Label: LBEL COULEUR LUXE ROUGE AMPLIFIER XP AMPLIFYING SPF 15 (MARRON ILLIMITE) - BROWN- octinoxate and oxybenzone lipstick
LBEL COULEUR LUXE ROUGE AMPLIFIER XP AMPLIFYING SPF 15 (CHOCOLAT MAJESTIC) - BROWN- octinoxate and oxybenzone lipstick
LBEL COULEUR LUXE ROUGE AMPLIFIER XP AMPLIFYING SPF 15 (CORAIL MAXIMUM) - ORANGE- octinoxate and oxybenzone lipstick
LBEL COULEUR LUXE ROUGE AMPLIFIER XP AMPLIFYING SPF 15 (ROMANCE) - PINK- octinoxate and oxybenzone lipstick
LBEL COULEUR LUXE ROUGE AMPLIFIER XP AMPLIFYING SPF 15 (ROSE FUCSIA) - MAGENTA- octinoxate and oxybenzone lipstick
LBEL COULEUR LUXE ROUGE AMPLIFIER XP AMPLIFYING SPF 15 (MIEL ECHANTER) - ORANGE- octinoxate and oxybenzone lipstick

  • Contains inactivated NDC Code(s)
    NDC Code(s):     13537-115-23, 13537-115-24, 13537-116-25, 13537-116-26, view more
    13537-117-27, 13537-117-28, 13537-118-29, 13537-118-30, 13537-119-31, 13537-119-32, 13537-146-33, 13537-146-34, 13537-149-35, 13537-149-36, 13537-151-37, 13537-151-38, 13537-158-39, 13537-158-40, 13537-159-41, 13537-159-42, 13537-160-41, 13537-160-42, 13537-161-41, 13537-161-42, 13537-162-41, 13537-162-42, 13537-163-41, 13537-163-42, 13537-164-41, 13537-164-42, 13537-165-41, 13537-165-42, 13537-166-41, 13537-166-42, 13537-167-41, 13537-167-42, 13537-168-41, 13537-168-42, 13537-410-01, 13537-410-02, 13537-411-03, 13537-411-04, 13537-412-05, 13537-412-06, 13537-413-07, 13537-413-08, 13537-414-09, 13537-414-10, 13537-415-11, 13537-415-12, 13537-416-13, 13537-416-14, 13537-417-15, 13537-417-16, 13537-418-17, 13537-418-18, 13537-419-19, 13537-419-20, 13537-420-21, 13537-420-22
  • Packager: Ventura Corporation LTD
  • 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 January 30, 2014

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

View All Sections
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active Ingredients Purpose
    Octinoxate 4.7%,Sunscreen
    Oxybenzone 0.9 %Sunscreen
  • Uses

    • Helps prevent sunburn.
  • Warnings

    • Skin Cancer / Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.

    • For external use only.

    • Do not use on damaged or broken skin.

    • When using this product keep out of eyes. Rinse with water to remove.

    • Stop use and ask a doctor if rash occurs.

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

    • Apply liberally and evenly 15 minutes before sun exposure.
    • Reapply at least every 2 hours.
    • Use a water resistant sunscreen if swimming or sweating.
    • Children under 6 months of age: Ask a doctor.
  • Other information

    • Protect the product in this container from excessive heat and direct sun.
  • Inactive ingredients

    Isostearyl neopentanoate, diisopropyl dimer dilinoleate, mica, methyl hydrogenated rosinate, polyethylene, castor isostearate beeswax succinate, hydrogenated polycyclopentadiene, ozokerite, silica, copernicia cerifera (carnauba) wax, euphorbia cerifera (candelilla) wax, ethylhexyl palmitate, isododecane, hydrogenated polyisobutene, paraffin, polyglyceryl-3 diisostearate, glyceryl isostearate, isostearyl alcohol, dipalmitoyl hydroxyproline, ceramide 3, butyrospermum parkii (shea) butter, beta-sitosterol, propylparaben, dimethicone, luffa cylindrica seed oil, silica silylate, methylparaben, disteardimonium hectorite, fragrance, peg-40 hydrogenated castor oil, polysorbate 80, ppg-26-buteth-26, bht, trimethylsiloxysilicate, hedera helix (ivy) leaf/stem extract, retinyl palmitate, tocopheryl acetate, bioflavonoids, allantoin, ascorbyl palmitate.

    May contain: mica, bismuth oxychloride, red 7 lake, manganese violet, iron oxides, titanium dioxide, yellow 5 lake, red 21 lake, red 27 lake, red 6 lake, calcium sodium borosilicate, iron oxides, talc, blue 1 lake, carmine, c9-15 fluoroalcohol phosphate, lauroyl lysine.

  • SPL UNCLASSIFIED SECTION

    PUERTO RICO: Distributed by Ventura Corporation, Ltd. San Juan, Puerto Rico 00926.

  • PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (MARRON ILLIMITÉ) - BROWN

    COULEUR LUXE ROUGE AMPLIFIER XP

    amplifying lipstick
    SPF 15

    Net Weight 0.14 oz. (4 g)

    L'BEL

    Principal Display Panel - 4 g Tube Box - (MARRON ILLIMITÉ) - BROWN
  • PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (CHOCOLAT MAJESTIC) - BROWN

    COULEUR LUXE ROUGE AMPLIFIER XP

    amplifying lipstick
    SPF 15

    Net Weight 0.14 oz. (4 g)

    L'BEL

    Principal Display Panel - 4 g Tube Box - (CHOCOLAT MAJESTIC) - BROWN
  • PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (CORAIL MAXIMUM) - ORANGE

    COULEUR LUXE ROUGE AMPLIFIER XP

    amplifying lipstick
    SPF 15

    Net Weight 0.14 oz. (4 g)

    L'BEL

    Principal Display Panel - 4 g Tube Box - (CORAIL MAXIMUM) - ORANGE
  • PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (FUCSIA SPLENDIDE) - MAGENTA

    COULEUR LUXE ROUGE AMPLIFIER XP

    amplifying lipstick
    SPF 15

    Net Weight 0.14 oz. (4 g)

    L'BEL

    Principal Display Panel - 4 g Tube Box - (FUCSIA SPLENDIDE) - MAGENTA
  • PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (ROUGE PRODIGEUX) - RED

    COULEUR LUXE ROUGE AMPLIFIER XP

    amplifying lipstick
    SPF 15

    Net Weight 0.14 oz. (4 g)

    L'BEL

    Principal Display Panel - 4 g Tube Box - (ROUGE PRODIGEUX) - RED
  • PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (ROUGE GRANDOISE) - RED

    COULEUR LUXE ROUGE AMPLIFIER XP

    amplifying lipstick
    SPF 15

    Net Weight 0.14 oz. (4 g)

    L'BEL

    Principal Display Panel - 4 g Tube Box - (ROUGE GRANDOISE) - RED
  • PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (ROSE CHAMPAGNE) - PINK

    COULEUR LUXE ROUGE AMPLIFIER XP

    amplifying lipstick
    SPF 15

    Net Weight 0.14 oz. (4 g)

    L'BEL

    Principal Display Panel - 4 g Tube Box - (ROSE CHAMPAGNE) - PINK
  • PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (ROSE D'AMOUR) - PINK

