Drug Facts

Active ingredients

Octinoxate 5.00%

Zinc oxide 4.20%

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

Water, Dimethicone, Isododecane, Peg-10 Dimethicone, Trimethylsiloxysilicate, Propylene Glycol, Mica, Dimethicone/vinyl Dimethicone Crosspolymer, Peg/ppg-18/18 Dimethicone, Polysilicone-11, Glycerin, Lecithin, Sodium Chloride, Phenoxyethanol, Silica, Silica Dimethyl Silylate, Backhousia Citriodora Leaf Extract, Maltodextrin, Caprylyl Glycol, Disteardimonium Hectorite, Hydroxyethyl Urea, Peg-8 Caprylic/capric Glycerides, Chlorphenesin, Tocopheryl Acetate, Lactobacillus Ferment, Octyldodeceth-25, Perfluorohexylethyl Triethoxysilane, Sodium Hyaluronate, Decylene Glycol.

May Contain: Titanium Dioxide, Iron Oxides, Triethoxycaprylylsilane.

Package Label CHAMPAGNE 170-N

Package Label CAPUCCINO 310-C

Package Label LATTE 180-F

Package Label BEIGE 220-C

Package Label ALMENDRA 230-N

LBEL SOLUTIONS PRO-HIALURON BASE SERUM CON ACIDO HIALURONICO FPS 20 SERUM FOUNDATION WITH HYALURONIC ACID SPF 20 CHAMPAGNE 170-N
octinoxate, zinc oxide emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:14141-321
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	50 mg in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	42 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
BACKHOUSIA CITRIODORA LEAF (UNII: FKN73KG747)
PEG-8 CAPRYLIC/CAPRIC GLYCERIDES (UNII: 00BT03FSO2)
PERFLUOROOCTYL TRIETHOXYSILANE (UNII: 814P46684U)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
HYDROXYETHYL UREA (UNII: MBQ7DDQ7AR)
CHLORPHENESIN (UNII: I670DAL4SZ)
LIMOSILACTOBACILLUS FERMENTUM (UNII: 2C1F12C6AP)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
FERRIC OXIDE RED (UNII: 1K09F3G675)
GLYCERIN (UNII: PDC6A3C0OX)
OCTYLDODECETH-25 (UNII: F8934HEL3M)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
DECYLENE GLYCOL (UNII: S57M60MI88)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
DIMETHICONE (UNII: 92RU3N3Y1O)
PEG-10 DIMETHICONE (220 CST) (UNII: 287GF3Y3WC)
ISODODECANE (UNII: A8289P68Y2)
TRIMETHYLSILOXYSILICATE (M/Q 0.8-1.0) (UNII: 25LXE464L2)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
MICA (UNII: V8A1AW0880)
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:14141-321-01	1 in 1 BOX	02/20/2023
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 final	M020	02/20/2023

LBEL SOLUTIONS PRO-HIALURON BASE SERUM CON ACIDO HIALURONICO FPS 20 SERUM FOUNDATION WITH HYALURONIC ACID SPF 20 CAPUCCINO 310-C
octinoxate, zinc oxide emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:14141-322
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	50 mg in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	42 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
BACKHOUSIA CITRIODORA LEAF (UNII: FKN73KG747)
PEG-8 CAPRYLIC/CAPRIC GLYCERIDES (UNII: 00BT03FSO2)
PERFLUOROOCTYL TRIETHOXYSILANE (UNII: 814P46684U)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
HYDROXYETHYL UREA (UNII: MBQ7DDQ7AR)
CHLORPHENESIN (UNII: I670DAL4SZ)
LIMOSILACTOBACILLUS FERMENTUM (UNII: 2C1F12C6AP)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
FERRIC OXIDE RED (UNII: 1K09F3G675)
GLYCERIN (UNII: PDC6A3C0OX)
OCTYLDODECETH-25 (UNII: F8934HEL3M)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
DECYLENE GLYCOL (UNII: S57M60MI88)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
DIMETHICONE (UNII: 92RU3N3Y1O)
PEG-10 DIMETHICONE (220 CST) (UNII: 287GF3Y3WC)
ISODODECANE (UNII: A8289P68Y2)
TRIMETHYLSILOXYSILICATE (M/Q 0.8-1.0) (UNII: 25LXE464L2)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
MICA (UNII: V8A1AW0880)
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:14141-322-01	1 in 1 BOX	02/20/2023
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 final	M020	02/20/2023

