DailyMed - LBEL SOLUTIONS PRO HIALURON BALM BALSAMO LABIAL HIDRATANTE 72H FPS 20 HYDRATING LIP BALM 72H SPF 20 NUDE UNIVERSEL- octinoxate, zinc oxide stick LBEL SOLUTIONS PRO HIALURON BALM BALSAMO LABIAL HIDRATANTE 72H FPS 20 HYDRATING LIP BALM 72H SPF 20 CORAL UNIVERSEL- octinoxate, zinc oxide stick LBEL SOLUTIONS PRO HIALURON BALM BALSAMO LABIAL HIDRATANTE 72H FPS 20 HYDRATING LIP BALM 72H SPF 20 BERRY UNIVERSEL- octinoxate, zinc oxide stick LBEL SOLUTIONS PRO HIALURON BALM BALSAMO LABIAL HIDRATANTE 72H FPS 20 HYDRATING LIP BALM 72H SPF 20 ROSE UNIVERSEL- octinoxate, zinc oxide stick LBEL SOLUTIONS PRO HIALURON BALM BALSAMO LABIAL HIDRATANTE 72H FPS 20 HYDRATING LIP BALM 72H SPF 20 CHERRY GLAZE- octinoxate, zinc oxide stick LBEL SOLUTIONS PRO HIALURON BALM BALSAMO LABIAL HIDRATANTE 72H FPS 20 HYDRATING LIP BALM 72H SPF 20 ROSE CREME- octinoxate, zinc oxide stick

NDC Code(s): 14141-350-01, 14141-351-01, 14141-352-01, 14141-353-01, view more
14141-463-01, 14141-464-01
Packager: BEL STAR S A

Category: HUMAN OTC DRUG LABEL
DEA Schedule: None

Drug Label Information

Updated December 3, 2025

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

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Official Label (Printer Friendly)

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Drug Facts
Active ingredients

Octinoxate 7.50%

Zinc Oxide 4.90%
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 ifrom excessive heat and direct sun.
Inactive Ingredients

Isononyl isononanoate, hydrogenated polycyclopentadiene, hydrogenated polyisobutene, polyethylene, glycerin, beeswax, butyrospermum parkii (shea) butter extract, isododecane, silica, polyglyceryl-3 diisostearate, simmondsia chinensis (jojoba) seed oil, octyldodecanol, dicaprylyl carbonate, butyrospermum parkii (shea) butter, diethylhexyl syringylidenemalonate, copernicia cerifera (carnauba) wax, cetyl peg/ppg-10/1 dimethicone, polyglyceryl-4 isostearate, disteardimonium hectorite, tocopheryl acetate, polymethylsilsesquioxane, menthyl lactate, hexyl laurate, irvingia gabonensis kernel butter, ethylhexyl palmitate, fragrance, glycine soja (soybean) seed extract, hdi/trimethylol hexyllactone crosspolymer, silica dimethyl silylate, butyrospermum parkii (shea) butter unsaponifiables, hydrogenated coco-glycerides, phenoxyethanol, sorbitol/sebacic acid copolymer behenate, argania spinosa kernel oil, sodium hyaluronate, caprylic/capric triglyceride, caprylyl glycol, sodium saccharin, triethoxycaprylylsilane, chlorphenesin, croton lechleri resin extract, luffa cylindrica seed oil, tocopherol, ascorbyl tetraisopalmitate, water, hydrolyzed soy protein, rice amino acids, proline, hydrolyzed adansonia digitata seed extract, geraniol, terpineol, hydroxycitronellal, benzyl alcohol, benzyl benzoate, pelargonium graveolens flower oil.

