Label: LBEL EFFET PARFAIT HYDRATESS LONG-LASTING INTENSE MOISTURIZING SPF 20 (MOKA) - BROWN- octinoxate and oxybenzone lipstick
LBEL EFFET PARFAIT HYDRATESS LONG-LASTING INTENSE MOISTURIZING SPF 20 (ROMANCE) - PINK- octinoxate and oxybenzone lipstick
LBEL EFFET PARFAIT HYDRATESS LONG-LASTING INTENSE MOISTURIZING SPF 20 (ROSE NATURAL) - PINK (octinoxate and oxybenzone) lipstick .......EFFET PARFAIT HYDRATESS LONG-LASTING INTENSE MOISTURIZING SPF 20 (CHERRY BLOSSOM) - PINK- octinoxate and oxybenzone lipstick
LBEL EFFET PARFAIT HYDRATESS LONG-LASTING INTENSE MOISTURIZING SPF 20 (VIN AMANT) - PURPLE- octinoxate and oxybenzone lipstick
LBEL EFFET PARFAIT HYDRATESS LONG-LASTING INTENSE MOISTURIZING SPF 20 (NUDE INTIME) - PURPLE- octinoxate and oxybenzone lipstick

  • Contains inactivated NDC Code(s)
    NDC Code(s):
    13537-085-01, 13537-085-02, 13537-086-01, 13537-086-02, view more
    13537-087-01, 13537-087-02, 13537-090-01, 13537-090-02, 13537-091-01, 13537-091-02, 13537-092-01, 13537-092-12, 13537-093-01, 13537-093-02, 13537-094-01, 13537-094-02, 13537-095-01, 13537-095-02, 13537-096-01, 13537-096-20, 13537-097-01, 13537-097-02, 13537-098-01, 13537-098-02, 13537-099-01, 13537-099-02, 13537-178-01, 13537-178-02, 13537-179-01, 13537-179-02, 13537-357-01, 13537-357-02, 13537-358-01, 13537-358-02, 13537-375-01, 13537-375-02, 13537-376-01, 13537-376-02, 13537-377-01, 13537-377-02, 13537-378-01, 13537-378-02, 13537-380-01, 13537-380-02, 13537-381-01, 13537-381-02, 13537-382-01, 13537-382-02, 13537-424-01, 13537-424-02
  • Packager: Ventura Corporation LTD
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated December 3, 2016

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active Ingredients Purpose
    OCTINOXATE 7.10 %Sunscreen
    OXYBENZONE 1.60 %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

    CAPRYLIC/CAPRIC TRIGLYCERIDE, DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE, TRIDECYL TRIMELLITATE, MICA, COPERNICIA CERIFERA (CARNAUBA) WAX, TRIDECYL STEARATE, POLYETHYLENE, OZOKERITE, POLYMETHYL METHACRYLATE, NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE, DISTEARDIMONIUM HECTORITE, PROPYLENE CARBONATE,PHENOXYETHANOL, COCOS NUCIFERA (COCONUT) OIL, TOCOPHERYL ACETATE, ALOE BARBADENSIS LEAF EXTRACT, SILICA, FRAGRANCE, BUTYROSPERMUM PARKII (SHEA) BUTTER, ELAEIS GUINEENSIS (PALM) OIL, GOSSYPIUM HERBACEUM (COTTON) SEED OIL, BIDENS PILOSA EXTRACT, DIMETHICONE,CAPRYLYL GLYCOL, LINUM USITATISSIMUM (LINSEED) SEED OIL, CHLORPHENESIN, BHT, CERAMIDE 3, CRAMBE MARITIMA EXTRACT, TRIMETHYLSILOXYSILICATE, PROPYLPARABEN, TOCOPHEROL, BENZYL BENZOATE, AMYL CINNAMAL, HEXYL CINNAMAL, LINALOOL, EUGENOL.

    MAY CONTAIN :

    MICA, TITANIUM DIOXIDE, IRON OXIDES, YELLOW 5 LAKE, RED 27 LAKE, RED 7 LAKE, RED 30 LAKE, TALC, BLUE 1 LAKE, SYNTHETIC FLUORPHLOGOPITE, RED 40 LAKE, CARMINE.

  • SPL UNCLASSIFIED SECTION

    Dist. by
    Ventura Corp, Ltd., San Juan,
    Puerto Rico 00926.

