Drug Facts

Active ingredients

Octinoxate 5.00%

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
Childrend 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, glycerin, polymethylsilsesquioxane, polymethylsilsesquioxane/trimethylsiloxysilicate, saccharide isomerate, hdi/trimethylol hexyllactone crosspolymer, hydroxyethyl urea, peg/ppg-18/18 dimethicone, peg-10 dimethicone, zea mays (corn) starch (zea mays starch), polysilicone-11, silica, sodium pca, dimethicone/vinyl dimethicone crosspolymer, phenoxyethanol, sorbitan sesquioleate, triethoxycaprylylsilane, caprylyl glycol, erythritol, chlorphenesin, disteardimonium hectorite, fragrance (parfum), niacinamide, tocopheryl acetate, peg-8 caprylic/capric glycerides, octyldodeceth-25, sodium hyaluronate, homarine hcl, propylene glycol, decylene glycol.

May Contain: Titanium dioxide, iron oxides.

Packaging - LATTE 180-F

Packaging - BEIGE 220-C

Packaging - ALMENDRA 230-N

Packaging - CAPUCCINO 310-C

Packaging - CHAMPAGNE 170-N

LBEL FOREVER HYDRA BASE HIDRATANTE DE LARGA DURACION FPS 15 HYDRATING LONGWEAR FOUNDATION SPF 15 CAPUCCINO 310-C
octinoxate, zinc oxide emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:14141-313
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	29.4 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
STARCH, CORN (UNII: O8232NY3SJ)
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
GLYCERIN (UNII: PDC6A3C0OX)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
CHLORPHENESIN (UNII: I670DAL4SZ)
OCTYLDODECETH-25 (UNII: F8934HEL3M)
POLYMETHYLSILSESQUIOXANE/TRIMETHYLSILOXYSILICATE (UNII: X2PZH4Y6HT)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
HYDROXYETHYL UREA (UNII: MBQ7DDQ7AR)
SACCHARIDE ISOMERATE (UNII: W8K377W98I)
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
HOMARINE HYDROCHLORIDE (UNII: 8866LNG61N)
DECYLENE GLYCOL (UNII: S57M60MI88)
ISODODECANE (UNII: A8289P68Y2)
PEG-8 CAPRYLIC/CAPRIC GLYCERIDES (UNII: 00BT03FSO2)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
FERRIC OXIDE RED (UNII: 1K09F3G675)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
DIMETHICONE (UNII: 92RU3N3Y1O)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
ERYTHRITOL (UNII: RA96B954X6)
NIACINAMIDE (UNII: 25X51I8RD4)
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:14141-313-01	1 in 1 BOX	10/07/2022
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 Drug	M020	10/07/2022

LBEL FOREVER HYDRA BASE HIDRATANTE DE LARGA DURACION FPS 15 HYDRATING LONGWEAR FOUNDATION SPF 15 BEIGE 220-C
octinoxate, zinc oxide emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:14141-311
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	29.4 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
WATER (UNII: 059QF0KO0R)
STARCH, CORN (UNII: O8232NY3SJ)
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
GLYCERIN (UNII: PDC6A3C0OX)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
CHLORPHENESIN (UNII: I670DAL4SZ)
OCTYLDODECETH-25 (UNII: F8934HEL3M)
POLYMETHYLSILSESQUIOXANE/TRIMETHYLSILOXYSILICATE (UNII: X2PZH4Y6HT)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
HYDROXYETHYL UREA (UNII: MBQ7DDQ7AR)
SACCHARIDE ISOMERATE (UNII: W8K377W98I)
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
HOMARINE HYDROCHLORIDE (UNII: 8866LNG61N)
DECYLENE GLYCOL (UNII: S57M60MI88)
ISODODECANE (UNII: A8289P68Y2)
PEG-8 CAPRYLIC/CAPRIC GLYCERIDES (UNII: 00BT03FSO2)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
FERRIC OXIDE RED (UNII: 1K09F3G675)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
DIMETHICONE (UNII: 92RU3N3Y1O)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
ERYTHRITOL (UNII: RA96B954X6)
NIACINAMIDE (UNII: 25X51I8RD4)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:14141-311-01	1 in 1 BOX	10/07/2022
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 Drug	M020	10/07/2022