May contain: Red 40 lake, red 6 lake, red 7 lake, iron oxides, titanium dioxide, isopropyl myristate, blue 1 lake, isopropyl titanium triisostearate, stearalkonium hectorite, polyhydroxystearic acid, propylene carbonate.
Product Packaging - Berry Universel
Product Packaging - Coral Universel
Product Packaging - Nude Universel
Product Packaging - Rose Universel
Product Packaging - Cherry Glaze
Product Packaging - Rose Creme

INGREDIENTS AND APPEARANCE

LBEL SOLUTIONS PRO HIALURON BALM BALSAMO LABIAL HIDRATANTE 72H FPS 20 HYDRATING LIP BALM 72H SPF 20 NUDE UNIVERSEL
octinoxate, zinc oxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:14141-352
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	49 mg in 1 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	75 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
MENTHYL LACTATE (UNII: 2BF9E65L7I)
PROLINE (UNII: 9DLQ4CIU6V)
GLYCERIN (UNII: PDC6A3C0OX)
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)
LUFFA CYLINDRICA SEED OIL (UNII: 1A281RJ859)
RICE AMINO ACIDS (UNII: 5ET1T25H82)
RED 40 LAKE (UNII: 6T47AS764T)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
BENZYL ALCOHOL (UNII: LKG8494WBH)
HYDROGENATED POLYCYCLOPENTADIENE (580 WAMW) (UNII: N6Z62H4CC9)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM HYALURONATE (UNII: YSE9PPT4TH)
TOCOPHEROL (UNII: R0ZB2556P8)
STEARALKONIUM HECTORITE (UNII: OLX698AH5P)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
HDI/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)
HYDROGENATED COCO-GLYCERIDES (UNII: XDD37N2GPR)
CHLORPHENESIN (UNII: I670DAL4SZ)
CI 77491 (UNII: 1K09F3G675)
POLYETHYLENE (UNII: UG00KM4WR7)
SHEA BUTTER (UNII: K49155WL9Y)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
GLYCINE SOJA (SOYBEAN) SEED (UNII: L7HT8F1ZOD)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
IRVINGIA GABONENSIS KERNEL BUTTER (UNII: 8Y12O726LX)
WATER (UNII: 059QF0KO0R)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
CARNAUBA WAX (UNII: R12CBM0EIZ)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
TERPINEOL (UNII: R53Q4ZWC99)
PELARGONIUM GRAVEOLENS FLOWER OIL (UNII: 3K0J1S7QGC)
D&C RED NO. 6 (UNII: 481744AI4O)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
ISOPROPYL TITANIUM TRIISOSTEARATE (UNII: 949E3KBJ1I)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
GERANIOL (UNII: L837108USY)
HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)
BEESWAX (UNII: 2ZA36H0S2V)
CI 77492 (UNII: EX438O2MRT)
CI 77499 (UNII: XM0M87F357)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
BUTYROSPERMUM PARKII (SHEA) BUTTER UNSAPONIFIABLES (UNII: 0C9AC7D6XU)
CAPRYLIC/CAPRIC TRIGLYCERIDE (UNII: C9H2L21V7U)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
ISODODECANE (UNII: A8289P68Y2)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
JOJOBA OIL (UNII: 724GKU717M)
OCTYLDODECANOL (UNII: 461N1O614Y)
SODIUM SACCHARIN (UNII: SB8ZUX40TY)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
ARGAN OIL (UNII: 4V59G5UW9X)
CROTON LECHLERI RESIN (UNII: GGG6W25C63)
ASCORBYL TETRAISOPALMITATE (UNII: 47143LT58A)
HYDROLYZED SOY PROTEIN (ENZYMATIC; 2000 MW) (UNII: 1394NXB9L6)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
HYDROGENATED POLYISOBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248)
CI 42090 (UNII: H3R47K3TBD)
BENZYL BENZOATE (UNII: N863NB338G)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:14141-352-01	1 in 1 BOX	10/30/2024
1		2 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	10/30/2024

