LBEL EFFET PARFAIT POLVOS COMPACTOS DE LARGA DURACION PARA ROSTRO FPS 15 LONG LASTING COMPACT SPF 15 (CLAIRE 1) - BEIGE- titanium dioxide and zinc oxide powder 
LBEL EFFET PARFAIT POLVOS COMPACTOS DE LARGA DURACION PARA ROSTRO FPS 15 LONG LASTING COMPACT SPF 15 (CLAIRE 2) - BEIGE- titanium dioxide and zinc oxide powder 
LBEL EFFET PARFAIT POLVOS COMPACTOS DE LARGA DURACION PARA ROSTRO FPS 15 LONG LASTING COMPACT SPF 15 (CLAIRE 3) - BEIGE- titanium dioxide and zinc oxide powder 
LBEL EFFET PARFAIT POLVOS COMPACTOS DE LARGA DURACION PARA ROSTRO FPS 15 LONG LASTING COMPACT SPF 15 (CLAIRE 4) - BEIGE- titanium dioxide and zinc oxide powder 
LBEL EFFET PARFAIT POLVOS COMPACTOS DE LARGA DURACION PARA ROSTRO FPS 15 LONG LASTING COMPACT SPF 15 (MEDIUM 5) - BEIGE- titanium dioxide and zinc oxide powder 
LBEL EFFET PARFAIT POLVOS COMPACTOS DE LARGA DURACION PARA ROSTRO FPS 15 LONG LASTING COMPACT SPF 15 (MEDIUM 6) - BEIGE- titanium dioxide and zinc oxide powder 
LBEL EFFET PARFAIT POLVOS COMPACTOS DE LARGA DURACION PARA ROSTRO FPS 15 LONG LASTING COMPACT SPF 15 (MEDIUM 7) - BEIGE- titanium dioxide and zinc oxide powder 
LBEL EFFET PARFAIT POLVOS COMPACTOS DE LARGA DURACION PARA ROSTRO FPS 15 LONG LASTING COMPACT SPF 15 (OBSCURE 8) - BROWN- titanium dioxide and zinc oxide powder 
LBEL EFFET PARFAIT POLVOS COMPACTOS DE LARGA DURACION PARA ROSTRO FPS 15 LONG LASTING COMPACT SPF 15 (OBSCURE 9) - BROWN- titanium dioxide and zinc oxide 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 5.7525 %Sunscreen
ZINC OXIDE 4.90 %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.

  • 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

Other information

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

Inactive ingredients

MICA, DIMETHICONE, POLYMETHYLSILSESQUIOXANE, ZINC STEARATE, HDI/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER, TRIMETHYLSILOXYSILICATE, CAPRYLIC/CAPRIC TRIGLYCERIDE, PERFLOUROOCTYL TRIETHOXYSILANE, TOCOPHERYL ACETATE, HYDROGEN DIMETHICONE, PHENOXYETHANOL, CETYL PEG/PPG-10/1 DIMETHICONE, POLYGLYCERYL-4 ISOSTEARATE, ALUMINA, HEXYL LAURATE, FRAGRANCE, CAPRYLYL GLYCOL, CRITHMUM MARITIMUM EXTRACT, TRIETHOXYCAPRYLYLSILANE, CHLORPHENESIN, CERAMIDE 3, BUTYLPHENYL METHYLPROPIONAL, HYDROXYISOHEXYL 3-CYCLOHEXENE CARBOXALDEHYDE, HYDROXYCITRONELLAL, CITRONELLOL, GERANIOL, d-LIMONENE, ALPHA-ISOMETHYL IONONE.

MAY CONTAIN: IRON OXIDES, TITANIUM DIOXIDE.

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

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

L'BEL

EFFET PARFAIT

long lasting compact powder SPF 15

Net Weight 0.42 oz. (12 g)

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

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

L'BEL

EFFET PARFAIT

long lasting compact powder SPF 15

Net Weight 0.42 oz. (12 g)

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

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

L'BEL

EFFET PARFAIT

long lasting compact powder SPF 15

Net Weight 0.42 oz. (12 g)

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

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

L'BEL

EFFET PARFAIT

long lasting compact powder SPF 15

Net Weight 0.42 oz. (12 g)

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

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

L'BEL

EFFET PARFAIT

long lasting compact powder SPF 15

Net Weight 0.42 oz. (12 g)

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

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

L'BEL

EFFET PARFAIT

long lasting compact powder SPF 15

Net Weight 0.42 oz. (12 g)

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

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

L'BEL

EFFET PARFAIT

long lasting compact powder SPF 15

Net Weight 0.42 oz. (12 g)

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

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

L'BEL

EFFET PARFAIT

long lasting compact powder SPF 15

Net Weight 0.42 oz. (12 g)

