LBEL EFFET PARFAIT LONG LASTING COMPACT SPF 15 CLAIRE 1/BEIGE- titanium dioxide and zinc oxide powder LBEL EFFET PARFAIT LONG LASTING COMPACT SPF 15 CLAIRE 2/BEIGE- titanium dioxide and zinc oxide powder LBEL EFFET PARFAIT LONG LASTING COMPACT SPF 15 CLAIRE 3/BEIGE- titanium dioxide and zinc oxide powder LBEL EFFET PARFAIT LONG LASTING COMPACT SPF 15 CLAIRE 4/BEIGE- titanium dioxide and zinc oxide powder LBEL EFFET PARFAIT LONG LASTING COMPACT SPF 15 MEDIUM 5/BEIGE- titanium dioxide and zinc oxide powder LBEL EFFET PARFAIT LONG LASTING COMPACT SPF 15 MEDIUM 6/BEIGE- titanium dioxide and zinc oxide powder LBEL EFFET PARFAIT LONG LASTING COMPACT SPF 15 MEDIUM 7/BEIGE- titanium dioxide and zinc oxide powder LBEL EFFET PARFAIT LONG LASTING COMPACT SPF 15 OBSCURE 8/BEIGE- titanium dioxide and zinc oxide powder LBEL EFFET PARFAIT LONG LASTING COMPACT SPF 15 OBSCURE 9/BEIGE- titanium dioxide and zinc oxide powder

LBEL EFFET PARFAIT LONG LASTING COMPACT SPF 15 by

Drug Labeling and Warnings

LBEL EFFET PARFAIT LONG LASTING COMPACT SPF 15 by is a Otc medication manufactured, distributed, or labeled by Ventura Corporation LTD, Bel Star S.A. (Colombia). Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active Ingredients	Purpose
TITANIUM DIOXIDE 5.75 %	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, PERFLUOROOCTYL 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 - 10 g Container Box - Claire 1/Beige

L'BEL

EFFET PARFAIT

Long lasting compact powder SPF 15

Net wt. 0.35 oz. e (10 g)

PRINCIPAL DISPLAY PANEL - 10 g Container Box - Claire 2/Beige

L'BEL

EFFET PARFAIT

Long lasting compact powder SPF 15

Net wt. 0.35 oz. e (10 g)

PRINCIPAL DISPLAY PANEL - 10 g Container Box - Claire 3/Beige

L'BEL

EFFET PARFAIT

Long lasting compact powder SPF 15

Net wt. 0.35 oz. e (10 g)

PRINCIPAL DISPLAY PANEL - 10 g Container Box - Claire 4/Beige

L'BEL

EFFET PARFAIT

Long lasting compact powder SPF 15

Net wt. 0.35 oz. e (10 g)

PRINCIPAL DISPLAY PANEL - 10 g Container Box - Medium 5/Beige

L'BEL

EFFET PARFAIT

Long lasting compact powder SPF 15

Net wt. 0.35 oz. e (10 g)

PRINCIPAL DISPLAY PANEL - 10 g Container Box - Medium 6/Beige

L'BEL

EFFET PARFAIT

Long lasting compact powder SPF 15

Net wt. 0.35 oz. e (10 g)

PRINCIPAL DISPLAY PANEL - 10 g Container Box - Medium 7/Beige

L'BEL

EFFET PARFAIT

Long lasting compact powder SPF 15

Net wt. 0.35 oz. e (10 g)

PRINCIPAL DISPLAY PANEL - 10 g Container Box - Obscure 8/Beige

L'BEL

EFFET PARFAIT

Long lasting compact powder SPF 15

Net wt. 0.35 oz. e (10 g)

PRINCIPAL DISPLAY PANEL - 10 g Container Box - Obscure 9/Beige

L'BEL

EFFET PARFAIT

Long lasting compact powder SPF 15

Net wt. 0.35 oz. e (10 g)

INGREDIENTS AND APPEARANCE

LBEL EFFET PARFAIT 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: 43596-0090
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	0.0575 g  in 1 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	0.049 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
MICA (UNII: V8A1AW0880)
DIMETHICONE (UNII: 92RU3N3Y1O)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
ZINC STEARATE (UNII: H92E6QA4FV)
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
PERFLUOROOCTYL TRIETHOXYSILANE (UNII: 814P46684U)
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)
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43596-0090-2	1 in 1 BOX	08/18/2018
1	NDC: 43596-0090-1	12 g in 1 CONTAINER; Type 0: Not a Combination Product
2	NDC: 43596-0090-4	1 in 1 BOX	08/18/2018
2	NDC: 43596-0090-3	10 g in 1 CONTAINER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	08/18/2018

LBEL EFFET PARFAIT 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: 43596-0091
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	0.0575 g  in 1 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	0.049 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
MICA (UNII: V8A1AW0880)
DIMETHICONE (UNII: 92RU3N3Y1O)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
ZINC STEARATE (UNII: H92E6QA4FV)
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
PERFLUOROOCTYL TRIETHOXYSILANE (UNII: 814P46684U)
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)
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43596-0091-2	1 in 1 BOX	08/18/2018
1	NDC: 43596-0091-1	12 g in 1 CONTAINER; Type 0: Not a Combination Product
2	NDC: 43596-0091-4	1 in 1 BOX	08/18/2018
2	NDC: 43596-0091-3	10 g in 1 CONTAINER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	08/18/2018