LBEL SOLUTIONS PRO HIALURON BALM BALSAMO LABIAL HIDRATANTE 72H FPS 20 HYDRATING LIP BALM 72H SPF 20 CORAL UNIVERSEL
octinoxate, zinc oxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:14141-351
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	49 mg in 1 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	75 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
MENTHYL LACTATE (UNII: 2BF9E65L7I)
PROLINE (UNII: 9DLQ4CIU6V)
GLYCERIN (UNII: PDC6A3C0OX)
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)
LUFFA CYLINDRICA SEED OIL (UNII: 1A281RJ859)
RICE AMINO ACIDS (UNII: 5ET1T25H82)
RED 40 LAKE (UNII: 6T47AS764T)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
BENZYL ALCOHOL (UNII: LKG8494WBH)
HYDROGENATED POLYCYCLOPENTADIENE (580 WAMW) (UNII: N6Z62H4CC9)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM HYALURONATE (UNII: YSE9PPT4TH)
TOCOPHEROL (UNII: R0ZB2556P8)
STEARALKONIUM HECTORITE (UNII: OLX698AH5P)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
HDI/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)
HYDROGENATED COCO-GLYCERIDES (UNII: XDD37N2GPR)
CHLORPHENESIN (UNII: I670DAL4SZ)
CI 77491 (UNII: 1K09F3G675)
POLYETHYLENE (UNII: UG00KM4WR7)
SHEA BUTTER (UNII: K49155WL9Y)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
GLYCINE SOJA (SOYBEAN) SEED (UNII: L7HT8F1ZOD)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
IRVINGIA GABONENSIS KERNEL BUTTER (UNII: 8Y12O726LX)
WATER (UNII: 059QF0KO0R)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
CARNAUBA WAX (UNII: R12CBM0EIZ)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
TERPINEOL (UNII: R53Q4ZWC99)
CI 42090 (UNII: H3R47K3TBD)
PELARGONIUM GRAVEOLENS FLOWER OIL (UNII: 3K0J1S7QGC)
D&C RED NO. 6 (UNII: 481744AI4O)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
ISOPROPYL TITANIUM TRIISOSTEARATE (UNII: 949E3KBJ1I)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
GERANIOL (UNII: L837108USY)
HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)
BEESWAX (UNII: 2ZA36H0S2V)
BENZYL BENZOATE (UNII: N863NB338G)
CI 77492 (UNII: EX438O2MRT)
CI 77499 (UNII: XM0M87F357)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
BUTYROSPERMUM PARKII (SHEA) BUTTER UNSAPONIFIABLES (UNII: 0C9AC7D6XU)
CAPRYLIC/CAPRIC TRIGLYCERIDE (UNII: C9H2L21V7U)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
ISODODECANE (UNII: A8289P68Y2)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
JOJOBA OIL (UNII: 724GKU717M)
OCTYLDODECANOL (UNII: 461N1O614Y)
SODIUM SACCHARIN (UNII: SB8ZUX40TY)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
ARGAN OIL (UNII: 4V59G5UW9X)
CROTON LECHLERI RESIN (UNII: GGG6W25C63)
ASCORBYL TETRAISOPALMITATE (UNII: 47143LT58A)
HYDROLYZED SOY PROTEIN (ENZYMATIC; 2000 MW) (UNII: 1394NXB9L6)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
HYDROGENATED POLYISOBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:14141-351-01	1 in 1 BOX	10/30/2024
1		2 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	10/30/2024

