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LBEL HYDRATESS (Ventura International LTD.)

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LIPSTICK 1 TUBE in 1 BOX (14783-095-02) > 4 g in 1 TUBE (14783-095-01) Label Information

Complete LBEL HYDRATESS Information

  • 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, MICA, TRIDECYL STEARATE, POLYETHYLENE, COPERNICIA CERIFERA CERA (COPERNICIA CERIFERA (CARNAUBA ) WAX), OZOKERITE, POLYMETHYL METHACRYLATE, NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE, DISTEARDIMONIUM HECTORITE, PROPYLENE CARBONATE, PHENOXYETHANOL, COCOS NUCIFERA OIL (COCOS NUCIFERA (COCONUT) OIL), TOCOPHERYL ACETATE, ALOE BARBADENSIS LEAF EXTRACT, SILICA, PARFUM (FRAGRANCE), BUTYROSPERMUM PARKII  BUTTER (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:
    RED 7 LAKE, TITANIUM DIOXIDE, IRON OXIDES, MICA, YELLOW 5 LAKE, RED 30 LAKE, TALC, BLUE 1 LAKE, RED 27 LAKE, CARMINE.


  • SPL UNCLASSIFIED SECTION

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


  • PRINCIPAL DISPLAY PANEL - 4g Tube Box - MOKA

    HYDRATESS

    long-lasting intense moisturizing lipstick SPF 20

    4 g e (.14 oz.)

    L'BEL

    PRINCIPAL DISPLAY PANEL - 4g Tube Box - MOKA

  • PRINCIPAL DISPLAY PANEL - 4g Tube Box - ROMANCE

    HYDRATESS

    long-lasting intense moisturizing lipstick SPF 20

    4 g e (.14 oz.)

    L'BEL

    PRINCIPAL DISPLAY PANEL - 4g Tube Box - ROMANCE

  • PRINCIPAL DISPLAY PANEL - 4g Tube Box - ROSE NATURAL

    HYDRATESS

    long-lasting intense moisturizing lipstick SPF 20

    4 g e (.14 oz.)

    L'BEL

    PRINCIPAL DISPLAY PANEL - 4g Tube Box - ROSE NATURAL

  • PRINCIPAL DISPLAY PANEL - 4g Tube Box - ROSE CLASIQUE

    HYDRATESS

    long-lasting intense moisturizing lipstick SPF 20

    4 g e (.14 oz.)

    L'BEL

    PRINCIPAL DISPLAY PANEL - 4g Tube Box - ROSE CLASIQUE

  • PRINCIPAL DISPLAY PANEL - 4g Tube Box - ROUGE INTENSE

    HYDRATESS

    long-lasting intense moisturizing lipstick SPF 20

    4 g e (.14 oz.)

    L'BEL

    PRINCIPAL DISPLAY PANEL - 4g Tube Box - ROUGE INTENSE

  • PRINCIPAL DISPLAY PANEL - 4g Tube Box - AMOUR

    HYDRATESS

    long-lasting intense moisturizing lipstick SPF 20

    4 g e (.14 oz.)

    L'BEL

    PRINCIPAL DISPLAY PANEL - 4g Tube Box - AMOUR

  • PRINCIPAL DISPLAY PANEL - 4g Tube Box - CHOCOLAT

    HYDRATESS

    long-lasting intense moisturizing lipstick SPF 20

    4 g e (.14 oz.)

    L'BEL

    PRINCIPAL DISPLAY PANEL - 4g Tube Box - CHOCOLAT

  • PRINCIPAL DISPLAY PANEL - 4g Tube Box - ALMOND

    HYDRATESS

    long-lasting intense moisturizing lipstick SPF 20

    4 g e (.14 oz.)

    L'BEL

    PRINCIPAL DISPLAY PANEL - 4g Tube Box - ALMOND

  • PRINCIPAL DISPLAY PANEL - 4g Tube Box - MALVE

    HYDRATESS

    long-lasting intense moisturizing lipstick SPF 20

    4 g e (.14 oz.)

    L'BEL

    PRINCIPAL DISPLAY PANEL - 4g Tube Box - MALVE

  • PRINCIPAL DISPLAY PANEL - 4g Tube Box - MARRON GLACÉ

    HYDRATESS

    long-lasting intense moisturizing lipstick SPF 20

    4 g e (.14 oz.)

    L'BEL

    PRINCIPAL DISPLAY PANEL - 4g Tube Box - MARRON GLACÉ

  • PRINCIPAL DISPLAY PANEL - 4g Tube Box - TULIP

    HYDRATESS

    long-lasting intense moisturizing lipstick SPF 20

    4 g e (.14 oz.)

    L'BEL

    PRINCIPAL DISPLAY PANEL - 4g Tube Box - TULIP

  • PRINCIPAL DISPLAY PANEL - 4g Tube Box - NUDE

    HYDRATESS

    long-lasting intense moisturizing lipstick SPF 20

    4 g e (.14 oz.)

