POLVOS COMPACTOS DE ALTA COBERTURA CON FPS 20 COCADA- octinoxate powder 
POLVOS COMPACTOS DE ALTA COBERTURA CON FPS 20 CAPUCCINO- octinoxate powder 
POLVOS COMPACTOS DE ALTA COBERTURA CON FPS 20 MANJAR- octinoxate powder 
POLVOS COMPACTOS DE ALTA COBERTURA CON FPS 20 MOCHA- octinoxate powder 
POLVOS COMPACTOS DE ALTA COBERTURA CON FPS 20 COCOA- octinoxate powder 
POLVOS COMPACTOS DE ALTA COBERTURA CON FPS 20 CREMA- octinoxate powder 
POLVOS COMPACTOS DE ALTA COBERTURA CON FPS 20 FLAN- octinoxate powder 
POLVOS COMPACTOS DE ALTA COBERTURA CON FPS 20 ALFAJOR- octinoxate powder 
POLVOS COMPACTOS DE ALTA COBERTURA CON FPS 20 WAFFLE- octinoxate powder 
Ventura Corporation 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.

----------

Studio Look Polvos Compactos de alta Cobertura SPF 20

Active Ingredients Purpose

Octinoxate 5.0% Sunscreen

Uses

Helps Prevent Sunburn

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

Stop use and ask a doctor if rash occurs.

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.

Do not use on damaged or broken skin
When using this product keep out of eyes. Rinse with water to remove
For external use only

Directions

Apply generously 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, talc, zinc stearate, methyl methacrylate crosspolymer, boron nitride, dimethicone, octyldodecanol, trimethylsiloxysilicate, perfluorooctyl triethoxysilane, tocopheryl acetate, magnesium myristate, phenoxyethanol, caprylyl glycol, fragrance, chlorphenesin, benzyl alcohol, linalool, hexyl cinnamal, limonene. May Contain: titanium dioxide, iron oxides.

