Label: LBEL MOUSSE MATIFFIANT MATTE FINISH MOUSSE FOUNDATION SPF 15 MEDIUM 7- octinoxate, titanium dioxide, zinc oxide paste
LBEL MOUSSE MATIFFIANT MATTE FINISH MOUSSE FOUNDATION SPF 15 OBSCURE 8- octinoxate, titanium dioxide, zinc oxide paste
LBEL MOUSSE MATIFFIANT MATTE FINISH MOUSSE FOUNDATION SPF 15 OBSCURE 9- octinoxate, titanium dioxide, zinc oxide paste
LBEL MOUSSE MATIFFIANT MATTE FINISH MOUSSE FOUNDATION SPF 15 CLAIRE 1- octinoxate, titanium dioxide, zinc oxide paste
LBEL MOUSSE MATIFFIANT MATTE FINISH MOUSSE FOUNDATION SPF 15 CLAIRE 2- octinoxate, titanium dioxide, zinc oxide paste
LBEL MOUSSE MATIFFIANT MATTE FINISH MOUSSE FOUNDATION SPF 15 CLAIRE 3- octinoxate, titanium dioxide, zinc oxide paste
LBEL MOUSSE MATIFFIANT MATTE FINISH MOUSSE FOUNDATION SPF 15 CLAIRE 4- octinoxate, titanium dioxide, zinc oxide paste
LBEL MOUSSE MATIFFIANT MATTE FINISH MOUSSE FOUNDATION SPF 15 MEDIUM 5- octinoxate, titanium dioxide, zinc oxide paste
LBEL MOUSSE MATIFFIANT MATTE FINISH MOUSSE FOUNDATION SPF 15 MEDIUM 6- octinoxate, titanium dioxide, zinc oxide paste
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Contains inactivated NDC Code(s)
NDC Code(s): 43596-0174-1, 43596-0175-1, 43596-0176-1, 43596-0177-1, view more43596-0178-1, 43596-0179-1, 43596-0180-1, 43596-0181-1, 43596-0182-1 - 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, 2020
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
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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.
- DOSAGE & ADMINISTRATION
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INACTIVE INGREDIENT
Cylcopentasiloxane, 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, hydrogen dimethicone, pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate, rhodiola rosea root extract, carnosine, triethoxycaprylylsilane. May Contain: titanium dioxide , iron oxides
- OTHER SAFETY INFORMATION
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INGREDIENTS AND APPEARANCE
LBEL MOUSSE MATIFFIANT MATTE FINISH MOUSSE FOUNDATION SPF 15 MEDIUM 7
octinoxate, titanium dioxide, zinc oxide pasteProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:43596-0174 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 2.44 g in 100 g OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 6.5 g in 100 g ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 1.57 g in 100 g Inactive Ingredients Ingredient Name Strength MICA (UNII: V8A1AW0880) DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6) PHENOXYETHANOL (UNII: HIE492ZZ3T) CARNOSINE (UNII: 8HO6PVN24W) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) HEXYL LAURATE (UNII: 4CG9F9W01Q) DIMETHICONOL (14000 CST) (UNII: M2HW98ZA4V) BIS-HYDROXYETHOXYPROPYL DIMETHICONE (37 CST) (UNII: 7K226YI89Y) IRVINGIA GABONENSIS SEED BUTTER (UNII: 8Y12O726LX) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) CYCLOMETHICONE 6 (UNII: XHK3U310BA) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) CHLORPHENESIN (UNII: I670DAL4SZ) LAUROYL LYSINE (UNII: 113171Q70B) SEDUM ROSEUM ROOT (UNII: 3S5ITS5ULN) PROPYLENE CARBONATE (UNII: 8D08K3S51E) HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI) PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS) POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7) HYDROGENATED COCO-GLYCERIDES (UNII: XDD37N2GPR) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN) CAPRYLYL GLYCOL (UNII: 00YIU5438U) OCTYLDODECANOL (UNII: 461N1O614Y) BORON NITRIDE (UNII: 2U4T60A6YD) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) ALUMINUM OXIDE (UNII: LMI26O6933) CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) ALANYL GLUTAMINE (UNII: U5JDO2770Z) FERRIC OXIDE RED (UNII: 1K09F3G675) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:43596-0174-1 30 g in 1 TUBE; Type 0: Not a Combination Product 11/12/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 11/12/2020 LBEL MOUSSE MATIFFIANT MATTE FINISH MOUSSE FOUNDATION SPF 15 OBSCURE 8
