DailyMed - 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

Contains inactivated NDC Code(s)
NDC Code(s): 43596-0854-1, 43596-0855-1, 43596-0856-1, 43596-0857-1, view more
43596-0858-1, 43596-0859-1, 43596-0860-1, 43596-0861-1, 43596-0862-1
Packager: Ventura Corporation 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 December 2, 2020

If you are a consumer or patient please visit this version.

Download DRUG LABEL INFO: PDF XML
Official Label (Printer Friendly)

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ACTIVE INGREDIENT

Active Ingredients Purpose

Octinoxate 5.0% Sunscreen
PURPOSE

Uses

Helps Prevent Sunburn
KEEP OUT OF REACH OF CHILDREN

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

Stop use and ask a doctor if rash occurs.
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.

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
DOSAGE & ADMINISTRATION

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 SAFETY INFORMATION

Other information

Protect the product in this container from excessive heat and direct sun
INACTIVE INGREDIENT

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.
PRINCIPAL DISPLAY PANEL

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Net wt. 0.24 oz 7g
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Polvos Compactos de alta cobertura con FPS 20 Flan

Net wt. 0.24 oz 7g
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Polvos Compactos de alta cobertura con FPS 20 Alfajor

Net wt. 0.24 oz 7g
PRINCIPAL DISPLAY PANEL

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Polvos Compactos de alta cobertura con FPS 20 Waffle

Net wt. 0.24 oz 7g
PRINCIPAL DISPLAY PANEL

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Polvos Compactos de alta cobertura con FPS 20 Cocada

Net wt. 0.24 oz 7g
PRINCIPAL DISPLAY PANEL

Cyzone

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Polvos Compactos de alta cobertura con FPS 20 Capuccino

Net wt. 0.24 oz 7g
PRINCIPAL DISPLAY PANEL

Cyzone

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Polvos Compactos de alta cobertura con FPS 20 Manjar

Net wt. 0.24 oz 7g
PRINCIPAL DISPLAY PANEL

Cyzone

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Polvos Compactos de alta cobertura con FPS 20 Mocha

Net wt. 0.24 oz 7g
PRINCIPAL DISPLAY PANEL

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Net wt. 0.24 oz 7g

INGREDIENTS AND APPEARANCE

POLVOS COMPACTOS DE ALTA COBERTURA CON FPS 20 COCADA
octinoxate powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:43596-0858
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	5 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:43596-0858-1	7 g in 1 CARTON; Type 0: Not a Combination Product	04/01/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part352	04/01/2020

POLVOS COMPACTOS DE ALTA COBERTURA CON FPS 20 CAPUCCINO
octinoxate powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:43596-0859
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	5 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:43596-0859-1	7 g in 1 CARTON; Type 0: Not a Combination Product	04/01/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part352	04/01/2020

POLVOS COMPACTOS DE ALTA COBERTURA CON FPS 20 MANJAR
octinoxate powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:43596-0860
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	5 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:43596-0860-1	7 g in 1 CARTON; Type 0: Not a Combination Product	04/01/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part352	04/01/2020

POLVOS COMPACTOS DE ALTA COBERTURA CON FPS 20 MOCHA
octinoxate powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:43596-0861
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	5 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:43596-0861-1	7 g in 1 CARTON; Type 0: Not a Combination Product	04/01/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part352	04/01/2020

POLVOS COMPACTOS DE ALTA COBERTURA CON FPS 20 COCOA
octinoxate powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:43596-0862
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	5 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:43596-0862-1	7 g in 1 CARTON; Type 0: Not a Combination Product	04/01/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part352	04/01/2020

POLVOS COMPACTOS DE ALTA COBERTURA CON FPS 20 CREMA
octinoxate powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:43596-0854
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	5 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:43596-0854-1	7 g in 1 CARTON; Type 0: Not a Combination Product	04/01/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part352	04/01/2020

POLVOS COMPACTOS DE ALTA COBERTURA CON FPS 20 FLAN
octinoxate powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:43596-0855
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	5 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:43596-0855-1	7 g in 1 CARTON; Type 0: Not a Combination Product	04/01/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part352	04/01/2020

POLVOS COMPACTOS DE ALTA COBERTURA CON FPS 20 ALFAJOR
octinoxate powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:43596-0856
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	5 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:43596-0856-1	7 g in 1 CARTON; Type 0: Not a Combination Product	04/01/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part352	04/01/2020

POLVOS COMPACTOS DE ALTA COBERTURA CON FPS 20 WAFFLE
octinoxate powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:43596-0857
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	5 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:43596-0857-1	7 g in 1 CARTON; Type 0: Not a Combination Product	04/01/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part352	04/01/2020

Labeler - Ventura Corporation LTD (602751344)

Name	Address	ID/FEI	Business Operations
Establishment
BEL STAR S A		880160197	manufacture(43596-0854, 43596-0855, 43596-0856, 43596-0857, 43596-0858, 43596-0859, 43596-0860, 43596-0861, 43596-0862)

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Published Date (What is this?)	Version	Files
Dec 7, 2020	2 (current)	download
Apr 30, 2020	1	download

	NDC
1	43596-0854-1 (inactivated)
2	43596-0855-1 (inactivated)
3	43596-0856-1 (inactivated)
4	43596-0857-1 (inactivated)
5	43596-0858-1 (inactivated)
6	43596-0859-1 (inactivated)
7	43596-0860-1 (inactivated)
8	43596-0861-1 (inactivated)
9	43596-0862-1 (inactivated)

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Number of versions: 2

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If this SPL contains inactivated NDCs listed by the FDA initiated compliance action, they will be specified as such.