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

    L'BEL

    EFFET
    PARFAIT
    HYDRATESS

    long-lasting
    intense
    moisturizing
    lipstick SPF 20

    Net Weight 0.14 oz (4g)

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

    L'BEL

    EFFET
    PARFAIT
    HYDRATESS

    long-lasting
    intense
    moisturizing
    lipstick SPF 20

    Net Weight 0.14 oz (4g)

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

    L'BEL

    EFFET
    PARFAIT
    HYDRATESS

    long-lasting
    intense
    moisturizing
    lipstick SPF 20

    Net Weight 0.14 oz (4g)

    Principal Display Panel - 4 g Tube Box - (ROSE NATURAL) - PINK
  • PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (ROJO CLASIQUE) - PINK

    L'BEL

    EFFET
    PARFAIT
    HYDRATESS

    long-lasting
    intense
    moisturizing
    lipstick SPF 20

    Net Weight 0.14 oz (4g)

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

    L'BEL

    EFFET
    PARFAIT
    HYDRATESS

    long-lasting
    intense
    moisturizing
    lipstick SPF 20

    Net Weight 0.14 oz (4g)

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

    L'BEL

    EFFET
    PARFAIT
    HYDRATESS

    long-lasting
    intense
    moisturizing
    lipstick SPF 20

    Net Weight 0.14 oz (4g)

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

    L'BEL

    EFFET
    PARFAIT
    HYDRATESS

    long-lasting
    intense
    moisturizing
    lipstick SPF 20

    Net Weight 0.14 oz (4g)

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

    L'BEL

    EFFET
    PARFAIT
    HYDRATESS

    long-lasting
    intense
    moisturizing
    lipstick SPF 20

    Net Weight 0.14 oz (4g)

    Principal Display Panel - 4 g Tube Box - (ALMOND) - BROWN
  • PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (MALVE) - BROWN

    L'BEL

    EFFET
    PARFAIT
    HYDRATESS

    long-lasting
    intense
    moisturizing
    lipstick SPF 20

    Net Weight 0.14 oz (4g)

    Principal Display Panel - 4 g Tube Box - (MALVE) - BROWN
  • PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (MARRON GLACE) - BROWN

    L'BEL

    EFFET
    PARFAIT
    HYDRATESS

    long-lasting
    intense
    moisturizing
    lipstick SPF 20

    Net Weight 0.14 oz (4g)

    Principal Display Panel - 4 g Tube Box - (MARRON GLACE) - BROWN
  • PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (TULIP) - PINK

    L'BEL

    EFFET
    PARFAIT
    HYDRATESS

    long-lasting
    intense
    moisturizing
    lipstick SPF 20

    Net Weight 0.14 oz (4g)

    Principal Display Panel - 4 g Tube Box - (TULIP) - PINK
  • PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (NUDE) - PINK

    L'BEL

    EFFET
    PARFAIT
    HYDRATESS

    long-lasting
    intense
    moisturizing
    lipstick SPF 20

    Net Weight 0.14 oz (4g)

    Principal Display Panel - 4 g Tube Box - (NUDE) - PINK
  • PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (LILY BEIGE) - BEIGE

    L'BEL

    EFFET
    PARFAIT
    HYDRATESS

    long-lasting
    intense
    moisturizing
    lipstick SPF 20

    Net Weight 0.14 oz (4g)

    Principal Display Panel - 4 g Tube Box - (LILY BEIGE) - BEIGE
  • PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (MANDARINE) - ORANGE

    L'BEL

    EFFET
    PARFAIT
    HYDRATESS

    long-lasting
    intense
    moisturizing
    lipstick SPF 20

    Net Weight 0.14 oz (4g)

    Principal Display Panel - 4 g Tube Box - (MANDARINE) - ORANGE
  • PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (VIN) - PURPLE

    L'BEL

    EFFET
    PARFAIT
    HYDRATESS

    long-lasting
    intense
    moisturizing
    lipstick SPF 20

    Net Weight 0.14 oz (4g)

    Principal Display Panel - 4 g Tube Box - (VIN) - PURPLE
  • PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (TEA ROSE) - PINK

    L'BEL

    EFFET
    PARFAIT
    HYDRATESS

    long-lasting
    intense
    moisturizing
    lipstick SPF 20

    Net Weight 0.14 oz (4g)

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

    L'BEL

    EFFET
    PARFAIT
    HYDRATESS

    long-lasting
    intense
    moisturizing
    lipstick SPF 20

    Net Weight 0.14 oz (4g)

    Principal Display Panel - 4 g Tube Box - (FRENESIE) - PINK
  • PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (RICHE PINK) - PINK

    L'BEL

    EFFET
    PARFAIT
    HYDRATESS

    long-lasting
    intense
    moisturizing
    lipstick SPF 20

    Net Weight 0.14 oz (4g)

    Principal Display Panel - 4 g Tube Box - (RICHE PINK) - PINK
  • PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (RED EXTASSY) - RED

