CONCENTRE TOTAL BASE SERUM BASE DE MAQUILLAJE ULTRA-FLUID FOUNDATION SPF 25 ALMENDRA 230-N- zinc oxide,octinoxate emulsion CONCENTRE TOTAL BASE SERUM BASE DE MAQUILLAJE ULTRA-FLUID FOUNDATION SPF 25 CHAMPAGNE 170-N- zinc oxide,octinoxate emulsion CONCENTRE TOTAL BASE SERUM BASE DE MAQUILLAJE ULTRA-FLUID FOUNDATION SPF 25 LATTE 180-F- zinc oxide,octinoxate emulsion CONCENTRE TOTAL BASE SERUM BASE DE MAQUILLAJE ULTRA-FLUID FOUNDATION SPF 25 BEIGE 220-C- zinc oxide,octinoxate emulsion CONCENTRE TOTAL BASE SERUM BASE DE MAQUILLAJE ULTRA-FLUID FOUNDATION SPF 25 CAPUCCINO 310-C- zinc oxide,octinoxate emulsion

CONCENTRE TOTAL BASE SERUM BASE DE MAQUILLAJE ULTRA-FLUID FOUNDATION SPF 25 CAPUCCINO 310-C by

Drug Labeling and Warnings

CONCENTRE TOTAL BASE SERUM BASE DE MAQUILLAJE ULTRA-FLUID FOUNDATION SPF 25 CAPUCCINO 310-C by is a Otc medication manufactured, distributed, or labeled by Ventura International LTD, Bel Star S.A. (Colombia). Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients Purpose
ZINC OXIDE 7.20 % Sunscreen
OCTINOXATE 7.00 % Sunscreen

PURPOSE

Uses
Helps prevent sunburn.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

INDICATIONS & USAGE

Stop use and ask a doctor if rash occurs.

WARNINGS

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.

DOSAGE & ADMINISTRATION

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 SAFETY INFORMATION

Other information
Protect the product in this container from excessive heat and direct sun.

INACTIVE INGREDIENT

Inactive Ingredients:

Water, Cyclohexasiloxane, Nylon-12, Isododecane, Glycerin, HDI/Trimethylol Hexyllactone Crosspolymer, PEG-10 Dimethicone Alcohol Denat., Dimethicone, Cetyl PEG/PPG-10/1 Dimethicone, Albizia Julibrissin Bark Extract, Cyclopentasiloxane, Phenoxyethanol, Silica, Polyglyceryl-4 Isostearate, Lectithin, Tocopheryl Acetate, Hexyl Laurate, Methylpropanediol, Disteardimonium Hectorite, Caprylyl Glycol, Chlorphenesin, Silanediol Salicylate, Tromethamine, Ceramide NP, Grifola Frondosa Fruiting Body Extract, Fragrance, Maltodextrin, Linalool, Limonene, Alpha-Isomethyl Ionone. May Contain: Titanium Dioxide, Iron Oxides, Triethoxycaprylylsilane

170-N

L'BEL

Concentre Total

Base Serum

base de maquillaje ultrafluida FPS 25

ultra-fluid foundation SPF 25

0.87 fl. oz. (26ml)

180-F Latte

L'BEL
Concentre Total
Base Serum
base de maquillaje ultrafluida FPS 25
ultra-fluid foundation SPF 25
0.87 fl. oz. (26ml)

220-C Beige

L'BEL
Concentre Total
Base Serum
base de maquillaje ultrafluida FPS 25
ultra-fluid foundation SPF 25
0.87 fl. oz. (26ml)

230-N Almendra

L'BEL
Concentre Total
Base Serum
base de maquillaje ultrafluida FPS 25
ultra-fluid foundation SPF 25
0.87 fl. oz. (26ml)

310-C Capuccino

L'BEL
Concentre Total
Base Serum
base de maquillaje ultrafluida FPS 25
ultra-fluid foundation SPF 25
0.87 fl. oz. (26ml)

INGREDIENTS AND APPEARANCE

CONCENTRE TOTAL BASE SERUM BASE DE MAQUILLAJE ULTRA-FLUID FOUNDATION SPF 25 ALMENDRA 230-N 
zinc oxide,octinoxate emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 14783-284
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7 g  in 100 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	7.2 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
NYLON-12 (UNII: 446U8J075B)
ALCOHOL (UNII: 3K9958V90M)
DIMETHICONE (UNII: 92RU3N3Y1O)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)
LECITHIN, SUNFLOWER (UNII: 834K0WOS5G)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
TROMETHAMINE (UNII: 023C2WHX2V)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SILANEDIOL SALICYLATE (UNII: C054DF30K0)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
MAITAKE (UNII: A1U5YJI0Z8)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CERAMIDE NP (UNII: 4370DF050B)
ISODODECANE (UNII: A8289P68Y2)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
METHYLPROPANEDIOL (UNII: N8F53B3R4R)
GLYCERIN (UNII: PDC6A3C0OX)
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
CHLORPHENESIN (UNII: I670DAL4SZ)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
PHENOXYETHANOL (UNII: HIE492ZZ3T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 14783-284-01	26 mL in 1 JAR; Type 0: Not a Combination Product	03/05/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	03/05/2021

