Label: CYZONE CY PLAY CREAMY LIP BALM HIDRATANTE EN BARRA PARA LABIOS 24H FPS 12 CORAL CREAMY- octinoxate, zinc oxide stick
CYZONE CY PLAY CREAMY LIP BALM HIDRATANTE EN BARRA PARA LABIOS 24H FPS 12 FUCHSIA CREAMY- octinoxate, zinc oxide stick
CYZONE CY PLAY CREAMY LIP BALM HIDRATANTE EN BARRA PARA LABIOS 24H FPS 12 PINK CREAMY- octinoxate, zinc oxide stick
CYZONE CY PLAY CREAMY LIP BALM HIDRATANTE EN BARRA PARA LABIOS 24H FPS 12 NUDE CREAMY- octinoxate, zinc oxide stick
CYZONE CY PLAY CREAMY LIP BALM HIDRATANTE EN BARRA PARA LABIOS 24H FPS 12 CHERRY CREAMY- octinoxate, zinc oxide stick
CYZONE CY PLAY CREAMY LIP BALM HIDRATANTE EN BARRA PARA LABIOS 24H FPS 12 BERRY CREAMY- octinoxate, zinc oxide stick

  • NDC Code(s): 14141-306-01, 14141-307-01, 14141-308-01, 14141-309-01, view more
    14141-348-01, 14141-349-01
  • Packager: BEL STAR S A
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated September 12, 2024

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

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  • Drug Facts

  • Active Ingredients

    Octinoxate 2.50%

    Zinc Oxide 3.92%

  • 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 damaged or broken skin.

    When using this product

    keep out of eyes. Rinse with water to remove.

    Stop use and ask a doctor if

    rash occurs.

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

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

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

    Octyldodecanol, ricinus communis (castor) seed oil, butyrospermum parkii (shea) butter, helianthus annuus (sunflower) seed wax, polyethylene, copernicia cerifera (carnauba) wax, glycerin, dipentaerythrityl hexacaprylate/hexacaprate, vegetable oil, oryza sativa (rice) bran oil, tridecyl trimellitate, olea europaea (olive) oil unsaponifiables, phytosteryl/behenyl/octyldodecyl lauroyl glutamate, oryza sativa (rice) bran wax, rhus succedanea fruit wax, fragrance, tridecyl stearate, disteardimonium hectorite, rhus verniciflua peel wax, shorea robusta resin, neopentyl glycol dicaprylate/dicaprate, phenoxyethanol, cetyl peg/ppg-10/1 dimethicone, polyglyceryl-4 isostearate, hexyl laurate, lauroyl lysine, punica granatum seed oil, prunus avium (sweet cherry) seed oil, pyrus malus (apple) seed oil, vaccinium macrocarpon (cranberry) seed oil, triethoxycaprylylsilane, caprylyl glycol, lecithin, chlorphenesin, water, citrus paradisi (grapefruit) fruit extract, ascorbyl palmitate, tocopherol, citronellol.

    May contain:

    Mica, titanium dioxide, talc, iron oxides, red 30 lake, red 7 lake, red 27 lake, red 40 lake, synthetic fluorphlogopite, hydrogenated polyisobutene, yellow 5 lake, blue 1 lake, red 21 lake, palmitic acid.

  • Company Information

    PUERTO RICO: Dist. by Ventura Corp, Ltd., San Juan, Puerto Rico 00926. Made in Colombia.