LBEL SOLUTIONS PRO HIALURON BALM BALSAMO LABIAL HIDRATANTE 72H FPS 20 HYDRATING LIP BALM 72H SPF 20 BERRY UNIVERSEL
octinoxate, zinc oxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:14141-350
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	75 mg in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	49 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
JOJOBA OIL (UNII: 724GKU717M)
OCTYLDODECANOL (UNII: 461N1O614Y)
SODIUM SACCHARIN (UNII: SB8ZUX40TY)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
SHEA BUTTER (UNII: K49155WL9Y)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
ARGAN OIL (UNII: 4V59G5UW9X)
CROTON LECHLERI RESIN (UNII: GGG6W25C63)
ASCORBYL TETRAISOPALMITATE (UNII: 47143LT58A)
HYDROLYZED SOY PROTEIN (ENZYMATIC; 2000 MW) (UNII: 1394NXB9L6)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
TOCOPHEROL (UNII: R0ZB2556P8)
STEARALKONIUM HECTORITE (UNII: OLX698AH5P)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
HYDROGENATED POLYISOBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248)
MENTHYL LACTATE (UNII: 2BF9E65L7I)
PROLINE (UNII: 9DLQ4CIU6V)
GLYCERIN (UNII: PDC6A3C0OX)
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)
LUFFA CYLINDRICA SEED OIL (UNII: 1A281RJ859)
RICE AMINO ACIDS (UNII: 5ET1T25H82)
RED 40 LAKE (UNII: 6T47AS764T)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
BENZYL ALCOHOL (UNII: LKG8494WBH)
HYDROGENATED POLYCYCLOPENTADIENE (580 WAMW) (UNII: N6Z62H4CC9)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM HYALURONATE (UNII: YSE9PPT4TH)
HDI/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)
HYDROGENATED COCO-GLYCERIDES (UNII: XDD37N2GPR)
CHLORPHENESIN (UNII: I670DAL4SZ)
CI 77491 (UNII: 1K09F3G675)
POLYETHYLENE (UNII: UG00KM4WR7)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
GLYCINE SOJA (SOYBEAN) SEED (UNII: L7HT8F1ZOD)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
IRVINGIA GABONENSIS KERNEL BUTTER (UNII: 8Y12O726LX)
WATER (UNII: 059QF0KO0R)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
CARNAUBA WAX (UNII: R12CBM0EIZ)
D&C RED NO. 6 (UNII: 481744AI4O)
TERPINEOL (UNII: R53Q4ZWC99)
CI 42090 (UNII: H3R47K3TBD)
PELARGONIUM GRAVEOLENS FLOWER OIL (UNII: 3K0J1S7QGC)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
ISOPROPYL TITANIUM TRIISOSTEARATE (UNII: 949E3KBJ1I)
CI 77499 (UNII: XM0M87F357)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
GERANIOL (UNII: L837108USY)
HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)
BEESWAX (UNII: 2ZA36H0S2V)
BENZYL BENZOATE (UNII: N863NB338G)
CI 77492 (UNII: EX438O2MRT)
CAPRYLIC/CAPRIC TRIGLYCERIDE (UNII: C9H2L21V7U)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
BUTYROSPERMUM PARKII (SHEA) BUTTER UNSAPONIFIABLES (UNII: 0C9AC7D6XU)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
ISODODECANE (UNII: A8289P68Y2)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:14141-350-01	1 in 1 BOX	10/30/2024
1		2 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	10/30/2024

LBEL SOLUTIONS PRO HIALURON BALM BALSAMO LABIAL HIDRATANTE 72H FPS 20 HYDRATING LIP BALM 72H SPF 20 ROSE UNIVERSEL
octinoxate, zinc oxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:14141-353
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	49 mg in 1 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	75 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
BENZYL ALCOHOL (UNII: LKG8494WBH)
HYDROGENATED POLYCYCLOPENTADIENE (580 WAMW) (UNII: N6Z62H4CC9)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM HYALURONATE (UNII: YSE9PPT4TH)
TOCOPHEROL (UNII: R0ZB2556P8)
STEARALKONIUM HECTORITE (UNII: OLX698AH5P)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
HDI/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)
HYDROGENATED COCO-GLYCERIDES (UNII: XDD37N2GPR)
CHLORPHENESIN (UNII: I670DAL4SZ)
CI 77491 (UNII: 1K09F3G675)
POLYETHYLENE (UNII: UG00KM4WR7)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
GLYCINE SOJA (SOYBEAN) SEED (UNII: L7HT8F1ZOD)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
IRVINGIA GABONENSIS KERNEL BUTTER (UNII: 8Y12O726LX)
WATER (UNII: 059QF0KO0R)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
CARNAUBA WAX (UNII: R12CBM0EIZ)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
TERPINEOL (UNII: R53Q4ZWC99)
CI 42090 (UNII: H3R47K3TBD)
PELARGONIUM GRAVEOLENS FLOWER OIL (UNII: 3K0J1S7QGC)
D&C RED NO. 6 (UNII: 481744AI4O)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
ISOPROPYL TITANIUM TRIISOSTEARATE (UNII: 949E3KBJ1I)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
GERANIOL (UNII: L837108USY)
HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)
BEESWAX (UNII: 2ZA36H0S2V)
BENZYL BENZOATE (UNII: N863NB338G)
CI 77492 (UNII: EX438O2MRT)
CI 77499 (UNII: XM0M87F357)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
BUTYROSPERMUM PARKII (SHEA) BUTTER UNSAPONIFIABLES (UNII: 0C9AC7D6XU)
CAPRYLIC/CAPRIC TRIGLYCERIDE (UNII: C9H2L21V7U)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
ISODODECANE (UNII: A8289P68Y2)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
JOJOBA OIL (UNII: 724GKU717M)
OCTYLDODECANOL (UNII: 461N1O614Y)
SODIUM SACCHARIN (UNII: SB8ZUX40TY)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
SHEA BUTTER (UNII: K49155WL9Y)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
ARGAN OIL (UNII: 4V59G5UW9X)
CROTON LECHLERI RESIN (UNII: GGG6W25C63)
ASCORBYL TETRAISOPALMITATE (UNII: 47143LT58A)
HYDROLYZED SOY PROTEIN (ENZYMATIC; 2000 MW) (UNII: 1394NXB9L6)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
HYDROGENATED POLYISOBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248)
MENTHYL LACTATE (UNII: 2BF9E65L7I)
PROLINE (UNII: 9DLQ4CIU6V)
GLYCERIN (UNII: PDC6A3C0OX)
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)
LUFFA CYLINDRICA SEED OIL (UNII: 1A281RJ859)
RICE AMINO ACIDS (UNII: 5ET1T25H82)
RED 40 LAKE (UNII: 6T47AS764T)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:14141-353-01	1 in 1 BOX	10/30/2024
1		2 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	10/30/2024

