Label: 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
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Contains inactivated NDC Code(s)
NDC Code(s): 14783-120-01, 14783-120-02, 14783-122-01, 14783-122-02, view more14783-123-01, 14783-123-02, 14783-124-01, 14783-124-02, 14783-125-01, 14783-125-02, 14783-126-01, 14783-126-02, 14783-127-01, 14783-127-02, 14783-128-01, 14783-128-02, 14783-131-01, 14783-131-02 - Packager: Ventura International LTD
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated August 8, 2018
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- Uses
- Warnings
- Directions
- Other information
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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
- PRINCIPAL DISPLAY PANEL - 30 g Tube Box - Clare 1/ Beige
- PRINCIPAL DISPLAY PANEL - 30 g Tube Box - Clare 2/ Beige
- PRINCIPAL DISPLAY PANEL - 30 g Tube Box - Clare 3/ Beige
- PRINCIPAL DISPLAY PANEL - 30 g Tube Box - Clare 4/ Beige
- PRINCIPAL DISPLAY PANEL - 30 g Tube Box - Medium 5/ Beige
- PRINCIPAL DISPLAY PANEL - 30 g Tube Box - Medium 6/ Beige
- PRINCIPAL DISPLAY PANEL - 30 g Tube Box - Medium 7/ Beige
- PRINCIPAL DISPLAY PANEL - 30 g Tube Box - Obscure 8/ Beige
- PRINCIPAL DISPLAY PANEL - 30 g Tube Box - Obscure 9/ Beige
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INGREDIENTS AND APPEARANCE
LBEL MOUSSE MATIFFIANT MATTE FINISH MOUSSE FOUNDATION SPF 15 CLARE 1/ BEIGE
octinoxate, titanium dioxide, and zinc oxide pasteProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:14783-120 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) 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:14783-120-02 1 in 1 BOX 08/08/2018 1 NDC:14783-120-01 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 pasteProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:14783-131 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) 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:14783-131-02 1 in 1 BOX 08/08/2018 1 NDC:14783-131-01 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 pasteProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:14783-122 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) 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:14783-122-02 1 in 1 BOX 08/08/2018 1 NDC:14783-122-01 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 pasteProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:14783-123 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) 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:14783-123-02 1 in 1 BOX 08/08/2018 1 NDC:14783-123-01 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 pasteProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:14783-124 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) 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:14783-124-02 1 in 1 BOX 08/08/2018 1 NDC:14783-124-01 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 pasteProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:14783-125 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) 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:14783-125-02 1 in 1 BOX 08/08/2018 1 NDC:14783-125-01 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 pasteProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:14783-126 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) 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:14783-126-02 1 in 1 BOX 08/08/2018 1 NDC:14783-126-01 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 pasteProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:14783-127 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) 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:14783-127-02 1 in 1 BOX 08/08/2018 1 NDC:14783-127-01 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 pasteProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:14783-128 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) 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:14783-128-02 1 in 1 BOX 08/08/2018 1 NDC:14783-128-01 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 International LTD (603192787) Establishment Name Address ID/FEI Business Operations Bel Star S.A. (Colombia) 880160197 MANUFACTURE(14783-120, 14783-131, 14783-122, 14783-123, 14783-124, 14783-125, 14783-126, 14783-127, 14783-128)