    L'BEL

    EFFET
    PARFAIT
    HYDRATESS

    long-lasting
    intense
    moisturizing
    lipstick SPF 20

    Net Weight 0.14 oz (4g)

    Principal Display Panel - 4 g Tube Box - (RED EXTASSY) - RED
  • PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (FUCSIA) - PINK

    L'BEL

    EFFET
    PARFAIT
    HYDRATESS

    long-lasting
    intense
    moisturizing
    lipstick SPF 20

    Net Weight 0.14 oz (4g)

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

    L'BEL

    EFFET
    PARFAIT
    HYDRATESS

    long-lasting
    intense
    moisturizing
    lipstick SPF 20

    Net Weight 0.14 oz (4g)

    Principal Display Panel - 4 g Tube Box - (SOLEIL) - BROWN
  • PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (TERRE) - BROWN

    L'BEL

    EFFET
    PARFAIT
    HYDRATESS

    long-lasting
    intense
    moisturizing
    lipstick SPF 20

    Net Weight 0.14 oz (4g)

    Principal Display Panel - 4 g Tube Box - (TERRE) - BROWN
  • PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (CHERRY BLOSSOM) - PINK

    L'BEL

    EFFET
    PARFAIT
    HYDRATESS

    long-lasting
    intense
    moisturizing
    lipstick SPF 20

    Net Weight 0.14 oz (4g)

    Principal Display Panel - 4 g Tube Box - (CHERRY BLOSSOM) - PINK
  • PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (VIN AMANT) - PURPLE

    L'BEL

    EFFET
    PARFAIT
    HYDRATESS

    long-lasting
    intense
    moisturizing
    lipstick SPF 20

    Net Weight 0.14 oz (4g)

    Principal Display Panel - 4 g Tube Box - (VIN AMANT) - PURPLE
  • PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (NUDE INTIME) - PURPLE

    L'BEL

    EFFET
    PARFAIT
    HYDRATESS

    long-lasting
    intense
    moisturizing
    lipstick SPF 20

    Net Weight 0.14 oz (4g)