LBEL SOLUTIONS PRO HIALURON BALM BALSAMO LABIAL HIDRATANTE 72H FPS 20 HYDRATING LIP BALM 72H SPF 20 CHERRY GLAZE
octinoxate, zinc oxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:14141-463
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	49 mg in 1 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	75 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
BENZYL ALCOHOL (UNII: LKG8494WBH)
HYDROGENATED POLYCYCLOPENTADIENE (580 WAMW) (UNII: N6Z62H4CC9)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM HYALURONATE (UNII: YSE9PPT4TH)
TOCOPHEROL (UNII: R0ZB2556P8)
STEARALKONIUM HECTORITE (UNII: OLX698AH5P)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
HDI/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)
HYDROGENATED COCO-GLYCERIDES (UNII: XDD37N2GPR)
CHLORPHENESIN (UNII: I670DAL4SZ)
CI 77491 (UNII: 1K09F3G675)
POLYETHYLENE (UNII: UG00KM4WR7)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
GLYCINE SOJA (SOYBEAN) SEED (UNII: L7HT8F1ZOD)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
IRVINGIA GABONENSIS KERNEL BUTTER (UNII: 8Y12O726LX)
WATER (UNII: 059QF0KO0R)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
CARNAUBA WAX (UNII: R12CBM0EIZ)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
TERPINEOL (UNII: R53Q4ZWC99)
CI 42090 (UNII: H3R47K3TBD)
PELARGONIUM GRAVEOLENS FLOWER OIL (UNII: 3K0J1S7QGC)
D&C RED NO. 6 (UNII: 481744AI4O)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
ISOPROPYL TITANIUM TRIISOSTEARATE (UNII: 949E3KBJ1I)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
GERANIOL (UNII: L837108USY)
HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)
BEESWAX (UNII: 2ZA36H0S2V)
BENZYL BENZOATE (UNII: N863NB338G)
CI 77492 (UNII: EX438O2MRT)
CI 77499 (UNII: XM0M87F357)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
BUTYROSPERMUM PARKII (SHEA) BUTTER UNSAPONIFIABLES (UNII: 0C9AC7D6XU)
CAPRYLIC/CAPRIC TRIGLYCERIDE (UNII: C9H2L21V7U)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
ISODODECANE (UNII: A8289P68Y2)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
JOJOBA OIL (UNII: 724GKU717M)
OCTYLDODECANOL (UNII: 461N1O614Y)
SODIUM SACCHARIN (UNII: SB8ZUX40TY)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
SHEA BUTTER (UNII: K49155WL9Y)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
ARGAN OIL (UNII: 4V59G5UW9X)
CROTON LECHLERI RESIN (UNII: GGG6W25C63)
ASCORBYL TETRAISOPALMITATE (UNII: 47143LT58A)
HYDROLYZED SOY PROTEIN (ENZYMATIC; 2000 MW) (UNII: 1394NXB9L6)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
HYDROGENATED POLYISOBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248)
MENTHYL LACTATE (UNII: 2BF9E65L7I)
PROLINE (UNII: 9DLQ4CIU6V)
GLYCERIN (UNII: PDC6A3C0OX)
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)
LUFFA CYLINDRICA SEED OIL (UNII: 1A281RJ859)
RICE AMINO ACIDS (UNII: 5ET1T25H82)
RED 40 LAKE (UNII: 6T47AS764T)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:14141-463-01	1 in 1 BOX	12/11/2025
1		2 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	12/11/2025