Cyzone

Studio Look

Polvos Compactos de alta cobertura con FPS 20 Crema

Net wt. 0.24 oz 7g

Polvos compactos SPF 20

Cyzone

Studio Look

Polvos Compactos de alta cobertura con FPS 20 Flan

Net wt. 0.24 oz 7g

Polvos compactos 2

Cyzone

Studio Look

Polvos Compactos de alta cobertura con FPS 20 Alfajor

Net wt. 0.24 oz 7g

Polvos compactos 3


Cyzone

Studio Look

Polvos Compactos de alta cobertura con FPS 20 Waffle

Net wt. 0.24 oz 7g

Polvos compactos 4

Cyzone

Studio Look

Polvos Compactos de alta cobertura con FPS 20 Cocada

Net wt. 0.24 oz 7g

Polvos Compactos 5

Cyzone

Studio Look

Polvos Compactos de alta cobertura con FPS 20 Capuccino

Net wt. 0.24 oz 7g

Polvos compactos 6

Cyzone

Studio Look

Polvos Compactos de alta cobertura con FPS 20 Manjar

Net wt. 0.24 oz 7g

Polvos compactos 7

Cyzone

Studio Look

Polvos Compactos de alta cobertura con FPS 20 Mocha

Net wt. 0.24 oz 7g

Polvos Compactos 8

Cyzone

Studio Look

Polvos Compactos de alta cobertura con FPS 20 Cocoa

Net wt. 0.24 oz 7g

Polvos Compactos 9

POLVOS COMPACTOS DE ALTA COBERTURA CON FPS 20 COCADA 
octinoxate powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43596-0858
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
LINALOOL, (+/-)- (UNII: D81QY6I88E)  
LIMONENE, (+)- (UNII: GFD7C86Q1W)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TRIMETHYLSILOXYSILICATE (M/Q 1.0-1.2) (UNII: 78GX033D7I)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EG97988M5Q)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
TALC (UNII: 7SEV7J4R1U)  
ZINC STEARATE (UNII: H92E6QA4FV)  
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)  
PERFLUOROOCTYL TRIETHOXYSILANE (UNII: 814P46684U)  
MAGNESIUM MYRISTATE (UNII: Z1917F0578)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
OCTYLDODECANOL (UNII: 461N1O614Y)  
MICA (UNII: V8A1AW0880)  
BORON NITRIDE (UNII: 2U4T60A6YD)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43596-0858-17 g in 1 CARTON; Type 0: Not a Combination Product04/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35204/01/2020
POLVOS COMPACTOS DE ALTA COBERTURA CON FPS 20 CAPUCCINO 
octinoxate powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43596-0859
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
LINALOOL, (+/-)- (UNII: D81QY6I88E)  
LIMONENE, (+)- (UNII: GFD7C86Q1W)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TRIMETHYLSILOXYSILICATE (M/Q 1.0-1.2) (UNII: 78GX033D7I)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EG97988M5Q)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
TALC (UNII: 7SEV7J4R1U)  
ZINC STEARATE (UNII: H92E6QA4FV)  
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)  
PERFLUOROOCTYL TRIETHOXYSILANE (UNII: 814P46684U)  
MAGNESIUM MYRISTATE (UNII: Z1917F0578)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
OCTYLDODECANOL (UNII: 461N1O614Y)  
MICA (UNII: V8A1AW0880)  
BORON NITRIDE (UNII: 2U4T60A6YD)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43596-0859-17 g in 1 CARTON; Type 0: Not a Combination Product04/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35204/01/2020
POLVOS COMPACTOS DE ALTA COBERTURA CON FPS 20 MANJAR 
octinoxate powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43596-0860
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
LINALOOL, (+/-)- (UNII: D81QY6I88E)  
LIMONENE, (+)- (UNII: GFD7C86Q1W)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TRIMETHYLSILOXYSILICATE (M/Q 1.0-1.2) (UNII: 78GX033D7I)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EG97988M5Q)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
TALC (UNII: 7SEV7J4R1U)  
ZINC STEARATE (UNII: H92E6QA4FV)  
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)  
PERFLUOROOCTYL TRIETHOXYSILANE (UNII: 814P46684U)  
MAGNESIUM MYRISTATE (UNII: Z1917F0578)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
OCTYLDODECANOL (UNII: 461N1O614Y)  
MICA (UNII: V8A1AW0880)  
BORON NITRIDE (UNII: 2U4T60A6YD)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43596-0860-17 g in 1 CARTON; Type 0: Not a Combination Product04/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35204/01/2020
POLVOS COMPACTOS DE ALTA COBERTURA CON FPS 20 MOCHA 
octinoxate powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43596-0861
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
LINALOOL, (+/-)- (UNII: D81QY6I88E)  
LIMONENE, (+)- (UNII: GFD7C86Q1W)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TRIMETHYLSILOXYSILICATE (M/Q 1.0-1.2) (UNII: 78GX033D7I)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EG97988M5Q)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
TALC (UNII: 7SEV7J4R1U)  
ZINC STEARATE (UNII: H92E6QA4FV)  
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)  
PERFLUOROOCTYL TRIETHOXYSILANE (UNII: 814P46684U)  
MAGNESIUM MYRISTATE (UNII: Z1917F0578)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
OCTYLDODECANOL (UNII: 461N1O614Y)  
MICA (UNII: V8A1AW0880)  
BORON NITRIDE (UNII: 2U4T60A6YD)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43596-0861-17 g in 1 CARTON; Type 0: Not a Combination Product04/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35204/01/2020
POLVOS COMPACTOS DE ALTA COBERTURA CON FPS 20 COCOA 
octinoxate powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43596-0862
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
