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, polyethylene, helianthus annuus (sunflower) seed wax, 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, lauroyl lysine, hexyl laurate, 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, iron oxides, synthetic fluorphlogopite, red 30 lake, red 7 lake, red 40 lake, talc, red 27 lake, yellow 5 lake, hydrogenated polyisobutene, blue 1 lake, red 21 lake, palmitic acid.

Product Packaging - Fuchsia Creamy

Product Packaging - Pink Creamy

Product Packaging - Nude Creamy

Product Packaging - Coral Creamy

Product Packaging - Berry Creamy

Product Packaging - Cherry Creamy

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 21 ALUMINUM LAKE (UNII: 2M7H5Y5MJP)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 21 ALUMINUM LAKE (UNII: 2M7H5Y5MJP)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)
SHOREA ROBUSTA RESIN (UNII: XUK1106UBO)
LAUROYL LYSINE (UNII: 113171Q70B)
D&C RED NO. 30 (UNII: 2S42T2808B)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M020	09/12/2024

Labeler - BEL STAR S A (880160197)

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