LBEL MOUSSE MATIFFIANT MATTE FINISH MOUSSE FOUNDATION SPF 15 CLARE 1/BEIGE- octinoxate, titanium dioxide, and zinc oxide paste LBEL MOUSSE MATIFFIANT MATTE FINISH MOUSSE FOUNDATION SPF 15 CLARE 2/ BEIGE- octinoxate, titanium dioxide, and zinc oxide paste LBEL MOUSSE MATIFFIANT MATTE FINISH MOUSSE FOUNDATION SPF 15 CLARE 3/ BEIGE- octinoxate, titanium dioxide, and zinc oxide paste LBEL MOUSSE MATIFFIANT MATTE FINISH MOUSSE FOUNDATION SPF 15 CLARE 4/ BEIGE- octinoxate, titanium dioxide, and zinc oxide paste LBEL MOUSSE MATIFFIANT MATTE FINISH MOUSSE FOUNDATION SPF 15 MEDIUM 5/ BEIGE- octinoxate, titanium dioxide, and zinc oxide paste LBEL MOUSSE MATIFFIANT MATTE FINISH MOUSSE FOUNDATION SPF 15 MEDIUM 6/ BEIGE- octinoxate, titanium dioxide, and zinc oxide paste LBEL MOUSSE MATIFFIANT MATTE FINISH MOUSSE FOUNDATION SPF 15 MEDIUM 7/ BEIGE- octinoxate, titanium dioxide, and zinc oxide paste LBEL MOUSSE MATIFFIANT MATTE FINISH MOUSSE FOUNDATION SPF 15 OBSCURE 8/ BEIGE- octinoxate, titanium dioxide, and zinc oxide paste LBEL MOUSSE MATIFFIANT MATTE FINISH MOUSSE FOUNDATION SPF 15 OBSCURE 9/ BEIGE- octinoxate, titanium dioxide, and zinc oxide paste

LBEL MOUSSE MATIFFIANT MATTE FINISH MOUSSE FOUNDATION SPF 15 by

Drug Labeling and Warnings

LBEL MOUSSE MATIFFIANT MATTE FINISH MOUSSE FOUNDATION 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
OCTINOXATE 6.5%	Sunscreen
TITANIUM DIOXIDE 2.44%	Sunscreen
ZINC OXIDE 1.57%	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

CYCLOPENTASILOXANE, MICA, DIMETHICONE CROSSPOLYMER, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, TRIMETHYLSILOXYSILICATE, CYCLOHEXASILOXANE, BIS-HYDROXYETHOXYPROPYL DIMETHICONE, OCTYLDODECANOL, PHENOXYETHANOL, BORON NITRIDE, IRVINGIA GABONENSIS KERNEL BUTTER, DISTEARDIMONIUM HECTORITE, ALUMINA, CETYL PEG/PPG-10/1 DIMETHICONE, POLYGLYCERYL-4 ISOSTEARATE, SILICA, HYDROGENATED COCO-GLYCERIDES, HEXYL LAURATE, DIMETHICONOL, CAPRYLYL GLYCOL, TOCOPHERYL ACETATE, CHLORPHENESIN, LAUROYL LYSINE, PROPYLENE CARBONATE, METHICONE, PENTAERYTHRITYL TETRA-DI-T-BUTYL HYDROXYHYDROCINNAMATE, RHODIOLA ROSEA ROOT EXTRACT, CARNOSINE, TRIETHOXYCAPRYLYLSILANE, ALANYL GLUTAMINE.

MAY CONTAIN:

TITANIUM DIOXIDE (CI 77891), IRON OXIDES (CI 77492), IRON OXIDES (CI 77491), IRON OXIDES (CI 77499).

SPL UNCLASSIFIED SECTION

Dist. by
Ventura Corp, Ltd., San Juan, Puerto Rico
00926

PRINCIPAL DISPLAY PANEL - 30 g Tube Box - Clare 1/Beige

L'BEL
MOUSSE
MATIFFIANT

Matte finish mousse
foundation SPF 15

Net wt. 1 oz. e (30 g)

PRINCIPAL DISPLAY PANEL - 30 g Tube Box - Clare 2/ Beige

L'BEL
MOUSSE
MATIFFIANT

Matte finish mousse
foundation SPF 15

Net wt. 1 oz. e (30 g)

PRINCIPAL DISPLAY PANEL - 30 g Tube Box - Clare 3/ Beige

L'BEL
MOUSSE
MATIFFIANT

Matte finish mousse
foundation SPF 15

Net wt. 1 oz. e (30 g)

