango butter which
leaves lips smooth and moisturised.

www.korres.com

K.Μάνου 20-26,
116 33 Αθήνα
20-26 K. Manou St.
116 33, Athens, Greece
T +30 210 756 5800
F +30 210 756 2122
Made in Italy for
Korres Natural Products

Carton Label - Orange Brown

Package/Label Principal Display Panel - Carton Label (12 Frost Pink)

LIPSTICK WITH A SHEER COLOUR
FOR A BRILLIANT HIGH SHINE

MANGO BUTTER LIPSTICK SPF 10

LIPSTICK

KORRES

MANGO BUTTER LIPSTICK
SHEER COLOUR / HIGH SHINE / SPF 10

12 FROST PINK

Lipstick with a sheer colour for a brilliant
high shine. With Mango butter which
leaves lips smooth and moisturised.

www.korres.com

K.Μάνου 20-26,
116 33 Αθήνα
20-26 K. Manou St.
116 33, Athens, Greece
T +30 210 756 5800
F +30 210 756 2122
Made in Italy for
Korres Natural Products

Carton Label - Frost Pink

Package/Label Principal Display Panel - Carton Label (14 Pink)

LIPSTICK WITH A SHEER COLOUR
FOR A BRILLIANT HIGH SHINE

MANGO BUTTER LIPSTICK SPF 10

LIPSTICK

KORRES

MANGO BUTTER LIPSTICK
SHEER COLOUR / HIGH SHINE / SPF 10

14 PINK

Lipstick with a sheer colour for a brilliant
high shine. With Mango butter which
leaves lips smooth and moisturised.

www.korres.com

K.Μάνου 20-26,
116 33 Αθήνα
20-26 K. Manou St.
116 33, Athens, Greece
T +30 210 756 5800
F +30 210 756 2122
Made in Italy for
Korres Natural Products

Carton Label - Pink

Package/Label Principal Display Panel - Carton Label (18 Peach)

LIPSTICK WITH A SHEER COLOUR
FOR A BRILLIANT HIGH SHINE

MANGO BUTTER LIPSTICK SPF 10

LIPSTICK

KORRES

MANGO BUTTER LIPSTICK
SHEER COLOUR / HIGH SHINE / SPF 10

18 PEACH

Lipstick with a sheer colour for a brilliant
high shine. With Mango butter which
leaves lips smooth and moisturised.

www.korres.com

K.Μάνου 20-26,
116 33 Αθήνα
20-26 K. Manou St.
116 33, Athens, Greece
T +30 210 756 5800
F +30 210 756 2122
Made in Italy for
Korres Natural Products

Carton Label - Peach

Package/Label Principal Display Panel - Carton Label (24 Purple)

LIPSTICK WITH A SHEER COLOUR
FOR A BRILLIANT HIGH SHINE

MANGO BUTTER LIPSTICK SPF 10

LIPSTICK

KORRES

MANGO BUTTER LIPSTICK
SHEER COLOUR / HIGH SHINE / SPF 10

24 PURPLE

Lipstick with a sheer colour for a brilliant
high shine. With Mango butter which
leaves lips smooth and moisturised.

www.korres.com

K.Μάνου 20-26,
116 33 Αθήνα
20-26 K. Manou St.
116 33, Athens, Greece
T +30 210 756 5800
F +30 210 756 2122
Made in Italy for
Korres Natural Products

Carton Label - Purple

Package/Label Principal Display Panel - Carton Label (54 Fuchsia)

LIPSTICK WITH A SHEER COLOUR
FOR A BRILLIANT HIGH SHINE

MANGO BUTTER LIPSTICK SPF 10

LIPSTICK

KORRES

MANGO BUTTER LIPSTICK
SHEER COLOUR / HIGH SHINE / SPF 10

54 FUCHSIA

Lipstick with a sheer colour for a brilliant
high shine. With Mango butter which
leaves lips smooth and moisturised.

