DailyMed - LBEL MOUSSE MATIFFIANT MATTE FINISH MOUSSE FOUNDATION SPF 16 BASE TEXTURA MOUSSE ACABADO MATE FPS 16 CLAIRE 1- BEIGE- octinoxate, titanium dioxide, and zinc oxide paste LBEL MOUSSE MATIFFIANT MATTE FINISH MOUSSE FOUNDATION SPF 16 BASE TEXTURA MOUSSE ACABADO MATE FPS 16 CLAIRE 2- BEIGE- octinoxate, titanium dioxide, and zinc oxide paste LBEL MOUSSE MATIFFIANT MATTE FINISH MOUSSE FOUNDATION SPF 16 BASE TEXTURA MOUSSE ACABADO MATE FPS 16 CLAIRE 3- BEIGE- octinoxate, titanium dioxide, and zinc oxide paste LBEL MOUSSE MATIFFIANT MATTE FINISH MOUSSE FOUNDATION SPF 16 BASE TEXTURA MOUSSE ACABADO MATE FPS 16 CLAIRE 4- BEIGE- octinoxate, titanium dioxide, and zinc oxide paste LBEL MOUSSE MATIFFIANT MATTE FINISH MOUSSE FOUNDATION SPF 16 BASE TEXTURA MOUSSE ACABADO MATE FPS 16 MEDIUM 5- BEIGE- octinoxate, titanium dioxide, and zinc oxide paste LBEL MOUSSE MATIFFIANT MATTE FINISH MOUSSE FOUNDATION SPF 16 BASE TEXTURA MOUSSE ACABADO MATE FPS 16 MEDIUM 6- BEIGE- octinoxate, titanium dioxide, and zinc oxide paste LBEL MOUSSE MATIFFIANT MATTE FINISH MOUSSE FOUNDATION SPF 16 BASE TEXTURA MOUSSE ACABADO MATE FPS 16 MEDIUM 7- BEIGE- octinoxate, titanium dioxide, and zinc oxide paste LBEL MOUSSE MATIFFIANT MATTE FINISH MOUSSE FOUNDATION SPF 16 BASE TEXTURA MOUSSE ACABADO MATE FPS 16 OBSCURE 8- BROWN- octinoxate, titanium dioxide, and zinc oxide paste LBEL MOUSSE MATIFFIANT MATTE FINISH MOUSSE FOUNDATION SPF 16 BASE TEXTURA MOUSSE ACABADO MATE FPS 16 OBSCURE 9- BROWN- octinoxate, titanium dioxide, and zinc oxide paste

Contains inactivated NDC Code(s)
NDC Code(s): 13537-670-01, 13537-670-02, 13537-671-01, 13537-671-02, view more
13537-672-01, 13537-672-02, 13537-673-01, 13537-673-02, 13537-674-01, 13537-674-02, 13537-675-01, 13537-675-02, 13537-676-01, 13537-676-02, 13537-677-01, 13537-677-02, 13537-678-01, 13537-678-02
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 November 19, 2015

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

OCTINOXATE 6.50 % Sunscreen

TITANIUM DIOXIDE 2.4% Sunscreen

ZINC OXIDE 1.568% 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 damage 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.
- Children under 6 months of age: Ask a doctor.
- Reapply at least every 2 hours.
- Use a water resistant sunscreen if swimming or sweating.
- Apply lipstick following the curves of natural lip line. For added definition, use with a lip pencil.
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, DISTEARDIMONIUM HECTORITE, ALUMINA, CETYL PEG/PPG-10/1 DIMETHICONE, POLYGLYCERYL-4 ISOSTEARATE, MICROCRYSTALLINE WAX, SILICA, HEXYL LAURATE, DIMETHICONOL, CAPRYLYL GLYCOL, TOCOPHERYL ACETATE, CHLORPHENESIN, LAUROYL LYSINE, PETROLATUM, PROPYLENE CARBONATE, METHICONE, PHOSPHOLIPIDS, RHODIOLA ROSEA ROOT EXTRACT, CHOLESTEROL, BHA, BHT, CARNOSINE, TRIETHOXYCAPRYLYLSILANE, EUPHORBIA CERIFERA (CANDELILLA) WAX, BEESWAX, CETEARYL ALCOHOL, CETEARYL GLUCOSIDE, COPERNICIA CERIFERA (CARNAUBA) WAX, POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE, GLYCOSPHINGOLIPIDS, ALANYL GLUTAMINE.

