L'BEL CONCENTRÉ TOTAL BASE SERÚM ULTRA-FLUID FOUNDATION SPF 25

L'BEL CONCENTRÉ TOTAL BASE SERÚM ULTRA-FLUID FOUNDATION SPF 25

Drug Labeling and Warnings

Drug Details

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LBEL CONCENTRE TOTAL BASE SERUM ULTRA-FLUID FOUNDATION SPF 25  CLAIRE 1 - BEIGE- octinoxate and zinc oxide liquid 
LBEL CONCENTRE TOTAL BASE SERUM ULTRA-FLUID FOUNDATION SPF 25  CLAIRE 2 - BEIGE- octinoxate and zinc oxide liquid 
LBEL CONCENTRE TOTAL BASE SERUM ULTRA-FLUID FOUNDATION SPF 25  CLAIRE 3 - BEIGE- octinoxate and zinc oxide liquid 
LBEL CONCENTRE TOTAL BASE SERUM ULTRA-FLUID FOUNDATION SPF 25  CLAIRE 4 - BEIGE- octinoxate and zinc oxide liquid 
LBEL CONCENTRE TOTAL BASE SERUM ULTRA-FLUID FOUNDATION SPF 25  MEDIUM 5 - BEIGE- octinoxate and zinc oxide liquid 
LBEL CONCENTRE TOTAL BASE SERUM ULTRA-FLUID FOUNDATION SPF 25  MEDIUM 6 - BEIGE- octinoxate and zinc oxide liquid 
LBEL CONCENTRE TOTAL BASE SERUM ULTRA-FLUID FOUNDATION SPF 25  MEDIUM 7 - BEIGE- octinoxate and zinc oxide liquid 
LBEL CONCENTRE TOTAL BASE SERUM ULTRA-FLUID FOUNDATION SPF 25  OBSCURE 8 - BEIGE- octinoxate and zinc oxide liquid 
LBEL CONCENTRE TOTAL BASE SERUM ULTRA-FLUID FOUNDATION SPF 25  OBSCURE 9 - BEIGE- octinoxate and zinc oxide liquid 
LBEL CONCENTRE TOTAL BASE SERUM ULTRA-FLUID FOUNDATION SPF 25  TONO HUT - BEIGE- octinoxate and zinc oxide liquid 
Ventura International LTD

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.

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L'BEL CONCENTRÉ TOTAL BASE SERÚM ULTRA-FLUID FOUNDATION SPF 25

Drug Facts

Active IngredientsPurpose
OCTINOXATE 7.%Sunscreen
ZINC OXIDE 7.2%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, ALCOHOL DENAT., GLYCERIN, POLYSILICONE-11, MICA, PEG/PPG-18/18 DIMETHICONE, ZEA MAYS (CORN) STARCH, PEG-10 DIMETHICONE, BARIUM SULFATE, ALBIZIA JULIBRISSIN BARK EXTRACT, PHENOXYETHANOL, SILICA, METHYLPROPANEDIOL, TRIETHOXYCAPRYLYLSILANE, CAPRYLYL GLYCOL, CHLORPHENESIN, SILANEDIOL SALICYLATE, DISTEARDIMONIUM HECTORITE, TROMETHAMINE, CERAMIDE 3, FRAGRANCE, GRIFOLA FRONDOSA FRUITING BODY EXTRACT, MALTODEXTRIN, LINALOOL, d-LIMONENE, ALPHA-ISOMETHYL IONONE.

MAY CONTAIN:
TITANIUM DIOXIDE , IRON OXIDES.

Dist. by Ventura Int Ltd. DBA Belcorp USA, Miami, FL 33126.

PRINCIPAL DISPLAY PANEL - 27 ml Tube Box - CLAIRE 1 - BEIGE

L'BEL

CONCENTRÉ
TOTAL

BASE SÉRUM

ultra-fluid foundation
SPF 25

27 ml e (0.91 fl. oz.)

PRINCIPAL DISPLAY PANEL - 27 ml Tube Box - CLAIRE 1 - BEIGE

PRINCIPAL DISPLAY PANEL - 27 ml Tube Box - CLAIRE 2 - BEIGE

L'BEL

CONCENTRÉ
TOTAL

BASE SÉRUM

ultra-fluid foundation
SPF 25

27 ml e (0.91 fl. oz.)