www.korres.com

K.Μάνου 20-26,
116 33 Αθήνα
20-26 K. Manou St.
116 33, Athens, Greece
T +30 210 756 5800
F +30 210 756 2122
Made in Italy for
Korres Natural Products

Carton Label - Fuchsia

Package/Label Principal Display Panel - Carton Label (45 Coral)

LIPSTICK WITH A SHEER COLOUR
FOR A BRILLIANT HIGH SHINE

MANGO BUTTER LIPSTICK SPF 10

LIPSTICK

KORRES

MANGO BUTTER LIPSTICK
SHEER COLOUR / HIGH SHINE / SPF 10

45 CORAL

Lipstick with a sheer colour for a brilliant
high shine. With Mango butter which
leaves lips smooth and moisturised.

www.korres.com

K.Μάνου 20-26,
116 33 Αθήνα
20-26 K. Manou St.
116 33, Athens, Greece
T +30 210 756 5800
F +30 210 756 2122
Made in Italy for
Korres Natural Products

Carton Label - Coral

Package/Label Principal Display Panel - Carton Label (52 Orange Red)

LIPSTICK WITH A SHEER COLOUR
FOR A BRILLIANT HIGH SHINE

MANGO BUTTER LIPSTICK SPF 10

LIPSTICK

KORRES

MANGO BUTTER LIPSTICK
SHEER COLOUR / HIGH SHINE / SPF 10

52 ORANGE RED

Lipstick with a sheer colour for a brilliant
high shine. With Mango butter which
leaves lips smooth and moisturised.

www.korres.com

K.Μάνου 20-26,
116 33 Αθήνα
20-26 K. Manou St.
116 33, Athens, Greece
T +30 210 756 5800
F +30 210 756 2122
Made in Italy for
Korres Natural Products

Carton Label - Orange Red

Package/Label Principal Display Panel - Carton Label (36 Natural Brown)

LIPSTICK WITH A SHEER COLOUR
FOR A BRILLIANT HIGH SHINE

MANGO BUTTER LIPSTICK SPF 10

LIPSTICK

KORRES

MANGO BUTTER LIPSTICK
SHEER COLOUR / HIGH SHINE / SPF 10

36 NATURAL BROWN

Lipstick with a sheer colour for a brilliant
high shine. With Mango butter which
leaves lips smooth and moisturised.

www.korres.com

K.Μάνου 20-26,
116 33 Αθήνα
20-26 K. Manou St.
116 33, Athens, Greece
T +30 210 756 5800
F +30 210 756 2122
Made in Italy for
Korres Natural Products

Carton Label - Natural Brown

Package/Label Principal Display Panel - Carton Label (22 Rose)

LIPSTICK WITH A SHEER COLOUR
FOR A BRILLIANT HIGH SHINE

MANGO BUTTER LIPSTICK SPF 10

LIPSTICK

KORRES

MANGO BUTTER LIPSTICK
SHEER COLOUR / HIGH SHINE / SPF 10

22 ROSE

Lipstick with a sheer colour for a brilliant
high shine. With Mango butter which
leaves lips smooth and moisturised.

www.korres.com

K.Μάνου 20-26,
116 33 Αθήνα
20-26 K. Manou St.
116 33, Athens, Greece
T +30 210 756 5800
F +30 210 756 2122
Made in Italy for
Korres Natural Products

Carton Label - Rose

Package/Label Principal Display Panel - Carton Label (38 Cinnamon)

LIPSTICK WITH A SHEER COLOUR
FOR A BRILLIANT HIGH SHINE

MANGO BUTTER LIPSTICK SPF 10

LIPSTICK

KORRES

MANGO BUTTER LIPSTICK
SHEER COLOUR / HIGH SHINE / SPF 10

38 CINNAMON

Lipstick with a sheer colour for a brilliant
high shine. With Mango butter which
leaves lips smooth and moisturised.

www.korres.com

K.Μάνου 20-26,
116 33 Αθήνα
20-26 K. Manou St.
116 33, Athens, Greece
T +30 210 756 5800
F +30 210 756 2122
Made in Italy for
Korres Natural Products

