Label: MANGO BUTTER LIPSTICK SPF 10- avobenzone and octinoxate lipstick
-
Contains inactivated NDC Code(s)
NDC Code(s): 42221-0001-1, 42221-0002-1, 42221-0003-1, 42221-0004-1, view more42221-0005-1, 42221-0006-1, 42221-0007-1, 42221-0008-1, 42221-0009-1, 42221-0010-1, 42221-0011-1, 42221-0012-1, 42221-0013-1, 42221-0014-1 - Packager: ART COSMETICS SRL
- Category: HUMAN OTC DRUG LABEL
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 August 30, 2010
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredients
-
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
- Directions
- Warnings
- SPL UNCLASSIFIED SECTION
-
Package/Label Principal Display Panel - Carton Label (13 Natural Pink)
LIPSTICK WITH A SHEER COLOUR
FOR A BRILLIANT HIGH SHINEMANGO BUTTER LIPSTICK SPF 10
LIPSTICK
KORRES
MANGO BUTTER LIPSTICK
SHEER COLOUR / HIGH SHINE / SPF 1013 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 ProductsCarton Label - Natural Pink
-
Package/Label Principal Display Panel - Carton Label (33 Nude)
LIPSTICK WITH A SHEER COLOUR
FOR A BRILLIANT HIGH SHINEMANGO BUTTER LIPSTICK SPF 10
LIPSTICK
KORRES
MANGO BUTTER LIPSTICK
SHEER COLOUR / HIGH SHINE / SPF 1033 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 ProductsCarton Label - Nude
-
Package/Label Principal Display Panel - Carton Label (25 Natural Purple)
LIPSTICK WITH A SHEER COLOUR
FOR A BRILLIANT HIGH SHINEMANGO BUTTER LIPSTICK SPF 10
LIPSTICK
KORRES
MANGO BUTTER LIPSTICK
SHEER COLOUR / HIGH SHINE / SPF 1025 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 ProductsCarton Label - Natural Purple
-
Package/Label Principal Display Panel - Carton Label (47 Orange Brown)
LIPSTICK WITH A SHEER COLOUR
FOR A BRILLIANT HIGH SHINEMANGO BUTTER LIPSTICK SPF 10
LIPSTICK
KORRES
MANGO BUTTER LIPSTICK
SHEER COLOUR / HIGH SHINE / SPF 1047 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 ProductsCarton Label - Orange Brown
-
Package/Label Principal Display Panel - Carton Label (12 Frost Pink)
LIPSTICK WITH A SHEER COLOUR
FOR A BRILLIANT HIGH SHINEMANGO BUTTER LIPSTICK SPF 10
LIPSTICK
KORRES
MANGO BUTTER LIPSTICK
SHEER COLOUR / HIGH SHINE / SPF 1012 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 ProductsCarton Label - Frost Pink
-
Package/Label Principal Display Panel - Carton Label (14 Pink)
LIPSTICK WITH A SHEER COLOUR
FOR A BRILLIANT HIGH SHINEMANGO BUTTER LIPSTICK SPF 10
LIPSTICK
KORRES
MANGO BUTTER LIPSTICK
SHEER COLOUR / HIGH SHINE / SPF 1014 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 ProductsCarton Label - Pink
-
Package/Label Principal Display Panel - Carton Label (18 Peach)
LIPSTICK WITH A SHEER COLOUR
FOR A BRILLIANT HIGH SHINEMANGO BUTTER LIPSTICK SPF 10
LIPSTICK
KORRES
MANGO BUTTER LIPSTICK
SHEER COLOUR / HIGH SHINE / SPF 1018 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 ProductsCarton Label - Peach
-
Package/Label Principal Display Panel - Carton Label (24 Purple)
LIPSTICK WITH A SHEER COLOUR
FOR A BRILLIANT HIGH SHINEMANGO BUTTER LIPSTICK SPF 10
LIPSTICK
KORRES
MANGO BUTTER LIPSTICK
SHEER COLOUR / HIGH SHINE / SPF 1024 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 ProductsCarton Label - Purple
-
Package/Label Principal Display Panel - Carton Label (54 Fuchsia)
LIPSTICK WITH A SHEER COLOUR
FOR A BRILLIANT HIGH SHINEMANGO BUTTER LIPSTICK SPF 10
LIPSTICK
KORRES
MANGO BUTTER LIPSTICK
SHEER COLOUR / HIGH SHINE / SPF 1054 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 ProductsCarton Label - Fuchsia
-
Package/Label Principal Display Panel - Carton Label (45 Coral)
LIPSTICK WITH A SHEER COLOUR
FOR A BRILLIANT HIGH SHINEMANGO BUTTER LIPSTICK SPF 10
LIPSTICK
KORRES
MANGO BUTTER LIPSTICK
SHEER COLOUR / HIGH SHINE / SPF 1045 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 ProductsCarton Label - Coral
-
Package/Label Principal Display Panel - Carton Label (52 Orange Red)
LIPSTICK WITH A SHEER COLOUR
FOR A BRILLIANT HIGH SHINEMANGO BUTTER LIPSTICK SPF 10
LIPSTICK
KORRES
MANGO BUTTER LIPSTICK
SHEER COLOUR / HIGH SHINE / SPF 1052 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 ProductsCarton Label - Orange Red
-
Package/Label Principal Display Panel - Carton Label (36 Natural Brown)
LIPSTICK WITH A SHEER COLOUR
FOR A BRILLIANT HIGH SHINEMANGO BUTTER LIPSTICK SPF 10
LIPSTICK
KORRES
MANGO BUTTER LIPSTICK
SHEER COLOUR / HIGH SHINE / SPF 1036 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 ProductsCarton Label - Natural Brown
-
Package/Label Principal Display Panel - Carton Label (22 Rose)
LIPSTICK WITH A SHEER COLOUR
FOR A BRILLIANT HIGH SHINEMANGO BUTTER LIPSTICK SPF 10
LIPSTICK
KORRES
MANGO BUTTER LIPSTICK
SHEER COLOUR / HIGH SHINE / SPF 1022 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 ProductsCarton Label - Rose
-
Package/Label Principal Display Panel - Carton Label (38 Cinnamon)
LIPSTICK WITH A SHEER COLOUR
FOR A BRILLIANT HIGH SHINEMANGO BUTTER LIPSTICK SPF 10
LIPSTICK
KORRES
MANGO BUTTER LIPSTICK
SHEER COLOUR / HIGH SHINE / SPF 1038 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 ProductsCarton Label - Cinnamon
-
INGREDIENTS AND APPEARANCE
MANGO BUTTER LIPSTICK SPF 10
avobenzone and octinoxate lipstickProduct 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 lipstickProduct 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 lipstickProduct 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 lipstickProduct 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 lipstickProduct 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 lipstickProduct 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 lipstickProduct 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 lipstickProduct 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 lipstickProduct 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 lipstickProduct 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 lipstickProduct 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 lipstickProduct 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 lipstickProduct 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 lipstickProduct 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