DailyMed - 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

Contains inactivated NDC Code(s)
NDC Code(s): 13537-237-01, 13537-237-02, 13537-238-01, 13537-238-02, view more
13537-239-01, 13537-239-02, 13537-702-01, 13537-702-02, 13537-748-01, 13537-748-02, 13537-749-01, 13537-749-02, 13537-750-01, 13537-750-02, 13537-991-01, 13537-991-02, 13537-992-01, 13537-992-02
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 August 31, 2016

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 5.7525 % 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, not skin cancer or early skin aging.
- 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
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.
SPL UNCLASSIFIED SECTION

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 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 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 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 - (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 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 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 - (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 9) - BROWN

L'BEL

EFFET PARFAIT

long lasting compact powder SPF 15

Net Weight 0.42 oz. (12 g)

Active Ingredients	Purpose
TITANIUM DIOXIDE 5.7525 %	Sunscreen
ZINC OXIDE 4.90 %	Sunscreen

INGREDIENTS AND APPEARANCE

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 Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-991
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:13537-991-02	1 in 1 BOX	08/17/2015
1	NDC:13537-991-01	12 g in 1 CASE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	08/17/2015

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 Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-992
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:13537-992-02	1 in 1 BOX	08/17/2015
1	NDC:13537-992-01	12 g in 1 CASE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	08/17/2015

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 Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-237
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:13537-237-02	1 in 1 BOX	08/17/2015
1	NDC:13537-237-01	12 g in 1 CASE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	08/17/2015

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 Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-238
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:13537-238-02	1 in 1 BOX	08/17/2015
1	NDC:13537-238-01	12 g in 1 CASE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	08/17/2015

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 Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-239
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:13537-239-02	1 in 1 BOX	08/17/2015
1	NDC:13537-239-01	12 g in 1 CASE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	08/17/2015

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 Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-702
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:13537-702-02	1 in 1 BOX	08/17/2015
1	NDC:13537-702-01	12 g in 1 CASE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	08/17/2015

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 Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-748
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:13537-748-02	1 in 1 BOX	08/17/2015
1	NDC:13537-748-01	12 g in 1 CASE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	08/17/2015

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 Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-749
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:13537-749-02	1 in 1 BOX	08/17/2015
1	NDC:13537-749-01	12 g in 1 CASE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	08/17/2015

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 Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-750
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:13537-750-02	1 in 1 BOX	08/17/2015
1	NDC:13537-750-01	12 g in 1 CASE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	08/17/2015

Labeler - Ventura Corporation LTD (602751344)

Name	Address	ID/FEI	Business Operations
Establishment
Bel Star S.A. (Colombia)		880160197	MANUFACTURE(13537-991, 13537-992, 13537-237, 13537-238, 13537-239, 13537-702, 13537-748, 13537-749, 13537-750)

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	NDC
1	13537-237-01
2	13537-237-02 (inactivated)
3	13537-238-01
4	13537-238-02 (inactivated)
5	13537-239-01
6	13537-239-02 (inactivated)
7	13537-702-01
8	13537-702-02 (inactivated)
9	13537-748-01
10	13537-748-02 (inactivated)
11	13537-749-01
12	13537-749-02 (inactivated)
13	13537-750-01
14	13537-750-02 (inactivated)
15	13537-991-01
16	13537-991-02 (inactivated)
17	13537-992-01
18	13537-992-02 (inactivated)

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