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 more13537-087-01, 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.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- Uses
- Warnings
- Directions
- Other information
-
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
- PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (MOKA) - BROWN
- PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (ROMANCE) - PINK
- PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (ROSE NATURAL) - PINK
- PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (ROJO CLASIQUE) - PINK
- PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (ROUGE INTENSE) - RED
- PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (AMOUR) - RED
- PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (CHOCOLAT) - BROWN
- PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (ALMOND) - BROWN
- PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (MALVE) - BROWN
- PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (MARRON GLACE) - BROWN
- PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (TULIP) - PINK
- PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (NUDE) - PINK
- PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (LILY BEIGE) - BEIGE
- PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (MANDARINE) - ORANGE
- PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (VIN) - PURPLE
- PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (TEA ROSE) - PINK
- PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (FRENESIE) - PINK
- PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (RICHE PINK) - PINK
- PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (RED EXTASSY) - RED
- PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (FUCSIA) - PINK
- PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (SOLEIL) - BROWN
- PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (TERRE) - BROWN
- PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (CHERRY BLOSSOM) - PINK
- PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (VIN AMANT) - PURPLE
- PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (NUDE INTIME) - PURPLE
-
INGREDIENTS AND APPEARANCE
LBEL EFFET PARFAIT HYDRATESS LONG-LASTING INTENSE MOISTURIZING SPF 20 Â (MOKA) - BROWN
octinoxate and oxybenzone lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-085 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.071 g  in 1 g OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 0.16 g  in 1 g Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-085-02 1 in 1 BOX 11/04/2016 1 NDC:13537-085-01 4 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 11/04/2016 LBEL EFFET PARFAIT HYDRATESS LONG-LASTING INTENSE MOISTURIZING SPF 20  (ROMANCE) - PINK
octinoxate and oxybenzone lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-086 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.071 g  in 1 g OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 0.16 g  in 1 g Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-086-02 1 in 1 BOX 11/04/2016 1 NDC:13537-086-01 4 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 11/04/2016 LBEL EFFET PARFAIT HYDRATESS LONG-LASTING INTENSE MOISTURIZING SPF 20  (ROSE NATURAL) - PINK
octinoxate and oxybenzone lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-087 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.071 g  in 1 g OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 0.16 g  in 1 g Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-087-02 1 in 1 BOX 11/04/2016 1 NDC:13537-087-01 4 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 11/04/2016 LBEL EFFET PARFAIT HYDRATESS LONG-LASTING INTENSE MOISTURIZING SPF 20  (ROJO CLASIQUE) - PINK
octinoxate and oxybenzone lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-090 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.071 g  in 1 g OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 0.16 g  in 1 g Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-090-02 1 in 1 BOX 11/04/2016 1 NDC:13537-090-01 4 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 11/04/2016 LBEL EFFET PARFAIT HYDRATESS LONG-LASTING INTENSE MOISTURIZING SPF 20  (ROUGE INTENSE) - RED
octinoxate and oxybenzone lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-091 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.071 g  in 1 g OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 0.16 g  in 1 g Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-091-02 1 in 1 BOX 11/04/2016 1 NDC:13537-091-01 4 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 11/04/2016 LBEL EFFET PARFAIT HYDRATESS LONG-LASTING INTENSE MOISTURIZING SPF 20  (AMOUR) - RED
octinoxate and oxybenzone lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-092 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.071 g  in 1 g OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 0.16 g  in 1 g Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-092-12 1 in 1 BOX 11/04/2016 1 NDC:13537-092-01 4 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 11/04/2016 LBEL EFFET PARFAIT HYDRATESS LONG-LASTING INTENSE MOISTURIZING SPF 20  (CHOCOLAT) - BROWN
octinoxate and oxybenzone lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-093 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.071 g  in 1 g OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 0.16 g  in 1 g Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-093-02 1 in 1 BOX 11/04/2016 1 NDC:13537-093-01 4 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 11/04/2016 LBEL EFFET PARFAIT HYDRATESS LONG-LASTING INTENSE MOISTURIZING SPF 20  (ALMOND) - BROWN
octinoxate and oxybenzone lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-094 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.071 g  in 1 g OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 0.16 g  in 1 g Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-094-02 1 in 1 BOX 11/04/2016 1 NDC:13537-094-01 4 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 11/04/2016 LBEL EFFET PARFAIT HYDRATESS LONG-LASTING INTENSE MOISTURIZING SPF 20  (MALVE) - BROWN
octinoxate and oxybenzone lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-095 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.071 g  in 1 g OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 0.16 g  in 1 g Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-095-02 1 in 1 BOX 11/04/2016 1 NDC:13537-095-01 4 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 11/04/2016 LBEL EFFET PARFAIT HYDRATESS LONG-LASTING INTENSE MOISTURIZING SPF 20  (MARRON GLACE) - BROWN
octinoxate and oxybenzone lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-096 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.071 g  in 1 g OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 0.16 g  in 1 g Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-096-20 1 in 1 BOX 11/04/2016 1 NDC:13537-096-01 4 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 11/04/2016 LBEL EFFET PARFAIT HYDRATESS LONG-LASTING INTENSE MOISTURIZING SPF 20  (TULIP) - PINK