octinoxate, titanium dioxide, zinc oxide pasteProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:43596-0175 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 2.44 g in 100 g OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 6.5 g in 100 g ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 1.57 g in 100 g Inactive Ingredients Ingredient Name Strength MICA (UNII: V8A1AW0880) DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6) PHENOXYETHANOL (UNII: HIE492ZZ3T) CARNOSINE (UNII: 8HO6PVN24W) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) HEXYL LAURATE (UNII: 4CG9F9W01Q) DIMETHICONOL (14000 CST) (UNII: M2HW98ZA4V) BIS-HYDROXYETHOXYPROPYL DIMETHICONE (37 CST) (UNII: 7K226YI89Y) IRVINGIA GABONENSIS SEED BUTTER (UNII: 8Y12O726LX) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) CYCLOMETHICONE 6 (UNII: XHK3U310BA) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) CHLORPHENESIN (UNII: I670DAL4SZ) LAUROYL LYSINE (UNII: 113171Q70B) SEDUM ROSEUM ROOT (UNII: 3S5ITS5ULN) PROPYLENE CARBONATE (UNII: 8D08K3S51E) HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI) PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS) POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7) HYDROGENATED COCO-GLYCERIDES (UNII: XDD37N2GPR) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN) CAPRYLYL GLYCOL (UNII: 00YIU5438U) OCTYLDODECANOL (UNII: 461N1O614Y) BORON NITRIDE (UNII: 2U4T60A6YD) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) ALUMINUM OXIDE (UNII: LMI26O6933) CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) ALANYL GLUTAMINE (UNII: U5JDO2770Z) FERRIC OXIDE RED (UNII: 1K09F3G675) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:43596-0175-1 30 g in 1 TUBE; Type 0: Not a Combination Product 11/12/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 11/12/2020 LBEL MOUSSE MATIFFIANT MATTE FINISH MOUSSE FOUNDATION SPF 15 OBSCURE 9
octinoxate, titanium dioxide, zinc oxide pasteProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:43596-0176 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 2.44 g in 100 g OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 6.5 g in 100 g ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 1.57 g in 100 g Inactive Ingredients Ingredient Name Strength MICA (UNII: V8A1AW0880) DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6) PHENOXYETHANOL (UNII: HIE492ZZ3T) CARNOSINE (UNII: 8HO6PVN24W) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) HEXYL LAURATE (UNII: 4CG9F9W01Q) DIMETHICONOL (14000 CST) (UNII: M2HW98ZA4V) BIS-HYDROXYETHOXYPROPYL DIMETHICONE (37 CST) (UNII: 7K226YI89Y) IRVINGIA GABONENSIS SEED BUTTER (UNII: 8Y12O726LX) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) CYCLOMETHICONE 6 (UNII: XHK3U310BA) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) CHLORPHENESIN (UNII: I670DAL4SZ) LAUROYL LYSINE (UNII: 113171Q70B) SEDUM ROSEUM ROOT (UNII: 3S5ITS5ULN) PROPYLENE CARBONATE (UNII: 8D08K3S51E) HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI) PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS) POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7) HYDROGENATED COCO-GLYCERIDES (UNII: XDD37N2GPR) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN) CAPRYLYL GLYCOL (UNII: 00YIU5438U) OCTYLDODECANOL (UNII: 461N1O614Y) BORON NITRIDE (UNII: 2U4T60A6YD) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) ALUMINUM OXIDE (UNII: LMI26O6933) CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) ALANYL GLUTAMINE (UNII: U5JDO2770Z) FERRIC OXIDE RED (UNII: 1K09F3G675) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:43596-0176-1 30 g in 1 TUBE; Type 0: Not a Combination Product 11/12/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 11/12/2020 LBEL MOUSSE MATIFFIANT MATTE FINISH MOUSSE FOUNDATION SPF 15 CLAIRE 1