CONCENTRE TOTAL BASE SERUM BASE DE MAQUILLAJE ULTRA-FLUID FOUNDATION SPF 25 CHAMPAGNE 170-N 
zinc oxide,octinoxate emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 14783-281
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7 g  in 100 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	7.2 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
NYLON-12 (UNII: 446U8J075B)
ALCOHOL (UNII: 3K9958V90M)
DIMETHICONE (UNII: 92RU3N3Y1O)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)
LECITHIN, SUNFLOWER (UNII: 834K0WOS5G)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
TROMETHAMINE (UNII: 023C2WHX2V)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SILANEDIOL SALICYLATE (UNII: C054DF30K0)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
MAITAKE (UNII: A1U5YJI0Z8)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CERAMIDE NP (UNII: 4370DF050B)
ISODODECANE (UNII: A8289P68Y2)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
METHYLPROPANEDIOL (UNII: N8F53B3R4R)
GLYCERIN (UNII: PDC6A3C0OX)
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
CHLORPHENESIN (UNII: I670DAL4SZ)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
PHENOXYETHANOL (UNII: HIE492ZZ3T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 14783-281-01	26 mL in 1 JAR; Type 0: Not a Combination Product	03/05/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	03/05/2021

CONCENTRE TOTAL BASE SERUM BASE DE MAQUILLAJE ULTRA-FLUID FOUNDATION SPF 25 LATTE 180-F 
zinc oxide,octinoxate emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 14783-282
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7 g  in 100 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	7.2 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
NYLON-12 (UNII: 446U8J075B)
ALCOHOL (UNII: 3K9958V90M)
DIMETHICONE (UNII: 92RU3N3Y1O)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)
LECITHIN, SUNFLOWER (UNII: 834K0WOS5G)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
TROMETHAMINE (UNII: 023C2WHX2V)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SILANEDIOL SALICYLATE (UNII: C054DF30K0)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
MAITAKE (UNII: A1U5YJI0Z8)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CERAMIDE NP (UNII: 4370DF050B)
ISODODECANE (UNII: A8289P68Y2)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
METHYLPROPANEDIOL (UNII: N8F53B3R4R)
GLYCERIN (UNII: PDC6A3C0OX)
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
CHLORPHENESIN (UNII: I670DAL4SZ)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
PHENOXYETHANOL (UNII: HIE492ZZ3T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 14783-282-01	26 mL in 1 JAR; Type 0: Not a Combination Product	03/05/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	03/05/2021

CONCENTRE TOTAL BASE SERUM BASE DE MAQUILLAJE ULTRA-FLUID FOUNDATION SPF 25 BEIGE 220-C 
zinc oxide,octinoxate emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 14783-283
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7 g  in 100 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	7.2 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
NYLON-12 (UNII: 446U8J075B)
ALCOHOL (UNII: 3K9958V90M)
DIMETHICONE (UNII: 92RU3N3Y1O)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)
LECITHIN, SUNFLOWER (UNII: 834K0WOS5G)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
TROMETHAMINE (UNII: 023C2WHX2V)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SILANEDIOL SALICYLATE (UNII: C054DF30K0)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
MAITAKE (UNII: A1U5YJI0Z8)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CERAMIDE NP (UNII: 4370DF050B)
ISODODECANE (UNII: A8289P68Y2)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
METHYLPROPANEDIOL (UNII: N8F53B3R4R)
GLYCERIN (UNII: PDC6A3C0OX)
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
CHLORPHENESIN (UNII: I670DAL4SZ)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
PHENOXYETHANOL (UNII: HIE492ZZ3T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 14783-283-01	26 mL in 1 JAR; Type 0: Not a Combination Product	03/05/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	03/05/2021

CONCENTRE TOTAL BASE SERUM BASE DE MAQUILLAJE ULTRA-FLUID FOUNDATION SPF 25 CAPUCCINO 310-C 
zinc oxide,octinoxate emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 14783-285
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7 g  in 100 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	7.2 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
NYLON-12 (UNII: 446U8J075B)
ALCOHOL (UNII: 3K9958V90M)
DIMETHICONE (UNII: 92RU3N3Y1O)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)
LECITHIN, SUNFLOWER (UNII: 834K0WOS5G)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
TROMETHAMINE (UNII: 023C2WHX2V)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SILANEDIOL SALICYLATE (UNII: C054DF30K0)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
MAITAKE (UNII: A1U5YJI0Z8)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CERAMIDE NP (UNII: 4370DF050B)
ISODODECANE (UNII: A8289P68Y2)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
METHYLPROPANEDIOL (UNII: N8F53B3R4R)
GLYCERIN (UNII: PDC6A3C0OX)
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
CHLORPHENESIN (UNII: I670DAL4SZ)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
PHENOXYETHANOL (UNII: HIE492ZZ3T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 14783-285-01	26 mL in 1 JAR; Type 0: Not a Combination Product	03/05/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	03/05/2021

Labeler - Ventura International LTD (603192787)

Establishment
Name	Address	ID/FEI	Business Operations
Bel Star S.A. (Colombia)		880160197	manufacture(14783-281, 14783-282, 14783-283, 14783-284, 14783-285)