Label: EFFET PARFAIT HYDRATESS LONG-LASTING INTENSE MOISTURIZING SPF 20 (MOKA) - PINK- octinoxate and oxybenzone lipstick
EFFET PARFAIT HYDRATESS LONG-LASTING INTENSE MOISTURIZING SPF 20 (ROMANCE) - PINK- octinoxate and oxybenzone lipstick
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) - RED- octinoxate and oxybenzone lipstick
EFFET PARFAIT HYDRATESS LONG-LASTING INTENSE MOISTURIZING SPF 20 (VIN AMANT) - PURPLE- octinoxate and oxybenzone lipstick
EFFET PARFAIT HYDRATESS LONG-LASTING INTENSE MOISTURIZING SPF 20 (NUDE INTIME) - PINK- octinoxate and oxybenzone lipstick

  • Contains inactivated NDC Code(s)
    NDC Code(s):     14783-891-01, 14783-891-02, 14783-892-03, 14783-892-04, view more
    14783-893-05, 14783-893-06, 14783-894-07, 14783-894-08, 14783-895-09, 14783-895-10, 14783-896-11, 14783-896-12, 14783-897-13, 14783-897-14, 14783-898-15, 14783-898-16, 14783-899-17, 14783-899-18, 14783-900-19, 14783-900-20, 14783-902-23, 14783-902-24, 14783-903-25, 14783-903-26, 14783-904-27, 14783-904-28, 14783-905-29, 14783-905-30, 14783-906-31, 14783-906-32, 14783-907-33, 14783-907-34, 14783-908-35, 14783-908-36, 14783-909-37, 14783-909-38, 14783-910-39, 14783-910-40, 14783-911-41, 14783-911-42, 14783-912-43, 14783-912-44, 14783-913-45, 14783-913-46, 14783-914-47, 14783-914-48, 14783-915-49, 14783-915-50, 14783-940-21, 14783-940-22
  • Packager: Ventura International 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 October 23, 2014

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

View All Sections
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredients

    OCTINOXATE: 7.1 %

    OXYBENZONE: 1.6 %

  • Purpose

    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 damage 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.
    • Children under 6 months of age: Ask a doctor.
    • Reapply at least every 2 hours.
    • Use a water resistant sunscreen if swimming or sweating.
    • Apply lipstick following the curves of natural lip line. For added definition, use with a lip pencil.
  • Other information

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

    CAPRYLIC/CAPRIC TRIGLYCERIDE, DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE, TRIDECYL TRIMELLITATE, COPERNICIA CERIFERA (CARNAUBA) WAX, MICA, 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. 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

    US:
    Dist. by Ventura Int Ltd. DBA
    Belcorp USA, San Francisco,
    CA 94111.

  • PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (MOKA) - 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 - (MOKA) - PINK
  • 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 - (ROSE 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 - (ROSE 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) - 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 - (MALVE) - RED
  • 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 - (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 - (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 - (LILY BEIGE) - 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 - (LILY BEIGE) - PINK
  • 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) - 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 - (VIN) - BROWN
  • 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) - 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 - (RICHE PINK) - RED
  • 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) - 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 - (FUCSIA) - PURPLE
  • PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (SOLEIL) - 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 - (SOLEIL) - ORANGE
  • 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) - 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 - (CHERRY BLOSSOM) - RED
  • 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) - 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 INTIME) - PINK
  • INGREDIENTS AND APPEARANCE
    EFFET PARFAIT HYDRATESS   LONG-LASTING INTENSE MOISTURIZING SPF 20 (MOKA) - PINK
    octinoxate and oxybenzone lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14783-891
    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) OXYBENZONE0.016 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    MICA (UNII: V8A1AW0880)  
    TRIDECYL STEARATE (UNII: A8OE252M6L)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    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 3 (UNII: 4370DF050B)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    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:14783-891-021 in 1 BOX
    1NDC:14783-891-014 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35209/12/2014
    EFFET PARFAIT HYDRATESS   LONG-LASTING INTENSE MOISTURIZING SPF 20 (ROMANCE) - PINK
    octinoxate and oxybenzone lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14783-892
    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) OXYBENZONE0.016 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    MICA (UNII: V8A1AW0880)  
    TRIDECYL STEARATE (UNII: A8OE252M6L)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    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 3 (UNII: 4370DF050B)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    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:14783-892-041 in 1 BOX
    1NDC:14783-892-034 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35209/12/2014
    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:14783-893
    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) OXYBENZONE0.016 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    MICA (UNII: V8A1AW0880)  
    TRIDECYL STEARATE (UNII: A8OE252M6L)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    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 3 (UNII: 4370DF050B)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    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:14783-893-061 in 1 BOX
    1NDC:14783-893-054 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35209/12/2014
    EFFET PARFAIT HYDRATESS   LONG-LASTING INTENSE MOISTURIZING SPF 20 (ROSE CLASIQUE) - PINK
    octinoxate and oxybenzone lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14783-894
    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) OXYBENZONE0.016 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    MICA (UNII: V8A1AW0880)  
    TRIDECYL STEARATE (UNII: A8OE252M6L)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    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 3 (UNII: 4370DF050B)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    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:14783-894-081 in 1 BOX
    1NDC:14783-894-074 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35209/12/2014
    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:14783-895
    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) OXYBENZONE0.016 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    MICA (UNII: V8A1AW0880)  
    TRIDECYL STEARATE (UNII: A8OE252M6L)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    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 3 (UNII: 4370DF050B)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    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:14783-895-101 in 1 BOX
    1NDC:14783-895-094 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35209/12/2014
    EFFET PARFAIT HYDRATESS   LONG-LASTING INTENSE MOISTURIZING SPF 20 (AMOUR) - RED
    octinoxate and oxybenzone lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14783-896
    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) OXYBENZONE0.016 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    MICA (UNII: V8A1AW0880)  
    TRIDECYL STEARATE (UNII: A8OE252M6L)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    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 3 (UNII: 4370DF050B)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    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:14783-896-121 in 1 BOX
    1NDC:14783-896-114 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35209/12/2014
    EFFET PARFAIT HYDRATESS   LONG-LASTING INTENSE MOISTURIZING SPF 20 (CHOCOLAT) - BROWN
    octinoxate and oxybenzone lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14783-897
    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) OXYBENZONE0.016 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    MICA (UNII: V8A1AW0880)  
    TRIDECYL STEARATE (UNII: A8OE252M6L)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    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 3 (UNII: 4370DF050B)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    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:14783-897-141 in 1 BOX
    1NDC:14783-897-134 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35209/12/2014
    EFFET PARFAIT HYDRATESS   LONG-LASTING INTENSE MOISTURIZING SPF 20 (ALMOND) - BROWN
    octinoxate and oxybenzone lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14783-898