    Principal Display Panel - 4 g Tube Box - (NUDE INTIME) - PURPLE
  • INGREDIENTS AND APPEARANCE
    LBEL EFFET PARFAIT HYDRATESS LONG-LASTING INTENSE MOISTURIZING SPF 20   (MOKA) - BROWN
    octinoxate and oxybenzone lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-085
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.071 g  in 1 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.16 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    MICA (UNII: V8A1AW0880)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    TRIDECYL STEARATE (UNII: A8OE252M6L)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    CERESIN (UNII: Q1LS2UJO3A)  
    POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
    NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    PALM OIL (UNII: 5QUO05548Z)  
    LEVANT COTTONSEED OIL (UNII: N5CFT140R8)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    LINSEED OIL (UNII: 84XB4DV00W)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    CERAMIDE NP (UNII: 4370DF050B)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    BENZYL BENZOATE (UNII: N863NB338G)  
    .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
    .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    EUGENOL (UNII: 3T8H1794QW)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    TALC (UNII: 7SEV7J4R1U)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-085-021 in 1 BOX11/04/2016
    1NDC:13537-085-014 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35211/04/2016
    LBEL EFFET PARFAIT HYDRATESS LONG-LASTING INTENSE MOISTURIZING SPF 20   (ROMANCE) - PINK
    octinoxate and oxybenzone lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-086
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.071 g  in 1 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.16 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    MICA (UNII: V8A1AW0880)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    TRIDECYL STEARATE (UNII: A8OE252M6L)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    CERESIN (UNII: Q1LS2UJO3A)  
    POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
    NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    PALM OIL (UNII: 5QUO05548Z)  
    LEVANT COTTONSEED OIL (UNII: N5CFT140R8)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    LINSEED OIL (UNII: 84XB4DV00W)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    CERAMIDE NP (UNII: 4370DF050B)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    BENZYL BENZOATE (UNII: N863NB338G)  
    .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
    .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    EUGENOL (UNII: 3T8H1794QW)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    TALC (UNII: 7SEV7J4R1U)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-086-021 in 1 BOX11/04/2016
    1NDC:13537-086-014 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35211/04/2016
    LBEL EFFET PARFAIT HYDRATESS LONG-LASTING INTENSE MOISTURIZING SPF 20   (ROSE NATURAL) - PINK
    octinoxate and oxybenzone lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-087
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.071 g  in 1 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.16 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    MICA (UNII: V8A1AW0880)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    TRIDECYL STEARATE (UNII: A8OE252M6L)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    CERESIN (UNII: Q1LS2UJO3A)  
    POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
    NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    PALM OIL (UNII: 5QUO05548Z)  
    LEVANT COTTONSEED OIL (UNII: N5CFT140R8)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    LINSEED OIL (UNII: 84XB4DV00W)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    CERAMIDE NP (UNII: 4370DF050B)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    BENZYL BENZOATE (UNII: N863NB338G)  
    .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
    .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    EUGENOL (UNII: 3T8H1794QW)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    TALC (UNII: 7SEV7J4R1U)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-087-021 in 1 BOX11/04/2016
    1NDC:13537-087-014 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35211/04/2016
    LBEL EFFET PARFAIT HYDRATESS LONG-LASTING INTENSE MOISTURIZING SPF 20   (ROJO CLASIQUE) - PINK
    octinoxate and oxybenzone lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-090
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.071 g  in 1 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.16 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    MICA (UNII: V8A1AW0880)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    TRIDECYL STEARATE (UNII: A8OE252M6L)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    CERESIN (UNII: Q1LS2UJO3A)  
    POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
    NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    PALM OIL (UNII: 5QUO05548Z)  
    LEVANT COTTONSEED OIL (UNII: N5CFT140R8)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    LINSEED OIL (UNII: 84XB4DV00W)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    CERAMIDE NP (UNII: 4370DF050B)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    BENZYL BENZOATE (UNII: N863NB338G)  
    .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
    .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    EUGENOL (UNII: 3T8H1794QW)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    TALC (UNII: 7SEV7J4R1U)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-090-021 in 1 BOX11/04/2016
    1NDC:13537-090-014 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35211/04/2016
    LBEL EFFET PARFAIT HYDRATESS LONG-LASTING INTENSE MOISTURIZING SPF 20   (ROUGE INTENSE) - RED
    octinoxate and oxybenzone lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-091
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.071 g  in 1 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.16 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    MICA (UNII: V8A1AW0880)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    TRIDECYL STEARATE (UNII: A8OE252M6L)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    CERESIN (UNII: Q1LS2UJO3A)  
    POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
    NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    PALM OIL (UNII: 5QUO05548Z)  
    LEVANT COTTONSEED OIL (UNII: N5CFT140R8)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    LINSEED OIL (UNII: 84XB4DV00W)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    CERAMIDE NP (UNII: 4370DF050B)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    BENZYL BENZOATE (UNII: N863NB338G)  
    .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
    .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    EUGENOL (UNII: 3T8H1794QW)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    TALC (UNII: 7SEV7J4R1U)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-091-021 in 1 BOX11/04/2016
    1NDC:13537-091-014 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35211/04/2016