    COULEUR LUXE ROUGE AMPLIFIER XP

    amplifying lipstick
    SPF 15

    Net Weight 0.14 oz. (4 g)

    L'BEL

    Principal Display Panel - 4 g Tube Box - (ROSE D'AMOUR) - PINK
  • PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (ROUGE RUBI) - RED

    COULEUR LUXE ROUGE AMPLIFIER XP

    amplifying lipstick
    SPF 15

    Net Weight 0.14 oz. (4 g)

    L'BEL

    Principal Display Panel - 4 g Tube Box - (ROUGE RUBI) - RED
  • PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (SAUMON ESSENTIEL) - PINK

    COULEUR LUXE ROUGE AMPLIFIER XP

    amplifying lipstick
    SPF 15

    Net Weight 0.14 oz. (4 g)

    L'BEL

    Principal Display Panel - 4 g Tube Box - (SAUMON ESSENTIEL) - PINK
  • PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (BOURGOGNE VIF) - BROWN

    COULEUR LUXE ROUGE AMPLIFIER XP

    amplifying lipstick
    SPF 15

    Net Weight 0.14 oz. (4 g)

    L'BEL

    Principal Display Panel - 4 g Tube Box - (BOURGOGNE VIF) - BROWN
  • PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (VIOLET POURPRE) - PURPLE

    COULEUR LUXE ROUGE AMPLIFIER XP

    amplifying lipstick
    SPF 15

    Net Weight 0.14 oz. (4 g)

    L'BEL

    Principal Display Panel - 4 g Tube Box - (VIOLET POURPRE) - PURPLE
  • PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (ORANGE DÉLIRANT) - ORANGE

    COULEUR LUXE ROUGE AMPLIFIER XP

    amplifying lipstick
    SPF 15

    Net Weight 0.14 oz. (4 g)

    L'BEL

    Principal Display Panel - 4 g Tube Box - (ORANGE DÉLIRANT) - ORANGE
  • PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (ROSE FEMME) - PINK

    COULEUR LUXE ROUGE AMPLIFIER XP

    amplifying lipstick
    SPF 15

    Net Weight 0.14 oz. (4 g)

    L'BEL

    Principal Display Panel - 4 g Tube Box - (ROSE FEMME) - PINK
  • PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (ROUGE INTENSE) - RED

    COULEUR LUXE ROUGE AMPLIFIER XP

    amplifying lipstick
    SPF 15

    Net Weight 0.14 oz. (4 g)

    L'BEL

    Principal Display Panel - 4 g Tube Box - (ROUGE INTENSE) - RED
  • PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (DORÉ CHOCOLAT) - BROWN

    COULEUR LUXE ROUGE AMPLIFIER XP

    amplifying lipstick
    SPF 15

    Net Weight 0.14 oz. (4 g)

    L'BEL

    Principal Display Panel - 4 g Tube Box - (DORÉ CHOCOLAT) - BROWN
  • PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (FUCSIA DÉSIR) - MAGENTA

    COULEUR LUXE ROUGE AMPLIFIER XP

    amplifying lipstick
    SPF 15

    Net Weight 0.14 oz. (4 g)

    L'BEL

    Principal Display Panel - 4 g Tube Box - (FUCSIA DÉSIR) - MAGENTA
  • PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (MER DE ROSES) - PINK

    COULEUR LUXE ROUGE AMPLIFIER XP

    amplifying lipstick
    SPF 15

    Net Weight 0.14 oz. (4 g)

    L'BEL

    Principal Display Panel - 4 g Tube Box - (MER DE ROSES) - PINK
  • PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (ROUGE PROVOCATION) - RED

    COULEUR LUXE ROUGE AMPLIFIER XP

    amplifying lipstick
    SPF 15

    Net Weight 0.14 oz. (4 g)

    L'BEL

    Principal Display Panel - 4 g Tube Box - (ROUGE PROVOCATION) - RED
  • PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (ROSE TENTATION) - PINK

    COULEUR LUXE ROUGE AMPLIFIER XP

    amplifying lipstick
    SPF 15

    Net Weight 0.14 oz. (4 g)

    L'BEL

    Principal Display Panel - 4 g Tube Box - (ROSE TENTATION) - PINK
  • PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (ROSE DÉLICAT) - PINK

    COULEUR LUXE ROUGE AMPLIFIER XP

    amplifying lipstick
    SPF 15

    Net Weight 0.14 oz. (4 g)

    L'BEL

    Principal Display Panel - 4 g Tube Box - (ROSE DÉLICAT) - PINK
  • PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (CARMINE) - RED

    COULEUR LUXE ROUGE AMPLIFIER XP

    amplifying lipstick
    SPF 15

    Net Weight 0.14 oz. (4 g)

    L'BEL

    Principal Display Panel - 4 g Tube Box - (CARMINE) - RED
  • PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (NOBLESSE) - RED

    COULEUR LUXE ROUGE AMPLIFIER XP

    amplifying lipstick
    SPF 15

    Net Weight 0.14 oz. (4 g)

    L'BEL

    Principal Display Panel - 4 g Tube Box - (NOBLESSE) - RED
  • PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (MALBEC) - BROWN

    COULEUR LUXE ROUGE AMPLIFIER XP

    amplifying lipstick
    SPF 15

    Net Weight 0.14 oz. (4 g)

    L'BEL

    Principal Display Panel - 4 g Tube Box - (MALBEC) - BROWN
  • PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (AMANDIER) - BROWN

    COULEUR LUXE ROUGE AMPLIFIER XP

    amplifying lipstick
    SPF 15

    Net Weight 0.14 oz. (4 g)

    L'BEL

    Principal Display Panel - 4 g Tube Box - (AMANDIER) - BROWN
  • PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (SOBRIETE) - BROWN

    COULEUR LUXE ROUGE AMPLIFIER XP

    amplifying lipstick
    SPF 15

    Net Weight 0.14 oz. (4 g)

    L'BEL

    Principal Display Panel - 4 g Tube Box - (SOBRIETE) - BROWN
  • PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (FIANCEE) - PINK

    COULEUR LUXE ROUGE AMPLIFIER XP

    amplifying lipstick
    SPF 15

    Net Weight 0.14 oz. (4 g)

    L'BEL

    Principal Display Panel - 4 g Tube Box - (FIANCEE) - PINK
  • PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (ROMANCE) - PINK

    COULEUR LUXE ROUGE AMPLIFIER XP

    amplifying lipstick
    SPF 15

    Net Weight 0.14 oz. (4 g)

    L'BEL

    Principal Display Panel - 4 g Tube Box - (ROMANCE) - PINK
  • PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (ROSE FUCSIA) - MAGENTA

    COULEUR LUXE ROUGE AMPLIFIER XP

    amplifying lipstick
    SPF 15

    Net Weight 0.14 oz. (4 g)

    L'BEL

    Principal Display Panel - 4 g Tube Box - (ROSE FUCSIA) - MAGENTA
  • PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (MIEL ECHANTER) - ORANGE

    COULEUR LUXE ROUGE AMPLIFIER XP

    amplifying lipstick
    SPF 15

    Net Weight 0.14 oz. (4 g)