    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) OXYBENZONE0.016 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    MICA (UNII: V8A1AW0880)  
    TRIDECYL STEARATE (UNII: A8OE252M6L)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    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 3 (UNII: 4370DF050B)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    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:14783-898-161 in 1 BOX
    1NDC:14783-898-154 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35209/12/2014
    EFFET PARFAIT HYDRATESS   LONG-LASTING INTENSE MOISTURIZING SPF 20 (MALVE) - RED
    octinoxate and oxybenzone lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14783-899
    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) OXYBENZONE0.016 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    MICA (UNII: V8A1AW0880)  
    TRIDECYL STEARATE (UNII: A8OE252M6L)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    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 3 (UNII: 4370DF050B)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    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:14783-899-181 in 1 BOX
    1NDC:14783-899-174 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35209/12/2014
    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:14783-900
    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) OXYBENZONE0.016 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    MICA (UNII: V8A1AW0880)  
    TRIDECYL STEARATE (UNII: A8OE252M6L)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    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 3 (UNII: 4370DF050B)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    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:14783-900-201 in 1 BOX
    1NDC:14783-900-194 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35209/12/2014
    EFFET PARFAIT HYDRATESS   LONG-LASTING INTENSE MOISTURIZING SPF 20 (NUDE) - PINK
    octinoxate and oxybenzone lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14783-940
    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) OXYBENZONE0.016 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    MICA (UNII: V8A1AW0880)  
    TRIDECYL STEARATE (UNII: A8OE252M6L)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    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 3 (UNII: 4370DF050B)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    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:14783-940-221 in 1 BOX
    1NDC:14783-940-214 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35209/12/2014
    EFFET PARFAIT HYDRATESS   LONG-LASTING INTENSE MOISTURIZING SPF 20 (TULIP) - PINK
    octinoxate and oxybenzone lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14783-902
    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) OXYBENZONE0.016 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    MICA (UNII: V8A1AW0880)  
    TRIDECYL STEARATE (UNII: A8OE252M6L)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    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 3 (UNII: 4370DF050B)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    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:14783-902-241 in 1 BOX
    1NDC:14783-902-234 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35209/12/2014
    EFFET PARFAIT HYDRATESS   LONG-LASTING INTENSE MOISTURIZING SPF 20 (LILY BEIGE) - PINK
    octinoxate and oxybenzone lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14783-903
    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) OXYBENZONE0.016 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    MICA (UNII: V8A1AW0880)  
    TRIDECYL STEARATE (UNII: A8OE252M6L)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    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 3 (UNII: 4370DF050B)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    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:14783-903-261 in 1 BOX
    1NDC:14783-903-254 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35209/12/2014
    EFFET PARFAIT HYDRATESS   LONG-LASTING INTENSE MOISTURIZING SPF 20 (MANDARINE) - ORANGE
    octinoxate and oxybenzone lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14783-904
    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) OXYBENZONE0.016 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    MICA (UNII: V8A1AW0880)  
    TRIDECYL STEARATE (UNII: A8OE252M6L)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    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 3 (UNII: 4370DF050B)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    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:14783-904-281 in 1 BOX
    1NDC:14783-904-274 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35209/12/2014
    EFFET PARFAIT HYDRATESS   LONG-LASTING INTENSE MOISTURIZING SPF 20 (VIN) - BROWN
    octinoxate and oxybenzone lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14783-905
    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) OXYBENZONE0.016 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    MICA (UNII: V8A1AW0880)  
    TRIDECYL STEARATE (UNII: A8OE252M6L)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    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 3 (UNII: 4370DF050B)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    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:14783-905-301 in 1 BOX
    1NDC:14783-905-294 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35209/12/2014
    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:14783-906
    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) OXYBENZONE0.016 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    MICA (UNII: V8A1AW0880)  
    TRIDECYL STEARATE (UNII: A8OE252M6L)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    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 3 (UNII: 4370DF050B)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    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:14783-906-321 in 1 BOX
    1NDC:14783-906-314 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35209/12/2014
    EFFET PARFAIT HYDRATESS   LONG-LASTING INTENSE MOISTURIZING SPF 20 (FRENESIE) - PINK
    octinoxate and oxybenzone lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14783-907
    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) OXYBENZONE0.016 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    MICA (UNII: V8A1AW0880)  