MAY CONTAIN:
TITANIUM DIOXIDE , IRON OXIDES..
SPL UNCLASSIFIED SECTION

Dist. by
Ventura Corp, Ltd., San Juan, Puerto Rico
00926
PRINCIPAL DISPLAY PANEL - 30 g Tube Box - CLAIRE 1 - BEIGE

L'BEL

MOUSSE

matte finish mousse
foundation
SPF 16

Net Wt. 1 oz. (30 g)
PRINCIPAL DISPLAY PANEL - 30 g Tube Box - CLAIRE 2 - BEIGE

L'BEL

MOUSSE

matte finish mousse
foundation
SPF 16

Net Wt. 1 oz. (30 g)
PRINCIPAL DISPLAY PANEL - 30 g Tube Box - CLAIRE 3 - BEIGE

L'BEL

MOUSSE

matte finish mousse
foundation
SPF 16

Net Wt. 1 oz. (30 g)
PRINCIPAL DISPLAY PANEL - 30 g Tube Box - CLAIRE 4 - BEIGE

L'BEL

MOUSSE

matte finish mousse
foundation
SPF 16

Net Wt. 1 oz. (30 g)
PRINCIPAL DISPLAY PANEL - 30 g Tube Box - MEDIUM 5 - BEIGE

L'BEL

MOUSSE

matte finish mousse
foundation
SPF 16

Net Wt. 1 oz. (30 g)
PRINCIPAL DISPLAY PANEL - 30 g Tube Box - MEDIUM 6 - BEIGE

L'BEL

MOUSSE

matte finish mousse
foundation
SPF 16

Net Wt. 1 oz. (30 g)
PRINCIPAL DISPLAY PANEL - 30 g Tube Box - MEDIUM 7 - BEIGE

L'BEL

MOUSSE

matte finish mousse
foundation
SPF 16

Net Wt. 1 oz. (30 g)
PRINCIPAL DISPLAY PANEL - 30 g Tube Box - OBSCURE 8 - BROWN

L'BEL

MOUSSE

matte finish mousse
foundation
SPF 16

Net Wt. 1 oz. (30 g)
PRINCIPAL DISPLAY PANEL - 30 g Tube Box - OBSCURE 9 - BROWN

L'BEL

MOUSSE

matte finish mousse
foundation
SPF 16

Net Wt. 1 oz. (30 g)

Active Ingredients	Purpose
OCTINOXATE 6.50 %	Sunscreen
TITANIUM DIOXIDE 2.4%	Sunscreen
ZINC OXIDE 1.568%	Sunscreen

INGREDIENTS AND APPEARANCE

LBEL MOUSSE MATIFFIANT MATTE FINISH MOUSSE FOUNDATION SPF 16 BASE TEXTURA MOUSSE ACABADO MATE FPS 16 CLAIRE 1- BEIGE
octinoxate, titanium dioxide, and zinc oxide paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-670
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.065 g in 1 g
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	0.024 g in 1 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	0.015 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
MICA (UNII: V8A1AW0880)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
OCTYLDODECANOL (UNII: 461N1O614Y)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
BORON NITRIDE (UNII: 2U4T60A6YD)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
ALUMINUM OXIDE (UNII: LMI26O6933)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CHLORPHENESIN (UNII: I670DAL4SZ)
LAUROYL LYSINE (UNII: 113171Q70B)
PETROLATUM (UNII: 4T6H12BN9U)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
SEDUM ROSEUM ROOT (UNII: 3S5ITS5ULN)
CHOLESTEROL (UNII: 97C5T2UQ7J)
BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
CARNOSINE (UNII: 8HO6PVN24W)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
CANDELILLA WAX (UNII: WL0328HX19)
YELLOW WAX (UNII: 2ZA36H0S2V)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
CARNAUBA WAX (UNII: R12CBM0EIZ)
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)
ALANYL GLUTAMINE (UNII: U5JDO2770Z)
FERRIC OXIDE RED (UNII: 1K09F3G675)

#	Item Code	Package Description
Packaging
1	NDC:13537-670-02	1 in 1 BOX
1	NDC:13537-670-01	30 g in 1 TUBE; 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	11/20/2015

