Label: 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
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Contains inactivated NDC Code(s)
NDC Code(s): 14783-281-01, 14783-282-01, 14783-283-01, 14783-284-01, view more14783-285-01 - Packager: Ventura International LTD
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated April 14, 2021
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
-
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
- OTHER SAFETY INFORMATION
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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
- 180-F Latte
- 220-C Beige
- 230-N Almendra
- 310-C Capuccino
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INGREDIENTS AND APPEARANCE
CONCENTRE TOTAL BASE SERUM BASE DE MAQUILLAJE ULTRA-FLUID FOUNDATION SPF 25 ALMENDRA 230-N
zinc oxide,octinoxate emulsionProduct 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 emulsionProduct 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 emulsionProduct 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 emulsionProduct 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 emulsionProduct 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)