    LBEL EFFET PARFAIT HYDRATESS LONG-LASTING INTENSE MOISTURIZING SPF 20   (AMOUR) - RED
    octinoxate and oxybenzone lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-092
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.071 g  in 1 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.16 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    MICA (UNII: V8A1AW0880)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    TRIDECYL STEARATE (UNII: A8OE252M6L)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    CERESIN (UNII: Q1LS2UJO3A)  
    POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
    NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    PALM OIL (UNII: 5QUO05548Z)  
    LEVANT COTTONSEED OIL (UNII: N5CFT140R8)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    LINSEED OIL (UNII: 84XB4DV00W)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    CERAMIDE NP (UNII: 4370DF050B)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    BENZYL BENZOATE (UNII: N863NB338G)  
    .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
    .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    EUGENOL (UNII: 3T8H1794QW)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    TALC (UNII: 7SEV7J4R1U)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-092-121 in 1 BOX11/04/2016
    1NDC:13537-092-014 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35211/04/2016
    LBEL EFFET PARFAIT HYDRATESS LONG-LASTING INTENSE MOISTURIZING SPF 20   (CHOCOLAT) - BROWN
    octinoxate and oxybenzone lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-093
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.071 g  in 1 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.16 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    MICA (UNII: V8A1AW0880)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    TRIDECYL STEARATE (UNII: A8OE252M6L)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    CERESIN (UNII: Q1LS2UJO3A)  
    POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
    NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    PALM OIL (UNII: 5QUO05548Z)  
    LEVANT COTTONSEED OIL (UNII: N5CFT140R8)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    LINSEED OIL (UNII: 84XB4DV00W)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    CERAMIDE NP (UNII: 4370DF050B)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    BENZYL BENZOATE (UNII: N863NB338G)  
    .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
    .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    EUGENOL (UNII: 3T8H1794QW)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    TALC (UNII: 7SEV7J4R1U)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-093-021 in 1 BOX11/04/2016
    1NDC:13537-093-014 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35211/04/2016
    LBEL EFFET PARFAIT HYDRATESS LONG-LASTING INTENSE MOISTURIZING SPF 20   (ALMOND) - BROWN
    octinoxate and oxybenzone lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-094
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.071 g  in 1 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.16 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    MICA (UNII: V8A1AW0880)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    TRIDECYL STEARATE (UNII: A8OE252M6L)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    CERESIN (UNII: Q1LS2UJO3A)  
    POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
    NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    PALM OIL (UNII: 5QUO05548Z)  
    LEVANT COTTONSEED OIL (UNII: N5CFT140R8)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    LINSEED OIL (UNII: 84XB4DV00W)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    CERAMIDE NP (UNII: 4370DF050B)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    BENZYL BENZOATE (UNII: N863NB338G)  
    .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
    .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    EUGENOL (UNII: 3T8H1794QW)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    TALC (UNII: 7SEV7J4R1U)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-094-021 in 1 BOX11/04/2016
    1NDC:13537-094-014 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35211/04/2016
    LBEL EFFET PARFAIT HYDRATESS LONG-LASTING INTENSE MOISTURIZING SPF 20   (MALVE) - BROWN
    octinoxate and oxybenzone lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-095
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.071 g  in 1 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.16 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    MICA (UNII: V8A1AW0880)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    TRIDECYL STEARATE (UNII: A8OE252M6L)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    CERESIN (UNII: Q1LS2UJO3A)  
    POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
    NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    PALM OIL (UNII: 5QUO05548Z)  
    LEVANT COTTONSEED OIL (UNII: N5CFT140R8)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    LINSEED OIL (UNII: 84XB4DV00W)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    CERAMIDE NP (UNII: 4370DF050B)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    BENZYL BENZOATE (UNII: N863NB338G)  
    .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
    .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    EUGENOL (UNII: 3T8H1794QW)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    TALC (UNII: 7SEV7J4R1U)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-095-021 in 1 BOX11/04/2016
    1NDC:13537-095-014 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35211/04/2016
    LBEL EFFET PARFAIT HYDRATESS LONG-LASTING INTENSE MOISTURIZING SPF 20   (MARRON GLACE) - BROWN
    octinoxate and oxybenzone lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-096
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.071 g  in 1 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.16 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    MICA (UNII: V8A1AW0880)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    TRIDECYL STEARATE (UNII: A8OE252M6L)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    CERESIN (UNII: Q1LS2UJO3A)  
    POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
    NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    PALM OIL (UNII: 5QUO05548Z)  
    LEVANT COTTONSEED OIL (UNII: N5CFT140R8)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    LINSEED OIL (UNII: 84XB4DV00W)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    CERAMIDE NP (UNII: 4370DF050B)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    BENZYL BENZOATE (UNII: N863NB338G)  
    .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
    .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    EUGENOL (UNII: 3T8H1794QW)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    TALC (UNII: 7SEV7J4R1U)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-096-201 in 1 BOX11/04/2016
    1NDC:13537-096-014 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35211/04/2016
    LBEL EFFET PARFAIT HYDRATESS LONG-LASTING INTENSE MOISTURIZING SPF 20   (TULIP) - PINK