octinoxate and oxybenzone lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-097 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.071 g  in 1 g OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 0.16 g  in 1 g Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-097-02 1 in 1 BOX 11/04/2016 1 NDC:13537-097-01 4 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 11/04/2016 LBEL EFFET PARFAIT HYDRATESS LONG-LASTING INTENSE MOISTURIZING SPF 20  (NUDE) - PINK
octinoxate and oxybenzone lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-098 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.071 g  in 1 g OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 0.16 g  in 1 g Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-098-02 1 in 1 BOX 11/04/2016 1 NDC:13537-098-01 4 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 11/04/2016 LBEL EFFET PARFAIT HYDRATESS LONG-LASTING INTENSE MOISTURIZING SPF 20  (LILY BEIGE) - BEIGE
octinoxate and oxybenzone lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-099 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.071 g  in 1 g OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 0.16 g  in 1 g Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-099-02 1 in 1 BOX 11/04/2016 1 NDC:13537-099-01 4 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 11/04/2016 LBEL EFFET PARFAIT HYDRATESS LONG-LASTING INTENSE MOISTURIZING SPF 20  (MANDARINE) - ORANGE
octinoxate and oxybenzone lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-178 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.071 g  in 1 g OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 0.16 g  in 1 g Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-178-02 1 in 1 BOX 11/04/2016 1 NDC:13537-178-01 4 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 11/04/2016 LBEL EFFET PARFAIT HYDRATESS LONG-LASTING INTENSE MOISTURIZING SPF 20  (VIN) - PURPLE
octinoxate and oxybenzone lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-179 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.071 g  in 1 g OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 0.16 g  in 1 g Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-179-02 1 in 1 BOX 11/04/2016 1 NDC:13537-179-01 4 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 11/04/2016 LBEL EFFET PARFAIT HYDRATESS LONG-LASTING INTENSE MOISTURIZING SPF 20  (TEA ROSE) - PINK
octinoxate and oxybenzone lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-357 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.071 g  in 1 g OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 0.16 g  in 1 g Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-357-02 1 in 1 BOX 11/04/2016 1 NDC:13537-357-01 4 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 11/04/2016 LBEL EFFET PARFAIT HYDRATESS LONG-LASTING INTENSE MOISTURIZING SPF 20  (FRENESIE) - PINK
octinoxate and oxybenzone lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-358 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.071 g  in 1 g OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 0.16 g  in 1 g Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-358-02 1 in 1 BOX 11/04/2016 1 NDC:13537-358-01 4 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 11/04/2016 LBEL EFFET PARFAIT HYDRATESS LONG-LASTING INTENSE MOISTURIZING SPF 20  (RICHE PINK) - PINK
octinoxate and oxybenzone lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-375 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.071 g  in 1 g OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 0.16 g  in 1 g Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-375-02 1 in 1 BOX 11/04/2016 1 NDC:13537-375-01 4 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 11/04/2016 LBEL EFFET PARFAIT HYDRATESS LONG-LASTING INTENSE MOISTURIZING SPF 20  (RED EXTASSY) - RED
octinoxate and oxybenzone lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-376 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.071 g  in 1 g OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 0.16 g  in 1 g Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-376-02 1 in 1 BOX 11/04/2016 1 NDC:13537-376-01 4 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 11/04/2016 LBEL EFFET PARFAIT HYDRATESS LONG-LASTING INTENSE MOISTURIZING SPF 20  (FUCSIA) - PINK
octinoxate and oxybenzone lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-377 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.071 g  in 1 g OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 0.16 g  in 1 g Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-377-02 1 in 1 BOX 11/04/2016 1 NDC:13537-377-01 4 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 11/04/2016 LBEL EFFET PARFAIT HYDRATESS LONG-LASTING INTENSE MOISTURIZING SPF 20  (SOLEIL) - BROWN
octinoxate and oxybenzone lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-378 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.071 g  in 1 g OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 0.16 g  in 1 g Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-378-02 1 in 1 BOX 11/04/2016 1 NDC:13537-378-01 4 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 11/04/2016 LBEL EFFET PARFAIT HYDRATESS LONG-LASTING INTENSE MOISTURIZING SPF 20  (TERRE) - BROWN
octinoxate and oxybenzone lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-380 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.071 g  in 1 g OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 0.16 g  in 1 g Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-380-02 1 in 1 BOX 11/04/2016 1 NDC:13537-380-01 4 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 11/04/2016 LBEL EFFET PARFAIT HYDRATESS LONG-LASTING INTENSE MOISTURIZING SPF 20  (CHERRY BLOSSOM) - PINK
octinoxate and oxybenzone lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-381 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.071 g  in 1 g OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 0.16 g  in 1 g Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-381-02 1 in 1 BOX 11/04/2016 1 NDC:13537-381-01 4 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 11/04/2016 LBEL EFFET PARFAIT HYDRATESS LONG-LASTING INTENSE MOISTURIZING SPF 20  (VIN AMANT) - PURPLE
octinoxate and oxybenzone lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-382 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.071 g  in 1 g OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 0.16 g  in 1 g Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-382-02 1 in 1 BOX 11/04/2016 1 NDC:13537-382-01 4 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 11/04/2016 LBEL EFFET PARFAIT HYDRATESS LONG-LASTING INTENSE MOISTURIZING SPF 20  (NUDE INTIME) - PURPLE
octinoxate and oxybenzone lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-424 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.071 g  in 1 g OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 0.16 g  in 1 g Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-424-02 1 in 1 BOX 11/04/2016 1 NDC:13537-424-01 4 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 11/04/2016 Labeler - Ventura Corporation LTD (602751344) Establishment Name Address ID/FEI Business Operations Bel Star S.A. (Colombia) 880160197 MANUFACTURE(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)