LINALOOL, (+/-)- (UNII: D81QY6I88E)  
LIMONENE, (+)- (UNII: GFD7C86Q1W)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TRIMETHYLSILOXYSILICATE (M/Q 1.0-1.2) (UNII: 78GX033D7I)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EG97988M5Q)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
TALC (UNII: 7SEV7J4R1U)  
ZINC STEARATE (UNII: H92E6QA4FV)  
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)  
PERFLUOROOCTYL TRIETHOXYSILANE (UNII: 814P46684U)  
MAGNESIUM MYRISTATE (UNII: Z1917F0578)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
OCTYLDODECANOL (UNII: 461N1O614Y)  
MICA (UNII: V8A1AW0880)  
BORON NITRIDE (UNII: 2U4T60A6YD)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43596-0862-17 g in 1 CARTON; Type 0: Not a Combination Product04/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35204/01/2020
POLVOS COMPACTOS DE ALTA COBERTURA CON FPS 20 CREMA 
octinoxate powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43596-0854
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EG97988M5Q)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
TRIMETHYLSILOXYSILICATE (M/Q 1.0-1.2) (UNII: 78GX033D7I)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
TALC (UNII: 7SEV7J4R1U)  
ZINC STEARATE (UNII: H92E6QA4FV)  
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)  
PERFLUOROOCTYL TRIETHOXYSILANE (UNII: 814P46684U)  
MAGNESIUM MYRISTATE (UNII: Z1917F0578)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
MICA (UNII: V8A1AW0880)  
BORON NITRIDE (UNII: 2U4T60A6YD)  
OCTYLDODECANOL (UNII: 461N1O614Y)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
LINALOOL, (+/-)- (UNII: D81QY6I88E)  
LIMONENE, (+)- (UNII: GFD7C86Q1W)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43596-0854-17 g in 1 CARTON; Type 0: Not a Combination Product04/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35204/01/2020
POLVOS COMPACTOS DE ALTA COBERTURA CON FPS 20 FLAN 
octinoxate powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43596-0855
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
LINALOOL, (+/-)- (UNII: D81QY6I88E)  
LIMONENE, (+)- (UNII: GFD7C86Q1W)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TRIMETHYLSILOXYSILICATE (M/Q 1.0-1.2) (UNII: 78GX033D7I)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EG97988M5Q)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
TALC (UNII: 7SEV7J4R1U)  
ZINC STEARATE (UNII: H92E6QA4FV)  
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)  
PERFLUOROOCTYL TRIETHOXYSILANE (UNII: 814P46684U)  
MAGNESIUM MYRISTATE (UNII: Z1917F0578)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
OCTYLDODECANOL (UNII: 461N1O614Y)  
MICA (UNII: V8A1AW0880)  
BORON NITRIDE (UNII: 2U4T60A6YD)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43596-0855-17 g in 1 CARTON; Type 0: Not a Combination Product04/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35204/01/2020
POLVOS COMPACTOS DE ALTA COBERTURA CON FPS 20 ALFAJOR 
octinoxate powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43596-0856
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
LINALOOL, (+/-)- (UNII: D81QY6I88E)  
LIMONENE, (+)- (UNII: GFD7C86Q1W)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TRIMETHYLSILOXYSILICATE (M/Q 1.0-1.2) (UNII: 78GX033D7I)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EG97988M5Q)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
TALC (UNII: 7SEV7J4R1U)  
ZINC STEARATE (UNII: H92E6QA4FV)  
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)  
PERFLUOROOCTYL TRIETHOXYSILANE (UNII: 814P46684U)  
MAGNESIUM MYRISTATE (UNII: Z1917F0578)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
OCTYLDODECANOL (UNII: 461N1O614Y)  
MICA (UNII: V8A1AW0880)  
BORON NITRIDE (UNII: 2U4T60A6YD)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43596-0856-17 g in 1 CARTON; Type 0: Not a Combination Product04/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35204/01/2020
POLVOS COMPACTOS DE ALTA COBERTURA CON FPS 20 WAFFLE 
octinoxate powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43596-0857
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
LINALOOL, (+/-)- (UNII: D81QY6I88E)  
LIMONENE, (+)- (UNII: GFD7C86Q1W)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TRIMETHYLSILOXYSILICATE (M/Q 1.0-1.2) (UNII: 78GX033D7I)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EG97988M5Q)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
TALC (UNII: 7SEV7J4R1U)  
ZINC STEARATE (UNII: H92E6QA4FV)  
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)  
PERFLUOROOCTYL TRIETHOXYSILANE (UNII: 814P46684U)  
MAGNESIUM MYRISTATE (UNII: Z1917F0578)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
OCTYLDODECANOL (UNII: 461N1O614Y)  
MICA (UNII: V8A1AW0880)  
BORON NITRIDE (UNII: 2U4T60A6YD)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43596-0857-17 g in 1 CARTON; Type 0: Not a Combination Product04/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35204/01/2020
Labeler - Ventura Corporation LTD (602751344)
Establishment
NameAddressID/FEIBusiness Operations
BEL STAR S A880160197manufacture(43596-0854, 43596-0855, 43596-0856, 43596-0857, 43596-0858, 43596-0859, 43596-0860, 43596-0861, 43596-0862)

Revised: 12/2020
Document Id: b57fe0ef-0ca0-0c47-e053-2995a90a8faa
Set id: a2f2f918-fdb6-27c0-e053-2a95a90a4fb9
Version: 2
Effective Time: 20201202
 
Ventura Corporation LTD