    L'BEL

    Principal Display Panel - 4 g Tube Box - (MIEL ECHANTER) - ORANGE
  • INGREDIENTS AND APPEARANCE
    LBEL COULEUR LUXE ROUGE AMPLIFIER XP AMPLIFYING SPF 15   (MARRON ILLIMITE) - BROWN
    octinoxate and oxybenzone lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-410
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.047 g  in 1 g
    Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone0.009 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)  
    DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)  
    MICA (UNII: V8A1AW0880)  
    METHYL HYDROGENATED ROSINATE (UNII: 13DHA19W9N)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    ISODODECANE (UNII: A8289P68Y2)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  
    ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)  
    DIPALMITOYL HYDROXYPROLINE (UNII: E6AHA53N1H)  
    CERAMIDE 3 (UNII: 4370DF050B)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    .BETA.-SITOSTEROL (UNII: S347WMO6M4)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    LUFFA AEGYPTIACA SEED OIL (UNII: 1A281RJ859)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PPG-26-BUTETH-26 (UNII: 2II1K6TZ4P)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    HEDERA HELIX LEAF (UNII: ZP9XFG71A7)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ALLANTOIN (UNII: 344S277G0Z)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    MANGANESE VIOLET (UNII: 72M48QQV8Q)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 21 (UNII: 08744Z6JNY)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    D&C RED NO. 6 (UNII: 481744AI4O)  
    TALC (UNII: 7SEV7J4R1U)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    LAUROYL LYSINE (UNII: 113171Q70B)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-410-021 in 1 BOX
    1NDC:13537-410-014 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35201/27/2014
    LBEL COULEUR LUXE ROUGE AMPLIFIER XP AMPLIFYING SPF 15   (CHOCOLAT MAJESTIC) - BROWN
    octinoxate and oxybenzone lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-411
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.047 g  in 1 g
    Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone0.009 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)  
    DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)  
    MICA (UNII: V8A1AW0880)  
    METHYL HYDROGENATED ROSINATE (UNII: 13DHA19W9N)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    ISODODECANE (UNII: A8289P68Y2)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  
    ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)  
    DIPALMITOYL HYDROXYPROLINE (UNII: E6AHA53N1H)  
    CERAMIDE 3 (UNII: 4370DF050B)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    .BETA.-SITOSTEROL (UNII: S347WMO6M4)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    LUFFA AEGYPTIACA SEED OIL (UNII: 1A281RJ859)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PPG-26-BUTETH-26 (UNII: 2II1K6TZ4P)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    HEDERA HELIX LEAF (UNII: ZP9XFG71A7)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ALLANTOIN (UNII: 344S277G0Z)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    MANGANESE VIOLET (UNII: 72M48QQV8Q)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 21 (UNII: 08744Z6JNY)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    D&C RED NO. 6 (UNII: 481744AI4O)  
    TALC (UNII: 7SEV7J4R1U)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    LAUROYL LYSINE (UNII: 113171Q70B)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-411-041 in 1 BOX
    1NDC:13537-411-034 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35201/27/2014
    LBEL COULEUR LUXE ROUGE AMPLIFIER XP AMPLIFYING SPF 15   (CORAIL MAXIMUM) - ORANGE
    octinoxate and oxybenzone lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-412
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.047 g  in 1 g
    Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone0.009 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)  
    DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)  
    MICA (UNII: V8A1AW0880)  
    METHYL HYDROGENATED ROSINATE (UNII: 13DHA19W9N)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    ISODODECANE (UNII: A8289P68Y2)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  
    ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)  
    DIPALMITOYL HYDROXYPROLINE (UNII: E6AHA53N1H)  
    CERAMIDE 3 (UNII: 4370DF050B)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    .BETA.-SITOSTEROL (UNII: S347WMO6M4)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    LUFFA AEGYPTIACA SEED OIL (UNII: 1A281RJ859)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PPG-26-BUTETH-26 (UNII: 2II1K6TZ4P)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    HEDERA HELIX LEAF (UNII: ZP9XFG71A7)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ALLANTOIN (UNII: 344S277G0Z)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    MANGANESE VIOLET (UNII: 72M48QQV8Q)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 21 (UNII: 08744Z6JNY)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    D&C RED NO. 6 (UNII: 481744AI4O)  
    TALC (UNII: 7SEV7J4R1U)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    LAUROYL LYSINE (UNII: 113171Q70B)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-412-061 in 1 BOX
    1NDC:13537-412-054 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35201/27/2014
    LBEL COULEUR LUXE ROUGE AMPLIFIER XP AMPLIFYING SPF 15   (FUCSIA SPLENDIDE) - MAGENTA
    octinoxate and oxybenzone lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-413
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.047 g  in 1 g
    Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone0.009 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)  
    DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)  
    MICA (UNII: V8A1AW0880)  
    METHYL HYDROGENATED ROSINATE (UNII: 13DHA19W9N)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    ISODODECANE (UNII: A8289P68Y2)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  
    ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)  
    DIPALMITOYL HYDROXYPROLINE (UNII: E6AHA53N1H)  
    CERAMIDE 3 (UNII: 4370DF050B)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    .BETA.-SITOSTEROL (UNII: S347WMO6M4)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    LUFFA AEGYPTIACA SEED OIL (UNII: 1A281RJ859)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PPG-26-BUTETH-26 (UNII: 2II1K6TZ4P)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    HEDERA HELIX LEAF (UNII: ZP9XFG71A7)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ALLANTOIN (UNII: 344S277G0Z)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    MANGANESE VIOLET (UNII: 72M48QQV8Q)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 21 (UNII: 08744Z6JNY)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    D&C RED NO. 6 (UNII: 481744AI4O)  
    TALC (UNII: 7SEV7J4R1U)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    LAUROYL LYSINE (UNII: 113171Q70B)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-413-081 in 1 BOX
    1NDC:13537-413-074 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35201/27/2014
    LBEL COULEUR LUXE ROUGE AMPLIFIER XP AMPLIFYING SPF 15   (ROUGE PRODIGEUX) - RED
    octinoxate and oxybenzone lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-414
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.047 g  in 1 g
    Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone0.009 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)  
    DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)  
    MICA (UNII: V8A1AW0880)  
    METHYL HYDROGENATED ROSINATE (UNII: 13DHA19W9N)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    ISODODECANE (UNII: A8289P68Y2)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  
    ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)  
    DIPALMITOYL HYDROXYPROLINE (UNII: E6AHA53N1H)  
    CERAMIDE 3 (UNII: 4370DF050B)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    .BETA.-SITOSTEROL (UNII: S347WMO6M4)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    LUFFA AEGYPTIACA SEED OIL (UNII: 1A281RJ859)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PPG-26-BUTETH-26 (UNII: 2II1K6TZ4P)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    HEDERA HELIX LEAF (UNII: ZP9XFG71A7)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ALLANTOIN (UNII: 344S277G0Z)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    MANGANESE VIOLET (UNII: 72M48QQV8Q)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 21 (UNII: 08744Z6JNY)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    D&C RED NO. 6 (UNII: 481744AI4O)  
    TALC (UNII: 7SEV7J4R1U)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    LAUROYL LYSINE (UNII: 113171Q70B)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-414-101 in 1 BOX
    1NDC:13537-414-094 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35201/27/2014