octinoxate, titanium dioxide, zinc oxide pasteProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:43596-0177 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 2.44 g in 100 g OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 6.5 g in 100 g ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 1.57 g in 100 g Inactive Ingredients Ingredient Name Strength MICA (UNII: V8A1AW0880) DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6) BORON NITRIDE (UNII: 2U4T60A6YD) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) ALUMINUM OXIDE (UNII: LMI26O6933) CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) FERRIC OXIDE RED (UNII: 1K09F3G675) PHENOXYETHANOL (UNII: HIE492ZZ3T) CARNOSINE (UNII: 8HO6PVN24W) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) HEXYL LAURATE (UNII: 4CG9F9W01Q) DIMETHICONOL (14000 CST) (UNII: M2HW98ZA4V) BIS-HYDROXYETHOXYPROPYL DIMETHICONE (37 CST) (UNII: 7K226YI89Y) IRVINGIA GABONENSIS SEED BUTTER (UNII: 8Y12O726LX) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) CYCLOMETHICONE 6 (UNII: XHK3U310BA) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) CHLORPHENESIN (UNII: I670DAL4SZ) LAUROYL LYSINE (UNII: 113171Q70B) SEDUM ROSEUM ROOT (UNII: 3S5ITS5ULN) PROPYLENE CARBONATE (UNII: 8D08K3S51E) HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI) PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS) POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7) HYDROGENATED COCO-GLYCERIDES (UNII: XDD37N2GPR) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN) CAPRYLYL GLYCOL (UNII: 00YIU5438U) OCTYLDODECANOL (UNII: 461N1O614Y) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) ALANYL GLUTAMINE (UNII: U5JDO2770Z) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:43596-0177-1 30 g in 1 TUBE; Type 0: Not a Combination Product 11/12/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 11/12/2020 LBEL MOUSSE MATIFFIANT MATTE FINISH MOUSSE FOUNDATION SPF 15 CLAIRE 2
octinoxate, titanium dioxide, zinc oxide pasteProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:43596-0178 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 2.44 g in 100 g OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 6.5 g in 100 g ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 1.57 g in 100 g Inactive Ingredients Ingredient Name Strength MICA (UNII: V8A1AW0880) DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6) PHENOXYETHANOL (UNII: HIE492ZZ3T) CARNOSINE (UNII: 8HO6PVN24W) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) HEXYL LAURATE (UNII: 4CG9F9W01Q) DIMETHICONOL (14000 CST) (UNII: M2HW98ZA4V) BIS-HYDROXYETHOXYPROPYL DIMETHICONE (37 CST) (UNII: 7K226YI89Y) IRVINGIA GABONENSIS SEED BUTTER (UNII: 8Y12O726LX) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) CYCLOMETHICONE 6 (UNII: XHK3U310BA) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) CHLORPHENESIN (UNII: I670DAL4SZ) LAUROYL LYSINE (UNII: 113171Q70B) SEDUM ROSEUM ROOT (UNII: 3S5ITS5ULN) PROPYLENE CARBONATE (UNII: 8D08K3S51E) HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI) PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS) POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7) HYDROGENATED COCO-GLYCERIDES (UNII: XDD37N2GPR) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN) CAPRYLYL GLYCOL (UNII: 00YIU5438U) OCTYLDODECANOL (UNII: 461N1O614Y) BORON NITRIDE (UNII: 2U4T60A6YD) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) ALUMINUM OXIDE (UNII: LMI26O6933) CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) ALANYL GLUTAMINE (UNII: U5JDO2770Z) FERRIC OXIDE RED (UNII: 1K09F3G675) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:43596-0178-1 30 g in 1 TUBE; Type 0: Not a Combination Product 11/12/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 11/12/2020 LBEL MOUSSE MATIFFIANT MATTE FINISH MOUSSE FOUNDATION SPF 15 CLAIRE 3