PRINCIPAL DISPLAY PANEL - 27 ml Tube Box - CLAIRE 2 - BEIGE

PRINCIPAL DISPLAY PANEL - 27 ml Tube Box - CLAIRE 3 - BEIGE

L'BEL

CONCENTRÉ
TOTAL

BASE SÉRUM

ultra-fluid foundation
SPF 25

27 ml e (0.91 fl. oz.)

PRINCIPAL DISPLAY PANEL - 27 ml Tube Box - CLAIRE 3 - BEIGE

PRINCIPAL DISPLAY PANEL - 27 ml Tube Box - CLAIRE 4 - BEIGE

L'BEL

CONCENTRÉ
TOTAL

BASE SÉRUM

ultra-fluid foundation
SPF 25

27 ml e (0.91 fl. oz.)

PRINCIPAL DISPLAY PANEL - 27 ml Tube Box - CLAIRE 4 - BEIGE

PRINCIPAL DISPLAY PANEL - 27 ml Tube Box - MEDIUM 5 - BEIGE

L'BEL

CONCENTRÉ
TOTAL

BASE SÉRUM

ultra-fluid foundation
SPF 25

27 ml e (0.91 fl. oz.)

PRINCIPAL DISPLAY PANEL - 27 ml Tube Box - MEDIUM 5 - BEIGE

PRINCIPAL DISPLAY PANEL - 27 ml Tube Box - MEDIUM 6 - BEIGE

L'BEL

CONCENTRÉ
TOTAL

BASE SÉRUM

ultra-fluid foundation
SPF 25

27 ml e (0.91 fl. oz.)

PRINCIPAL DISPLAY PANEL - 27 ml Tube Box - MEDIUM 6 - BEIGE

PRINCIPAL DISPLAY PANEL - 27 ml Tube Box - MEDIUM 7 - BEIGE

L'BEL

CONCENTRÉ
TOTAL

BASE SÉRUM

ultra-fluid foundation
SPF 25

27 ml e (0.91 fl. oz.)

PRINCIPAL DISPLAY PANEL - 27 ml Tube Box - MEDIUM 7 - BEIGE

PRINCIPAL DISPLAY PANEL - 27 ml Tube Box - OBSCURE 8 - BEIGE

L'BEL

CONCENTRÉ
TOTAL

BASE SÉRUM

ultra-fluid foundation
SPF 25

27 ml e (0.91 fl. oz.)

PRINCIPAL DISPLAY PANEL - 27 ml Tube Box - OBSCURE 8 - BEIGE

PRINCIPAL DISPLAY PANEL - 27 ml Tube Box - OBSCURE 9 - BEIGE

L'BEL

CONCENTRÉ
TOTAL

BASE SÉRUM

ultra-fluid foundation
SPF 25

27 ml e (0.91 fl. oz.)

PRINCIPAL DISPLAY PANEL - 27 ml Tube Box - OBSCURE 9 - BEIGE

PRINCIPAL DISPLAY PANEL - 27 ml Tube Box - TONO HUT - BEIGE

L'BEL

CONCENTRÉ
TOTAL

BASE SÉRUM

ultra-fluid foundation
SPF 25

27 ml e (0.91 fl. oz.)