LBEL SOLUTIONS PRO-HIALURON BASE SERUM CON ACIDO HIALURONICO FPS 20 SERUM FOUNDATION WITH HYALURONIC ACID SPF 20 LATTE 180-F
octinoxate, zinc oxide emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:14141-323
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	50 mg in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	42 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
BACKHOUSIA CITRIODORA LEAF (UNII: FKN73KG747)
PEG-8 CAPRYLIC/CAPRIC GLYCERIDES (UNII: 00BT03FSO2)
PERFLUOROOCTYL TRIETHOXYSILANE (UNII: 814P46684U)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
HYDROXYETHYL UREA (UNII: MBQ7DDQ7AR)
CHLORPHENESIN (UNII: I670DAL4SZ)
LIMOSILACTOBACILLUS FERMENTUM (UNII: 2C1F12C6AP)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
FERRIC OXIDE RED (UNII: 1K09F3G675)
GLYCERIN (UNII: PDC6A3C0OX)
OCTYLDODECETH-25 (UNII: F8934HEL3M)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
DECYLENE GLYCOL (UNII: S57M60MI88)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
DIMETHICONE (UNII: 92RU3N3Y1O)
PEG-10 DIMETHICONE (220 CST) (UNII: 287GF3Y3WC)
ISODODECANE (UNII: A8289P68Y2)
TRIMETHYLSILOXYSILICATE (M/Q 0.8-1.0) (UNII: 25LXE464L2)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
MICA (UNII: V8A1AW0880)
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:14141-323-01	1 in 1 BOX	02/20/2023
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 final	M020	02/20/2023

LBEL SOLUTIONS PRO-HIALURON BASE SERUM CON ACIDO HIALURONICO FPS 20 SERUM FOUNDATION WITH HYALURONIC ACID SPF 20 BEIGE 220-C
octinoxate, zinc oxide emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:14141-324
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	50 mg in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	42 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
BACKHOUSIA CITRIODORA LEAF (UNII: FKN73KG747)
PEG-8 CAPRYLIC/CAPRIC GLYCERIDES (UNII: 00BT03FSO2)
PERFLUOROOCTYL TRIETHOXYSILANE (UNII: 814P46684U)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
HYDROXYETHYL UREA (UNII: MBQ7DDQ7AR)
CHLORPHENESIN (UNII: I670DAL4SZ)
LIMOSILACTOBACILLUS FERMENTUM (UNII: 2C1F12C6AP)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
FERRIC OXIDE RED (UNII: 1K09F3G675)
GLYCERIN (UNII: PDC6A3C0OX)
OCTYLDODECETH-25 (UNII: F8934HEL3M)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
DECYLENE GLYCOL (UNII: S57M60MI88)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
DIMETHICONE (UNII: 92RU3N3Y1O)
PEG-10 DIMETHICONE (220 CST) (UNII: 287GF3Y3WC)
ISODODECANE (UNII: A8289P68Y2)
TRIMETHYLSILOXYSILICATE (M/Q 0.8-1.0) (UNII: 25LXE464L2)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
MICA (UNII: V8A1AW0880)
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:14141-324-01	1 in 1 BOX	02/20/2023
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 final	M020	02/20/2023

LBEL SOLUTIONS PRO-HIALURON BASE SERUM CON ACIDO HIALURONICO FPS 20 SERUM FOUNDATION WITH HYALURONIC ACID SPF 20 ALMENDRA 230-N
octinoxate, zinc oxide emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:14141-325
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	50 mg in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	42 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
BACKHOUSIA CITRIODORA LEAF (UNII: FKN73KG747)
PEG-8 CAPRYLIC/CAPRIC GLYCERIDES (UNII: 00BT03FSO2)
PERFLUOROOCTYL TRIETHOXYSILANE (UNII: 814P46684U)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
HYDROXYETHYL UREA (UNII: MBQ7DDQ7AR)
CHLORPHENESIN (UNII: I670DAL4SZ)
LIMOSILACTOBACILLUS FERMENTUM (UNII: 2C1F12C6AP)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
FERRIC OXIDE RED (UNII: 1K09F3G675)
GLYCERIN (UNII: PDC6A3C0OX)
OCTYLDODECETH-25 (UNII: F8934HEL3M)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
DECYLENE GLYCOL (UNII: S57M60MI88)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
DIMETHICONE (UNII: 92RU3N3Y1O)
PEG-10 DIMETHICONE (220 CST) (UNII: 287GF3Y3WC)
ISODODECANE (UNII: A8289P68Y2)
TRIMETHYLSILOXYSILICATE (M/Q 0.8-1.0) (UNII: 25LXE464L2)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
MICA (UNII: V8A1AW0880)
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:14141-325-01	1 in 1 BOX	02/20/2023
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 final	M020	02/20/2023

Labeler - BEL STAR SA (880160197)

LBEL SOLUTIONS PRO-HIALURON BASE SERUM CON ACIDO HIALURONICO FPS 20 SERUM FOUNDATION WITH HYALURONIC ACID SPF 20