PRINCIPAL DISPLAY PANEL - 30 g Tube Box - Clare 4/ Beige

L'BEL
MOUSSE
MATIFFIANT

Matte finish mousse
foundation SPF 15

Net wt. 1 oz. e (30 g)

PRINCIPAL DISPLAY PANEL - 30 g Tube Box - Medium 5/ Beige

L'BEL
MOUSSE
MATIFFIANT

Matte finish mousse
foundation SPF 15

Net wt. 1 oz. e (30 g)

PRINCIPAL DISPLAY PANEL - 30 g Tube Box - Medium 6/ Beige

L'BEL
MOUSSE
MATIFFIANT

Matte finish mousse
foundation SPF 15

Net wt. 1 oz. e (30 g)

PRINCIPAL DISPLAY PANEL - 30 g Tube Box - Medium 7/ Beige

L'BEL
MOUSSE
MATIFFIANT

Matte finish mousse
foundation SPF 15

Net wt. 1 oz. e (30 g)

PRINCIPAL DISPLAY PANEL - 30 g Tube Box - Obscure 8/ Beige

L'BEL
MOUSSE
MATIFFIANT

Matte finish mousse
foundation SPF 15

Net wt. 1 oz. e (30 g)

PRINCIPAL DISPLAY PANEL - 30 g Tube Box - Obscure 9/ Beige

L'BEL
MOUSSE
MATIFFIANT

Matte finish mousse
foundation SPF 15

Net wt. 1 oz. e (30 g)

INGREDIENTS AND APPEARANCE

LBEL MOUSSE MATIFFIANT MATTE FINISH MOUSSE FOUNDATION SPF 15   CLARE 1/BEIGE
octinoxate, titanium dioxide, and zinc oxide paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43596-0079
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.065 g  in 1 g
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	0.0244 g  in 1 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	0.0157 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
MICA (UNII: V8A1AW0880)
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
OCTYLDODECANOL (UNII: 461N1O614Y)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
BORON NITRIDE (UNII: 2U4T60A6YD)
IRVINGIA GABONENSIS SEED BUTTER (UNII: 8Y12O726LX)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
ALUMINUM OXIDE (UNII: LMI26O6933)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
HYDROGENATED COCO-GLYCERIDES (UNII: XDD37N2GPR)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
LAUROYL LYSINE (UNII: 113171Q70B)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
METHICONE (20 CST) (UNII: 6777U11MKT)
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)
SEDUM ROSEUM ROOT (UNII: 3S5ITS5ULN)
CARNOSINE (UNII: 8HO6PVN24W)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
ALANYL GLUTAMINE (UNII: U5JDO2770Z)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43596-0079-2	1 in 1 BOX	08/08/2018
1	NDC: 43596-0079-1	30 g in 1 TUBE; 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	08/08/2018

LBEL MOUSSE MATIFFIANT MATTE FINISH MOUSSE FOUNDATION SPF 15   CLARE 2/ BEIGE
octinoxate, titanium dioxide, and zinc oxide paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43596-0080
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.065 g  in 1 g
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	0.0244 g  in 1 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	0.0157 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
MICA (UNII: V8A1AW0880)
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
OCTYLDODECANOL (UNII: 461N1O614Y)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
BORON NITRIDE (UNII: 2U4T60A6YD)
IRVINGIA GABONENSIS SEED BUTTER (UNII: 8Y12O726LX)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
ALUMINUM OXIDE (UNII: LMI26O6933)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
HYDROGENATED COCO-GLYCERIDES (UNII: XDD37N2GPR)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
LAUROYL LYSINE (UNII: 113171Q70B)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
METHICONE (20 CST) (UNII: 6777U11MKT)
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)
SEDUM ROSEUM ROOT (UNII: 3S5ITS5ULN)
CARNOSINE (UNII: 8HO6PVN24W)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
ALANYL GLUTAMINE (UNII: U5JDO2770Z)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43596-0080-2	1 in 1 BOX	08/08/2018
1	NDC: 43596-0080-1	30 g in 1 TUBE; 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	08/08/2018

