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

Dimethicone, water, isododecane, peg-10 dimethicone, trimethylsiloxysilicate, glycerin, polymethylsilsesquioxane, propylene glycol, peg/ppg-18/18 dimethicone, hdi/trimethylol hexyllactone crosspolymer, polysilicone-11, dimethicone/vinyl dimethicone crosspolymer, sodium chloride, phenoxyethanol, silica, lecithin, silica dimethyl silylate, tocopheryl acetate, caprylyl glycol, triethoxycaprylylsilane, butylene glycol, chlorphenesin, disteardimonium hectorite, fragrance, kaolin, mica, camellia sinensis leaf extract, enantia chlorantha bark extract, aesculus hippocastanum (horse chestnut) seed extract, hydrolyzed wheat protein, silybum marianum fruit extract, potassium sorbate, sodium benzoate, oleanolic acid.

May Contain :

Titanium dioxide, iron oxides.

LATTE 180-F

CHAMPAGNE 170-N

ALMENDRA 230-N

BEIGE 220-C

CAPUCCINO 310-C

LBEL FOREVER ULTRA MATTE BASE CONTROL BRILLO DE LARGA DURACION FPS 15 SHINE CONTROL LONGWEAR FOUNDATION SPF 15 LATTE 180-F
octinoxate, zinc oxide emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:14141-316
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
MICA (UNII: V8A1AW0880)
ANNICKIA CHLORANTHA BARK (UNII: H70115MP4A)
HYDROLYZED WHEAT PROTEIN (ENZYMATIC, 3000 MW) (UNII: J2S07SB0YL)
MILK THISTLE (UNII: U946SH95EE)
WATER (UNII: 059QF0KO0R)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
KAOLIN (UNII: 24H4NWX5CO)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SODIUM BENZOATE (UNII: OJ245FE5EU)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
PEG-10 DIMETHICONE (220 CST) (UNII: 287GF3Y3WC)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CHLORPHENESIN (UNII: I670DAL4SZ)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
DIMETHICONE (UNII: 92RU3N3Y1O)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
OLEANOLIC ACID (UNII: 6SMK8R7TGJ)
HORSE CHESTNUT (UNII: 3C18L6RJAZ)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
ISODODECANE (UNII: A8289P68Y2)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:14141-316-01	1 in 1 BOX	11/30/2022
1		27 mL 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 final	M020	11/30/2022

LBEL FOREVER ULTRA MATTE BASE CONTROL BRILLO DE LARGA DURACION FPS 15 SHINE CONTROL LONGWEAR FOUNDATION SPF 15 ALMENDRA 230-N
octinoxate, zinc oxide emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:14141-318
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
MICA (UNII: V8A1AW0880)
ANNICKIA CHLORANTHA BARK (UNII: H70115MP4A)
HYDROLYZED WHEAT PROTEIN (ENZYMATIC, 3000 MW) (UNII: J2S07SB0YL)
MILK THISTLE (UNII: U946SH95EE)
WATER (UNII: 059QF0KO0R)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
KAOLIN (UNII: 24H4NWX5CO)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SODIUM BENZOATE (UNII: OJ245FE5EU)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
PEG-10 DIMETHICONE (220 CST) (UNII: 287GF3Y3WC)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CHLORPHENESIN (UNII: I670DAL4SZ)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
DIMETHICONE (UNII: 92RU3N3Y1O)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
OLEANOLIC ACID (UNII: 6SMK8R7TGJ)
HORSE CHESTNUT (UNII: 3C18L6RJAZ)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
ISODODECANE (UNII: A8289P68Y2)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:14141-318-01	1 in 1 BOX	11/30/2022
1		27 mL 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 final	M020	11/30/2022

