LBEL EFFET PARFAIT POLVOS COMPACTOS DE LARGA DURACION PARA ROSTRO FPS 15 /LONG LASTING COMPACT SPF 15 (CLAIRE 1) - BEIGE- zinc oxide and titanium dioxide powder 
LBEL EFFET PARFAIT POLVOS COMPACTOS DE LARGA DURACION PARA ROSTRO FPS 15 /LONG LASTING COMPACT SPF 15 (CLAIRE 2) - BEIGE- zinc oxide and titanium dioxide powder 
LBEL EFFET PARFAIT POLVOS COMPACTOS DE LARGA DURACION PARA ROSTRO FPS 15 /LONG LASTING COMPACT SPF 15 (CLAIRE 3) - BEIGE- zinc oxide and titanium dioxide powder 
LBEL EFFET PARFAIT POLVOS COMPACTOS DE LARGA DURACION PARA ROSTRO FPS 15 /LONG LASTING COMPACT SPF 15 (CLAIRE 4) - BEIGE- zinc oxide and titanium dioxide powder 
LBEL EFFET PARFAIT POLVOS COMPACTOS DE LARGA DURACION PARA ROSTRO FPS 15 /LONG LASTING COMPACT SPF 15 (MEDIUM 5) - BROWN- zinc oxide and titanium dioxide powder 
LBEL EFFET PARFAIT POLVOS COMPACTOS DE LARGA DURACION PARA ROSTRO FPS 15 /LONG LASTING COMPACT SPF 15 (MEDIUM 6) - BROWN- zinc oxide and titanium dioxide powder 
LBEL EFFET PARFAIT POLVOS COMPACTOS DE LARGA DURACION PARA ROSTRO FPS 15 /LONG LASTING COMPACT SPF 15 (MEDIUM 7) - BROWN- zinc oxide and titanium dioxide powder 
LBEL EFFET PARFAIT POLVOS COMPACTOS DE LARGA DURACION PARA ROSTRO FPS 15 /LONG LASTING COMPACT SPF 15 (OBSCURE 8) - BROWN- zinc oxide and titanium dioxide powder 
LBEL EFFET PARFAIT POLVOS COMPACTOS DE LARGA DURACION PARA ROSTRO FPS 15 /LONG LASTING COMPACT SPF 15 (OBSCURE 9) - BROWN- zinc oxide and titanium dioxide powder 
Ventura Corporation LTD

----------

L'BEL EFFET PARFAIT Polvos Compactos de Larga Duración para rostro FPS 15 /Long Lasting Compact Powder SPF 15

Drug Facts

Active IngredientsPurpose
TITANIUM DIOXIDE (5.7%)Sunscreen
ZINC OXIDE (4.9%)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, notskin cancer or early skin aging. Rinse with water to remove. If swallowed, get medical help or contact a Poison Control Center right away.

  • For external use only.

  • Do not useon damaged or broken skin.

  • When using this productkeep out of eyes.Rinse with water to remove.

  • Stop use and ask a doctor ifrash 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
  • Apply stick following the curves of natural lip line. For added definition, use with a lip pencil

Other information

  • Protect this product in this container form excesive heat and direct sun.

Inactive ingredients

Mica,dimethicone, polymethylsilsesquioxane, zinc stearate, hdi/trimethylol hexyllactone crosspolymer, trimethylsiloxysilicate, caprylic/capric triglyceride, perfluorooctyl triethoxysilane, tocopheryl acetate, hydrogen dimethicone, phenoxyethanol, cetyl peg/ppg-10/1 dimethicone, polyglyceryl-4 isostearate, alumina, hexyl laurate, parfum (fragrance), caprylyl glycol, triethoxycaprylylsilane, chlorphenesin, crithmum maritimum extract, ceramide 3.

May contain:

CI 77492 (iron oxides), CI 77491 (iron oxides), CI 77499 (iron oxides), CI 77891 (titanium dioxide ).

P.R.: Dist by Ventura Corp, Ltd., San Juan, Puerto Rico 00926.

PRINCIPAL DISPLAY PANEL - 12 g Case Box - (CLAIRE 1) - Beige

EFFET PARFAIT

long lasting compact powder SPF 15

Net Weigth 0.42 oz. (12 g)

L'BEL

Principal Display Panel - 12 g Case Box - (CLAIRE 1) - Beige

PRINCIPAL DISPLAY PANEL - 12 g Case Box - (CLAIRE 2) - Beige

EFFET PARFAIT

long lasting compact powder SPF 15

Net Weigth 0.42 oz. (12 g)

L'BEL

Principal Display Panel - 12 g Case Box - (CLAIRE 2) - Beige

PRINCIPAL DISPLAY PANEL - 12 g Case Box - (CLAIRE 3) - Beige

EFFET PARFAIT

long lasting compact powder SPF 15

Net Weigth 0.42 oz. (12 g)

