Active Ingredients

OCTINOXATE 6.00 %

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 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

Dimethicone, isododecane, water, mica, glycerin, trimethylsiloxysilicate, peg-10 dimethicone, hdi/trimethylol hexyllactone crosspolymer, alcohol denat., hydroxyethyl urea, peg/ppg-18/18 dimethicone, dimethicone/vinyl dimethicone crosspolymer, sodium pca, polysilicone-11, lecithin, phenoxyethanol, silica, sodium chloride, niacinamide, silica dimethyl silylate, triethoxycaprylylsilane, caprylyl glycol, disteardimonium hectorite, chlorphenesin, fragrance, panthenol, tocopheryl acetate, saccharomyces lysate, perfluorohexylethyl triethoxysilane, disodium succinate, glutamic acid, glycine, threonine, valine, amyl salicylate, tetramethyl acetyloctahydronaphthalenes. MAY CONTAIN : titanium dioxide, iron oxides.

Product Label CHAMPAGNE 170N

Product Label LATTE 180F

Product Label BEIGE 220C

Product Label ALMENDRA 230N

Product Label CAPUCCINO 310C

LBEL SOLUTIONS PRO-NUDE SKIN ULTRA-LIGHT SERUM FOUNDATION WITH NIACINAMIDE SPF 20 CHAMPAGNE 170N
octinoxate, zinc oxide emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:14141-377
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	60 mg in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	29.4 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)
DISODIUM SUCCINATE (UNII: V8ZGC8ISR3)
GLUTAMIC ACID (UNII: 3KX376GY7L)
VALINE (UNII: HG18B9YRS7)
AMYL SALICYLATE (UNII: VZO9C30208)
TETRAMETHYL ACETYLOCTAHYDRONAPHTHALENES (UNII: 2JU6ZH6GRE)
SODIUM PCA (UNII: 469OTG57A2)
NIACINAMIDE (UNII: 25X51I8RD4)
PANTHENOL (UNII: WV9CM0O67Z)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
PEG-10 DIMETHICONE (220 CST) (UNII: 287GF3Y3WC)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
GLYCERIN (UNII: PDC6A3C0OX)
HDI/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)
ISODODECANE (UNII: A8289P68Y2)
LECITHIN, SUNFLOWER (UNII: 834K0WOS5G)
WATER (UNII: 059QF0KO0R)
GLYCINE (UNII: TE7660XO1C)
THREONINE (UNII: 2ZD004190S)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
CHLORPHENESIN (UNII: I670DAL4SZ)
SACCHAROMYCES LYSATE (UNII: R85W246Z1C)
FERROUS OXIDE (UNII: G7036X8B5H)
DIMETHICONE (UNII: 92RU3N3Y1O)
MICA (UNII: V8A1AW0880)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
HYDROXYETHYL UREA (UNII: MBQ7DDQ7AR)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
ALCOHOL (UNII: 3K9958V90M)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:14141-377-01	1 in 1 BOX	03/03/2025
1		26 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	03/03/2025

LBEL SOLUTIONS PRO-NUDE SKIN ULTRA-LIGHT SERUM FOUNDATION WITH NIACINAMIDE SPF 20 CAPUCCINO 310C
octinoxate, zinc oxide emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:14141-381
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	60 mg in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	29.4 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)
DISODIUM SUCCINATE (UNII: V8ZGC8ISR3)
GLUTAMIC ACID (UNII: 3KX376GY7L)
VALINE (UNII: HG18B9YRS7)
AMYL SALICYLATE (UNII: VZO9C30208)
TETRAMETHYL ACETYLOCTAHYDRONAPHTHALENES (UNII: 2JU6ZH6GRE)
SODIUM PCA (UNII: 469OTG57A2)
NIACINAMIDE (UNII: 25X51I8RD4)
PANTHENOL (UNII: WV9CM0O67Z)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
PEG-10 DIMETHICONE (220 CST) (UNII: 287GF3Y3WC)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
GLYCERIN (UNII: PDC6A3C0OX)
HDI/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)
ISODODECANE (UNII: A8289P68Y2)
LECITHIN, SUNFLOWER (UNII: 834K0WOS5G)
WATER (UNII: 059QF0KO0R)
GLYCINE (UNII: TE7660XO1C)
THREONINE (UNII: 2ZD004190S)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
CHLORPHENESIN (UNII: I670DAL4SZ)
SACCHAROMYCES LYSATE (UNII: R85W246Z1C)
FERROUS OXIDE (UNII: G7036X8B5H)
DIMETHICONE (UNII: 92RU3N3Y1O)
MICA (UNII: V8A1AW0880)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
HYDROXYETHYL UREA (UNII: MBQ7DDQ7AR)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
ALCOHOL (UNII: 3K9958V90M)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:14141-381-01	1 in 1 BOX	03/03/2025
1		26 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	03/03/2025