LBEL SOLUTIONS PRO HIALURON BALM BALSAMO LABIAL HIDRATANTE 72H FPS 20 HYDRATING LIP BALM 72H SPF 20 ROSE CREME
octinoxate, zinc oxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:14141-464
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	49 mg in 1 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	75 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
BENZYL ALCOHOL (UNII: LKG8494WBH)
HYDROGENATED POLYCYCLOPENTADIENE (580 WAMW) (UNII: N6Z62H4CC9)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM HYALURONATE (UNII: YSE9PPT4TH)
TOCOPHEROL (UNII: R0ZB2556P8)
STEARALKONIUM HECTORITE (UNII: OLX698AH5P)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
HDI/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)
HYDROGENATED COCO-GLYCERIDES (UNII: XDD37N2GPR)
CHLORPHENESIN (UNII: I670DAL4SZ)
CI 77491 (UNII: 1K09F3G675)
POLYETHYLENE (UNII: UG00KM4WR7)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
GLYCINE SOJA (SOYBEAN) SEED (UNII: L7HT8F1ZOD)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
IRVINGIA GABONENSIS KERNEL BUTTER (UNII: 8Y12O726LX)
WATER (UNII: 059QF0KO0R)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
CARNAUBA WAX (UNII: R12CBM0EIZ)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
TERPINEOL (UNII: R53Q4ZWC99)
CI 42090 (UNII: H3R47K3TBD)
PELARGONIUM GRAVEOLENS FLOWER OIL (UNII: 3K0J1S7QGC)
D&C RED NO. 6 (UNII: 481744AI4O)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
ISOPROPYL TITANIUM TRIISOSTEARATE (UNII: 949E3KBJ1I)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
GERANIOL (UNII: L837108USY)
HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)
BEESWAX (UNII: 2ZA36H0S2V)
BENZYL BENZOATE (UNII: N863NB338G)
CI 77492 (UNII: EX438O2MRT)
CI 77499 (UNII: XM0M87F357)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
BUTYROSPERMUM PARKII (SHEA) BUTTER UNSAPONIFIABLES (UNII: 0C9AC7D6XU)
CAPRYLIC/CAPRIC TRIGLYCERIDE (UNII: C9H2L21V7U)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
ISODODECANE (UNII: A8289P68Y2)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
JOJOBA OIL (UNII: 724GKU717M)
OCTYLDODECANOL (UNII: 461N1O614Y)
SODIUM SACCHARIN (UNII: SB8ZUX40TY)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
SHEA BUTTER (UNII: K49155WL9Y)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
ARGAN OIL (UNII: 4V59G5UW9X)
CROTON LECHLERI RESIN (UNII: GGG6W25C63)
ASCORBYL TETRAISOPALMITATE (UNII: 47143LT58A)
HYDROLYZED SOY PROTEIN (ENZYMATIC; 2000 MW) (UNII: 1394NXB9L6)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
HYDROGENATED POLYISOBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248)
MENTHYL LACTATE (UNII: 2BF9E65L7I)
PROLINE (UNII: 9DLQ4CIU6V)
GLYCERIN (UNII: PDC6A3C0OX)
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)
LUFFA CYLINDRICA SEED OIL (UNII: 1A281RJ859)
RICE AMINO ACIDS (UNII: 5ET1T25H82)
RED 40 LAKE (UNII: 6T47AS764T)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:14141-464-01	1 in 1 BOX	12/11/2025
1		2 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	12/11/2025

Labeler - BEL STAR S A (880160197)

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Published Date (What is this?)	Version	Files
Dec 12, 2025	2 (current)	download
Nov 4, 2024	1	download

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	NDC
1	14141-350-01
2	14141-351-01
3	14141-352-01
4	14141-353-01
5	14141-463-01
6	14141-464-01

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