    L'BEL

    PRINCIPAL DISPLAY PANEL - 4g Tube Box - NUDE

  • PRINCIPAL DISPLAY PANEL - 4g Tube Box - LILY BEIGE

    HYDRATESS

    long-lasting intense moisturizing lipstick SPF 20

    4 g e (.14 oz.)

    L'BEL

    PRINCIPAL DISPLAY PANEL - 4g Tube Box - LILY BEIGE

  • PRINCIPAL DISPLAY PANEL - 4g Tube Box - MANDARINE

    HYDRATESS

    long-lasting intense moisturizing lipstick SPF 20

    4 g e (.14 oz.)

    L'BEL

    PRINCIPAL DISPLAY PANEL - 4g Tube Box - MANDARINE

  • PRINCIPAL DISPLAY PANEL - 4g Tube Box - VIN

    HYDRATESS

    long-lasting intense moisturizing lipstick SPF 20

    4 g e (.14 oz.)

    L'BEL

    PRINCIPAL DISPLAY PANEL - 4g Tube Box - VIN

  • INGREDIENTS AND APPEARANCE
    LBEL HYDRATESS   LONG-LASTING INTENSE MOISTURIZING SPF 20 - MOKA
    octinoxate and oxybenzone lipstick
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:14783-095
    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 0.016 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)  
    TRIDECYL STEARATE (UNII: A8OE252M6L)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    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)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    TALC (UNII: 7SEV7J4R1U)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    Product Characteristics
    Color BROWN (Pink brown) Score     
    Shape Size
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:14783-095-02 1 in 1 BOX
    1 NDC:14783-095-01 4 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH NOT FINAL part352 05/27/2013
    LBEL HYDRATESS   LONG-LASTING INTENSE MOISTURIZING SPF 20 - ROMANCE
    octinoxate and oxybenzone lipstick
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:14783-096
    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 0.016 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)  
    TRIDECYL STEARATE (UNII: A8OE252M6L)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    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)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    TALC (UNII: 7SEV7J4R1U)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    Product Characteristics
    Color PINK (Dark magenta) Score     
    Shape Size
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:14783-096-02 1 in 1 BOX
    1 NDC:14783-096-01 4 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH NOT FINAL part352 05/27/2013
    LBEL HYDRATESS   LONG-LASTING INTENSE MOISTURIZING SPF 20 - ROSE NATURAL
    octinoxate and oxybenzone lipstick
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:14783-097
    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 0.016 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)  
    TRIDECYL STEARATE (UNII: A8OE252M6L)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    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)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    TALC (UNII: 7SEV7J4R1U)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    Product Characteristics
    Color PINK (Intense yellowish pink) Score     
    Shape Size
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:14783-097-02 1 in 1 BOX
    1 NDC:14783-097-01 4 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH NOT FINAL part352 05/27/2013
    LBEL HYDRATESS   LONG-LASTING INTENSE MOISTURIZING SPF 20 - ROSE CLASIQUE
    octinoxate and oxybenzone lipstick
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:14783-098
    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 0.016 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)  
    TRIDECYL STEARATE (UNII: A8OE252M6L)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    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)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    TALC (UNII: 7SEV7J4R1U)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    Product Characteristics
    Color PINK (Intense bluish pink) Score     
    Shape Size
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:14783-098-02 1 in 1 BOX
    1 NDC:14783-098-01 4 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH NOT FINAL part352 05/27/2013
    LBEL HYDRATESS   LONG-LASTING INTENSE MOISTURIZING SPF 20 - ROUGE INTENSE
    octinoxate and oxybenzone lipstick
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:14783-099
    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 0.016 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)  
    TRIDECYL STEARATE (UNII: A8OE252M6L)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    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)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    TALC (UNII: 7SEV7J4R1U)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    Product Characteristics
    Color RED (Bluish red) Score     
    Shape Size
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:14783-099-02 1 in 1 BOX
    1 NDC:14783-099-01 4 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH NOT FINAL part352 05/27/2013
    LBEL HYDRATESS   LONG-LASTING INTENSE MOISTURIZING SPF 20 - AMOUR
    octinoxate and oxybenzone lipstick
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:14783-100
    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 0.016 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)  
    TRIDECYL STEARATE (UNII: A8OE252M6L)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    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)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    TALC (UNII: 7SEV7J4R1U)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    Product Characteristics
    Color BROWN (Red brown) Score     
    Shape Size
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:14783-100-02 1 in 1 BOX
    1 NDC:14783-100-01 4 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH NOT FINAL part352 05/27/2013
    LBEL HYDRATESS   LONG-LASTING INTENSE MOISTURIZING SPF 20 - CHOCOLAT
    octinoxate and oxybenzone lipstick
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:14783-101
    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 0.016 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)  
    TRIDECYL STEARATE (UNII: A8OE252M6L)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    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)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    TALC (UNII: 7SEV7J4R1U)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    Product Characteristics
    Color BROWN (Yellowish brown) Score     
    Shape Size
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:14783-101-02 1 in 1 BOX
    1 NDC:14783-101-01 4 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH NOT FINAL part352 05/27/2013
    LBEL HYDRATESS   LONG-LASTING INTENSE MOISTURIZING SPF 20 - ALMOND
    octinoxate and oxybenzone lipstick
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:14783-102