LBEL MOUSSE MATIFFIANT MATTE FINISH MOUSSE FOUNDATION SPF 15   CLARE 3/ BEIGE
octinoxate, titanium dioxide, and zinc oxide paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43596-0081
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.065 g  in 1 g
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	0.0244 g  in 1 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	0.0157 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
MICA (UNII: V8A1AW0880)
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
OCTYLDODECANOL (UNII: 461N1O614Y)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
BORON NITRIDE (UNII: 2U4T60A6YD)
IRVINGIA GABONENSIS SEED BUTTER (UNII: 8Y12O726LX)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
ALUMINUM OXIDE (UNII: LMI26O6933)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
HYDROGENATED COCO-GLYCERIDES (UNII: XDD37N2GPR)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
LAUROYL LYSINE (UNII: 113171Q70B)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
METHICONE (20 CST) (UNII: 6777U11MKT)
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)
SEDUM ROSEUM ROOT (UNII: 3S5ITS5ULN)
CARNOSINE (UNII: 8HO6PVN24W)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
ALANYL GLUTAMINE (UNII: U5JDO2770Z)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43596-0081-2	1 in 1 BOX	08/08/2018
1	NDC: 43596-0081-1	30 g in 1 TUBE; 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	08/08/2018

LBEL MOUSSE MATIFFIANT MATTE FINISH MOUSSE FOUNDATION SPF 15   CLARE 4/ BEIGE
octinoxate, titanium dioxide, and zinc oxide paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43596-0082
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.065 g  in 1 g
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	0.0244 g  in 1 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	0.0157 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
MICA (UNII: V8A1AW0880)
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
OCTYLDODECANOL (UNII: 461N1O614Y)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
BORON NITRIDE (UNII: 2U4T60A6YD)
IRVINGIA GABONENSIS SEED BUTTER (UNII: 8Y12O726LX)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
ALUMINUM OXIDE (UNII: LMI26O6933)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
HYDROGENATED COCO-GLYCERIDES (UNII: XDD37N2GPR)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
LAUROYL LYSINE (UNII: 113171Q70B)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
METHICONE (20 CST) (UNII: 6777U11MKT)
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)
SEDUM ROSEUM ROOT (UNII: 3S5ITS5ULN)
CARNOSINE (UNII: 8HO6PVN24W)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
ALANYL GLUTAMINE (UNII: U5JDO2770Z)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43596-0082-2	1 in 1 BOX	08/08/2018
1	NDC: 43596-0082-1	30 g in 1 TUBE; 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	08/08/2018

LBEL MOUSSE MATIFFIANT MATTE FINISH MOUSSE FOUNDATION SPF 15   MEDIUM 5/ BEIGE
octinoxate, titanium dioxide, and zinc oxide paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43596-0083
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.065 g  in 1 g
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	0.0244 g  in 1 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	0.0157 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
MICA (UNII: V8A1AW0880)
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
OCTYLDODECANOL (UNII: 461N1O614Y)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
BORON NITRIDE (UNII: 2U4T60A6YD)
IRVINGIA GABONENSIS SEED BUTTER (UNII: 8Y12O726LX)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
ALUMINUM OXIDE (UNII: LMI26O6933)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
HYDROGENATED COCO-GLYCERIDES (UNII: XDD37N2GPR)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
LAUROYL LYSINE (UNII: 113171Q70B)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
METHICONE (20 CST) (UNII: 6777U11MKT)
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)
SEDUM ROSEUM ROOT (UNII: 3S5ITS5ULN)
CARNOSINE (UNII: 8HO6PVN24W)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
ALANYL GLUTAMINE (UNII: U5JDO2770Z)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43596-0083-2	1 in 1 BOX	08/08/2018
1	NDC: 43596-0083-1	30 g in 1 TUBE; 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	08/08/2018

LBEL MOUSSE MATIFFIANT MATTE FINISH MOUSSE FOUNDATION SPF 15   MEDIUM 6/ BEIGE
octinoxate, titanium dioxide, and zinc oxide paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43596-0084
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.065 g  in 1 g
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	0.0244 g  in 1 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	0.0157 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
MICA (UNII: V8A1AW0880)
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
OCTYLDODECANOL (UNII: 461N1O614Y)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
BORON NITRIDE (UNII: 2U4T60A6YD)
IRVINGIA GABONENSIS SEED BUTTER (UNII: 8Y12O726LX)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
ALUMINUM OXIDE (UNII: LMI26O6933)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
HYDROGENATED COCO-GLYCERIDES (UNII: XDD37N2GPR)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
LAUROYL LYSINE (UNII: 113171Q70B)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
METHICONE (20 CST) (UNII: 6777U11MKT)
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)
SEDUM ROSEUM ROOT (UNII: 3S5ITS5ULN)
CARNOSINE (UNII: 8HO6PVN24W)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
ALANYL GLUTAMINE (UNII: U5JDO2770Z)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43596-0084-2	1 in 1 BOX	08/08/2018
1	NDC: 43596-0084-1	30 g in 1 TUBE; 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	08/08/2018