LBEL EFFET PARFAIT 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: 43596-0092
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	0.0575 g  in 1 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	0.049 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
MICA (UNII: V8A1AW0880)
DIMETHICONE (UNII: 92RU3N3Y1O)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
ZINC STEARATE (UNII: H92E6QA4FV)
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
PERFLUOROOCTYL TRIETHOXYSILANE (UNII: 814P46684U)
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)
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43596-0092-2	1 in 1 BOX	08/18/2018
1	NDC: 43596-0092-1	12 g in 1 CONTAINER; Type 0: Not a Combination Product
2	NDC: 43596-0092-4	1 in 1 BOX	08/18/2018
2	NDC: 43596-0092-3	10 g in 1 CONTAINER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	08/18/2018

LBEL EFFET PARFAIT 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: 43596-0093
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	0.0575 g  in 1 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	0.049 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
MICA (UNII: V8A1AW0880)
DIMETHICONE (UNII: 92RU3N3Y1O)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
ZINC STEARATE (UNII: H92E6QA4FV)
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
PERFLUOROOCTYL TRIETHOXYSILANE (UNII: 814P46684U)
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)
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43596-0093-2	1 in 1 BOX	08/18/2018
1	NDC: 43596-0093-1	12 g in 1 CONTAINER; Type 0: Not a Combination Product
2	NDC: 43596-0093-4	1 in 1 BOX	08/18/2018
2	NDC: 43596-0093-3	10 g in 1 CONTAINER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	08/18/2018

LBEL EFFET PARFAIT 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: 43596-0094
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	0.0575 g  in 1 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	0.049 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
MICA (UNII: V8A1AW0880)
DIMETHICONE (UNII: 92RU3N3Y1O)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
ZINC STEARATE (UNII: H92E6QA4FV)
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
PERFLUOROOCTYL TRIETHOXYSILANE (UNII: 814P46684U)
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)
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43596-0094-2	1 in 1 BOX	08/18/2018
1	NDC: 43596-0094-1	12 g in 1 CONTAINER; Type 0: Not a Combination Product
2	NDC: 43596-0094-4	1 in 1 BOX	08/18/2018
2	NDC: 43596-0094-3	10 g in 1 CONTAINER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	08/18/2018

LBEL EFFET PARFAIT 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: 43596-0095
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	0.0575 g  in 1 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	0.049 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
MICA (UNII: V8A1AW0880)
DIMETHICONE (UNII: 92RU3N3Y1O)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
ZINC STEARATE (UNII: H92E6QA4FV)
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
PERFLUOROOCTYL TRIETHOXYSILANE (UNII: 814P46684U)
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)
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43596-0095-2	1 in 1 BOX	08/18/2018
1	NDC: 43596-0095-1	12 g in 1 CONTAINER; Type 0: Not a Combination Product
2	NDC: 43596-0095-4	1 in 1 BOX	08/18/2018
2	NDC: 43596-0095-3	10 g in 1 CONTAINER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	08/18/2018

LBEL EFFET PARFAIT 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: 43596-0096
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	0.0575 g  in 1 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	0.049 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
MICA (UNII: V8A1AW0880)
DIMETHICONE (UNII: 92RU3N3Y1O)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
ZINC STEARATE (UNII: H92E6QA4FV)
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
PERFLUOROOCTYL TRIETHOXYSILANE (UNII: 814P46684U)
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)
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43596-0096-2	1 in 1 BOX	08/18/2018
1	NDC: 43596-0096-1	12 g in 1 CONTAINER; Type 0: Not a Combination Product
2	NDC: 43596-0096-4	1 in 1 BOX	08/18/2018
2	NDC: 43596-0096-3	10 g in 1 CONTAINER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	08/18/2018

LBEL EFFET PARFAIT LONG LASTING COMPACT SPF 15   OBSCURE 8/BEIGE
titanium dioxide and zinc oxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43596-0097
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	0.0575 g  in 1 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	0.049 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
MICA (UNII: V8A1AW0880)
DIMETHICONE (UNII: 92RU3N3Y1O)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
ZINC STEARATE (UNII: H92E6QA4FV)
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
PERFLUOROOCTYL TRIETHOXYSILANE (UNII: 814P46684U)
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)
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43596-0097-2	1 in 1 BOX	08/18/2018
1	NDC: 43596-0097-1	12 g in 1 CONTAINER; Type 0: Not a Combination Product
2	NDC: 43596-0097-4	1 in 1 BOX	08/18/2018
2	NDC: 43596-0097-3	10 g in 1 CONTAINER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	08/18/2018

LBEL EFFET PARFAIT LONG LASTING COMPACT SPF 15   OBSCURE 9/BEIGE
titanium dioxide and zinc oxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43596-0098
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	0.0575 g  in 1 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	0.049 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
MICA (UNII: V8A1AW0880)
DIMETHICONE (UNII: 92RU3N3Y1O)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
ZINC STEARATE (UNII: H92E6QA4FV)
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
PERFLUOROOCTYL TRIETHOXYSILANE (UNII: 814P46684U)
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)
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43596-0098-2	1 in 1 BOX	08/18/2018
1	NDC: 43596-0098-1	12 g in 1 CONTAINER; Type 0: Not a Combination Product
2	NDC: 43596-0098-4	1 in 1 BOX	08/18/2018
2	NDC: 43596-0098-3	10 g in 1 CONTAINER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	08/18/2018

Labeler - Ventura Corporation LTD (602751344)

Establishment
Name	Address	ID/FEI	Business Operations
Bel Star S.A. (Colombia)		880160197	MANUFACTURE(43596-0090, 43596-0091, 43596-0092, 43596-0093, 43596-0094, 43596-0095, 43596-0096, 43596-0097, 43596-0098)