Carton Label - Cinnamon

INGREDIENTS AND APPEARANCE

MANGO BUTTER LIPSTICK  SPF 10
avobenzone and octinoxate lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42221-0001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	2 g  in 100 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	6 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
OCTYLDODECANOL (UNII: 461N1O614Y)
CANDELILLA WAX (UNII: WL0328HX19)
CERESIN (UNII: Q1LS2UJO3A)
ANISYL ALCOHOL (UNII: 7N6XGV3U49)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)
MANGO (UNII: I629I3NR86)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
MICA (UNII: V8A1AW0880)
D&C RED NO. 6 (UNII: 481744AI4O)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
D&C RED NO. 28 (UNII: 767IP0Y5NH)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)

Product Characteristics
Color	PINK (Natural Pink)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42221-0001-1	1 in 1 CARTON
1		100 g in 1 TUBE, WITH APPLICATOR

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	08/30/2010

MANGO BUTTER LIPSTICK  SPF 10
avobenzone and octinoxate lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42221-0002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	2 g  in 100 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	6 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
OCTYLDODECANOL (UNII: 461N1O614Y)
CANDELILLA WAX (UNII: WL0328HX19)
CERESIN (UNII: Q1LS2UJO3A)
ANISYL ALCOHOL (UNII: 7N6XGV3U49)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)
MANGO (UNII: I629I3NR86)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
MICA (UNII: V8A1AW0880)
D&C RED NO. 6 (UNII: 481744AI4O)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
D&C RED NO. 28 (UNII: 767IP0Y5NH)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)

Product Characteristics
Color	BROWN (Nude)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42221-0002-1	1 in 1 CARTON
1		100 g in 1 TUBE, WITH APPLICATOR

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	08/30/2010

MANGO BUTTER LIPSTICK  SPF 10
avobenzone and octinoxate lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42221-0003
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	2 g  in 100 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	6 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
OCTYLDODECANOL (UNII: 461N1O614Y)
CANDELILLA WAX (UNII: WL0328HX19)
CERESIN (UNII: Q1LS2UJO3A)
ANISYL ALCOHOL (UNII: 7N6XGV3U49)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)
MANGO (UNII: I629I3NR86)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
MICA (UNII: V8A1AW0880)
D&C RED NO. 6 (UNII: 481744AI4O)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
D&C RED NO. 28 (UNII: 767IP0Y5NH)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)

Product Characteristics
Color	PURPLE (Natural Purple)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42221-0003-1	1 in 1 CARTON
1		100 g in 1 TUBE, WITH APPLICATOR

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	08/30/2010

MANGO BUTTER LIPSTICK  SPF 10
avobenzone and octinoxate lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42221-0004
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	2 g  in 100 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	6 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
OCTYLDODECANOL (UNII: 461N1O614Y)
CANDELILLA WAX (UNII: WL0328HX19)
CERESIN (UNII: Q1LS2UJO3A)
ANISYL ALCOHOL (UNII: 7N6XGV3U49)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)
MANGO (UNII: I629I3NR86)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
MICA (UNII: V8A1AW0880)
D&C RED NO. 6 (UNII: 481744AI4O)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
D&C RED NO. 28 (UNII: 767IP0Y5NH)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)

Product Characteristics
Color	ORANGE (Orange Brown)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42221-0004-1	1 in 1 CARTON
1		100 g in 1 TUBE, WITH APPLICATOR

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	08/30/2010

MANGO BUTTER LIPSTICK  SPF 10
avobenzone and octinoxate lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42221-0005
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	2 g  in 100 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	6 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
OCTYLDODECANOL (UNII: 461N1O614Y)
CANDELILLA WAX (UNII: WL0328HX19)
CERESIN (UNII: Q1LS2UJO3A)
ANISYL ALCOHOL (UNII: 7N6XGV3U49)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)
MANGO (UNII: I629I3NR86)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
MICA (UNII: V8A1AW0880)
D&C RED NO. 6 (UNII: 481744AI4O)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
D&C RED NO. 28 (UNII: 767IP0Y5NH)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)