LBEL FOREVER ULTRA MATTE BASE CONTROL BRILLO DE LARGA DURACION FPS 15 SHINE CONTROL LONGWEAR FOUNDATION SPF 15 BEIGE 220-C
octinoxate, zinc oxide emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:14141-319
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
MICA (UNII: V8A1AW0880)
ANNICKIA CHLORANTHA BARK (UNII: H70115MP4A)
HYDROLYZED WHEAT PROTEIN (ENZYMATIC, 3000 MW) (UNII: J2S07SB0YL)
MILK THISTLE (UNII: U946SH95EE)
WATER (UNII: 059QF0KO0R)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
KAOLIN (UNII: 24H4NWX5CO)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SODIUM BENZOATE (UNII: OJ245FE5EU)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
PEG-10 DIMETHICONE (220 CST) (UNII: 287GF3Y3WC)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CHLORPHENESIN (UNII: I670DAL4SZ)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
DIMETHICONE (UNII: 92RU3N3Y1O)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
OLEANOLIC ACID (UNII: 6SMK8R7TGJ)
HORSE CHESTNUT (UNII: 3C18L6RJAZ)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
ISODODECANE (UNII: A8289P68Y2)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:14141-319-01	1 in 1 BOX	11/30/2022
1		27 mL 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 final	M020	11/30/2022

LBEL FOREVER ULTRA MATTE BASE CONTROL BRILLO DE LARGA DURACION FPS 15 SHINE CONTROL LONGWEAR FOUNDATION SPF 15 CAPUCCINO 310-C
octinoxate, zinc oxide emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:14141-320
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
MICA (UNII: V8A1AW0880)
ANNICKIA CHLORANTHA BARK (UNII: H70115MP4A)
HYDROLYZED WHEAT PROTEIN (ENZYMATIC, 3000 MW) (UNII: J2S07SB0YL)
MILK THISTLE (UNII: U946SH95EE)
WATER (UNII: 059QF0KO0R)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
KAOLIN (UNII: 24H4NWX5CO)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SODIUM BENZOATE (UNII: OJ245FE5EU)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
PEG-10 DIMETHICONE (220 CST) (UNII: 287GF3Y3WC)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CHLORPHENESIN (UNII: I670DAL4SZ)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
DIMETHICONE (UNII: 92RU3N3Y1O)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
OLEANOLIC ACID (UNII: 6SMK8R7TGJ)
HORSE CHESTNUT (UNII: 3C18L6RJAZ)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
ISODODECANE (UNII: A8289P68Y2)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:14141-320-01	1 in 1 BOX	11/30/2022
1		27 mL 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 final	M020	11/30/2022

LBEL FOREVER ULTRA MATTE BASE CONTROL BRILLO DE LARGA DURACION FPS 15 SHINE CONTROL LONGWEAR FOUNDATION SPF 15 CHAMPAGNE 170-N
octinoxate, zinc oxide emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:14141-317
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
MICA (UNII: V8A1AW0880)
ANNICKIA CHLORANTHA BARK (UNII: H70115MP4A)
HYDROLYZED WHEAT PROTEIN (ENZYMATIC, 3000 MW) (UNII: J2S07SB0YL)
MILK THISTLE (UNII: U946SH95EE)
WATER (UNII: 059QF0KO0R)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
KAOLIN (UNII: 24H4NWX5CO)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SODIUM BENZOATE (UNII: OJ245FE5EU)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
PEG-10 DIMETHICONE (220 CST) (UNII: 287GF3Y3WC)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CHLORPHENESIN (UNII: I670DAL4SZ)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
DIMETHICONE (UNII: 92RU3N3Y1O)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
OLEANOLIC ACID (UNII: 6SMK8R7TGJ)
HORSE CHESTNUT (UNII: 3C18L6RJAZ)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
ISODODECANE (UNII: A8289P68Y2)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:14141-317-01	1 in 1 BOX	11/30/2022
1		27 mL 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 final	M020	11/30/2022

Labeler - Bel Star S.A. (880160197)

L'BEL FOREVER ULTRA MATTE BASE CONTROL BRILLO DE LARGA DURACIÓN FPS 15 SHINE CONTROL LONGWEAR FOUNDATION SPF 15