L'BEL

Principal Display Panel - 12 g Case Box - (CLAIRE 3) - Beige

PRINCIPAL DISPLAY PANEL - 12 g Case Box - (CLAIRE 4) - Beige

EFFET PARFAIT

long lasting compact powder SPF 15

Net Weigth 0.42 oz. (12 g)

L'BEL

Principal Display Panel - 12 g Case Box - (CLAIRE 4) - Beige

PRINCIPAL DISPLAY PANEL - 12 g Case Box - (MEDIUM 5) - Brown

EFFET PARFAIT

long lasting compact powder SPF 15

Net Weigth 0.42 oz. (12 g)

L'BEL

Principal Display Panel - 12 g Case Box - (MEDIUM 5) - Brown

PRINCIPAL DISPLAY PANEL - 12 g Case Box - (MEDIUM 6) - Brown

EFFET PARFAIT

long lasting compact powder SPF 15

Net Weigth 0.42 oz. (12 g)

L'BEL

Principal Display Panel - 12 g Case Box - (MEDIUM 6) - Brown

PRINCIPAL DISPLAY PANEL - 12 g Case Box - (MEDIUM 7) - Brown

EFFET PARFAIT

long lasting compact powder SPF 15

Net Weigth 0.42 oz. (12 g)

L'BEL

Principal Display Panel - 12 g Case Box - (MEDIUM 7) - Brown

PRINCIPAL DISPLAY PANEL - 12 g Case Box - (OBSCURE 8) - Brown

EFFET PARFAIT

long lasting compact powder SPF 15

Net Weigth 0.42 oz. (12 g)

L'BEL

Principal Display Panel - 12 g Case Box - (OBSCURE 8) - Brown

PRINCIPAL DISPLAY PANEL - 12 g Case Box - (OBSCURE 9) - Brown

EFFET PARFAIT

long lasting compact powder SPF 15

Net Weigth 0.42 oz. (12 g)