PRINCIPAL DISPLAY PANEL - 27 ml Tube Box - TONO HUT - BEIGE
LBEL CONCENTRE TOTAL BASE SERUM ULTRA-FLUID FOUNDATION SPF 25   CLAIRE 1 - BEIGE
octinoxate and zinc oxide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 14783-080
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.07 g  in 1 mL
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide0.072 g  in 1 mL
Inactive Ingredients
Ingredient NameStrength
DIMETHICONE (UNII: 92RU3N3Y1O)  
ALCOHOL (UNII: 3K9958V90M)  
GLYCERIN (UNII: PDC6A3C0OX)  
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
MICA (UNII: V8A1AW0880)  
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)  
STARCH, CORN (UNII: O8232NY3SJ)  
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
BARIUM SULFATE (UNII: 25BB7EKE2E)  
ALBIZIA JULIBRISSIN BARK (UNII: 0J9G6W44DV)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
METHYLPROPANEDIOL (UNII: N8F53B3R4R)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
SILANEDIOL SALICYLATE (UNII: C054DF30K0)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
TROMETHAMINE (UNII: 023C2WHX2V)  
CERAMIDE NP (UNII: 4370DF050B)  
MAITAKE (UNII: A1U5YJI0Z8)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
LINALOOL, (+/-)- (UNII: D81QY6I88E)  
LIMONENE, (+)- (UNII: GFD7C86Q1W)  
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 14783-080-021 in 1 BOX01/27/2017
1NDC: 14783-080-0127 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35201/27/2017
LBEL CONCENTRE TOTAL BASE SERUM ULTRA-FLUID FOUNDATION SPF 25   CLAIRE 2 - BEIGE
octinoxate and zinc oxide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 14783-082
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.07 g  in 1 mL
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide0.072 g  in 1 mL
Inactive Ingredients
Ingredient NameStrength
DIMETHICONE (UNII: 92RU3N3Y1O)  
ALCOHOL (UNII: 3K9958V90M)  
GLYCERIN (UNII: PDC6A3C0OX)  
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
MICA (UNII: V8A1AW0880)  
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)  
STARCH, CORN (UNII: O8232NY3SJ)  
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
BARIUM SULFATE (UNII: 25BB7EKE2E)  
ALBIZIA JULIBRISSIN BARK (UNII: 0J9G6W44DV)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
METHYLPROPANEDIOL (UNII: N8F53B3R4R)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
SILANEDIOL SALICYLATE (UNII: C054DF30K0)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
TROMETHAMINE (UNII: 023C2WHX2V)  
CERAMIDE NP (UNII: 4370DF050B)  
MAITAKE (UNII: A1U5YJI0Z8)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
LINALOOL, (+/-)- (UNII: D81QY6I88E)  
LIMONENE, (+)- (UNII: GFD7C86Q1W)  
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 14783-082-021 in 1 BOX01/27/2017
1NDC: 14783-082-0127 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35201/27/2017
LBEL CONCENTRE TOTAL BASE SERUM ULTRA-FLUID FOUNDATION SPF 25   CLAIRE 3 - BEIGE
octinoxate and zinc oxide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 14783-084
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.07 g  in 1 mL
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide0.072 g  in 1 mL
Inactive Ingredients
Ingredient NameStrength
DIMETHICONE (UNII: 92RU3N3Y1O)  
ALCOHOL (UNII: 3K9958V90M)  
GLYCERIN (UNII: PDC6A3C0OX)  
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
MICA (UNII: V8A1AW0880)  
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)  
STARCH, CORN (UNII: O8232NY3SJ)  
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
BARIUM SULFATE (UNII: 25BB7EKE2E)  
ALBIZIA JULIBRISSIN BARK (UNII: 0J9G6W44DV)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
METHYLPROPANEDIOL (UNII: N8F53B3R4R)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
SILANEDIOL SALICYLATE (UNII: C054DF30K0)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
TROMETHAMINE (UNII: 023C2WHX2V)  
CERAMIDE NP (UNII: 4370DF050B)  
MAITAKE (UNII: A1U5YJI0Z8)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
LINALOOL, (+/-)- (UNII: D81QY6I88E)  
LIMONENE, (+)- (UNII: GFD7C86Q1W)  
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 14783-084-021 in 1 BOX01/27/2017
1NDC: 14783-084-0127 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35201/27/2017
LBEL CONCENTRE TOTAL BASE SERUM ULTRA-FLUID FOUNDATION SPF 25   CLAIRE 4 - BEIGE
octinoxate and zinc oxide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 14783-086
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.07 g  in 1 mL
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide0.072 g  in 1 mL
Inactive Ingredients
Ingredient NameStrength
DIMETHICONE (UNII: 92RU3N3Y1O)  
ALCOHOL (UNII: 3K9958V90M)  
GLYCERIN (UNII: PDC6A3C0OX)  
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
MICA (UNII: V8A1AW0880)  
