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
- NDC Code(s): 14141-306-01, 14141-307-01, 14141-308-01, 14141-309-01
- Packager: BEL STAR S A
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated October 13, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Active Ingredients
- Purpose
- Uses
- Warnings
- Directions
- Other information
-
Inactive Ingredients
Octyldodecanol, ricinus communis (castor) seed oil, butyrospermum parkii (shea) butter, helianthus annuus (sunflower) seed wax, polyethylene, copernicia cerifera (carnauba) wax, glycerin, vegetable oil, oryza sativa (rice) bran oil, olea europaea (olive) oil unsaponifiables, phytosteryl/behenyl/octyldodecyl lauroyl glutamate, oryza sativa (rice) bran wax, rhus succedanea fruit wax, dipentaerythrityl hexacaprylate/hexacaprate, fragrance, tridecyl trimellitate, disteardimonium hectorite, rhus verniciflua peel wax, shorea robusta resin, phenoxyethanol, cetyl peg/ppg-10/1 dimethicone, polyglyceryl-4 isostearate, tridecyl stearate, hexyl laurate, lauroyl lysine, punica granatum seed oil, prunus avium (sweet cherry) seed oil, pyrus malus (apple) seed oil, vaccinium macrocarpon (cranberry) seed oil, neopentyl glycol dicaprylate/dicaprate, triethoxycaprylylsilane, caprylyl glycol, chlorphenesin, water, lecithin, citrus paradisi (grapefruit) fruit extract, ascorbyl palmitate, tocopherol, citronellol.
May contain:
Mica, titanium dioxide, red 30 lake, red 7 lake, red 40 lake, synthetic fluorphlogopite, red 27 lake, hydrogenated polyisobutene, iron oxides, blue 1 lake, palmitic acid, talc.
- Company Information
- Product Packaging - Fuchsia Creamy
- Product Packaging - Pink Creamy
- Product Packaging - Nude Creamy
- Product Packaging - Coral Creamy
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INGREDIENTS AND APPEARANCE
CYZONE CY PLAY CREAMY LIP BALM HIDRATANTE EN BARRA PARA LABIOS 24H FPS 12 CORAL CREAMY
octinoxate, zinc oxide stickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:14141-309 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 39.2 mg in 1 g OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 25 mg in 1 g Inactive Ingredients Ingredient Name Strength 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) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:14141-309-01 1 in 1 CARTON 10/07/2022 1 3 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 M020 10/07/2022 CYZONE CY PLAY CREAMY LIP BALM HIDRATANTE EN BARRA PARA LABIOS 24H FPS 12 FUCHSIA CREAMY
octinoxate, zinc oxide stickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:14141-306 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 25 mg in 1 g ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 39.2 mg in 1 g Inactive Ingredients Ingredient Name Strength 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) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:14141-306-01 1 in 1 CARTON 10/07/2022 1 3 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 M020 10/07/2022 CYZONE CY PLAY CREAMY LIP BALM HIDRATANTE EN BARRA PARA LABIOS 24H FPS 12 PINK CREAMY
octinoxate, zinc oxide stickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:14141-307 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 39.2 mg in 1 g OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 25 mg in 1 g Inactive Ingredients Ingredient Name Strength 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) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:14141-307-01 1 in 1 CARTON 10/07/2022 1 3 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 M020 10/07/2022 CYZONE CY PLAY CREAMY LIP BALM HIDRATANTE EN BARRA PARA LABIOS 24H FPS 12 NUDE CREAMY
octinoxate, zinc oxide stickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:14141-308 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 39.2 mg in 1 g OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 25 mg in 1 g Inactive Ingredients Ingredient Name Strength 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) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:14141-308-01 1 in 1 CARTON 10/07/2022 1 3 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 M020 10/07/2022 Labeler - BEL STAR S A (880160197)