    LBEL COULEUR LUXE ROUGE AMPLIFIER XP AMPLIFYING SPF 15   (ROUGE GRANDOISE) - RED
    octinoxate and oxybenzone lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-415
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.047 g  in 1 g
    Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone0.009 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)  
    DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)  
    MICA (UNII: V8A1AW0880)  
    METHYL HYDROGENATED ROSINATE (UNII: 13DHA19W9N)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    ISODODECANE (UNII: A8289P68Y2)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  
    ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)  
    DIPALMITOYL HYDROXYPROLINE (UNII: E6AHA53N1H)  
    CERAMIDE 3 (UNII: 4370DF050B)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    .BETA.-SITOSTEROL (UNII: S347WMO6M4)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    LUFFA AEGYPTIACA SEED OIL (UNII: 1A281RJ859)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PPG-26-BUTETH-26 (UNII: 2II1K6TZ4P)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    HEDERA HELIX LEAF (UNII: ZP9XFG71A7)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ALLANTOIN (UNII: 344S277G0Z)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    MANGANESE VIOLET (UNII: 72M48QQV8Q)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 21 (UNII: 08744Z6JNY)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    D&C RED NO. 6 (UNII: 481744AI4O)  
    TALC (UNII: 7SEV7J4R1U)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    LAUROYL LYSINE (UNII: 113171Q70B)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-415-121 in 1 BOX
    1NDC:13537-415-114 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35201/27/2014
    LBEL COULEUR LUXE ROUGE AMPLIFIER XP AMPLIFYING SPF 15   (ROSE CHAMPAGNE) - PINK
    octinoxate and oxybenzone lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-416
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.047 g  in 1 g
    Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone0.009 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)  
    DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)  
    MICA (UNII: V8A1AW0880)  
    METHYL HYDROGENATED ROSINATE (UNII: 13DHA19W9N)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    ISODODECANE (UNII: A8289P68Y2)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  
    ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)  
    DIPALMITOYL HYDROXYPROLINE (UNII: E6AHA53N1H)  
    CERAMIDE 3 (UNII: 4370DF050B)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    .BETA.-SITOSTEROL (UNII: S347WMO6M4)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    LUFFA AEGYPTIACA SEED OIL (UNII: 1A281RJ859)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PPG-26-BUTETH-26 (UNII: 2II1K6TZ4P)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    HEDERA HELIX LEAF (UNII: ZP9XFG71A7)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ALLANTOIN (UNII: 344S277G0Z)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    MANGANESE VIOLET (UNII: 72M48QQV8Q)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 21 (UNII: 08744Z6JNY)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    D&C RED NO. 6 (UNII: 481744AI4O)  
    TALC (UNII: 7SEV7J4R1U)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    LAUROYL LYSINE (UNII: 113171Q70B)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-416-141 in 1 BOX
    1NDC:13537-416-134 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35201/27/2014
    LBEL COULEUR LUXE ROUGE AMPLIFIER XP AMPLIFYING SPF 15   (ROSE DAMOUR) - PINK
    octinoxate and oxybenzone lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-417
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.047 g  in 1 g
    Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone0.009 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)  
    DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)  
    MICA (UNII: V8A1AW0880)  
    METHYL HYDROGENATED ROSINATE (UNII: 13DHA19W9N)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    ISODODECANE (UNII: A8289P68Y2)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  
    ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)  
    DIPALMITOYL HYDROXYPROLINE (UNII: E6AHA53N1H)  
    CERAMIDE 3 (UNII: 4370DF050B)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    .BETA.-SITOSTEROL (UNII: S347WMO6M4)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    LUFFA AEGYPTIACA SEED OIL (UNII: 1A281RJ859)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PPG-26-BUTETH-26 (UNII: 2II1K6TZ4P)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    HEDERA HELIX LEAF (UNII: ZP9XFG71A7)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ALLANTOIN (UNII: 344S277G0Z)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    MANGANESE VIOLET (UNII: 72M48QQV8Q)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 21 (UNII: 08744Z6JNY)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    D&C RED NO. 6 (UNII: 481744AI4O)  
    TALC (UNII: 7SEV7J4R1U)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    LAUROYL LYSINE (UNII: 113171Q70B)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-417-161 in 1 BOX
    1NDC:13537-417-154 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35201/27/2014
    LBEL COULEUR LUXE ROUGE AMPLIFIER XP AMPLIFYING SPF 15   (ROUGE RUBI) - RED
    octinoxate and oxybenzone lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-418
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.047 g  in 1 g
    Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone0.009 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)  
    DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)  
    MICA (UNII: V8A1AW0880)  
    METHYL HYDROGENATED ROSINATE (UNII: 13DHA19W9N)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    ISODODECANE (UNII: A8289P68Y2)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  
    ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)  
    DIPALMITOYL HYDROXYPROLINE (UNII: E6AHA53N1H)  
    CERAMIDE 3 (UNII: 4370DF050B)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    .BETA.-SITOSTEROL (UNII: S347WMO6M4)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    LUFFA AEGYPTIACA SEED OIL (UNII: 1A281RJ859)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PPG-26-BUTETH-26 (UNII: 2II1K6TZ4P)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    HEDERA HELIX LEAF (UNII: ZP9XFG71A7)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ALLANTOIN (UNII: 344S277G0Z)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    MANGANESE VIOLET (UNII: 72M48QQV8Q)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 21 (UNII: 08744Z6JNY)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    D&C RED NO. 6 (UNII: 481744AI4O)  
    TALC (UNII: 7SEV7J4R1U)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    LAUROYL LYSINE (UNII: 113171Q70B)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-418-181 in 1 BOX
    1NDC:13537-418-174 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35201/27/2014
    LBEL COULEUR LUXE ROUGE AMPLIFIER XP AMPLIFYING SPF 15   (SAUMON ESSENTIEL) - PINK
    octinoxate and oxybenzone lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-419
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.047 g  in 1 g
    Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone0.009 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)  
    DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)  
    MICA (UNII: V8A1AW0880)  
    METHYL HYDROGENATED ROSINATE (UNII: 13DHA19W9N)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    ISODODECANE (UNII: A8289P68Y2)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  
    ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)  
    DIPALMITOYL HYDROXYPROLINE (UNII: E6AHA53N1H)  
    CERAMIDE 3 (UNII: 4370DF050B)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    .BETA.-SITOSTEROL (UNII: S347WMO6M4)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    LUFFA AEGYPTIACA SEED OIL (UNII: 1A281RJ859)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PPG-26-BUTETH-26 (UNII: 2II1K6TZ4P)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    HEDERA HELIX LEAF (UNII: ZP9XFG71A7)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ALLANTOIN (UNII: 344S277G0Z)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    MANGANESE VIOLET (UNII: 72M48QQV8Q)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 21 (UNII: 08744Z6JNY)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    D&C RED NO. 6 (UNII: 481744AI4O)  
    TALC (UNII: 7SEV7J4R1U)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    LAUROYL LYSINE (UNII: 113171Q70B)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-419-201 in 1 BOX
    1NDC:13537-419-194 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35201/27/2014
    LBEL COULEUR LUXE ROUGE AMPLIFIER XP AMPLIFYING SPF 15   (BOURGOGNE VIF) - BROWN