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)  
STARCH, CORN (UNII: O8232NY3SJ)  
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
BARIUM SULFATE (UNII: 25BB7EKE2E)  
ALBIZIA JULIBRISSIN BARK (UNII: 0J9G6W44DV)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
METHYLPROPANEDIOL (UNII: N8F53B3R4R)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
SILANEDIOL SALICYLATE (UNII: C054DF30K0)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
TROMETHAMINE (UNII: 023C2WHX2V)  
CERAMIDE NP (UNII: 4370DF050B)  
MAITAKE (UNII: A1U5YJI0Z8)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
LINALOOL, (+/-)- (UNII: D81QY6I88E)  
LIMONENE, (+)- (UNII: GFD7C86Q1W)  
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 14783-086-021 in 1 BOX01/27/2017
1NDC: 14783-086-0127 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35201/27/2017
LBEL CONCENTRE TOTAL BASE SERUM ULTRA-FLUID FOUNDATION SPF 25   MEDIUM 5 - BEIGE
octinoxate and zinc oxide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 14783-087
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.07 g  in 1 mL
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide0.072 g  in 1 mL
Inactive Ingredients
Ingredient NameStrength
DIMETHICONE (UNII: 92RU3N3Y1O)  
ALCOHOL (UNII: 3K9958V90M)  
GLYCERIN (UNII: PDC6A3C0OX)  
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
MICA (UNII: V8A1AW0880)  
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)  
STARCH, CORN (UNII: O8232NY3SJ)  
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
BARIUM SULFATE (UNII: 25BB7EKE2E)  
ALBIZIA JULIBRISSIN BARK (UNII: 0J9G6W44DV)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
METHYLPROPANEDIOL (UNII: N8F53B3R4R)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
SILANEDIOL SALICYLATE (UNII: C054DF30K0)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
TROMETHAMINE (UNII: 023C2WHX2V)  
CERAMIDE NP (UNII: 4370DF050B)  
MAITAKE (UNII: A1U5YJI0Z8)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
LINALOOL, (+/-)- (UNII: D81QY6I88E)  
LIMONENE, (+)- (UNII: GFD7C86Q1W)  
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 14783-087-021 in 1 BOX01/27/2017
1NDC: 14783-087-0127 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35201/27/2017
LBEL CONCENTRE TOTAL BASE SERUM ULTRA-FLUID FOUNDATION SPF 25   MEDIUM 6 - BEIGE
octinoxate and zinc oxide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 14783-088
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.07 g  in 1 mL
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide0.072 g  in 1 mL
Inactive Ingredients
Ingredient NameStrength
DIMETHICONE (UNII: 92RU3N3Y1O)  
ALCOHOL (UNII: 3K9958V90M)  
GLYCERIN (UNII: PDC6A3C0OX)  
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
MICA (UNII: V8A1AW0880)  
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)  
STARCH, CORN (UNII: O8232NY3SJ)  
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
BARIUM SULFATE (UNII: 25BB7EKE2E)  
ALBIZIA JULIBRISSIN BARK (UNII: 0J9G6W44DV)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
METHYLPROPANEDIOL (UNII: N8F53B3R4R)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
SILANEDIOL SALICYLATE (UNII: C054DF30K0)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
TROMETHAMINE (UNII: 023C2WHX2V)  
CERAMIDE NP (UNII: 4370DF050B)  
MAITAKE (UNII: A1U5YJI0Z8)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
LINALOOL, (+/-)- (UNII: D81QY6I88E)  
LIMONENE, (+)- (UNII: GFD7C86Q1W)  
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 14783-088-021 in 1 BOX01/27/2017
1NDC: 14783-088-0127 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35201/27/2017
LBEL CONCENTRE TOTAL BASE SERUM ULTRA-FLUID FOUNDATION SPF 25   MEDIUM 7 - BEIGE
octinoxate and zinc oxide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 14783-089
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.07 g  in 1 mL
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide0.072 g  in 1 mL
Inactive Ingredients
Ingredient NameStrength
DIMETHICONE (UNII: 92RU3N3Y1O)  
ALCOHOL (UNII: 3K9958V90M)  
GLYCERIN (UNII: PDC6A3C0OX)  
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
MICA (UNII: V8A1AW0880)  
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)  
STARCH, CORN (UNII: O8232NY3SJ)  
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
BARIUM SULFATE (UNII: 25BB7EKE2E)  
ALBIZIA JULIBRISSIN BARK (UNII: 0J9G6W44DV)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
METHYLPROPANEDIOL (UNII: N8F53B3R4R)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
SILANEDIOL SALICYLATE (UNII: C054DF30K0)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
TROMETHAMINE (UNII: 023C2WHX2V)  
CERAMIDE NP (UNII: 4370DF050B)  
MAITAKE (UNII: A1U5YJI0Z8)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