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

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

L'BEL

EFFET PARFAIT

long lasting compact powder SPF 15

Net Weight 0.42 oz. (12 g)

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
titanium dioxide and zinc oxide powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-991
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE0.057 g  in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE0.049 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
MICA (UNII: V8A1AW0880)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
ZINC STEARATE (UNII: H92E6QA4FV)  
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
.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)  
CRITHMUM MARITIMUM (UNII: J7IHY79BKY)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
CERAMIDE NP (UNII: 4370DF050B)  
BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)  
HYDROXYISOHEXYL 3-CYCLOHEXENE CARBOXALDEHYDE (UNII: QUE43B9Z2Q)  
HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)  
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
GERANIOL (UNII: L837108USY)  
LIMONENE, (+)- (UNII: GFD7C86Q1W)  
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-991-021 in 1 BOX08/17/201512/31/2021
1NDC:13537-991-0112 g in 1 CASE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02008/17/201512/31/2021
LBEL EFFET PARFAIT POLVOS COMPACTOS DE LARGA DURACION PARA ROSTRO FPS 15 LONG LASTING COMPACT SPF 15  (CLAIRE 2) - BEIGE
titanium dioxide and zinc oxide powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-992
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE0.057 g  in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE0.049 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
MICA (UNII: V8A1AW0880)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
ZINC STEARATE (UNII: H92E6QA4FV)  
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
.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)  
CRITHMUM MARITIMUM (UNII: J7IHY79BKY)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
CERAMIDE NP (UNII: 4370DF050B)  
BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)  
HYDROXYISOHEXYL 3-CYCLOHEXENE CARBOXALDEHYDE (UNII: QUE43B9Z2Q)  
HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)  
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
GERANIOL (UNII: L837108USY)  
LIMONENE, (+)- (UNII: GFD7C86Q1W)  
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-992-021 in 1 BOX08/17/201512/31/2021
1NDC:13537-992-0112 g in 1 CASE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02008/17/201512/31/2021
LBEL EFFET PARFAIT POLVOS COMPACTOS DE LARGA DURACION PARA ROSTRO FPS 15 LONG LASTING COMPACT SPF 15  (CLAIRE 3) - BEIGE
titanium dioxide and zinc oxide powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-237
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE0.057 g  in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE0.049 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
MICA (UNII: V8A1AW0880)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
ZINC STEARATE (UNII: H92E6QA4FV)  
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
.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)  
CRITHMUM MARITIMUM (UNII: J7IHY79BKY)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
CERAMIDE NP (UNII: 4370DF050B)  
BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)  
HYDROXYISOHEXYL 3-CYCLOHEXENE CARBOXALDEHYDE (UNII: QUE43B9Z2Q)  
HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)  
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
GERANIOL (UNII: L837108USY)  
LIMONENE, (+)- (UNII: GFD7C86Q1W)  
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-237-021 in 1 BOX08/17/201512/31/2021
1NDC:13537-237-0112 g in 1 CASE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02008/17/201512/31/2021
LBEL EFFET PARFAIT POLVOS COMPACTOS DE LARGA DURACION PARA ROSTRO FPS 15 LONG LASTING COMPACT SPF 15  (CLAIRE 4) - BEIGE
titanium dioxide and zinc oxide powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-238
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE0.057 g  in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE0.049 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
MICA (UNII: V8A1AW0880)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
ZINC STEARATE (UNII: H92E6QA4FV)  
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
.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)  
CRITHMUM MARITIMUM (UNII: J7IHY79BKY)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
CERAMIDE NP (UNII: 4370DF050B)  
BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)  
HYDROXYISOHEXYL 3-CYCLOHEXENE CARBOXALDEHYDE (UNII: QUE43B9Z2Q)  
HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)  
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
GERANIOL (UNII: L837108USY)  
LIMONENE, (+)- (UNII: GFD7C86Q1W)  
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-238-021 in 1 BOX08/17/201512/31/2021
1NDC:13537-238-0112 g in 1 CASE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02008/17/201512/31/2021
LBEL EFFET PARFAIT POLVOS COMPACTOS DE LARGA DURACION PARA ROSTRO FPS 15 LONG LASTING COMPACT SPF 15  (MEDIUM 5) - BEIGE
titanium dioxide and zinc oxide powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-239
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE0.057 g  in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE0.049 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
MICA (UNII: V8A1AW0880)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
ZINC STEARATE (UNII: H92E6QA4FV)  
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
.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)  
CRITHMUM MARITIMUM (UNII: J7IHY79BKY)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
CERAMIDE NP (UNII: 4370DF050B)  
BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)  
HYDROXYISOHEXYL 3-CYCLOHEXENE CARBOXALDEHYDE (UNII: QUE43B9Z2Q)  
HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)  
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
GERANIOL (UNII: L837108USY)  
LIMONENE, (+)- (UNII: GFD7C86Q1W)  
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-239-021 in 1 BOX08/17/201512/31/2021
1NDC:13537-239-0112 g in 1 CASE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02008/17/201512/31/2021
LBEL EFFET PARFAIT POLVOS COMPACTOS DE LARGA DURACION PARA ROSTRO FPS 15 LONG LASTING COMPACT SPF 15  (MEDIUM 6) - BEIGE
titanium dioxide and zinc oxide powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-702
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE0.057 g  in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE0.049 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
MICA (UNII: V8A1AW0880)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
ZINC STEARATE (UNII: H92E6QA4FV)  
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
.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)  
CRITHMUM MARITIMUM (UNII: J7IHY79BKY)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
CERAMIDE NP (UNII: 4370DF050B)  
BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)  
HYDROXYISOHEXYL 3-CYCLOHEXENE CARBOXALDEHYDE (UNII: QUE43B9Z2Q)  
HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)  
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
GERANIOL (UNII: L837108USY)  
LIMONENE, (+)- (UNII: GFD7C86Q1W)  
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-702-021 in 1 BOX08/17/201512/31/2021
1NDC:13537-702-0112 g in 1 CASE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02008/17/201512/31/2021
LBEL EFFET PARFAIT POLVOS COMPACTOS DE LARGA DURACION PARA ROSTRO FPS 15 LONG LASTING COMPACT SPF 15  (MEDIUM 7) - BEIGE
titanium dioxide and zinc oxide powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-748
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE0.057 g  in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE0.049 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
MICA (UNII: V8A1AW0880)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
ZINC STEARATE (UNII: H92E6QA4FV)  
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
.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)  
CRITHMUM MARITIMUM (UNII: J7IHY79BKY)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
CERAMIDE NP (UNII: 4370DF050B)  
BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)  
HYDROXYISOHEXYL 3-CYCLOHEXENE CARBOXALDEHYDE (UNII: QUE43B9Z2Q)  
HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)  
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
GERANIOL (UNII: L837108USY)  
LIMONENE, (+)- (UNII: GFD7C86Q1W)  
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-748-021 in 1 BOX08/17/2015
1NDC:13537-748-0112 g in 1 CASE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02008/17/201512/31/2021
LBEL EFFET PARFAIT POLVOS COMPACTOS DE LARGA DURACION PARA ROSTRO FPS 15 LONG LASTING COMPACT SPF 15  (OBSCURE 8) - BROWN
titanium dioxide and zinc oxide powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-749
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE0.057 g  in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE0.049 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
MICA (UNII: V8A1AW0880)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
ZINC STEARATE (UNII: H92E6QA4FV)  
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
.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)  
CRITHMUM MARITIMUM (UNII: J7IHY79BKY)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
CERAMIDE NP (UNII: 4370DF050B)  
BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)  
HYDROXYISOHEXYL 3-CYCLOHEXENE CARBOXALDEHYDE (UNII: QUE43B9Z2Q)  
HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)  
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
GERANIOL (UNII: L837108USY)  
LIMONENE, (+)- (UNII: GFD7C86Q1W)  
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-749-021 in 1 BOX08/17/201512/31/2021
1NDC:13537-749-0112 g in 1 CASE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02008/17/201512/31/2021
LBEL EFFET PARFAIT POLVOS COMPACTOS DE LARGA DURACION PARA ROSTRO FPS 15 LONG LASTING COMPACT SPF 15  (OBSCURE 9) - BROWN
titanium dioxide and zinc oxide powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-750
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE0.057 g  in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE0.049 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
MICA (UNII: V8A1AW0880)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
ZINC STEARATE (UNII: H92E6QA4FV)  
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
.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)  
CRITHMUM MARITIMUM (UNII: J7IHY79BKY)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
CERAMIDE NP (UNII: 4370DF050B)  
BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)  
HYDROXYISOHEXYL 3-CYCLOHEXENE CARBOXALDEHYDE (UNII: QUE43B9Z2Q)  
HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)  
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
GERANIOL (UNII: L837108USY)  
LIMONENE, (+)- (UNII: GFD7C86Q1W)  
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-750-021 in 1 BOX08/17/201512/31/2021
1NDC:13537-750-0112 g in 1 CASE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02008/17/201512/31/2021
Labeler - Ventura Corporation LTD (602751344)
Establishment
NameAddressID/FEIBusiness Operations
Bel Star S.A. (Colombia)880160197manufacture(13537-991, 13537-992, 13537-237, 13537-238, 13537-239, 13537-702, 13537-748, 13537-749, 13537-750)

Revised: 5/2025
Document Id: 3416baec-d0c6-c851-e063-6394a90a6ca9
Set id: 99f55784-1ff2-4d42-a22f-831c86e0e858
Version: 4
Effective Time: 20250501
 
Ventura Corporation LTD