    octinoxate and oxybenzone lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-420
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.047 g  in 1 g
    Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone0.009 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)  
    DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)  
    MICA (UNII: V8A1AW0880)  
    METHYL HYDROGENATED ROSINATE (UNII: 13DHA19W9N)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    ISODODECANE (UNII: A8289P68Y2)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  
    ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)  
    DIPALMITOYL HYDROXYPROLINE (UNII: E6AHA53N1H)  
    CERAMIDE 3 (UNII: 4370DF050B)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    .BETA.-SITOSTEROL (UNII: S347WMO6M4)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    LUFFA AEGYPTIACA SEED OIL (UNII: 1A281RJ859)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PPG-26-BUTETH-26 (UNII: 2II1K6TZ4P)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    HEDERA HELIX LEAF (UNII: ZP9XFG71A7)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ALLANTOIN (UNII: 344S277G0Z)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    MANGANESE VIOLET (UNII: 72M48QQV8Q)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 21 (UNII: 08744Z6JNY)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    D&C RED NO. 6 (UNII: 481744AI4O)  
    TALC (UNII: 7SEV7J4R1U)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    LAUROYL LYSINE (UNII: 113171Q70B)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-420-221 in 1 BOX
    1NDC:13537-420-214 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35201/27/2014
    LBEL COULEUR LUXE ROUGE AMPLIFIER XP AMPLIFYING SPF 15   (VIOLET POURPRE) - PURPLE
    octinoxate and oxybenzone lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-115
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.047 g  in 1 g
    Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone0.009 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)  
    DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)  
    MICA (UNII: V8A1AW0880)  
    METHYL HYDROGENATED ROSINATE (UNII: 13DHA19W9N)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    ISODODECANE (UNII: A8289P68Y2)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  
    ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)  
    DIPALMITOYL HYDROXYPROLINE (UNII: E6AHA53N1H)  
    CERAMIDE 3 (UNII: 4370DF050B)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    .BETA.-SITOSTEROL (UNII: S347WMO6M4)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    LUFFA AEGYPTIACA SEED OIL (UNII: 1A281RJ859)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PPG-26-BUTETH-26 (UNII: 2II1K6TZ4P)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    HEDERA HELIX LEAF (UNII: ZP9XFG71A7)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ALLANTOIN (UNII: 344S277G0Z)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    MANGANESE VIOLET (UNII: 72M48QQV8Q)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 21 (UNII: 08744Z6JNY)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    D&C RED NO. 6 (UNII: 481744AI4O)  
    TALC (UNII: 7SEV7J4R1U)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    LAUROYL LYSINE (UNII: 113171Q70B)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-115-241 in 1 BOX
    1NDC:13537-115-234 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35201/27/2014
    LBEL COULEUR LUXE ROUGE AMPLIFIER XP AMPLIFYING SPF 15   (ORANGE DELIRANT) - ORANGE
    octinoxate and oxybenzone lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-116
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.047 g  in 1 g
    Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone0.009 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)  
    DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)  
    MICA (UNII: V8A1AW0880)  
    METHYL HYDROGENATED ROSINATE (UNII: 13DHA19W9N)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    ISODODECANE (UNII: A8289P68Y2)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  
    ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)  
    DIPALMITOYL HYDROXYPROLINE (UNII: E6AHA53N1H)  
    CERAMIDE 3 (UNII: 4370DF050B)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    .BETA.-SITOSTEROL (UNII: S347WMO6M4)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    LUFFA AEGYPTIACA SEED OIL (UNII: 1A281RJ859)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PPG-26-BUTETH-26 (UNII: 2II1K6TZ4P)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    HEDERA HELIX LEAF (UNII: ZP9XFG71A7)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ALLANTOIN (UNII: 344S277G0Z)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    MANGANESE VIOLET (UNII: 72M48QQV8Q)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 21 (UNII: 08744Z6JNY)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    D&C RED NO. 6 (UNII: 481744AI4O)  
    TALC (UNII: 7SEV7J4R1U)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    LAUROYL LYSINE (UNII: 113171Q70B)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-116-261 in 1 BOX
    1NDC:13537-116-254 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35201/27/2014
    LBEL COULEUR LUXE ROUGE AMPLIFIER XP AMPLIFYING SPF 15   (ROSE FEMME) - PINK
    octinoxate and oxybenzone lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-117
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.047 g  in 1 g
    Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone0.009 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)  
    DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)  
    MICA (UNII: V8A1AW0880)  
    METHYL HYDROGENATED ROSINATE (UNII: 13DHA19W9N)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    ISODODECANE (UNII: A8289P68Y2)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  
    ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)  
    DIPALMITOYL HYDROXYPROLINE (UNII: E6AHA53N1H)  
    CERAMIDE 3 (UNII: 4370DF050B)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    .BETA.-SITOSTEROL (UNII: S347WMO6M4)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    LUFFA AEGYPTIACA SEED OIL (UNII: 1A281RJ859)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PPG-26-BUTETH-26 (UNII: 2II1K6TZ4P)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    HEDERA HELIX LEAF (UNII: ZP9XFG71A7)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ALLANTOIN (UNII: 344S277G0Z)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    MANGANESE VIOLET (UNII: 72M48QQV8Q)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 21 (UNII: 08744Z6JNY)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    D&C RED NO. 6 (UNII: 481744AI4O)  
    TALC (UNII: 7SEV7J4R1U)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    LAUROYL LYSINE (UNII: 113171Q70B)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-117-281 in 1 BOX
    1NDC:13537-117-274 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35201/27/2014
    LBEL COULEUR LUXE ROUGE AMPLIFIER XP AMPLIFYING SPF 15   (ROUGE INTENSE) - RED
    octinoxate and oxybenzone lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-118
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.047 g  in 1 g
    Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone0.009 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)  
    DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)  
    MICA (UNII: V8A1AW0880)  
    METHYL HYDROGENATED ROSINATE (UNII: 13DHA19W9N)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    ISODODECANE (UNII: A8289P68Y2)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  
    ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)  
    DIPALMITOYL HYDROXYPROLINE (UNII: E6AHA53N1H)  
    CERAMIDE 3 (UNII: 4370DF050B)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    .BETA.-SITOSTEROL (UNII: S347WMO6M4)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    LUFFA AEGYPTIACA SEED OIL (UNII: 1A281RJ859)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PPG-26-BUTETH-26 (UNII: 2II1K6TZ4P)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    HEDERA HELIX LEAF (UNII: ZP9XFG71A7)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ALLANTOIN (UNII: 344S277G0Z)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    MANGANESE VIOLET (UNII: 72M48QQV8Q)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 21 (UNII: 08744Z6JNY)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    D&C RED NO. 6 (UNII: 481744AI4O)  
    TALC (UNII: 7SEV7J4R1U)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    LAUROYL LYSINE (UNII: 113171Q70B)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-118-301 in 1 BOX
    1NDC:13537-118-294 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35201/27/2014
    LBEL COULEUR LUXE ROUGE AMPLIFIER XP AMPLIFYING SPF 15   (DORE CHOCOLAT) - BROWN
    octinoxate and oxybenzone lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-119
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.047 g  in 1 g
    Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone0.009 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)  
    DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)  
    MICA (UNII: V8A1AW0880)  
    METHYL HYDROGENATED ROSINATE (UNII: 13DHA19W9N)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    ISODODECANE (UNII: A8289P68Y2)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  
    ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)  
    DIPALMITOYL HYDROXYPROLINE (UNII: E6AHA53N1H)  
    CERAMIDE 3 (UNII: 4370DF050B)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    .BETA.-SITOSTEROL (UNII: S347WMO6M4)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    LUFFA AEGYPTIACA SEED OIL (UNII: 1A281RJ859)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PPG-26-BUTETH-26 (UNII: 2II1K6TZ4P)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    HEDERA HELIX LEAF (UNII: ZP9XFG71A7)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ALLANTOIN (UNII: 344S277G0Z)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    MANGANESE VIOLET (UNII: 72M48QQV8Q)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 21 (UNII: 08744Z6JNY)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    D&C RED NO. 6 (UNII: 481744AI4O)  
    TALC (UNII: 7SEV7J4R1U)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    LAUROYL LYSINE (UNII: 113171Q70B)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-119-321 in 1 BOX
    1NDC:13537-119-314 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35201/27/2014
    LBEL COULEUR LUXE ROUGE AMPLIFIER XP AMPLIFYING SPF 15   (FUCSIA DESIR) - MAGENTA
    octinoxate and oxybenzone lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-146
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.047 g  in 1 g
    Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone0.009 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)  
    DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)  
    MICA (UNII: V8A1AW0880)  
    METHYL HYDROGENATED ROSINATE (UNII: 13DHA19W9N)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    ISODODECANE (UNII: A8289P68Y2)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  
    ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)  
    DIPALMITOYL HYDROXYPROLINE (UNII: E6AHA53N1H)  
    CERAMIDE 3 (UNII: 4370DF050B)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    .BETA.-SITOSTEROL (UNII: S347WMO6M4)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    LUFFA AEGYPTIACA SEED OIL (UNII: 1A281RJ859)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PPG-26-BUTETH-26 (UNII: 2II1K6TZ4P)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    HEDERA HELIX LEAF (UNII: ZP9XFG71A7)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ALLANTOIN (UNII: 344S277G0Z)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    MANGANESE VIOLET (UNII: 72M48QQV8Q)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 21 (UNII: 08744Z6JNY)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    D&C RED NO. 6 (UNII: 481744AI4O)  
    TALC (UNII: 7SEV7J4R1U)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    LAUROYL LYSINE (UNII: 113171Q70B)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-146-341 in 1 BOX
    1NDC:13537-146-334 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35201/27/2014
    LBEL COULEUR LUXE ROUGE AMPLIFIER XP AMPLIFYING SPF 15   (MER DE ROSES) - PINK
    octinoxate and oxybenzone lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-149
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.047 g  in 1 g
    Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone0.009 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)  
    DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)  
    MICA (UNII: V8A1AW0880)  
    METHYL HYDROGENATED ROSINATE (UNII: 13DHA19W9N)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    ISODODECANE (UNII: A8289P68Y2)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  
    ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)  
    DIPALMITOYL HYDROXYPROLINE (UNII: E6AHA53N1H)  
    CERAMIDE 3 (UNII: 4370DF050B)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    .BETA.-SITOSTEROL (UNII: S347WMO6M4)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    LUFFA AEGYPTIACA SEED OIL (UNII: 1A281RJ859)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PPG-26-BUTETH-26 (UNII: 2II1K6TZ4P)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    HEDERA HELIX LEAF (UNII: ZP9XFG71A7)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ALLANTOIN (UNII: 344S277G0Z)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    MANGANESE VIOLET (UNII: 72M48QQV8Q)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 21 (UNII: 08744Z6JNY)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    D&C RED NO. 6 (UNII: 481744AI4O)  
    TALC (UNII: 7SEV7J4R1U)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    LAUROYL LYSINE (UNII: 113171Q70B)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-149-361 in 1 BOX
    1NDC:13537-149-354 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35201/27/2014
    LBEL COULEUR LUXE ROUGE AMPLIFIER XP AMPLIFYING SPF 15   (ROUGE PROVOCATION) - RED
    octinoxate and oxybenzone lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-151
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.047 g  in 1 g
    Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone0.009 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)  
    DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)  
    MICA (UNII: V8A1AW0880)  
    METHYL HYDROGENATED ROSINATE (UNII: 13DHA19W9N)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    ISODODECANE (UNII: A8289P68Y2)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  
    ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)  
    DIPALMITOYL HYDROXYPROLINE (UNII: E6AHA53N1H)  
    CERAMIDE 3 (UNII: 4370DF050B)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    .BETA.-SITOSTEROL (UNII: S347WMO6M4)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    LUFFA AEGYPTIACA SEED OIL (UNII: 1A281RJ859)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PPG-26-BUTETH-26 (UNII: 2II1K6TZ4P)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    HEDERA HELIX LEAF (UNII: ZP9XFG71A7)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ALLANTOIN (UNII: 344S277G0Z)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    MANGANESE VIOLET (UNII: 72M48QQV8Q)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 21 (UNII: 08744Z6JNY)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    D&C RED NO. 6 (UNII: 481744AI4O)  
    TALC (UNII: 7SEV7J4R1U)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    LAUROYL LYSINE (UNII: 113171Q70B)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-151-381 in 1 BOX
    1NDC:13537-151-374 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35201/27/2014
    LBEL COULEUR LUXE ROUGE AMPLIFIER XP AMPLIFYING SPF 15   (ROSE TENTATION) - PINK
    octinoxate and oxybenzone lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-158
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.047 g  in 1 g
    Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone0.009 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)  
    DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)  
    MICA (UNII: V8A1AW0880)  
    METHYL HYDROGENATED ROSINATE (UNII: 13DHA19W9N)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    ISODODECANE (UNII: A8289P68Y2)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  
    ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)  
    DIPALMITOYL HYDROXYPROLINE (UNII: E6AHA53N1H)  
    CERAMIDE 3 (UNII: 4370DF050B)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    .BETA.-SITOSTEROL (UNII: S347WMO6M4)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    LUFFA AEGYPTIACA SEED OIL (UNII: 1A281RJ859)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PPG-26-BUTETH-26 (UNII: 2II1K6TZ4P)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    HEDERA HELIX LEAF (UNII: ZP9XFG71A7)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ALLANTOIN (UNII: 344S277G0Z)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    MANGANESE VIOLET (UNII: 72M48QQV8Q)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 21 (UNII: 08744Z6JNY)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    D&C RED NO. 6 (UNII: 481744AI4O)  
    TALC (UNII: 7SEV7J4R1U)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    LAUROYL LYSINE (UNII: 113171Q70B)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-158-401 in 1 BOX
    1NDC:13537-158-394 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35201/27/2014
    LBEL COULEUR LUXE ROUGE AMPLIFIER XP AMPLIFYING SPF 15   (ROSE DELICAT) - PINK
    octinoxate and oxybenzone lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-159
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.047 g  in 1 g
    Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone0.009 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)  
    DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)  
    MICA (UNII: V8A1AW0880)  
    METHYL HYDROGENATED ROSINATE (UNII: 13DHA19W9N)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    ISODODECANE (UNII: A8289P68Y2)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  
    ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)  
    DIPALMITOYL HYDROXYPROLINE (UNII: E6AHA53N1H)  
    CERAMIDE 3 (UNII: 4370DF050B)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    .BETA.-SITOSTEROL (UNII: S347WMO6M4)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    LUFFA AEGYPTIACA SEED OIL (UNII: 1A281RJ859)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PPG-26-BUTETH-26 (UNII: 2II1K6TZ4P)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    HEDERA HELIX LEAF (UNII: ZP9XFG71A7)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ALLANTOIN (UNII: 344S277G0Z)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    MANGANESE VIOLET (UNII: 72M48QQV8Q)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 21 (UNII: 08744Z6JNY)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    D&C RED NO. 6 (UNII: 481744AI4O)  
    TALC (UNII: 7SEV7J4R1U)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    LAUROYL LYSINE (UNII: 113171Q70B)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-159-421 in 1 BOX
    1NDC:13537-159-414 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35201/27/2014
    LBEL COULEUR LUXE ROUGE AMPLIFIER XP AMPLIFYING SPF 15   (CARMINE) - RED
    octinoxate and oxybenzone lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-160
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.047 g  in 1 g
    Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone0.009 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)  
    DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)  
    MICA (UNII: V8A1AW0880)  
    METHYL HYDROGENATED ROSINATE (UNII: 13DHA19W9N)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    ISODODECANE (UNII: A8289P68Y2)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  
    ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)  
    DIPALMITOYL HYDROXYPROLINE (UNII: E6AHA53N1H)  
    CERAMIDE 3 (UNII: 4370DF050B)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    .BETA.-SITOSTEROL (UNII: S347WMO6M4)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    LUFFA AEGYPTIACA SEED OIL (UNII: 1A281RJ859)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PPG-26-BUTETH-26 (UNII: 2II1K6TZ4P)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    HEDERA HELIX LEAF (UNII: ZP9XFG71A7)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ALLANTOIN (UNII: 344S277G0Z)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    MANGANESE VIOLET (UNII: 72M48QQV8Q)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 21 (UNII: 08744Z6JNY)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    D&C RED NO. 6 (UNII: 481744AI4O)  
    TALC (UNII: 7SEV7J4R1U)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    LAUROYL LYSINE (UNII: 113171Q70B)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-160-421 in 1 BOX
    1NDC:13537-160-414 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35201/27/2014
    LBEL COULEUR LUXE ROUGE AMPLIFIER XP AMPLIFYING SPF 15   (NOBLESSE) - RED
    octinoxate and oxybenzone lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-161
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.047 g  in 1 g
    Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone0.009 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)  
    DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)  
    MICA (UNII: V8A1AW0880)  
    METHYL HYDROGENATED ROSINATE (UNII: 13DHA19W9N)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    ISODODECANE (UNII: A8289P68Y2)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  
    ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)  
    DIPALMITOYL HYDROXYPROLINE (UNII: E6AHA53N1H)  
    CERAMIDE 3 (UNII: 4370DF050B)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    .BETA.-SITOSTEROL (UNII: S347WMO6M4)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    LUFFA AEGYPTIACA SEED OIL (UNII: 1A281RJ859)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PPG-26-BUTETH-26 (UNII: 2II1K6TZ4P)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    HEDERA HELIX LEAF (UNII: ZP9XFG71A7)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ALLANTOIN (UNII: 344S277G0Z)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    MANGANESE VIOLET (UNII: 72M48QQV8Q)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 21 (UNII: 08744Z6JNY)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    D&C RED NO. 6 (UNII: 481744AI4O)  
    TALC (UNII: 7SEV7J4R1U)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    LAUROYL LYSINE (UNII: 113171Q70B)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-161-421 in 1 BOX
    1NDC:13537-161-414 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35201/27/2014
    LBEL COULEUR LUXE ROUGE AMPLIFIER XP AMPLIFYING SPF 15   (MALBEC) - BROWN
    octinoxate and oxybenzone lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-162
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.047 g  in 1 g
    Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone0.009 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)  
    DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)  
    MICA (UNII: V8A1AW0880)  
    METHYL HYDROGENATED ROSINATE (UNII: 13DHA19W9N)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    ISODODECANE (UNII: A8289P68Y2)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  
    ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)  
    DIPALMITOYL HYDROXYPROLINE (UNII: E6AHA53N1H)  
    CERAMIDE 3 (UNII: 4370DF050B)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    .BETA.-SITOSTEROL (UNII: S347WMO6M4)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    LUFFA AEGYPTIACA SEED OIL (UNII: 1A281RJ859)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PPG-26-BUTETH-26 (UNII: 2II1K6TZ4P)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    HEDERA HELIX LEAF (UNII: ZP9XFG71A7)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ALLANTOIN (UNII: 344S277G0Z)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    MANGANESE VIOLET (UNII: 72M48QQV8Q)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 21 (UNII: 08744Z6JNY)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    D&C RED NO. 6 (UNII: 481744AI4O)  
    TALC (UNII: 7SEV7J4R1U)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    LAUROYL LYSINE (UNII: 113171Q70B)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-162-421 in 1 BOX
    1NDC:13537-162-414 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35201/27/2014
    LBEL COULEUR LUXE ROUGE AMPLIFIER XP AMPLIFYING SPF 15   (AMANDIER) - BROWN
    octinoxate and oxybenzone lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-163
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.047 g  in 1 g
    Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone0.009 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)  
    DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)  
    MICA (UNII: V8A1AW0880)  
    METHYL HYDROGENATED ROSINATE (UNII: 13DHA19W9N)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    ISODODECANE (UNII: A8289P68Y2)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  
    ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)  
    DIPALMITOYL HYDROXYPROLINE (UNII: E6AHA53N1H)  
    CERAMIDE 3 (UNII: 4370DF050B)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    .BETA.-SITOSTEROL (UNII: S347WMO6M4)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    LUFFA AEGYPTIACA SEED OIL (UNII: 1A281RJ859)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PPG-26-BUTETH-26 (UNII: 2II1K6TZ4P)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    HEDERA HELIX LEAF (UNII: ZP9XFG71A7)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ALLANTOIN (UNII: 344S277G0Z)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    MANGANESE VIOLET (UNII: 72M48QQV8Q)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 21 (UNII: 08744Z6JNY)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    D&C RED NO. 6 (UNII: 481744AI4O)  
    TALC (UNII: 7SEV7J4R1U)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    LAUROYL LYSINE (UNII: 113171Q70B)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-163-421 in 1 BOX
    1NDC:13537-163-414 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35201/27/2014
    LBEL COULEUR LUXE ROUGE AMPLIFIER XP AMPLIFYING SPF 15   (SOBRIETE) - BROWN
    octinoxate and oxybenzone lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-164
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.047 g  in 1 g
    Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone0.009 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)  
    DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)  
    MICA (UNII: V8A1AW0880)  