    www.cyzone.com

  • Product Packaging - Fuchsia Creamy

    1

  • Product Packaging - Pink Creamy

    1

  • Product Packaging - Nude Creamy

    1

  • Product Packaging - Coral Creamy

    1

  • Product Packaging - Berry Creamy

    5

  • Product Packaging - Cherry Creamy

    6

  • INGREDIENTS AND APPEARANCE
    CYZONE CY PLAY CREAMY LIP BALM HIDRATANTE EN BARRA PARA LABIOS 24H FPS 12 CORAL CREAMY 
    octinoxate, zinc oxide stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14141-309
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE39.2 mg  in 1 g
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE25 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    SHOREA ROBUSTA RESIN (UNII: XUK1106UBO)  
    LAUROYL LYSINE (UNII: 113171Q70B)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    GRAPEFRUIT (UNII: O82C39RR8C)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    MICA (UNII: V8A1AW0880)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    CORN OIL (UNII: 8470G57WFM)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FD&C BLUE NO. 1 ALUMINUM LAKE (UNII: J9EQA3S2JM)  
    SWEET CHERRY SEED OIL (UNII: 9X3RP3RJFH)  
    NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    WATER (UNII: 059QF0KO0R)  
    LECITHIN, SUNFLOWER (UNII: 834K0WOS5G)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    RICE BRAN OIL (UNII: LZO6K1506A)  
    OLEA EUROPAEA (OLIVE) OIL UNSAPONIFIABLES (UNII: XO45V955LT)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    PALMITIC ACID (UNII: 2V16EO95H1)  
    TALC (UNII: 7SEV7J4R1U)  
    HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    CRANBERRY SEED OIL (UNII: 73KDS3BW5E)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDE (UNII: YK3DC63Y5M)  
    RICE BRAN (UNII: R60QEP13IC)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    APPLE SEED OIL (UNII: 9ACA4K9013)  
    TOXICODENDRON SUCCEDANEUM FRUIT WAX (UNII: 684PA7HRMI)  
    DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    TOXICODENDRON VERNICIFLUUM FRUIT RIND WAX (UNII: 6RG2461FCH)  
    POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
    TRIDECYL STEARATE (UNII: A8OE252M6L)  
    PUNICA GRANATUM SEED OIL (UNII: 0UI45XV0T6)  
    HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)  
    OCTYLDODECANOL (UNII: 461N1O614Y)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)  
    HEXYL LAURATE (UNII: 4CG9F9W01Q)  
    D&C RED NO. 21 ALUMINUM LAKE (UNII: 2M7H5Y5MJP)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:14141-309-011 in 1 CARTON10/07/2022
    13 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02010/07/2022
    CYZONE CY PLAY CREAMY LIP BALM HIDRATANTE EN BARRA PARA LABIOS 24H FPS 12 FUCHSIA CREAMY 
    octinoxate, zinc oxide stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14141-306
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE25 mg  in 1 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE39.2 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    D&C RED NO. 21 ALUMINUM LAKE (UNII: 2M7H5Y5MJP)  
    SHOREA ROBUSTA RESIN (UNII: XUK1106UBO)  
    LAUROYL LYSINE (UNII: 113171Q70B)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    GRAPEFRUIT (UNII: O82C39RR8C)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    MICA (UNII: V8A1AW0880)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    CORN OIL (UNII: 8470G57WFM)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FD&C BLUE NO. 1 ALUMINUM LAKE (UNII: J9EQA3S2JM)  
    SWEET CHERRY SEED OIL (UNII: 9X3RP3RJFH)  
    NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    WATER (UNII: 059QF0KO0R)  
    LECITHIN, SUNFLOWER (UNII: 834K0WOS5G)  
    OLEA EUROPAEA (OLIVE) OIL UNSAPONIFIABLES (UNII: XO45V955LT)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    RICE BRAN OIL (UNII: LZO6K1506A)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    PALMITIC ACID (UNII: 2V16EO95H1)  
    TALC (UNII: 7SEV7J4R1U)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    CRANBERRY SEED OIL (UNII: 73KDS3BW5E)  
    MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDE (UNII: YK3DC63Y5M)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    RICE BRAN (UNII: R60QEP13IC)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    APPLE SEED OIL (UNII: 9ACA4K9013)  
    TOXICODENDRON SUCCEDANEUM FRUIT WAX (UNII: 684PA7HRMI)  
    DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
    TOXICODENDRON VERNICIFLUUM FRUIT RIND WAX (UNII: 6RG2461FCH)  
    POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
    TRIDECYL STEARATE (UNII: A8OE252M6L)  
    PUNICA GRANATUM SEED OIL (UNII: 0UI45XV0T6)  
    HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)  
    CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)  