LBEL FOREVER HYDRA BASE HIDRATANTE DE LARGA DURACION FPS 15 HYDRATING LONGWEAR FOUNDATION SPF 15 ALMENDRA 230-N
octinoxate, zinc oxide emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:14141-312
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	29.4 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
STARCH, CORN (UNII: O8232NY3SJ)
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
GLYCERIN (UNII: PDC6A3C0OX)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
CHLORPHENESIN (UNII: I670DAL4SZ)
OCTYLDODECETH-25 (UNII: F8934HEL3M)
POLYMETHYLSILSESQUIOXANE/TRIMETHYLSILOXYSILICATE (UNII: X2PZH4Y6HT)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
HYDROXYETHYL UREA (UNII: MBQ7DDQ7AR)
SACCHARIDE ISOMERATE (UNII: W8K377W98I)
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
HOMARINE HYDROCHLORIDE (UNII: 8866LNG61N)
DECYLENE GLYCOL (UNII: S57M60MI88)
ISODODECANE (UNII: A8289P68Y2)
PEG-8 CAPRYLIC/CAPRIC GLYCERIDES (UNII: 00BT03FSO2)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
FERRIC OXIDE RED (UNII: 1K09F3G675)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
DIMETHICONE (UNII: 92RU3N3Y1O)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
ERYTHRITOL (UNII: RA96B954X6)
NIACINAMIDE (UNII: 25X51I8RD4)
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:14141-312-01	1 in 1 BOX	10/07/2022
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 Drug	M020	10/07/2022

LBEL FOREVER HYDRA BASE HIDRATANTE DE LARGA DURACION FPS 15 HYDRATING LONGWEAR FOUNDATION SPF 15 LATTE 180-F
octinoxate, zinc oxide emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:14141-310
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	29.4 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
STARCH, CORN (UNII: O8232NY3SJ)
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
GLYCERIN (UNII: PDC6A3C0OX)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
CHLORPHENESIN (UNII: I670DAL4SZ)
OCTYLDODECETH-25 (UNII: F8934HEL3M)
POLYMETHYLSILSESQUIOXANE/TRIMETHYLSILOXYSILICATE (UNII: X2PZH4Y6HT)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
HYDROXYETHYL UREA (UNII: MBQ7DDQ7AR)
SACCHARIDE ISOMERATE (UNII: W8K377W98I)
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
HOMARINE HYDROCHLORIDE (UNII: 8866LNG61N)
DECYLENE GLYCOL (UNII: S57M60MI88)
ISODODECANE (UNII: A8289P68Y2)
PEG-8 CAPRYLIC/CAPRIC GLYCERIDES (UNII: 00BT03FSO2)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
FERRIC OXIDE RED (UNII: 1K09F3G675)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
DIMETHICONE (UNII: 92RU3N3Y1O)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
ERYTHRITOL (UNII: RA96B954X6)
NIACINAMIDE (UNII: 25X51I8RD4)
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:14141-310-01	1 in 1 BOX	10/07/2022
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 Drug	M020	10/07/2022

LBEL FOREVER HYDRA BASE HIDRATANTE DE LARGA DURACION FPS 15 HYDRATING LONGWEAR FOUNDATION SPF 15 CHAMPAGNE 170-N
octinoxate, zinc oxide emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:14141-314
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	29.4 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
STARCH, CORN (UNII: O8232NY3SJ)
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
GLYCERIN (UNII: PDC6A3C0OX)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
CHLORPHENESIN (UNII: I670DAL4SZ)
OCTYLDODECETH-25 (UNII: F8934HEL3M)
POLYMETHYLSILSESQUIOXANE/TRIMETHYLSILOXYSILICATE (UNII: X2PZH4Y6HT)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
HYDROXYETHYL UREA (UNII: MBQ7DDQ7AR)
SACCHARIDE ISOMERATE (UNII: W8K377W98I)
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
HOMARINE HYDROCHLORIDE (UNII: 8866LNG61N)
DECYLENE GLYCOL (UNII: S57M60MI88)
ISODODECANE (UNII: A8289P68Y2)
PEG-8 CAPRYLIC/CAPRIC GLYCERIDES (UNII: 00BT03FSO2)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
FERRIC OXIDE RED (UNII: 1K09F3G675)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
DIMETHICONE (UNII: 92RU3N3Y1O)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
ERYTHRITOL (UNII: RA96B954X6)
NIACINAMIDE (UNII: 25X51I8RD4)
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:14141-314-01	1 in 1 BOX	10/07/2022
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 Drug	M020	10/07/2022

Labeler - BEL STAR S A (880160197)

L'BEL FOREVER HYDRA BASE HIDRATANTE DE LARGA DURACIÓN FPS 15 HYDRATING LONGWEAR FOUNDATION SPF 15