    octinoxate and oxybenzone lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-097
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.071 g  in 1 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.16 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    MICA (UNII: V8A1AW0880)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    TRIDECYL STEARATE (UNII: A8OE252M6L)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    CERESIN (UNII: Q1LS2UJO3A)  
    POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
    NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    PALM OIL (UNII: 5QUO05548Z)  
    LEVANT COTTONSEED OIL (UNII: N5CFT140R8)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    LINSEED OIL (UNII: 84XB4DV00W)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    CERAMIDE NP (UNII: 4370DF050B)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    BENZYL BENZOATE (UNII: N863NB338G)  
    .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
    .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    EUGENOL (UNII: 3T8H1794QW)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    TALC (UNII: 7SEV7J4R1U)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-097-021 in 1 BOX11/04/2016
    1NDC:13537-097-014 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35211/04/2016
    LBEL EFFET PARFAIT HYDRATESS LONG-LASTING INTENSE MOISTURIZING SPF 20   (NUDE) - PINK
    octinoxate and oxybenzone lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-098
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.071 g  in 1 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.16 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    MICA (UNII: V8A1AW0880)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    TRIDECYL STEARATE (UNII: A8OE252M6L)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    CERESIN (UNII: Q1LS2UJO3A)  
    POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
    NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    PALM OIL (UNII: 5QUO05548Z)  
    LEVANT COTTONSEED OIL (UNII: N5CFT140R8)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    LINSEED OIL (UNII: 84XB4DV00W)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    CERAMIDE NP (UNII: 4370DF050B)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    BENZYL BENZOATE (UNII: N863NB338G)  
    .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
    .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    EUGENOL (UNII: 3T8H1794QW)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    TALC (UNII: 7SEV7J4R1U)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-098-021 in 1 BOX11/04/2016
    1NDC:13537-098-014 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35211/04/2016
    LBEL EFFET PARFAIT HYDRATESS LONG-LASTING INTENSE MOISTURIZING SPF 20   (LILY BEIGE) - BEIGE
    octinoxate and oxybenzone lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-099
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.071 g  in 1 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.16 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    MICA (UNII: V8A1AW0880)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    TRIDECYL STEARATE (UNII: A8OE252M6L)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    CERESIN (UNII: Q1LS2UJO3A)  
    POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
    NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    PALM OIL (UNII: 5QUO05548Z)  
    LEVANT COTTONSEED OIL (UNII: N5CFT140R8)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    LINSEED OIL (UNII: 84XB4DV00W)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    CERAMIDE NP (UNII: 4370DF050B)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    BENZYL BENZOATE (UNII: N863NB338G)  
    .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
    .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    EUGENOL (UNII: 3T8H1794QW)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    TALC (UNII: 7SEV7J4R1U)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-099-021 in 1 BOX11/04/2016
    1NDC:13537-099-014 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35211/04/2016
    LBEL EFFET PARFAIT HYDRATESS LONG-LASTING INTENSE MOISTURIZING SPF 20   (MANDARINE) - ORANGE
    octinoxate and oxybenzone lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-178
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.071 g  in 1 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.16 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    MICA (UNII: V8A1AW0880)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    TRIDECYL STEARATE (UNII: A8OE252M6L)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    CERESIN (UNII: Q1LS2UJO3A)  
    POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
    NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    PALM OIL (UNII: 5QUO05548Z)  
    LEVANT COTTONSEED OIL (UNII: N5CFT140R8)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    LINSEED OIL (UNII: 84XB4DV00W)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    CERAMIDE NP (UNII: 4370DF050B)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    BENZYL BENZOATE (UNII: N863NB338G)  
    .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
    .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    EUGENOL (UNII: 3T8H1794QW)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    TALC (UNII: 7SEV7J4R1U)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-178-021 in 1 BOX11/04/2016
    1NDC:13537-178-014 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35211/04/2016
    LBEL EFFET PARFAIT HYDRATESS LONG-LASTING INTENSE MOISTURIZING SPF 20   (VIN) - PURPLE
    octinoxate and oxybenzone lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-179
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.071 g  in 1 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.16 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    MICA (UNII: V8A1AW0880)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    TRIDECYL STEARATE (UNII: A8OE252M6L)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    CERESIN (UNII: Q1LS2UJO3A)  
    POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
    NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    PALM OIL (UNII: 5QUO05548Z)  
    LEVANT COTTONSEED OIL (UNII: N5CFT140R8)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    LINSEED OIL (UNII: 84XB4DV00W)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    CERAMIDE NP (UNII: 4370DF050B)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    BENZYL BENZOATE (UNII: N863NB338G)  
    .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
    .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    EUGENOL (UNII: 3T8H1794QW)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    TALC (UNII: 7SEV7J4R1U)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-179-021 in 1 BOX11/04/2016
    1NDC:13537-179-014 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35211/04/2016
    LBEL EFFET PARFAIT HYDRATESS LONG-LASTING INTENSE MOISTURIZING SPF 20   (TEA ROSE) - PINK
    octinoxate and oxybenzone lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-357