    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 0.016 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)  
    TRIDECYL STEARATE (UNII: A8OE252M6L)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    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)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    TALC (UNII: 7SEV7J4R1U)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    Product Characteristics
    Color BROWN (Reddish brown) Score     
    Shape Size
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:14783-102-02 1 in 1 BOX
    1 NDC:14783-102-01 4 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH NOT FINAL part352 05/27/2013
    LBEL HYDRATESS   LONG-LASTING INTENSE MOISTURIZING SPF 20 - MALVE
    octinoxate and oxybenzone lipstick
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:14783-103
    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 0.016 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)  
    TRIDECYL STEARATE (UNII: A8OE252M6L)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    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)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    TALC (UNII: 7SEV7J4R1U)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    Product Characteristics
    Color RED (Yellowish red) Score     
    Shape Size
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:14783-103-02 1 in 1 BOX
    1 NDC:14783-103-01 4 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH NOT FINAL part352 05/27/2013
    LBEL HYDRATESS   LONG-LASTING INTENSE MOISTURIZING SPF 20 - MARRON GLACE
    octinoxate and oxybenzone lipstick
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:14783-104
    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 0.016 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)  
    TRIDECYL STEARATE (UNII: A8OE252M6L)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    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)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    TALC (UNII: 7SEV7J4R1U)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    Product Characteristics
    Color BROWN (Purplish brown) Score     
    Shape Size
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:14783-104-02 1 in 1 BOX
    1 NDC:14783-104-01 4 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH NOT FINAL part352 05/27/2013
    LBEL HYDRATESS   LONG-LASTING INTENSE MOISTURIZING SPF 20 - TULIP
    octinoxate and oxybenzone lipstick
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:14783-105
    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 0.016 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)  
    TRIDECYL STEARATE (UNII: A8OE252M6L)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    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)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    TALC (UNII: 7SEV7J4R1U)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    Product Characteristics
    Color PINK (Yellowish pink) Score     
    Shape Size
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:14783-105-02 1 in 1 BOX
    1 NDC:14783-105-01 4 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH NOT FINAL part352 05/27/2013
    LBEL HYDRATESS   LONG-LASTING INTENSE MOISTURIZING SPF 20 - NUDE
    octinoxate and oxybenzone lipstick
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:14783-106
    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 0.016 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)  
    TRIDECYL STEARATE (UNII: A8OE252M6L)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    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)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    TALC (UNII: 7SEV7J4R1U)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    Product Characteristics
    Color PINK (Light Yellowish pink) Score     
    Shape Size
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:14783-106-02 1 in 1 BOX
    1 NDC:14783-106-01 4 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH NOT FINAL part352 05/27/2013
    LBEL HYDRATESS   LONG-LASTING INTENSE MOISTURIZING SPF 20 - LILY BEIGE
    octinoxate and oxybenzone lipstick
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:14783-107
    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 0.016 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)  
    TRIDECYL STEARATE (UNII: A8OE252M6L)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    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)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    TALC (UNII: 7SEV7J4R1U)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    Product Characteristics
    Color BROWN (Light pinkish brown) Score     
    Shape Size
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:14783-107-02 1 in 1 BOX
    1 NDC:14783-107-01 4 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH NOT FINAL part352 05/27/2013
    LBEL HYDRATESS   LONG-LASTING INTENSE MOISTURIZING SPF 20 - MANDARINE
    octinoxate and oxybenzone lipstick
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:14783-108
    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 0.016 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)  
    TRIDECYL STEARATE (UNII: A8OE252M6L)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    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)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    TALC (UNII: 7SEV7J4R1U)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    Product Characteristics
    Color ORANGE Score     
    Shape Size
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:14783-108-02 1 in 1 BOX
    1 NDC:14783-108-01 4 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH NOT FINAL part352 05/27/2013
    LBEL HYDRATESS   LONG-LASTING INTENSE MOISTURIZING SPF 20 - VIN
    octinoxate and oxybenzone lipstick
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:14783-109
    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 0.016 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)  
    TRIDECYL STEARATE (UNII: A8OE252M6L)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    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)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    TALC (UNII: 7SEV7J4R1U)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    Product Characteristics
    Color PURPLE (Brownish purple) Score     
    Shape Size
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:14783-109-02 1 in 1 BOX
    1 NDC:14783-109-01 4 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH NOT FINAL part352 05/27/2013
    Labeler - Ventura International LTD. (603192787)
    Establishment
    Name Address ID/FEI Business Operations
    Bel Star S.A. (Colombia) 880160197 MANUFACTURE(14783-095, 14783-096, 14783-097, 14783-098, 14783-099, 14783-100, 14783-101, 14783-102, 14783-103, 14783-104, 14783-105, 14783-106, 14783-107, 14783-108, 14783-109)