    OCTYLDODECANOL (UNII: 461N1O614Y)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    HEXYL LAURATE (UNII: 4CG9F9W01Q)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:14141-306-011 in 1 CARTON10/07/2022
    13 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02010/07/2022
    CYZONE CY PLAY CREAMY LIP BALM HIDRATANTE EN BARRA PARA LABIOS 24H FPS 12 PINK CREAMY 
    octinoxate, zinc oxide stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14141-307
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE39.2 mg  in 1 g
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE25 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    SHOREA ROBUSTA RESIN (UNII: XUK1106UBO)  
    LAUROYL LYSINE (UNII: 113171Q70B)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    GRAPEFRUIT (UNII: O82C39RR8C)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    MICA (UNII: V8A1AW0880)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    CORN OIL (UNII: 8470G57WFM)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FD&C BLUE NO. 1 ALUMINUM LAKE (UNII: J9EQA3S2JM)  
    SWEET CHERRY SEED OIL (UNII: 9X3RP3RJFH)  
    NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    WATER (UNII: 059QF0KO0R)  
    LECITHIN, SUNFLOWER (UNII: 834K0WOS5G)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    RICE BRAN OIL (UNII: LZO6K1506A)  
    OLEA EUROPAEA (OLIVE) OIL UNSAPONIFIABLES (UNII: XO45V955LT)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    PALMITIC ACID (UNII: 2V16EO95H1)  
    TALC (UNII: 7SEV7J4R1U)  
    HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    CRANBERRY SEED OIL (UNII: 73KDS3BW5E)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDE (UNII: YK3DC63Y5M)  
    RICE BRAN (UNII: R60QEP13IC)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    APPLE SEED OIL (UNII: 9ACA4K9013)  
    TOXICODENDRON SUCCEDANEUM FRUIT WAX (UNII: 684PA7HRMI)  
    DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    TOXICODENDRON VERNICIFLUUM FRUIT RIND WAX (UNII: 6RG2461FCH)  
    POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
    TRIDECYL STEARATE (UNII: A8OE252M6L)  
    PUNICA GRANATUM SEED OIL (UNII: 0UI45XV0T6)  
    HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)  
    OCTYLDODECANOL (UNII: 461N1O614Y)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)  
    HEXYL LAURATE (UNII: 4CG9F9W01Q)  
    D&C RED NO. 21 ALUMINUM LAKE (UNII: 2M7H5Y5MJP)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:14141-307-011 in 1 CARTON10/07/2022
    13 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02010/07/2022
    CYZONE CY PLAY CREAMY LIP BALM HIDRATANTE EN BARRA PARA LABIOS 24H FPS 12 NUDE CREAMY 
    octinoxate, zinc oxide stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14141-308
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE39.2 mg  in 1 g
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE25 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    SHOREA ROBUSTA RESIN (UNII: XUK1106UBO)  
    LAUROYL LYSINE (UNII: 113171Q70B)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    GRAPEFRUIT (UNII: O82C39RR8C)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    MICA (UNII: V8A1AW0880)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    CORN OIL (UNII: 8470G57WFM)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FD&C BLUE NO. 1 ALUMINUM LAKE (UNII: J9EQA3S2JM)  
    SWEET CHERRY SEED OIL (UNII: 9X3RP3RJFH)  
    NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    WATER (UNII: 059QF0KO0R)  
    LECITHIN, SUNFLOWER (UNII: 834K0WOS5G)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    RICE BRAN OIL (UNII: LZO6K1506A)  
    OLEA EUROPAEA (OLIVE) OIL UNSAPONIFIABLES (UNII: XO45V955LT)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    PALMITIC ACID (UNII: 2V16EO95H1)  
    TALC (UNII: 7SEV7J4R1U)  
    HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    CRANBERRY SEED OIL (UNII: 73KDS3BW5E)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDE (UNII: YK3DC63Y5M)  
    RICE BRAN (UNII: R60QEP13IC)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    APPLE SEED OIL (UNII: 9ACA4K9013)  
    TOXICODENDRON SUCCEDANEUM FRUIT WAX (UNII: 684PA7HRMI)  
    DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    TOXICODENDRON VERNICIFLUUM FRUIT RIND WAX (UNII: 6RG2461FCH)  
    POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
    TRIDECYL STEARATE (UNII: A8OE252M6L)  
    PUNICA GRANATUM SEED OIL (UNII: 0UI45XV0T6)  
    HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)  
    OCTYLDODECANOL (UNII: 461N1O614Y)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)  
    HEXYL LAURATE (UNII: 4CG9F9W01Q)  
    D&C RED NO. 21 ALUMINUM LAKE (UNII: 2M7H5Y5MJP)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:14141-308-011 in 1 CARTON10/07/2022
