Drug Facts

Active Ingredients

Octinoxate 4.50%

Zinc oxide 2.94%

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 hep 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

Dimethicone, water, isododecane, trimethylsiloxysilicate, peg-10 dimethicone, glycerin, polysilicone-11, peg/ppg-18/18 dimethicone, polymethylsilsesquioxane, hydroxyethyl urea, hdi/trimethylol hexyllactone crosspolymer, dimethicone/vinyl dimethicone crosspolymer, sodium chloride, phenoxyethano, butylene glycol, silica, silica dimethyl silylate, triethoxycaprylylsilane, caprylyl glycol, disteardimonium hectorite, chlorphenesin, tocopheryl acetate, sucrose palmitate, glyceryl linoleate, carbomer, laureth-12, backhousia citriodora leaf extract, polysorbate 20, benzyl alcohol, citric acid, potassium sorbate, sodium hyaluronate, ethylhexylglycerin, palmitoyl tripeptide-1, palmitoyl tetrapeptide-7.

May Contain: titanium dioxide, iron oxides.

Product Packaging - CHAMPAGNE 170-N

Product Packaging - LATTE 180-F

Product Packaging - BEIGE 220-C

Product Packaging - ALMENDRA 230-N

Product Packaging - CAPUCCINO 310-C

LBEL SOLUTIONS PRO-HIALURON BASE SERUM CON EFECTO RELLENO DE ARRUGAS FPS 15 WRINKLE FILLER EFFECT SERUM FOUNDATION SPF 15 CAPUCCINO 310-C
octinoxate, zinc oxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:14141-337
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	29.4 mg in 1 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	45 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
CHLORPHENESIN (UNII: I670DAL4SZ)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
HYDROXYETHYL UREA (UNII: MBQ7DDQ7AR)
FERRIC OXIDE RED (UNII: 1K09F3G675)
LAURETH-12 (UNII: OAH19558U1)
BACKHOUSIA CITRIODORA LEAF (UNII: FKN73KG747)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
DIMETHICONE (UNII: 92RU3N3Y1O)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)
PALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R)
ISODODECANE (UNII: A8289P68Y2)
GLYCERIN (UNII: PDC6A3C0OX)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
SUCROSE PALMITATE (UNII: 3OSQ643ZK5)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
WATER (UNII: 059QF0KO0R)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
GLYCERYL LINOLEATE (UNII: 7B8K5VPO5S)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
PALMITOYL TRIPEPTIDE-1 (UNII: RV743D216M)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
BENZYL ALCOHOL (UNII: LKG8494WBH)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:14141-337-01	1 in 1 BOX	12/14/2023
1		30 mL in 1 BOTTLE, GLASS; 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	12/14/2023

LBEL SOLUTIONS PRO-HIALURON BASE SERUM CON EFECTO RELLENO DE ARRUGAS FPS 15 WRINKLE FILLER EFFECT SERUM FOUNDATION SPF 15 BEIGE 220-C
octinoxate, zinc oxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:14141-335
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	29.4 mg in 1 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	45 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
CHLORPHENESIN (UNII: I670DAL4SZ)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
HYDROXYETHYL UREA (UNII: MBQ7DDQ7AR)
FERRIC OXIDE RED (UNII: 1K09F3G675)
LAURETH-12 (UNII: OAH19558U1)
BACKHOUSIA CITRIODORA LEAF (UNII: FKN73KG747)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
DIMETHICONE (UNII: 92RU3N3Y1O)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)
PALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R)
ISODODECANE (UNII: A8289P68Y2)
GLYCERIN (UNII: PDC6A3C0OX)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
SUCROSE PALMITATE (UNII: 3OSQ643ZK5)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
WATER (UNII: 059QF0KO0R)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
GLYCERYL LINOLEATE (UNII: 7B8K5VPO5S)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
PALMITOYL TRIPEPTIDE-1 (UNII: RV743D216M)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
BENZYL ALCOHOL (UNII: LKG8494WBH)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:14141-335-01	1 in 1 BOX	12/14/2023
1		30 mL in 1 BOTTLE, GLASS; 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	12/14/2023