LBEL SOLUTIONS PRO-NUDE SKIN ULTRA-LIGHT SERUM FOUNDATION WITH NIACINAMIDE SPF 20 LATTE 180F
octinoxate, zinc oxide emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:14141-378
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	60 mg in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	29.4 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)
DISODIUM SUCCINATE (UNII: V8ZGC8ISR3)
GLUTAMIC ACID (UNII: 3KX376GY7L)
VALINE (UNII: HG18B9YRS7)
AMYL SALICYLATE (UNII: VZO9C30208)
TETRAMETHYL ACETYLOCTAHYDRONAPHTHALENES (UNII: 2JU6ZH6GRE)
SODIUM PCA (UNII: 469OTG57A2)
NIACINAMIDE (UNII: 25X51I8RD4)
PANTHENOL (UNII: WV9CM0O67Z)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
PEG-10 DIMETHICONE (220 CST) (UNII: 287GF3Y3WC)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
GLYCERIN (UNII: PDC6A3C0OX)
HDI/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)
ISODODECANE (UNII: A8289P68Y2)
LECITHIN, SUNFLOWER (UNII: 834K0WOS5G)
WATER (UNII: 059QF0KO0R)
GLYCINE (UNII: TE7660XO1C)
THREONINE (UNII: 2ZD004190S)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
CHLORPHENESIN (UNII: I670DAL4SZ)
SACCHAROMYCES LYSATE (UNII: R85W246Z1C)
FERROUS OXIDE (UNII: G7036X8B5H)
DIMETHICONE (UNII: 92RU3N3Y1O)
MICA (UNII: V8A1AW0880)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
HYDROXYETHYL UREA (UNII: MBQ7DDQ7AR)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
ALCOHOL (UNII: 3K9958V90M)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:14141-378-01	1 in 1 BOX	03/03/2025
1		26 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	03/03/2025

LBEL SOLUTIONS PRO-NUDE SKIN ULTRA-LIGHT SERUM FOUNDATION WITH NIACINAMIDE SPF 20 ALMENDRA 230N
octinoxate, zinc oxide emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:14141-380
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	60 mg in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	29.4 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
SODIUM CHLORIDE (UNII: 451W47IQ8X)
HYDROXYETHYL UREA (UNII: MBQ7DDQ7AR)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
ALCOHOL (UNII: 3K9958V90M)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)
DISODIUM SUCCINATE (UNII: V8ZGC8ISR3)
GLUTAMIC ACID (UNII: 3KX376GY7L)
VALINE (UNII: HG18B9YRS7)
AMYL SALICYLATE (UNII: VZO9C30208)
TETRAMETHYL ACETYLOCTAHYDRONAPHTHALENES (UNII: 2JU6ZH6GRE)
SODIUM PCA (UNII: 469OTG57A2)
NIACINAMIDE (UNII: 25X51I8RD4)
PANTHENOL (UNII: WV9CM0O67Z)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
PEG-10 DIMETHICONE (220 CST) (UNII: 287GF3Y3WC)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
GLYCERIN (UNII: PDC6A3C0OX)
HDI/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)
ISODODECANE (UNII: A8289P68Y2)
LECITHIN, SUNFLOWER (UNII: 834K0WOS5G)
WATER (UNII: 059QF0KO0R)
GLYCINE (UNII: TE7660XO1C)
THREONINE (UNII: 2ZD004190S)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
CHLORPHENESIN (UNII: I670DAL4SZ)
SACCHAROMYCES LYSATE (UNII: R85W246Z1C)
FERROUS OXIDE (UNII: G7036X8B5H)
DIMETHICONE (UNII: 92RU3N3Y1O)
MICA (UNII: V8A1AW0880)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:14141-380-01	1 in 1 BOX	03/03/2025
1		26 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	03/03/2025

LBEL SOLUTIONS PRO-NUDE SKIN ULTRA-LIGHT SERUM FOUNDATION WITH NIACINAMIDE SPF 20 BEIGE 220C
octinoxate, zinc oxide emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:14141-379
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	60 mg in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	29.4 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)
DISODIUM SUCCINATE (UNII: V8ZGC8ISR3)
GLUTAMIC ACID (UNII: 3KX376GY7L)
VALINE (UNII: HG18B9YRS7)
AMYL SALICYLATE (UNII: VZO9C30208)
TETRAMETHYL ACETYLOCTAHYDRONAPHTHALENES (UNII: 2JU6ZH6GRE)
SODIUM PCA (UNII: 469OTG57A2)
NIACINAMIDE (UNII: 25X51I8RD4)
PANTHENOL (UNII: WV9CM0O67Z)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
PEG-10 DIMETHICONE (220 CST) (UNII: 287GF3Y3WC)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
GLYCERIN (UNII: PDC6A3C0OX)
HDI/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)
ISODODECANE (UNII: A8289P68Y2)
LECITHIN, SUNFLOWER (UNII: 834K0WOS5G)
WATER (UNII: 059QF0KO0R)
GLYCINE (UNII: TE7660XO1C)
THREONINE (UNII: 2ZD004190S)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
CHLORPHENESIN (UNII: I670DAL4SZ)
SACCHAROMYCES LYSATE (UNII: R85W246Z1C)
FERROUS OXIDE (UNII: G7036X8B5H)
DIMETHICONE (UNII: 92RU3N3Y1O)
MICA (UNII: V8A1AW0880)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
HYDROXYETHYL UREA (UNII: MBQ7DDQ7AR)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
ALCOHOL (UNII: 3K9958V90M)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:14141-379-01	1 in 1 BOX	03/03/2025
1		26 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	03/03/2025

Labeler - BEL STAR S.A. (880160197)

Name	Address	ID/FEI	Business Operations
Establishment
BEL STAR S.A.		880160197	manufacture(14141-377, 14141-378, 14141-379, 14141-380, 14141-381)