    TRIDECYL STEARATE (UNII: A8OE252M6L)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    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 3 (UNII: 4370DF050B)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    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:14783-907-341 in 1 BOX
    1NDC:14783-907-334 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35209/12/2014
    EFFET PARFAIT HYDRATESS   LONG-LASTING INTENSE MOISTURIZING SPF 20 (RICHE PINK) - RED
    octinoxate and oxybenzone lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14783-908
    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) OXYBENZONE0.016 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    MICA (UNII: V8A1AW0880)  
    TRIDECYL STEARATE (UNII: A8OE252M6L)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    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 3 (UNII: 4370DF050B)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    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:14783-908-361 in 1 BOX
    1NDC:14783-908-354 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35209/12/2014
    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:14783-909
    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) OXYBENZONE0.016 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    MICA (UNII: V8A1AW0880)  
    TRIDECYL STEARATE (UNII: A8OE252M6L)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    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 3 (UNII: 4370DF050B)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    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:14783-909-381 in 1 BOX
    1NDC:14783-909-374 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35209/12/2014
    EFFET PARFAIT HYDRATESS   LONG-LASTING INTENSE MOISTURIZING SPF 20 (FUCSIA) - PURPLE
    octinoxate and oxybenzone lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14783-910
    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) OXYBENZONE0.016 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    MICA (UNII: V8A1AW0880)  
    TRIDECYL STEARATE (UNII: A8OE252M6L)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    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 3 (UNII: 4370DF050B)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    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:14783-910-401 in 1 BOX
    1NDC:14783-910-394 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35209/12/2014
    EFFET PARFAIT HYDRATESS   LONG-LASTING INTENSE MOISTURIZING SPF 20 (SOLEIL) - ORANGE
    octinoxate and oxybenzone lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14783-911
    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) OXYBENZONE0.016 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    MICA (UNII: V8A1AW0880)  
    TRIDECYL STEARATE (UNII: A8OE252M6L)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    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 3 (UNII: 4370DF050B)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    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:14783-911-421 in 1 BOX
    1NDC:14783-911-414 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35209/12/2014
    EFFET PARFAIT HYDRATESS   LONG-LASTING INTENSE MOISTURIZING SPF 20 (TERRE) - BROWN
    octinoxate and oxybenzone lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14783-912
    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) OXYBENZONE0.016 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    MICA (UNII: V8A1AW0880)  
    TRIDECYL STEARATE (UNII: A8OE252M6L)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    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 3 (UNII: 4370DF050B)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    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:14783-912-441 in 1 BOX
    1NDC:14783-912-434 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35209/12/2014
    EFFET PARFAIT HYDRATESS   LONG-LASTING INTENSE MOISTURIZING SPF 20 (CHERRY BLOSSOM) - RED
    octinoxate and oxybenzone lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14783-913
    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) OXYBENZONE0.016 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    MICA (UNII: V8A1AW0880)  
    TRIDECYL STEARATE (UNII: A8OE252M6L)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    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 3 (UNII: 4370DF050B)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    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:14783-913-461 in 1 BOX
    1NDC:14783-913-454 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35209/12/2014
    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:14783-914
    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) OXYBENZONE0.016 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    MICA (UNII: V8A1AW0880)  
    TRIDECYL STEARATE (UNII: A8OE252M6L)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    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 3 (UNII: 4370DF050B)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    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:14783-914-481 in 1 BOX
    1NDC:14783-914-474 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35209/12/2014
    EFFET PARFAIT HYDRATESS   LONG-LASTING INTENSE MOISTURIZING SPF 20 (NUDE INTIME) - PINK
    octinoxate and oxybenzone lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14783-915
    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) OXYBENZONE0.016 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    MICA (UNII: V8A1AW0880)  
    TRIDECYL STEARATE (UNII: A8OE252M6L)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    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 3 (UNII: 4370DF050B)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    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:14783-915-501 in 1 BOX
    1NDC:14783-915-494 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35209/12/2014
    Labeler - Ventura International LTD (603192787)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bel Star S.A. (Colombia)880160197MANUFACTURE(14783-891, 14783-892, 14783-893, 14783-894, 14783-895, 14783-896, 14783-897, 14783-898, 14783-899, 14783-900, 14783-940, 14783-902, 14783-903, 14783-904, 14783-905, 14783-906, 14783-907, 14783-908, 14783-909, 14783-910, 14783-911, 14783-912, 14783-913, 14783-914, 14783-915)
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