Product Characteristics
Color	PINK (Frost Pink)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42221-0005-1	1 in 1 CARTON
1		100 g in 1 TUBE, WITH APPLICATOR

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	08/30/2010

MANGO BUTTER LIPSTICK  SPF 10
avobenzone and octinoxate lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42221-0006
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	2 g  in 100 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	6 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
OCTYLDODECANOL (UNII: 461N1O614Y)
CANDELILLA WAX (UNII: WL0328HX19)
CERESIN (UNII: Q1LS2UJO3A)
ANISYL ALCOHOL (UNII: 7N6XGV3U49)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)
MANGO (UNII: I629I3NR86)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
MICA (UNII: V8A1AW0880)
D&C RED NO. 6 (UNII: 481744AI4O)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
D&C RED NO. 28 (UNII: 767IP0Y5NH)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)

Product Characteristics
Color	PINK (Pink)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42221-0006-1	1 in 1 CARTON
1		100 g in 1 TUBE, WITH APPLICATOR

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	08/30/2010

MANGO BUTTER LIPSTICK  SPF 10
avobenzone and octinoxate lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42221-0007
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	2 g  in 100 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	6 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
OCTYLDODECANOL (UNII: 461N1O614Y)
CANDELILLA WAX (UNII: WL0328HX19)
CERESIN (UNII: Q1LS2UJO3A)
ANISYL ALCOHOL (UNII: 7N6XGV3U49)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)
MANGO (UNII: I629I3NR86)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
MICA (UNII: V8A1AW0880)
D&C RED NO. 6 (UNII: 481744AI4O)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
D&C RED NO. 28 (UNII: 767IP0Y5NH)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)

Product Characteristics
Color	PINK (Peach)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42221-0007-1	1 in 1 CARTON
1		100 g in 1 TUBE, WITH APPLICATOR

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	08/30/2010

MANGO BUTTER LIPSTICK  SPF 10
avobenzone and octinoxate lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42221-0008
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	2 g  in 100 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	6 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
OCTYLDODECANOL (UNII: 461N1O614Y)
CANDELILLA WAX (UNII: WL0328HX19)
CERESIN (UNII: Q1LS2UJO3A)
ANISYL ALCOHOL (UNII: 7N6XGV3U49)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)
MANGO (UNII: I629I3NR86)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
MICA (UNII: V8A1AW0880)
D&C RED NO. 6 (UNII: 481744AI4O)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
D&C RED NO. 28 (UNII: 767IP0Y5NH)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)

Product Characteristics
Color	PURPLE (Purple)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42221-0008-1	1 in 1 CARTON
1		100 g in 1 TUBE, WITH APPLICATOR

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	08/30/2010

MANGO BUTTER LIPSTICK  SPF 10
avobenzone and octinoxate lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42221-0009
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	2 g  in 100 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	6 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
OCTYLDODECANOL (UNII: 461N1O614Y)
CANDELILLA WAX (UNII: WL0328HX19)
CERESIN (UNII: Q1LS2UJO3A)
ANISYL ALCOHOL (UNII: 7N6XGV3U49)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)
MANGO (UNII: I629I3NR86)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
MICA (UNII: V8A1AW0880)
D&C RED NO. 6 (UNII: 481744AI4O)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
D&C RED NO. 28 (UNII: 767IP0Y5NH)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)

Product Characteristics
Color	RED (Fuchsia)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42221-0009-1	1 in 1 CARTON
1		100 g in 1 TUBE, WITH APPLICATOR

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	08/30/2010

MANGO BUTTER LIPSTICK  SPF 10
avobenzone and octinoxate lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42221-0010
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	2 g  in 100 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	6 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
OCTYLDODECANOL (UNII: 461N1O614Y)
CANDELILLA WAX (UNII: WL0328HX19)
CERESIN (UNII: Q1LS2UJO3A)
ANISYL ALCOHOL (UNII: 7N6XGV3U49)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)
MANGO (UNII: I629I3NR86)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
MICA (UNII: V8A1AW0880)
D&C RED NO. 6 (UNII: 481744AI4O)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
D&C RED NO. 28 (UNII: 767IP0Y5NH)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)

