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 more
    42221-0005-1, 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
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 August 30, 2010

If you are a consumer or patient please visit this version.

  • 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

    Principal Display Panel - Carton Label

    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

    Principal Display Panel - Carton Label

    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

    Principal Display Panel - Carton Label

    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

    Principal Display Panel - Carton Label

    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

    Principal Display Panel - Carton Label

    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

    Principal Display Panel - Carton Label

    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

    Principal Display Panel - Carton Label

    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

    Principal Display Panel - Carton Label

    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

    Principal Display Panel - Carton Label

    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

    Principal Display Panel - Carton Label

    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

    Principal Display Panel - Carton Label

    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

    Principal Display Panel - Carton Label

    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

    Principal Display Panel - Carton Label

    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

    Principal Display Panel - Carton Label

    Carton Label - Cinnamon

  • INGREDIENTS AND APPEARANCE
    MANGO BUTTER LIPSTICK  SPF 10
    avobenzone and octinoxate lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42221-0001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE2 g  in 100 g
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE6 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    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
    ColorPINK (Natural Pink) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42221-0001-11 in 1 CARTON
    1100 g in 1 TUBE, WITH APPLICATOR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35208/30/2010
    MANGO BUTTER LIPSTICK  SPF 10
    avobenzone and octinoxate lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42221-0002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE2 g  in 100 g
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE6 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    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
    ColorBROWN (Nude) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42221-0002-11 in 1 CARTON
    1100 g in 1 TUBE, WITH APPLICATOR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35208/30/2010
    MANGO BUTTER LIPSTICK  SPF 10
    avobenzone and octinoxate lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42221-0003
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE2 g  in 100 g
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE6 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    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
    ColorPURPLE (Natural Purple) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42221-0003-11 in 1 CARTON
    1100 g in 1 TUBE, WITH APPLICATOR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35208/30/2010
    MANGO BUTTER LIPSTICK  SPF 10
    avobenzone and octinoxate lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42221-0004
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE2 g  in 100 g
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE6 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    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
    ColorORANGE (Orange Brown) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42221-0004-11 in 1 CARTON
    1100 g in 1 TUBE, WITH APPLICATOR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35208/30/2010
    MANGO BUTTER LIPSTICK  SPF 10
    avobenzone and octinoxate lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42221-0005
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE2 g  in 100 g
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE6 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    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
    ColorPINK (Frost Pink) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42221-0005-11 in 1 CARTON
    1100 g in 1 TUBE, WITH APPLICATOR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35208/30/2010
    MANGO BUTTER LIPSTICK  SPF 10
    avobenzone and octinoxate lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42221-0006
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE2 g  in 100 g
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE6 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    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
    ColorPINK (Pink) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42221-0006-11 in 1 CARTON
    1100 g in 1 TUBE, WITH APPLICATOR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35208/30/2010
    MANGO BUTTER LIPSTICK  SPF 10
    avobenzone and octinoxate lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42221-0007
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE2 g  in 100 g
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE6 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    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
    ColorPINK (Peach) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42221-0007-11 in 1 CARTON
    1100 g in 1 TUBE, WITH APPLICATOR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35208/30/2010
    MANGO BUTTER LIPSTICK  SPF 10
    avobenzone and octinoxate lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42221-0008
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE2 g  in 100 g
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE6 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    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
    ColorPURPLE (Purple) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42221-0008-11 in 1 CARTON
    1100 g in 1 TUBE, WITH APPLICATOR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35208/30/2010
    MANGO BUTTER LIPSTICK  SPF 10
    avobenzone and octinoxate lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42221-0009
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE2 g  in 100 g
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE6 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    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
    ColorRED (Fuchsia) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42221-0009-11 in 1 CARTON
    1100 g in 1 TUBE, WITH APPLICATOR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35208/30/2010
    MANGO BUTTER LIPSTICK  SPF 10
    avobenzone and octinoxate lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42221-0010
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE2 g  in 100 g
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE6 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    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
    ColorORANGE (Coral) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42221-0010-11 in 1 CARTON
    1100 g in 1 TUBE, WITH APPLICATOR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35208/30/2010
    MANGO BUTTER LIPSTICK  SPF 10
    avobenzone and octinoxate lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42221-0011
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE2 g  in 100 g
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE6 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    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
    ColorRED (Orange Red) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42221-0011-11 in 1 CARTON
    1100 g in 1 TUBE, WITH APPLICATOR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35208/30/2010
    MANGO BUTTER LIPSTICK  SPF 10
    avobenzone and octinoxate lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42221-0012
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE2 g  in 100 g
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE6 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    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
    ColorBROWN (Natural Brown) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42221-0012-11 in 1 CARTON
    1100 g in 1 TUBE, WITH APPLICATOR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35208/30/2010
    MANGO BUTTER LIPSTICK  SPF 10
    avobenzone and octinoxate lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42221-0013
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE2 g  in 100 g
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE6 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    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
    ColorPINK (Rose) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42221-0013-11 in 1 CARTON
    1100 g in 1 TUBE, WITH APPLICATOR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35208/30/2010
    MANGO BUTTER LIPSTICK  SPF 10
    avobenzone and octinoxate lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42221-0014
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE2 g  in 100 g
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE6 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    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
    ColorBROWN (Cinnamon) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42221-0014-11 in 1 CARTON
    1100 g in 1 TUBE, WITH APPLICATOR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35208/30/2010
    Labeler - ART COSMETICS SRL (439177106)
    Establishment
    NameAddressID/FEIBusiness Operations
    ART COSMETICS SRL439177106ANALYSIS, MANUFACTURE