LBEL MOUSSE MATIFFIANT MATTE FINISH MOUSSE FOUNDATION SPF 16 BASE TEXTURA MOUSSE ACABADO MATE FPS 16 CLAIRE 2- BEIGE
octinoxate, titanium dioxide, and zinc oxide paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-671
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.065 g in 1 g
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	0.024 g in 1 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	0.015 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
MICA (UNII: V8A1AW0880)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
OCTYLDODECANOL (UNII: 461N1O614Y)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
BORON NITRIDE (UNII: 2U4T60A6YD)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
ALUMINUM OXIDE (UNII: LMI26O6933)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CHLORPHENESIN (UNII: I670DAL4SZ)
LAUROYL LYSINE (UNII: 113171Q70B)
PETROLATUM (UNII: 4T6H12BN9U)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
SEDUM ROSEUM ROOT (UNII: 3S5ITS5ULN)
CHOLESTEROL (UNII: 97C5T2UQ7J)
BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
CARNOSINE (UNII: 8HO6PVN24W)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
CANDELILLA WAX (UNII: WL0328HX19)
YELLOW WAX (UNII: 2ZA36H0S2V)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
CARNAUBA WAX (UNII: R12CBM0EIZ)
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)
ALANYL GLUTAMINE (UNII: U5JDO2770Z)
FERRIC OXIDE RED (UNII: 1K09F3G675)

#	Item Code	Package Description
Packaging
1	NDC:13537-671-02	1 in 1 BOX
1	NDC:13537-671-01	30 g in 1 TUBE; 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	11/20/2015

LBEL MOUSSE MATIFFIANT MATTE FINISH MOUSSE FOUNDATION SPF 16 BASE TEXTURA MOUSSE ACABADO MATE FPS 16 CLAIRE 3- BEIGE
octinoxate, titanium dioxide, and zinc oxide paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-672
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.065 g in 1 g
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	0.024 g in 1 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	0.015 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
MICA (UNII: V8A1AW0880)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
OCTYLDODECANOL (UNII: 461N1O614Y)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
BORON NITRIDE (UNII: 2U4T60A6YD)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
ALUMINUM OXIDE (UNII: LMI26O6933)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CHLORPHENESIN (UNII: I670DAL4SZ)
LAUROYL LYSINE (UNII: 113171Q70B)
PETROLATUM (UNII: 4T6H12BN9U)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
SEDUM ROSEUM ROOT (UNII: 3S5ITS5ULN)
CHOLESTEROL (UNII: 97C5T2UQ7J)
BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
CARNOSINE (UNII: 8HO6PVN24W)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
CANDELILLA WAX (UNII: WL0328HX19)
YELLOW WAX (UNII: 2ZA36H0S2V)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
CARNAUBA WAX (UNII: R12CBM0EIZ)
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)
ALANYL GLUTAMINE (UNII: U5JDO2770Z)
FERRIC OXIDE RED (UNII: 1K09F3G675)

#	Item Code	Package Description
Packaging
1	NDC:13537-672-02	1 in 1 BOX
1	NDC:13537-672-01	30 g in 1 TUBE; 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	11/20/2015

LBEL MOUSSE MATIFFIANT MATTE FINISH MOUSSE FOUNDATION SPF 16 BASE TEXTURA MOUSSE ACABADO MATE FPS 16 CLAIRE 4- BEIGE
octinoxate, titanium dioxide, and zinc oxide paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-673
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.065 g in 1 g
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	0.024 g in 1 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	0.015 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
MICA (UNII: V8A1AW0880)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
OCTYLDODECANOL (UNII: 461N1O614Y)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
BORON NITRIDE (UNII: 2U4T60A6YD)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
ALUMINUM OXIDE (UNII: LMI26O6933)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CHLORPHENESIN (UNII: I670DAL4SZ)
LAUROYL LYSINE (UNII: 113171Q70B)
PETROLATUM (UNII: 4T6H12BN9U)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
SEDUM ROSEUM ROOT (UNII: 3S5ITS5ULN)
CHOLESTEROL (UNII: 97C5T2UQ7J)
BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
CARNOSINE (UNII: 8HO6PVN24W)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
CANDELILLA WAX (UNII: WL0328HX19)
YELLOW WAX (UNII: 2ZA36H0S2V)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
CARNAUBA WAX (UNII: R12CBM0EIZ)
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)
ALANYL GLUTAMINE (UNII: U5JDO2770Z)
FERRIC OXIDE RED (UNII: 1K09F3G675)

#	Item Code	Package Description
Packaging
1	NDC:13537-673-02	1 in 1 BOX
1	NDC:13537-673-01	30 g in 1 TUBE; 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	11/20/2015