LBEL SOLUTIONS PRO-HIALURON BASE SERUM CON EFECTO RELLENO DE ARRUGAS FPS 15 WRINKLE FILLER EFFECT SERUM FOUNDATION SPF 15 LATTE 180-F
octinoxate, zinc oxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:14141-334
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	29.4 mg in 1 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	45 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
CHLORPHENESIN (UNII: I670DAL4SZ)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
HYDROXYETHYL UREA (UNII: MBQ7DDQ7AR)
FERRIC OXIDE RED (UNII: 1K09F3G675)
LAURETH-12 (UNII: OAH19558U1)
BACKHOUSIA CITRIODORA LEAF (UNII: FKN73KG747)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
DIMETHICONE (UNII: 92RU3N3Y1O)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)
PALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R)
ISODODECANE (UNII: A8289P68Y2)
GLYCERIN (UNII: PDC6A3C0OX)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
SUCROSE PALMITATE (UNII: 3OSQ643ZK5)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
WATER (UNII: 059QF0KO0R)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
GLYCERYL LINOLEATE (UNII: 7B8K5VPO5S)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
PALMITOYL TRIPEPTIDE-1 (UNII: RV743D216M)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
BENZYL ALCOHOL (UNII: LKG8494WBH)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:14141-334-01	1 in 1 BOX	12/14/2023
1		30 mL in 1 BOTTLE, GLASS; 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	12/14/2023

LBEL SOLUTIONS PRO-HIALURON BASE SERUM CON EFECTO RELLENO DE ARRUGAS FPS 15 WRINKLE FILLER EFFECT SERUM FOUNDATION SPF 15 ALMENDRA 230-N
octinoxate, zinc oxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:14141-336
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	29.4 mg in 1 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	45 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
CHLORPHENESIN (UNII: I670DAL4SZ)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
HYDROXYETHYL UREA (UNII: MBQ7DDQ7AR)
FERRIC OXIDE RED (UNII: 1K09F3G675)
LAURETH-12 (UNII: OAH19558U1)
BACKHOUSIA CITRIODORA LEAF (UNII: FKN73KG747)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
DIMETHICONE (UNII: 92RU3N3Y1O)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)
PALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R)
ISODODECANE (UNII: A8289P68Y2)
GLYCERIN (UNII: PDC6A3C0OX)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
SUCROSE PALMITATE (UNII: 3OSQ643ZK5)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
WATER (UNII: 059QF0KO0R)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
GLYCERYL LINOLEATE (UNII: 7B8K5VPO5S)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
PALMITOYL TRIPEPTIDE-1 (UNII: RV743D216M)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
BENZYL ALCOHOL (UNII: LKG8494WBH)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:14141-336-01	1 in 1 BOX	12/14/2023
1		30 mL in 1 BOTTLE, GLASS; 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	12/14/2023

LBEL SOLUTIONS PRO-HIALURON BASE SERUM CON EFECTO RELLENO DE ARRUGAS FPS 15 WRINKLE FILLER EFFECT SERUM FOUNDATION SPF 15 CHAMPAGNE 170-N
octinoxate, zinc oxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:14141-333
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	29.4 mg in 1 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	45 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
LAURETH-12 (UNII: OAH19558U1)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
WATER (UNII: 059QF0KO0R)
CHLORPHENESIN (UNII: I670DAL4SZ)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
HYDROXYETHYL UREA (UNII: MBQ7DDQ7AR)
FERRIC OXIDE RED (UNII: 1K09F3G675)
BACKHOUSIA CITRIODORA LEAF (UNII: FKN73KG747)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
DIMETHICONE (UNII: 92RU3N3Y1O)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)
PALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R)
ISODODECANE (UNII: A8289P68Y2)
GLYCERIN (UNII: PDC6A3C0OX)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
SUCROSE PALMITATE (UNII: 3OSQ643ZK5)
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
GLYCERYL LINOLEATE (UNII: 7B8K5VPO5S)
BENZYL ALCOHOL (UNII: LKG8494WBH)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
PALMITOYL TRIPEPTIDE-1 (UNII: RV743D216M)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:14141-333-01	1 in 1 BOX	12/14/2023
1		30 mL in 1 BOTTLE, GLASS; 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	12/14/2023

Labeler - BEL STAR S.A. (880160197)

L'BEL SOLUTIONS PRO-HIALURON BASE SERUM CON EFECTO RELLENO DE ARRUGAS FPS 15 WRINKLE FILLER EFFECT SERUM FOUNDATION SPF 15