    METHYL HYDROGENATED ROSINATE (UNII: 13DHA19W9N)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    ISODODECANE (UNII: A8289P68Y2)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  
    ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)  
    DIPALMITOYL HYDROXYPROLINE (UNII: E6AHA53N1H)  
    CERAMIDE 3 (UNII: 4370DF050B)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    .BETA.-SITOSTEROL (UNII: S347WMO6M4)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    LUFFA AEGYPTIACA SEED OIL (UNII: 1A281RJ859)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PPG-26-BUTETH-26 (UNII: 2II1K6TZ4P)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    HEDERA HELIX LEAF (UNII: ZP9XFG71A7)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ALLANTOIN (UNII: 344S277G0Z)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    MANGANESE VIOLET (UNII: 72M48QQV8Q)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 21 (UNII: 08744Z6JNY)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    D&C RED NO. 6 (UNII: 481744AI4O)  
    TALC (UNII: 7SEV7J4R1U)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    LAUROYL LYSINE (UNII: 113171Q70B)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-164-421 in 1 BOX
    1NDC:13537-164-414 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35201/27/2014
    LBEL COULEUR LUXE ROUGE AMPLIFIER XP AMPLIFYING SPF 15   (FIANCEE) - PINK
    octinoxate and oxybenzone lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-165
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.047 g  in 1 g
    Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone0.009 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)  
    DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)  
    MICA (UNII: V8A1AW0880)  
    METHYL HYDROGENATED ROSINATE (UNII: 13DHA19W9N)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    ISODODECANE (UNII: A8289P68Y2)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  
    ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)  
    DIPALMITOYL HYDROXYPROLINE (UNII: E6AHA53N1H)  
    CERAMIDE 3 (UNII: 4370DF050B)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    .BETA.-SITOSTEROL (UNII: S347WMO6M4)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    LUFFA AEGYPTIACA SEED OIL (UNII: 1A281RJ859)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PPG-26-BUTETH-26 (UNII: 2II1K6TZ4P)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    HEDERA HELIX LEAF (UNII: ZP9XFG71A7)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ALLANTOIN (UNII: 344S277G0Z)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    MANGANESE VIOLET (UNII: 72M48QQV8Q)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 21 (UNII: 08744Z6JNY)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    D&C RED NO. 6 (UNII: 481744AI4O)  
    TALC (UNII: 7SEV7J4R1U)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    LAUROYL LYSINE (UNII: 113171Q70B)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-165-421 in 1 BOX
    1NDC:13537-165-414 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35201/27/2014
    LBEL COULEUR LUXE ROUGE AMPLIFIER XP AMPLIFYING SPF 15   (ROMANCE) - PINK
    octinoxate and oxybenzone lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-166
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.047 g  in 1 g
    Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone0.009 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)  
    DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)  
    MICA (UNII: V8A1AW0880)  
    METHYL HYDROGENATED ROSINATE (UNII: 13DHA19W9N)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    ISODODECANE (UNII: A8289P68Y2)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  
    ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)  
    DIPALMITOYL HYDROXYPROLINE (UNII: E6AHA53N1H)  
    CERAMIDE 3 (UNII: 4370DF050B)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    .BETA.-SITOSTEROL (UNII: S347WMO6M4)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    LUFFA AEGYPTIACA SEED OIL (UNII: 1A281RJ859)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PPG-26-BUTETH-26 (UNII: 2II1K6TZ4P)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    HEDERA HELIX LEAF (UNII: ZP9XFG71A7)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ALLANTOIN (UNII: 344S277G0Z)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    MANGANESE VIOLET (UNII: 72M48QQV8Q)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 21 (UNII: 08744Z6JNY)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    D&C RED NO. 6 (UNII: 481744AI4O)  
    TALC (UNII: 7SEV7J4R1U)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    LAUROYL LYSINE (UNII: 113171Q70B)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-166-421 in 1 BOX
    1NDC:13537-166-414 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35201/27/2014
    LBEL COULEUR LUXE ROUGE AMPLIFIER XP AMPLIFYING SPF 15   (ROSE FUCSIA) - MAGENTA
    octinoxate and oxybenzone lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-167
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.047 g  in 1 g
    Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone0.009 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)  
    DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)  
    MICA (UNII: V8A1AW0880)  
    METHYL HYDROGENATED ROSINATE (UNII: 13DHA19W9N)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    ISODODECANE (UNII: A8289P68Y2)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  
    ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)  
    DIPALMITOYL HYDROXYPROLINE (UNII: E6AHA53N1H)  
    CERAMIDE 3 (UNII: 4370DF050B)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    .BETA.-SITOSTEROL (UNII: S347WMO6M4)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    LUFFA AEGYPTIACA SEED OIL (UNII: 1A281RJ859)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PPG-26-BUTETH-26 (UNII: 2II1K6TZ4P)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    HEDERA HELIX LEAF (UNII: ZP9XFG71A7)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ALLANTOIN (UNII: 344S277G0Z)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    MANGANESE VIOLET (UNII: 72M48QQV8Q)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 21 (UNII: 08744Z6JNY)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    D&C RED NO. 6 (UNII: 481744AI4O)  
    TALC (UNII: 7SEV7J4R1U)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    LAUROYL LYSINE (UNII: 113171Q70B)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-167-421 in 1 BOX
    1NDC:13537-167-414 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35201/27/2014
    LBEL COULEUR LUXE ROUGE AMPLIFIER XP AMPLIFYING SPF 15   (MIEL ECHANTER) - ORANGE
    octinoxate and oxybenzone lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-168
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.047 g  in 1 g
    Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone0.009 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)  
    DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)  
    MICA (UNII: V8A1AW0880)  
    METHYL HYDROGENATED ROSINATE (UNII: 13DHA19W9N)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    ISODODECANE (UNII: A8289P68Y2)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  
    ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)  
    DIPALMITOYL HYDROXYPROLINE (UNII: E6AHA53N1H)  
    CERAMIDE 3 (UNII: 4370DF050B)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    .BETA.-SITOSTEROL (UNII: S347WMO6M4)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    LUFFA AEGYPTIACA SEED OIL (UNII: 1A281RJ859)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PPG-26-BUTETH-26 (UNII: 2II1K6TZ4P)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    HEDERA HELIX LEAF (UNII: ZP9XFG71A7)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ALLANTOIN (UNII: 344S277G0Z)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    MANGANESE VIOLET (UNII: 72M48QQV8Q)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 21 (UNII: 08744Z6JNY)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    D&C RED NO. 6 (UNII: 481744AI4O)  
    TALC (UNII: 7SEV7J4R1U)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    LAUROYL LYSINE (UNII: 113171Q70B)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-168-421 in 1 BOX
    1NDC:13537-168-414 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35201/27/2014
    Labeler - Ventura Corporation LTD (602751344)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bel Star S.A. (Colombia)880160197MANUFACTURE(13537-410, 13537-411, 13537-412, 13537-413, 13537-414, 13537-415, 13537-416, 13537-417, 13537-418, 13537-419, 13537-420, 13537-115, 13537-116, 13537-117, 13537-118, 13537-119, 13537-146, 13537-149, 13537-151, 13537-158, 13537-159, 13537-160, 13537-161, 13537-162, 13537-163, 13537-164, 13537-165, 13537-166, 13537-167, 13537-168)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials

More Info on this Drug

Get Label RSS Feed, View NDC Code(s)NEW!