LBEL MOUSSE MATIFFIANT MATTE FINISH MOUSSE FOUNDATION SPF 16 BASE TEXTURA MOUSSE ACABADO MATE FPS 16 MEDIUM 5- BEIGE
octinoxate, titanium dioxide, and zinc oxide paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-674
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.065 g in 1 g
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	0.024 g in 1 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	0.015 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
MICA (UNII: V8A1AW0880)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
OCTYLDODECANOL (UNII: 461N1O614Y)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
BORON NITRIDE (UNII: 2U4T60A6YD)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
ALUMINUM OXIDE (UNII: LMI26O6933)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CHLORPHENESIN (UNII: I670DAL4SZ)
LAUROYL LYSINE (UNII: 113171Q70B)
PETROLATUM (UNII: 4T6H12BN9U)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
SEDUM ROSEUM ROOT (UNII: 3S5ITS5ULN)
CHOLESTEROL (UNII: 97C5T2UQ7J)
BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
CARNOSINE (UNII: 8HO6PVN24W)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
CANDELILLA WAX (UNII: WL0328HX19)
YELLOW WAX (UNII: 2ZA36H0S2V)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
CARNAUBA WAX (UNII: R12CBM0EIZ)
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)
ALANYL GLUTAMINE (UNII: U5JDO2770Z)
FERRIC OXIDE RED (UNII: 1K09F3G675)

#	Item Code	Package Description
Packaging
1	NDC:13537-674-02	1 in 1 BOX
1	NDC:13537-674-01	30 g in 1 TUBE; 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	11/20/2015

LBEL MOUSSE MATIFFIANT MATTE FINISH MOUSSE FOUNDATION SPF 16 BASE TEXTURA MOUSSE ACABADO MATE FPS 16 MEDIUM 6- BEIGE
octinoxate, titanium dioxide, and zinc oxide paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-675
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.065 g in 1 g
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	0.024 g in 1 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	0.015 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
MICA (UNII: V8A1AW0880)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
OCTYLDODECANOL (UNII: 461N1O614Y)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
BORON NITRIDE (UNII: 2U4T60A6YD)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
ALUMINUM OXIDE (UNII: LMI26O6933)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CHLORPHENESIN (UNII: I670DAL4SZ)
LAUROYL LYSINE (UNII: 113171Q70B)
PETROLATUM (UNII: 4T6H12BN9U)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
SEDUM ROSEUM ROOT (UNII: 3S5ITS5ULN)
CHOLESTEROL (UNII: 97C5T2UQ7J)
BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
CARNOSINE (UNII: 8HO6PVN24W)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
CANDELILLA WAX (UNII: WL0328HX19)
YELLOW WAX (UNII: 2ZA36H0S2V)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
CARNAUBA WAX (UNII: R12CBM0EIZ)
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)
ALANYL GLUTAMINE (UNII: U5JDO2770Z)
FERRIC OXIDE RED (UNII: 1K09F3G675)

#	Item Code	Package Description
Packaging
1	NDC:13537-675-02	1 in 1 BOX
1	NDC:13537-675-01	30 g in 1 TUBE; 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	11/20/2015

LBEL MOUSSE MATIFFIANT MATTE FINISH MOUSSE FOUNDATION SPF 16 BASE TEXTURA MOUSSE ACABADO MATE FPS 16 MEDIUM 7- BEIGE
octinoxate, titanium dioxide, and zinc oxide paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-676
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.065 g in 1 g
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	0.024 g in 1 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	0.015 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
MICA (UNII: V8A1AW0880)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
OCTYLDODECANOL (UNII: 461N1O614Y)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
BORON NITRIDE (UNII: 2U4T60A6YD)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
ALUMINUM OXIDE (UNII: LMI26O6933)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CHLORPHENESIN (UNII: I670DAL4SZ)
LAUROYL LYSINE (UNII: 113171Q70B)
PETROLATUM (UNII: 4T6H12BN9U)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
SEDUM ROSEUM ROOT (UNII: 3S5ITS5ULN)
CHOLESTEROL (UNII: 97C5T2UQ7J)
BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
CARNOSINE (UNII: 8HO6PVN24W)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
CANDELILLA WAX (UNII: WL0328HX19)
YELLOW WAX (UNII: 2ZA36H0S2V)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
CARNAUBA WAX (UNII: R12CBM0EIZ)
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)
ALANYL GLUTAMINE (UNII: U5JDO2770Z)
FERRIC OXIDE RED (UNII: 1K09F3G675)