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.071 g  in 1 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.16 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    MICA (UNII: V8A1AW0880)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    TRIDECYL STEARATE (UNII: A8OE252M6L)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    CERESIN (UNII: Q1LS2UJO3A)  
    POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
    NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    PALM OIL (UNII: 5QUO05548Z)  
    LEVANT COTTONSEED OIL (UNII: N5CFT140R8)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    LINSEED OIL (UNII: 84XB4DV00W)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    CERAMIDE NP (UNII: 4370DF050B)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    BENZYL BENZOATE (UNII: N863NB338G)  
    .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
    .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    EUGENOL (UNII: 3T8H1794QW)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    TALC (UNII: 7SEV7J4R1U)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-357-021 in 1 BOX11/04/2016
    1NDC:13537-357-014 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35211/04/2016
    LBEL EFFET PARFAIT HYDRATESS LONG-LASTING INTENSE MOISTURIZING SPF 20   (FRENESIE) - PINK
    octinoxate and oxybenzone lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-358
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.071 g  in 1 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.16 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    MICA (UNII: V8A1AW0880)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    TRIDECYL STEARATE (UNII: A8OE252M6L)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    CERESIN (UNII: Q1LS2UJO3A)  
    POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
    NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    PALM OIL (UNII: 5QUO05548Z)  
    LEVANT COTTONSEED OIL (UNII: N5CFT140R8)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    LINSEED OIL (UNII: 84XB4DV00W)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    CERAMIDE NP (UNII: 4370DF050B)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    BENZYL BENZOATE (UNII: N863NB338G)  
    .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
    .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    EUGENOL (UNII: 3T8H1794QW)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    TALC (UNII: 7SEV7J4R1U)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-358-021 in 1 BOX11/04/2016
    1NDC:13537-358-014 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35211/04/2016
    LBEL EFFET PARFAIT HYDRATESS LONG-LASTING INTENSE MOISTURIZING SPF 20   (RICHE PINK) - PINK
    octinoxate and oxybenzone lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-375
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.071 g  in 1 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.16 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    MICA (UNII: V8A1AW0880)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    TRIDECYL STEARATE (UNII: A8OE252M6L)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    CERESIN (UNII: Q1LS2UJO3A)  
    POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
    NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    PALM OIL (UNII: 5QUO05548Z)  
    LEVANT COTTONSEED OIL (UNII: N5CFT140R8)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    LINSEED OIL (UNII: 84XB4DV00W)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    CERAMIDE NP (UNII: 4370DF050B)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    BENZYL BENZOATE (UNII: N863NB338G)  
    .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
    .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    EUGENOL (UNII: 3T8H1794QW)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    TALC (UNII: 7SEV7J4R1U)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-375-021 in 1 BOX11/04/2016
    1NDC:13537-375-014 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35211/04/2016
    LBEL EFFET PARFAIT HYDRATESS LONG-LASTING INTENSE MOISTURIZING SPF 20   (RED EXTASSY) - RED
    octinoxate and oxybenzone lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-376
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.071 g  in 1 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.16 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    MICA (UNII: V8A1AW0880)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    TRIDECYL STEARATE (UNII: A8OE252M6L)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    CERESIN (UNII: Q1LS2UJO3A)  
    POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
    NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    PALM OIL (UNII: 5QUO05548Z)  
    LEVANT COTTONSEED OIL (UNII: N5CFT140R8)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    LINSEED OIL (UNII: 84XB4DV00W)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    CERAMIDE NP (UNII: 4370DF050B)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    BENZYL BENZOATE (UNII: N863NB338G)  
    .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
    .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    EUGENOL (UNII: 3T8H1794QW)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    TALC (UNII: 7SEV7J4R1U)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-376-021 in 1 BOX11/04/2016
    1NDC:13537-376-014 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35211/04/2016
    LBEL EFFET PARFAIT HYDRATESS LONG-LASTING INTENSE MOISTURIZING SPF 20   (FUCSIA) - PINK
    octinoxate and oxybenzone lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-377
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.071 g  in 1 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.16 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    MICA (UNII: V8A1AW0880)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    TRIDECYL STEARATE (UNII: A8OE252M6L)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    CERESIN (UNII: Q1LS2UJO3A)  
    POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
    NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    PALM OIL (UNII: 5QUO05548Z)  
    LEVANT COTTONSEED OIL (UNII: N5CFT140R8)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    LINSEED OIL (UNII: 84XB4DV00W)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    CERAMIDE NP (UNII: 4370DF050B)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    BENZYL BENZOATE (UNII: N863NB338G)  
    .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
    .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    EUGENOL (UNII: 3T8H1794QW)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    TALC (UNII: 7SEV7J4R1U)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-377-021 in 1 BOX11/04/2016
    1NDC:13537-377-014 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35211/04/2016
    LBEL EFFET PARFAIT HYDRATESS LONG-LASTING INTENSE MOISTURIZING SPF 20   (SOLEIL) - BROWN
    octinoxate and oxybenzone lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-378