LINALOOL, (+/-)- (UNII: D81QY6I88E)  
LIMONENE, (+)- (UNII: GFD7C86Q1W)  
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 14783-089-021 in 1 BOX01/27/2017
1NDC: 14783-089-0127 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35201/27/2017
LBEL CONCENTRE TOTAL BASE SERUM ULTRA-FLUID FOUNDATION SPF 25   OBSCURE 8 - BEIGE
octinoxate and zinc oxide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 14783-090
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.07 g  in 1 mL
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide0.072 g  in 1 mL
Inactive Ingredients
Ingredient NameStrength
DIMETHICONE (UNII: 92RU3N3Y1O)  
ALCOHOL (UNII: 3K9958V90M)  
GLYCERIN (UNII: PDC6A3C0OX)  
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
MICA (UNII: V8A1AW0880)  
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)  
STARCH, CORN (UNII: O8232NY3SJ)  
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
BARIUM SULFATE (UNII: 25BB7EKE2E)  
ALBIZIA JULIBRISSIN BARK (UNII: 0J9G6W44DV)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
METHYLPROPANEDIOL (UNII: N8F53B3R4R)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
SILANEDIOL SALICYLATE (UNII: C054DF30K0)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
TROMETHAMINE (UNII: 023C2WHX2V)  
CERAMIDE NP (UNII: 4370DF050B)  
MAITAKE (UNII: A1U5YJI0Z8)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
LINALOOL, (+/-)- (UNII: D81QY6I88E)  
LIMONENE, (+)- (UNII: GFD7C86Q1W)  
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 14783-090-021 in 1 BOX01/27/2017
1NDC: 14783-090-0127 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35201/27/2017
LBEL CONCENTRE TOTAL BASE SERUM ULTRA-FLUID FOUNDATION SPF 25   OBSCURE 9 - BEIGE
octinoxate and zinc oxide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 14783-092
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.07 g  in 1 mL
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide0.072 g  in 1 mL
Inactive Ingredients
Ingredient NameStrength
DIMETHICONE (UNII: 92RU3N3Y1O)  
ALCOHOL (UNII: 3K9958V90M)  
GLYCERIN (UNII: PDC6A3C0OX)  
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
MICA (UNII: V8A1AW0880)  
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)  
STARCH, CORN (UNII: O8232NY3SJ)  
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
BARIUM SULFATE (UNII: 25BB7EKE2E)  
ALBIZIA JULIBRISSIN BARK (UNII: 0J9G6W44DV)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
METHYLPROPANEDIOL (UNII: N8F53B3R4R)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
SILANEDIOL SALICYLATE (UNII: C054DF30K0)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
TROMETHAMINE (UNII: 023C2WHX2V)  
CERAMIDE NP (UNII: 4370DF050B)  
MAITAKE (UNII: A1U5YJI0Z8)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
LINALOOL, (+/-)- (UNII: D81QY6I88E)  
LIMONENE, (+)- (UNII: GFD7C86Q1W)  
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 14783-092-021 in 1 BOX01/27/2017
1NDC: 14783-092-0127 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35201/27/2017
LBEL CONCENTRE TOTAL BASE SERUM ULTRA-FLUID FOUNDATION SPF 25   TONO HUT - BEIGE
octinoxate and zinc oxide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 14783-110
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.07 g  in 1 mL
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide0.072 g  in 1 mL
Inactive Ingredients
Ingredient NameStrength
DIMETHICONE (UNII: 92RU3N3Y1O)  
ALCOHOL (UNII: 3K9958V90M)  
GLYCERIN (UNII: PDC6A3C0OX)  
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
MICA (UNII: V8A1AW0880)  
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)  
STARCH, CORN (UNII: O8232NY3SJ)  
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
BARIUM SULFATE (UNII: 25BB7EKE2E)  
ALBIZIA JULIBRISSIN BARK (UNII: 0J9G6W44DV)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
METHYLPROPANEDIOL (UNII: N8F53B3R4R)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
SILANEDIOL SALICYLATE (UNII: C054DF30K0)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
TROMETHAMINE (UNII: 023C2WHX2V)  
CERAMIDE NP (UNII: 4370DF050B)  
MAITAKE (UNII: A1U5YJI0Z8)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
LINALOOL, (+/-)- (UNII: D81QY6I88E)  
LIMONENE, (+)- (UNII: GFD7C86Q1W)  
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 14783-110-021 in 1 BOX01/27/2017
1NDC: 14783-110-0127 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35201/27/2017
Labeler - Ventura International LTD (603192787)
Establishment
NameAddressID/FEIBusiness Operations
Bel Star S.A. (Colombia)880160197MANUFACTURE(14783-080, 14783-082, 14783-084, 14783-086, 14783-087, 14783-088, 14783-089, 14783-090, 14783-092, 14783-110)

Revised: 1/2017
 
Ventura International LTD


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