Product Characteristics
Color	ORANGE (Coral)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42221-0010-1	1 in 1 CARTON
1		100 g in 1 TUBE, WITH APPLICATOR

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	08/30/2010

MANGO BUTTER LIPSTICK  SPF 10
avobenzone and octinoxate lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42221-0011
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	2 g  in 100 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	6 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
OCTYLDODECANOL (UNII: 461N1O614Y)
CANDELILLA WAX (UNII: WL0328HX19)
CERESIN (UNII: Q1LS2UJO3A)
ANISYL ALCOHOL (UNII: 7N6XGV3U49)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)
MANGO (UNII: I629I3NR86)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
MICA (UNII: V8A1AW0880)
D&C RED NO. 6 (UNII: 481744AI4O)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
D&C RED NO. 28 (UNII: 767IP0Y5NH)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)

Product Characteristics
Color	RED (Orange Red)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42221-0011-1	1 in 1 CARTON
1		100 g in 1 TUBE, WITH APPLICATOR

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	08/30/2010

MANGO BUTTER LIPSTICK  SPF 10
avobenzone and octinoxate lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42221-0012
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	2 g  in 100 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	6 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
OCTYLDODECANOL (UNII: 461N1O614Y)
CANDELILLA WAX (UNII: WL0328HX19)
CERESIN (UNII: Q1LS2UJO3A)
ANISYL ALCOHOL (UNII: 7N6XGV3U49)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)
MANGO (UNII: I629I3NR86)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
MICA (UNII: V8A1AW0880)
D&C RED NO. 6 (UNII: 481744AI4O)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
D&C RED NO. 28 (UNII: 767IP0Y5NH)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)

Product Characteristics
Color	BROWN (Natural Brown)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42221-0012-1	1 in 1 CARTON
1		100 g in 1 TUBE, WITH APPLICATOR

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	08/30/2010

MANGO BUTTER LIPSTICK  SPF 10
avobenzone and octinoxate lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42221-0013
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	2 g  in 100 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	6 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
OCTYLDODECANOL (UNII: 461N1O614Y)
CANDELILLA WAX (UNII: WL0328HX19)
CERESIN (UNII: Q1LS2UJO3A)
ANISYL ALCOHOL (UNII: 7N6XGV3U49)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)
MANGO (UNII: I629I3NR86)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
MICA (UNII: V8A1AW0880)
D&C RED NO. 6 (UNII: 481744AI4O)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
D&C RED NO. 28 (UNII: 767IP0Y5NH)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)

Product Characteristics
Color	PINK (Rose)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42221-0013-1	1 in 1 CARTON
1		100 g in 1 TUBE, WITH APPLICATOR

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	08/30/2010

MANGO BUTTER LIPSTICK  SPF 10
avobenzone and octinoxate lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42221-0014
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	2 g  in 100 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	6 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
OCTYLDODECANOL (UNII: 461N1O614Y)
CANDELILLA WAX (UNII: WL0328HX19)
CERESIN (UNII: Q1LS2UJO3A)
ANISYL ALCOHOL (UNII: 7N6XGV3U49)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)
MANGO (UNII: I629I3NR86)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
MICA (UNII: V8A1AW0880)
D&C RED NO. 6 (UNII: 481744AI4O)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
D&C RED NO. 28 (UNII: 767IP0Y5NH)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)

Product Characteristics
Color	BROWN (Cinnamon)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42221-0014-1	1 in 1 CARTON
1		100 g in 1 TUBE, WITH APPLICATOR

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	08/30/2010

Labeler - ART COSMETICS SRL (439177106)

Establishment
Name	Address	ID/FEI	Business Operations
ART COSMETICS SRL		439177106	ANALYSIS, MANUFACTURE