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.071 g  in 1 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.16 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    MICA (UNII: V8A1AW0880)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    TRIDECYL STEARATE (UNII: A8OE252M6L)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    CERESIN (UNII: Q1LS2UJO3A)  
    POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
    NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    PALM OIL (UNII: 5QUO05548Z)  
    LEVANT COTTONSEED OIL (UNII: N5CFT140R8)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    LINSEED OIL (UNII: 84XB4DV00W)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    CERAMIDE NP (UNII: 4370DF050B)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    BENZYL BENZOATE (UNII: N863NB338G)  
    .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
    .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    EUGENOL (UNII: 3T8H1794QW)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    TALC (UNII: 7SEV7J4R1U)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-378-021 in 1 BOX11/04/2016
    1NDC:13537-378-014 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35211/04/2016
    LBEL EFFET PARFAIT HYDRATESS LONG-LASTING INTENSE MOISTURIZING SPF 20   (TERRE) - BROWN
    octinoxate and oxybenzone lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-380
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.071 g  in 1 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.16 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    MICA (UNII: V8A1AW0880)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    TRIDECYL STEARATE (UNII: A8OE252M6L)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    CERESIN (UNII: Q1LS2UJO3A)  
    POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
    NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    PALM OIL (UNII: 5QUO05548Z)  
    LEVANT COTTONSEED OIL (UNII: N5CFT140R8)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    LINSEED OIL (UNII: 84XB4DV00W)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    CERAMIDE NP (UNII: 4370DF050B)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    BENZYL BENZOATE (UNII: N863NB338G)  
    .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
    .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    EUGENOL (UNII: 3T8H1794QW)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    TALC (UNII: 7SEV7J4R1U)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-380-021 in 1 BOX11/04/2016
    1NDC:13537-380-014 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35211/04/2016
    LBEL EFFET PARFAIT HYDRATESS LONG-LASTING INTENSE MOISTURIZING SPF 20   (CHERRY BLOSSOM) - PINK
    octinoxate and oxybenzone lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-381
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.071 g  in 1 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.16 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    MICA (UNII: V8A1AW0880)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    TRIDECYL STEARATE (UNII: A8OE252M6L)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    CERESIN (UNII: Q1LS2UJO3A)  
    POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
    NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    PALM OIL (UNII: 5QUO05548Z)  
    LEVANT COTTONSEED OIL (UNII: N5CFT140R8)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    LINSEED OIL (UNII: 84XB4DV00W)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    CERAMIDE NP (UNII: 4370DF050B)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    BENZYL BENZOATE (UNII: N863NB338G)  
    .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
    .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    EUGENOL (UNII: 3T8H1794QW)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    TALC (UNII: 7SEV7J4R1U)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-381-021 in 1 BOX11/04/2016
    1NDC:13537-381-014 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35211/04/2016
    LBEL EFFET PARFAIT HYDRATESS LONG-LASTING INTENSE MOISTURIZING SPF 20   (VIN AMANT) - PURPLE
    octinoxate and oxybenzone lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-382
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.071 g  in 1 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.16 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    MICA (UNII: V8A1AW0880)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    TRIDECYL STEARATE (UNII: A8OE252M6L)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    CERESIN (UNII: Q1LS2UJO3A)  
    POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
    NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    PALM OIL (UNII: 5QUO05548Z)  
    LEVANT COTTONSEED OIL (UNII: N5CFT140R8)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    LINSEED OIL (UNII: 84XB4DV00W)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    CERAMIDE NP (UNII: 4370DF050B)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    BENZYL BENZOATE (UNII: N863NB338G)  
    .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
    .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    EUGENOL (UNII: 3T8H1794QW)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    TALC (UNII: 7SEV7J4R1U)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-382-021 in 1 BOX11/04/2016
    1NDC:13537-382-014 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35211/04/2016
    LBEL EFFET PARFAIT HYDRATESS LONG-LASTING INTENSE MOISTURIZING SPF 20   (NUDE INTIME) - PURPLE
    octinoxate and oxybenzone lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-424
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.071 g  in 1 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.16 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    MICA (UNII: V8A1AW0880)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    TRIDECYL STEARATE (UNII: A8OE252M6L)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    CERESIN (UNII: Q1LS2UJO3A)  
    POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
    NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    PALM OIL (UNII: 5QUO05548Z)  
    LEVANT COTTONSEED OIL (UNII: N5CFT140R8)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    LINSEED OIL (UNII: 84XB4DV00W)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    CERAMIDE NP (UNII: 4370DF050B)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    BENZYL BENZOATE (UNII: N863NB338G)  
    .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
    .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    EUGENOL (UNII: 3T8H1794QW)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    TALC (UNII: 7SEV7J4R1U)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-424-021 in 1 BOX11/04/2016
    1NDC:13537-424-014 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35211/04/2016
    Labeler - Ventura Corporation LTD (602751344)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bel Star S.A. (Colombia)880160197MANUFACTURE(13537-085, 13537-086, 13537-087, 13537-090, 13537-091, 13537-092, 13537-093, 13537-094, 13537-095, 13537-096, 13537-097, 13537-098, 13537-099, 13537-178, 13537-179, 13537-357, 13537-358, 13537-375, 13537-376, 13537-377, 13537-378, 13537-380, 13537-381, 13537-382, 13537-424)