DailyMed - LBEL MOUSSE MATIFFIANT MATTE FINISH MOUSSE FOUNDATION SPF 15 CLAIRE 1/BEIGE- octinoxate, titanium dioxide, and zinc oxide paste LBEL MOUSSE MATIFFIANT MATTE FINISH MOUSSE FOUNDATION SPF 15 CLAIRE 2/ BEIGE- octinoxate, titanium dioxide, and zinc oxide paste LBEL MOUSSE MATIFFIANT MATTE FINISH MOUSSE FOUNDATION SPF 15 CLAIRE 3/ BEIGE- octinoxate, titanium dioxide, and zinc oxide paste LBEL MOUSSE MATIFFIANT MATTE FINISH MOUSSE FOUNDATION SPF 15 CLAIRE 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

Contains inactivated NDC Code(s)
NDC Code(s): 14141-079-01, 14141-079-02, 14141-080-01, 14141-080-02, view more
14141-081-01, 14141-081-02, 14141-082-01, 14141-082-02, 14141-083-01, 14141-083-02, 14141-084-01, 14141-084-02, 14141-085-01, 14141-085-02, 14141-086-01, 14141-086-02, 14141-087-01, 14141-087-02
Packager: Bel Star S.A. (Colombia)

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 15, 2019

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 6.5% 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 - Claire 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 - Claire 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 - Claire 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 - Claire 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)

Active Ingredients	Purpose
OCTINOXATE 6.5%	Sunscreen
TITANIUM DIOXIDE 2.44%	Sunscreen
ZINC OXIDE 1.57%	Sunscreen

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:14141-079
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	0.0244 g in 1 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	0.0157 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:14141-079-02	1 in 1 BOX	08/08/2018
1	NDC:14141-079-01	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	08/08/2018

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:14141-080
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	0.0244 g in 1 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	0.0157 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:14141-080-02	1 in 1 BOX	08/08/2018
1	NDC:14141-080-01	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	08/08/2018

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:14141-081
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	0.0244 g in 1 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	0.0157 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:14141-081-02	1 in 1 BOX	08/08/2018
1	NDC:14141-081-01	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	08/08/2018

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:14141-082
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	0.0244 g in 1 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	0.0157 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:14141-082-02	1 in 1 BOX	08/08/2018
1	NDC:14141-082-01	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	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:14141-083
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	0.0244 g in 1 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	0.0157 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:14141-083-02	1 in 1 BOX	08/08/2018
1	NDC:14141-083-01	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	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:14141-084
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	0.0244 g in 1 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	0.0157 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:14141-084-02	1 in 1 BOX	08/08/2018
1	NDC:14141-084-01	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	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:14141-085
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	0.0244 g in 1 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	0.0157 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:14141-085-02	1 in 1 BOX	08/08/2018
1	NDC:14141-085-01	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	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:14141-086
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	0.0244 g in 1 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	0.0157 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:14141-086-02	1 in 1 BOX	08/08/2018
1	NDC:14141-086-01	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	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:14141-087
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	0.0244 g in 1 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	0.0157 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:14141-087-02	1 in 1 BOX	08/08/2018
1	NDC:14141-087-01	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	08/08/2018

Labeler - Bel Star S.A. (Colombia) (880160197)

Name	Address	ID/FEI	Business Operations
Establishment
Bel Star S.A. (Colombia)		880160197	MANUFACTURE(14141-079, 14141-080, 14141-081, 14141-082, 14141-083, 14141-084, 14141-085, 14141-086, 14141-087)

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	NDC
1	14141-079-01
2	14141-079-02 (inactivated)
3	14141-080-01
4	14141-080-02 (inactivated)
5	14141-081-01
6	14141-081-02 (inactivated)
7	14141-082-01
8	14141-082-02 (inactivated)
9	14141-083-01
10	14141-083-02 (inactivated)
11	14141-084-01
12	14141-084-02 (inactivated)
13	14141-085-01
14	14141-085-02 (inactivated)
15	14141-086-01
16	14141-086-02 (inactivated)
17	14141-087-01
18	14141-087-02 (inactivated)

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