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

CYZONE CY PLAY CREAMY LIP BALM HIDRATANTE EN BARRA PARA LABIOS 24H FPS 12 NUDE CREAMY by

Drug Labeling and Warnings

CYZONE CY PLAY CREAMY LIP BALM HIDRATANTE EN BARRA PARA LABIOS 24H FPS 12 NUDE CREAMY by is a Otc medication manufactured, distributed, or labeled by BEL STAR S A. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

Product Packaging - Pink Creamy

Product Packaging - Nude Creamy

Product Packaging - Coral Creamy

Product Packaging - Berry Creamy

Product Packaging - Cherry Creamy

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 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)
D&C RED NO. 21 ALUMINUM LAKE (UNII: 2M7H5Y5MJP)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

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 Drug	M020	10/07/2022

CYZONE CY PLAY CREAMY LIP BALM HIDRATANTE EN BARRA PARA LABIOS 24H FPS 12 FUCHSIA CREAMY 
octinoxate, zinc oxide stick

Product Information
Product 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
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 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 Drug	M020	10/07/2022

CYZONE CY PLAY CREAMY LIP BALM HIDRATANTE EN BARRA PARA LABIOS 24H FPS 12 PINK CREAMY 
octinoxate, zinc oxide stick

Product Information
Product 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)
D&C RED NO. 21 ALUMINUM LAKE (UNII: 2M7H5Y5MJP)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

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 Drug	M020	10/07/2022

CYZONE CY PLAY CREAMY LIP BALM HIDRATANTE EN BARRA PARA LABIOS 24H FPS 12 NUDE CREAMY 
octinoxate, zinc oxide stick

Product Information
Product 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)
D&C RED NO. 21 ALUMINUM LAKE (UNII: 2M7H5Y5MJP)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

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 Drug	M020	10/07/2022

CYZONE CY PLAY CREAMY LIP BALM HIDRATANTE EN BARRA PARA LABIOS 24H FPS 12 CHERRY CREAMY 
octinoxate, zinc oxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 14141-349
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)
D&C RED NO. 21 ALUMINUM LAKE (UNII: 2M7H5Y5MJP)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 14141-349-01	1 in 1 CARTON	09/12/2024
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 Drug	M020	09/12/2024

CYZONE CY PLAY CREAMY LIP BALM HIDRATANTE EN BARRA PARA LABIOS 24H FPS 12 BERRY CREAMY 
octinoxate, zinc oxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 14141-348
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)
D&C RED NO. 21 ALUMINUM LAKE (UNII: 2M7H5Y5MJP)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 14141-348-01	1 in 1 CARTON	09/12/2024
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 Drug	M020	09/12/2024

Labeler - BEL STAR S A (880160197)