DailyMed - 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

Contains inactivated NDC Code(s)
NDC Code(s): 13537-112-01, 13537-112-02, 13537-113-05, 13537-113-06, view more
13537-114-13, 13537-114-14, 13537-403-09, 13537-403-10, 13537-405-17, 13537-405-18, 13537-406-21, 13537-406-22, 13537-407-25, 13537-407-26, 13537-408-29, 13537-408-30, 13537-409-33, 13537-409-34
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 January 27, 2014

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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SPL UNCLASSIFIED SECTION

Drug Facts
ACTIVE INGREDIENT

Active Ingredients Purpose

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, not skin 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 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
- 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 ).
SPL UNCLASSIFIED SECTION

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 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 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 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 - (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 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 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 - (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 9) - Brown

EFFET PARFAIT

long lasting compact powder SPF 15

Net Weigth 0.42 oz. (12 g)

L'BEL

Active Ingredients	Purpose
TITANIUM DIOXIDE (5.7%)	Sunscreen
ZINC OXIDE (4.9%)	Sunscreen

INGREDIENTS AND APPEARANCE

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 Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-112
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	0.049 g in 1 g
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	0.057 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description
Packaging
1	NDC:13537-112-02	1 in 1 BOX
1	NDC:13537-112-01	12 g in 1 CASE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	01/27/2014

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 Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-113
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	0.049 g in 1 g
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	0.057 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description
Packaging
1	NDC:13537-113-06	1 in 1 BOX
1	NDC:13537-113-05	12 g in 1 CASE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	01/27/2014

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 Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-403
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	0.049 g in 1 g
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	0.057 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description
Packaging
1	NDC:13537-403-10	1 in 1 BOX
1	NDC:13537-403-09	12 g in 1 CASE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	01/27/2014

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 Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-114
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	0.049 g in 1 g
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	0.057 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description
Packaging
1	NDC:13537-114-14	1 in 1 BOX
1	NDC:13537-114-13	12 g in 1 CASE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	01/27/2014

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 Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-405
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	0.049 g in 1 g
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	0.057 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description
Packaging
1	NDC:13537-405-18	1 in 1 BOX
1	NDC:13537-405-17	12 g in 1 CASE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	01/27/2014

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 Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-406
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	0.049 g in 1 g
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	0.057 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description
Packaging
1	NDC:13537-406-22	1 in 1 BOX
1	NDC:13537-406-21	12 g in 1 CASE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	01/27/2014

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 Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-407
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	0.049 g in 1 g
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	0.057 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description
Packaging
1	NDC:13537-407-26	1 in 1 BOX
1	NDC:13537-407-25	12 g in 1 CASE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	01/27/2014

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 Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-408
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	0.049 g in 1 g
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	0.057 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description
Packaging
1	NDC:13537-408-30	1 in 1 BOX
1	NDC:13537-408-29	12 g in 1 CASE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	01/27/2014

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 Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-409
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	0.049 g in 1 g
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	0.057 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description
Packaging
1	NDC:13537-409-34	1 in 1 BOX
1	NDC:13537-409-33	12 g in 1 CASE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	01/27/2014

Labeler - Ventura Corporation LTD (602751344)

Name	Address	ID/FEI	Business Operations
Establishment
Bel Star S.A. (Colombia)		880160197	MANUFACTURE(13537-112, 13537-113, 13537-403, 13537-114, 13537-405, 13537-406, 13537-407, 13537-408, 13537-409)

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	NDC
1	13537-112-01
2	13537-112-02 (inactivated)
3	13537-113-05
4	13537-113-06 (inactivated)
5	13537-114-13
6	13537-114-14 (inactivated)
7	13537-403-09
8	13537-403-10 (inactivated)
9	13537-405-17
10	13537-405-18 (inactivated)
11	13537-406-21
12	13537-406-22 (inactivated)
13	13537-407-25
14	13537-407-26 (inactivated)
15	13537-408-29
16	13537-408-30 (inactivated)
17	13537-409-33
18	13537-409-34 (inactivated)

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