#	Item Code	Package Description
Packaging
1	NDC:13537-676-02	1 in 1 BOX
1	NDC:13537-676-01	30 g in 1 TUBE; 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	11/20/2015

LBEL MOUSSE MATIFFIANT MATTE FINISH MOUSSE FOUNDATION SPF 16 BASE TEXTURA MOUSSE ACABADO MATE FPS 16 OBSCURE 8- BROWN
octinoxate, titanium dioxide, and zinc oxide paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-677
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.065 g in 1 g
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	0.024 g in 1 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	0.015 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
MICA (UNII: V8A1AW0880)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
OCTYLDODECANOL (UNII: 461N1O614Y)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
BORON NITRIDE (UNII: 2U4T60A6YD)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
ALUMINUM OXIDE (UNII: LMI26O6933)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CHLORPHENESIN (UNII: I670DAL4SZ)
LAUROYL LYSINE (UNII: 113171Q70B)
PETROLATUM (UNII: 4T6H12BN9U)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
SEDUM ROSEUM ROOT (UNII: 3S5ITS5ULN)
CHOLESTEROL (UNII: 97C5T2UQ7J)
BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
CARNOSINE (UNII: 8HO6PVN24W)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
CANDELILLA WAX (UNII: WL0328HX19)
YELLOW WAX (UNII: 2ZA36H0S2V)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
CARNAUBA WAX (UNII: R12CBM0EIZ)
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)
ALANYL GLUTAMINE (UNII: U5JDO2770Z)
FERRIC OXIDE RED (UNII: 1K09F3G675)

#	Item Code	Package Description
Packaging
1	NDC:13537-677-02	1 in 1 BOX
1	NDC:13537-677-01	30 g in 1 TUBE; 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	11/20/2015

LBEL MOUSSE MATIFFIANT MATTE FINISH MOUSSE FOUNDATION SPF 16 BASE TEXTURA MOUSSE ACABADO MATE FPS 16 OBSCURE 9- BROWN
octinoxate, titanium dioxide, and zinc oxide paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-678
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.065 g in 1 g
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	0.024 g in 1 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	0.015 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
MICA (UNII: V8A1AW0880)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
OCTYLDODECANOL (UNII: 461N1O614Y)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
BORON NITRIDE (UNII: 2U4T60A6YD)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
ALUMINUM OXIDE (UNII: LMI26O6933)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CHLORPHENESIN (UNII: I670DAL4SZ)
LAUROYL LYSINE (UNII: 113171Q70B)
PETROLATUM (UNII: 4T6H12BN9U)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
SEDUM ROSEUM ROOT (UNII: 3S5ITS5ULN)
CHOLESTEROL (UNII: 97C5T2UQ7J)
BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
CARNOSINE (UNII: 8HO6PVN24W)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
CANDELILLA WAX (UNII: WL0328HX19)
YELLOW WAX (UNII: 2ZA36H0S2V)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
CARNAUBA WAX (UNII: R12CBM0EIZ)
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)
ALANYL GLUTAMINE (UNII: U5JDO2770Z)
FERRIC OXIDE RED (UNII: 1K09F3G675)

#	Item Code	Package Description
Packaging
1	NDC:13537-678-02	1 in 1 BOX
1	NDC:13537-678-01	30 g in 1 TUBE; 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	11/20/2015

Labeler - Ventura Corporation LTD (602751344)

Name	Address	ID/FEI	Business Operations
Establishment
Bel Star S.A. (Colombia)		880160197	MANUFACTURE(13537-670, 13537-671, 13537-672, 13537-673, 13537-674, 13537-675, 13537-676, 13537-677, 13537-678)

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	NDC
1	13537-670-01
2	13537-670-02 (inactivated)
3	13537-671-01
4	13537-671-02 (inactivated)
5	13537-672-01
6	13537-672-02 (inactivated)
7	13537-673-01
8	13537-673-02 (inactivated)
9	13537-674-01
10	13537-674-02 (inactivated)
11	13537-675-01
12	13537-675-02 (inactivated)
13	13537-676-01
14	13537-676-02 (inactivated)
15	13537-677-01
16	13537-677-02 (inactivated)
17	13537-678-01
18	13537-678-02 (inactivated)

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