    13 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02010/07/2022
    CYZONE CY PLAY CREAMY LIP BALM HIDRATANTE EN BARRA PARA LABIOS 24H FPS 12 CHERRY CREAMY 
    octinoxate, zinc oxide stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14141-349
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE39.2 mg  in 1 g
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE25 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    SHOREA ROBUSTA RESIN (UNII: XUK1106UBO)  
    LAUROYL LYSINE (UNII: 113171Q70B)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    GRAPEFRUIT (UNII: O82C39RR8C)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    MICA (UNII: V8A1AW0880)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    CORN OIL (UNII: 8470G57WFM)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FD&C BLUE NO. 1 ALUMINUM LAKE (UNII: J9EQA3S2JM)  
    SWEET CHERRY SEED OIL (UNII: 9X3RP3RJFH)  
    NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    WATER (UNII: 059QF0KO0R)  
    LECITHIN, SUNFLOWER (UNII: 834K0WOS5G)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    RICE BRAN OIL (UNII: LZO6K1506A)  
    OLEA EUROPAEA (OLIVE) OIL UNSAPONIFIABLES (UNII: XO45V955LT)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    PALMITIC ACID (UNII: 2V16EO95H1)  
    TALC (UNII: 7SEV7J4R1U)  
    HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    CRANBERRY SEED OIL (UNII: 73KDS3BW5E)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDE (UNII: YK3DC63Y5M)  
    RICE BRAN (UNII: R60QEP13IC)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    APPLE SEED OIL (UNII: 9ACA4K9013)  
    TOXICODENDRON SUCCEDANEUM FRUIT WAX (UNII: 684PA7HRMI)  
    DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    TOXICODENDRON VERNICIFLUUM FRUIT RIND WAX (UNII: 6RG2461FCH)  
    POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
    TRIDECYL STEARATE (UNII: A8OE252M6L)  
    PUNICA GRANATUM SEED OIL (UNII: 0UI45XV0T6)  
    HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)  
    OCTYLDODECANOL (UNII: 461N1O614Y)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)  
    HEXYL LAURATE (UNII: 4CG9F9W01Q)  
    D&C RED NO. 21 ALUMINUM LAKE (UNII: 2M7H5Y5MJP)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:14141-349-011 in 1 CARTON09/12/2024
    13 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02009/12/2024
    CYZONE CY PLAY CREAMY LIP BALM HIDRATANTE EN BARRA PARA LABIOS 24H FPS 12 BERRY CREAMY 
    octinoxate, zinc oxide stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14141-348
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE39.2 mg  in 1 g
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE25 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    SHOREA ROBUSTA RESIN (UNII: XUK1106UBO)  
    LAUROYL LYSINE (UNII: 113171Q70B)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    GRAPEFRUIT (UNII: O82C39RR8C)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    MICA (UNII: V8A1AW0880)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    CORN OIL (UNII: 8470G57WFM)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FD&C BLUE NO. 1 ALUMINUM LAKE (UNII: J9EQA3S2JM)  
    SWEET CHERRY SEED OIL (UNII: 9X3RP3RJFH)  
    NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    WATER (UNII: 059QF0KO0R)  
    LECITHIN, SUNFLOWER (UNII: 834K0WOS5G)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    RICE BRAN OIL (UNII: LZO6K1506A)  
    OLEA EUROPAEA (OLIVE) OIL UNSAPONIFIABLES (UNII: XO45V955LT)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    PALMITIC ACID (UNII: 2V16EO95H1)  
    TALC (UNII: 7SEV7J4R1U)  
    HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    CRANBERRY SEED OIL (UNII: 73KDS3BW5E)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDE (UNII: YK3DC63Y5M)  
    RICE BRAN (UNII: R60QEP13IC)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    APPLE SEED OIL (UNII: 9ACA4K9013)  
    TOXICODENDRON SUCCEDANEUM FRUIT WAX (UNII: 684PA7HRMI)  
    DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    TOXICODENDRON VERNICIFLUUM FRUIT RIND WAX (UNII: 6RG2461FCH)  
    POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
    TRIDECYL STEARATE (UNII: A8OE252M6L)  
    PUNICA GRANATUM SEED OIL (UNII: 0UI45XV0T6)  
    HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)  
    OCTYLDODECANOL (UNII: 461N1O614Y)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)  
    HEXYL LAURATE (UNII: 4CG9F9W01Q)  
    D&C RED NO. 21 ALUMINUM LAKE (UNII: 2M7H5Y5MJP)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:14141-348-011 in 1 CARTON09/12/2024
    13 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02009/12/2024
    Labeler - BEL STAR S A (880160197)
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