L'BEL

Principal Display Panel - 12 g Case Box - (OBSCURE 9) - Brown
LBEL EFFET PARFAIT POLVOS COMPACTOS DE LARGA DURACION PARA ROSTRO FPS 15 /LONG LASTING COMPACT SPF 15  (CLAIRE 1) - BEIGE
zinc oxide and titanium dioxide powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-112
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE0.049 g  in 1 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE0.057 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
MICA (UNII: V8A1AW0880)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
ZINC STEARATE (UNII: H92E6QA4FV)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
PERFLUOROOCTYL TRIETHOXYSILANE (UNII: 814P46684U)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
CRITHMUM MARITIMUM (UNII: J7IHY79BKY)  
CERAMIDE 3 (UNII: 4370DF050B)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-112-021 in 1 BOX01/27/201412/31/2021
1NDC:13537-112-0112 g in 1 CASE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02001/27/201412/31/2021
LBEL EFFET PARFAIT POLVOS COMPACTOS DE LARGA DURACION PARA ROSTRO FPS 15 /LONG LASTING COMPACT SPF 15  (CLAIRE 2) - BEIGE
zinc oxide and titanium dioxide powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-113
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE0.049 g  in 1 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE0.057 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
MICA (UNII: V8A1AW0880)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
ZINC STEARATE (UNII: H92E6QA4FV)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
PERFLUOROOCTYL TRIETHOXYSILANE (UNII: 814P46684U)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
CRITHMUM MARITIMUM (UNII: J7IHY79BKY)  
CERAMIDE 3 (UNII: 4370DF050B)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-113-061 in 1 BOX01/27/201412/31/2021
1NDC:13537-113-0512 g in 1 CASE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02001/27/201412/31/2021
LBEL EFFET PARFAIT POLVOS COMPACTOS DE LARGA DURACION PARA ROSTRO FPS 15 /LONG LASTING COMPACT SPF 15  (CLAIRE 3) - BEIGE
zinc oxide and titanium dioxide powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-403
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE0.049 g  in 1 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE0.057 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
MICA (UNII: V8A1AW0880)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
ZINC STEARATE (UNII: H92E6QA4FV)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
PERFLUOROOCTYL TRIETHOXYSILANE (UNII: 814P46684U)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
CRITHMUM MARITIMUM (UNII: J7IHY79BKY)  
CERAMIDE 3 (UNII: 4370DF050B)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-403-101 in 1 BOX01/27/201412/31/2021
1NDC:13537-403-0912 g in 1 CASE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02001/27/201412/31/2021
LBEL EFFET PARFAIT POLVOS COMPACTOS DE LARGA DURACION PARA ROSTRO FPS 15 /LONG LASTING COMPACT SPF 15  (CLAIRE 4) - BEIGE
zinc oxide and titanium dioxide powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-114
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE0.049 g  in 1 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE0.057 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
MICA (UNII: V8A1AW0880)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
ZINC STEARATE (UNII: H92E6QA4FV)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
PERFLUOROOCTYL TRIETHOXYSILANE (UNII: 814P46684U)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
CRITHMUM MARITIMUM (UNII: J7IHY79BKY)  
CERAMIDE 3 (UNII: 4370DF050B)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-114-141 in 1 BOX01/27/201412/31/2021
1NDC:13537-114-1312 g in 1 CASE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02001/27/201412/31/2021
LBEL EFFET PARFAIT POLVOS COMPACTOS DE LARGA DURACION PARA ROSTRO FPS 15 /LONG LASTING COMPACT SPF 15  (MEDIUM 5) - BROWN
zinc oxide and titanium dioxide powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-405
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE0.049 g  in 1 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE0.057 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
DIMETHICONE (UNII: 92RU3N3Y1O)  
ZINC STEARATE (UNII: H92E6QA4FV)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
PERFLUOROOCTYL TRIETHOXYSILANE (UNII: 814P46684U)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
CRITHMUM MARITIMUM (UNII: J7IHY79BKY)  
CERAMIDE 3 (UNII: 4370DF050B)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
MICA (UNII: V8A1AW0880)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-405-181 in 1 BOX01/27/201412/31/2021
1NDC:13537-405-1712 g in 1 CASE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02001/27/201412/31/2021
LBEL EFFET PARFAIT POLVOS COMPACTOS DE LARGA DURACION PARA ROSTRO FPS 15 /LONG LASTING COMPACT SPF 15  (MEDIUM 6) - BROWN
zinc oxide and titanium dioxide powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-406
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE0.049 g  in 1 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE0.057 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
ZINC STEARATE (UNII: H92E6QA4FV)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
PERFLUOROOCTYL TRIETHOXYSILANE (UNII: 814P46684U)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
CRITHMUM MARITIMUM (UNII: J7IHY79BKY)  
CERAMIDE 3 (UNII: 4370DF050B)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
MICA (UNII: V8A1AW0880)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-406-221 in 1 BOX01/27/201412/31/2021
1NDC:13537-406-2112 g in 1 CASE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02001/27/201412/31/2021
LBEL EFFET PARFAIT POLVOS COMPACTOS DE LARGA DURACION PARA ROSTRO FPS 15 /LONG LASTING COMPACT SPF 15  (MEDIUM 7) - BROWN
zinc oxide and titanium dioxide powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-407
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE0.049 g  in 1 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE0.057 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
MICA (UNII: V8A1AW0880)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
ZINC STEARATE (UNII: H92E6QA4FV)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
PERFLUOROOCTYL TRIETHOXYSILANE (UNII: 814P46684U)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
CRITHMUM MARITIMUM (UNII: J7IHY79BKY)  
CERAMIDE 3 (UNII: 4370DF050B)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-407-261 in 1 BOX01/27/201412/31/2021
1NDC:13537-407-2512 g in 1 CASE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02001/27/201412/31/2021
LBEL EFFET PARFAIT POLVOS COMPACTOS DE LARGA DURACION PARA ROSTRO FPS 15 /LONG LASTING COMPACT SPF 15  (OBSCURE 8) - BROWN
zinc oxide and titanium dioxide powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-408
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE0.049 g  in 1 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE0.057 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
MICA (UNII: V8A1AW0880)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
ZINC STEARATE (UNII: H92E6QA4FV)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
PERFLUOROOCTYL TRIETHOXYSILANE (UNII: 814P46684U)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
CRITHMUM MARITIMUM (UNII: J7IHY79BKY)  
CERAMIDE 3 (UNII: 4370DF050B)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-408-301 in 1 BOX01/27/201412/31/2021
1NDC:13537-408-2912 g in 1 CASE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02001/27/201412/31/2021
LBEL EFFET PARFAIT POLVOS COMPACTOS DE LARGA DURACION PARA ROSTRO FPS 15 /LONG LASTING COMPACT SPF 15  (OBSCURE 9) - BROWN
zinc oxide and titanium dioxide powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-409
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE0.049 g  in 1 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE0.057 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
MICA (UNII: V8A1AW0880)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
ZINC STEARATE (UNII: H92E6QA4FV)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
PERFLUOROOCTYL TRIETHOXYSILANE (UNII: 814P46684U)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
CRITHMUM MARITIMUM (UNII: J7IHY79BKY)  
CERAMIDE 3 (UNII: 4370DF050B)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-409-341 in 1 BOX01/27/201412/31/2021
1NDC:13537-409-3312 g in 1 CASE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02001/27/201412/31/2021
Labeler - Ventura Corporation LTD (602751344)
Establishment
NameAddressID/FEIBusiness Operations
Bel Star S.A. (Colombia)880160197manufacture(13537-112, 13537-113, 13537-403, 13537-114, 13537-405, 13537-406, 13537-407, 13537-408, 13537-409)

Revised: 4/2025
Document Id: 31be1bfc-55fd-d105-e063-6294a90aaf28
Set id: 66b28743-1477-462a-9842-bce9e9df2387
Version: 2
Effective Time: 20250401
 
Ventura Corporation LTD