LBEL MOUSSE MATIFFIANT MATTE FINISH MOUSSE FOUNDATION SPF 15   MEDIUM 7/ BEIGE
octinoxate, titanium dioxide, and zinc oxide paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43596-0085
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.065 g  in 1 g
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	0.0244 g  in 1 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	0.0157 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
MICA (UNII: V8A1AW0880)
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
OCTYLDODECANOL (UNII: 461N1O614Y)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
BORON NITRIDE (UNII: 2U4T60A6YD)
IRVINGIA GABONENSIS SEED BUTTER (UNII: 8Y12O726LX)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
ALUMINUM OXIDE (UNII: LMI26O6933)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
HYDROGENATED COCO-GLYCERIDES (UNII: XDD37N2GPR)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
LAUROYL LYSINE (UNII: 113171Q70B)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
METHICONE (20 CST) (UNII: 6777U11MKT)
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)
SEDUM ROSEUM ROOT (UNII: 3S5ITS5ULN)
CARNOSINE (UNII: 8HO6PVN24W)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
ALANYL GLUTAMINE (UNII: U5JDO2770Z)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43596-0085-2	1 in 1 BOX	08/08/2018
1	NDC: 43596-0085-1	30 g in 1 TUBE; 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	08/08/2018

LBEL MOUSSE MATIFFIANT MATTE FINISH MOUSSE FOUNDATION SPF 15   OBSCURE 8/ BEIGE
octinoxate, titanium dioxide, and zinc oxide paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43596-0086
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.065 g  in 1 g
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	0.0244 g  in 1 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	0.0157 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
MICA (UNII: V8A1AW0880)
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
OCTYLDODECANOL (UNII: 461N1O614Y)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
BORON NITRIDE (UNII: 2U4T60A6YD)
IRVINGIA GABONENSIS SEED BUTTER (UNII: 8Y12O726LX)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
ALUMINUM OXIDE (UNII: LMI26O6933)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
HYDROGENATED COCO-GLYCERIDES (UNII: XDD37N2GPR)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
LAUROYL LYSINE (UNII: 113171Q70B)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
METHICONE (20 CST) (UNII: 6777U11MKT)
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)
SEDUM ROSEUM ROOT (UNII: 3S5ITS5ULN)
CARNOSINE (UNII: 8HO6PVN24W)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
ALANYL GLUTAMINE (UNII: U5JDO2770Z)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43596-0086-2	1 in 1 BOX	08/08/2018
1	NDC: 43596-0086-1	30 g in 1 TUBE; 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	08/08/2018

LBEL MOUSSE MATIFFIANT MATTE FINISH MOUSSE FOUNDATION SPF 15   OBSCURE 9/ BEIGE
octinoxate, titanium dioxide, and zinc oxide paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43596-0087
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.065 g  in 1 g
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	0.0244 g  in 1 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	0.0157 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
MICA (UNII: V8A1AW0880)
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
OCTYLDODECANOL (UNII: 461N1O614Y)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
BORON NITRIDE (UNII: 2U4T60A6YD)
IRVINGIA GABONENSIS SEED BUTTER (UNII: 8Y12O726LX)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
ALUMINUM OXIDE (UNII: LMI26O6933)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
HYDROGENATED COCO-GLYCERIDES (UNII: XDD37N2GPR)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
LAUROYL LYSINE (UNII: 113171Q70B)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
METHICONE (20 CST) (UNII: 6777U11MKT)
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)
SEDUM ROSEUM ROOT (UNII: 3S5ITS5ULN)
CARNOSINE (UNII: 8HO6PVN24W)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
ALANYL GLUTAMINE (UNII: U5JDO2770Z)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43596-0087-2	1 in 1 BOX	08/08/2018
1	NDC: 43596-0087-1	30 g in 1 TUBE; 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	08/08/2018

Labeler - Ventura Corporation LTD (602751344)

Establishment
Name	Address	ID/FEI	Business Operations
Bel Star S.A. (Colombia)		880160197	MANUFACTURE(43596-0079, 43596-0080, 43596-0081, 43596-0082, 43596-0083, 43596-0084, 43596-0085, 43596-0086, 43596-0087)