octinoxate, titanium dioxide, zinc oxide pasteProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:43596-0179 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 2.44 g in 100 g OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 6.5 g in 100 g ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 1.57 g in 100 g Inactive Ingredients Ingredient Name Strength MICA (UNII: V8A1AW0880) DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6) PHENOXYETHANOL (UNII: HIE492ZZ3T) CARNOSINE (UNII: 8HO6PVN24W) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) HEXYL LAURATE (UNII: 4CG9F9W01Q) DIMETHICONOL (14000 CST) (UNII: M2HW98ZA4V) BIS-HYDROXYETHOXYPROPYL DIMETHICONE (37 CST) (UNII: 7K226YI89Y) IRVINGIA GABONENSIS SEED BUTTER (UNII: 8Y12O726LX) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) CYCLOMETHICONE 6 (UNII: XHK3U310BA) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) CHLORPHENESIN (UNII: I670DAL4SZ) LAUROYL LYSINE (UNII: 113171Q70B) SEDUM ROSEUM ROOT (UNII: 3S5ITS5ULN) PROPYLENE CARBONATE (UNII: 8D08K3S51E) HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI) PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS) POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7) HYDROGENATED COCO-GLYCERIDES (UNII: XDD37N2GPR) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN) CAPRYLYL GLYCOL (UNII: 00YIU5438U) OCTYLDODECANOL (UNII: 461N1O614Y) BORON NITRIDE (UNII: 2U4T60A6YD) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) ALUMINUM OXIDE (UNII: LMI26O6933) CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) ALANYL GLUTAMINE (UNII: U5JDO2770Z) FERRIC OXIDE RED (UNII: 1K09F3G675) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:43596-0179-1 30 g in 1 TUBE; Type 0: Not a Combination Product 11/12/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 11/12/2020 LBEL MOUSSE MATIFFIANT MATTE FINISH MOUSSE FOUNDATION SPF 15 CLAIRE 4
octinoxate, titanium dioxide, zinc oxide pasteProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:43596-0180 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 2.44 g in 100 g OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 6.5 g in 100 g ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 1.57 g in 100 g Inactive Ingredients Ingredient Name Strength MICA (UNII: V8A1AW0880) DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6) PHENOXYETHANOL (UNII: HIE492ZZ3T) CARNOSINE (UNII: 8HO6PVN24W) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) HEXYL LAURATE (UNII: 4CG9F9W01Q) DIMETHICONOL (14000 CST) (UNII: M2HW98ZA4V) BIS-HYDROXYETHOXYPROPYL DIMETHICONE (37 CST) (UNII: 7K226YI89Y) IRVINGIA GABONENSIS SEED BUTTER (UNII: 8Y12O726LX) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) CYCLOMETHICONE 6 (UNII: XHK3U310BA) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) CHLORPHENESIN (UNII: I670DAL4SZ) LAUROYL LYSINE (UNII: 113171Q70B) SEDUM ROSEUM ROOT (UNII: 3S5ITS5ULN) PROPYLENE CARBONATE (UNII: 8D08K3S51E) HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI) PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS) POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7) HYDROGENATED COCO-GLYCERIDES (UNII: XDD37N2GPR) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN) CAPRYLYL GLYCOL (UNII: 00YIU5438U) OCTYLDODECANOL (UNII: 461N1O614Y) BORON NITRIDE (UNII: 2U4T60A6YD) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) ALUMINUM OXIDE (UNII: LMI26O6933) CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) ALANYL GLUTAMINE (UNII: U5JDO2770Z) FERRIC OXIDE RED (UNII: 1K09F3G675) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:43596-0180-1 30 g in 1 TUBE; Type 0: Not a Combination Product 11/12/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 11/12/2020 LBEL MOUSSE MATIFFIANT MATTE FINISH MOUSSE FOUNDATION SPF 15 MEDIUM 5
octinoxate, titanium dioxide, zinc oxide pasteProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:43596-0181 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 2.44 g in 100 g OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 6.5 g in 100 g ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 1.57 g in 100 g Inactive Ingredients Ingredient Name Strength MICA (UNII: V8A1AW0880) DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6) PHENOXYETHANOL (UNII: HIE492ZZ3T) CARNOSINE (UNII: 8HO6PVN24W) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) HEXYL LAURATE (UNII: 4CG9F9W01Q) DIMETHICONOL (14000 CST) (UNII: M2HW98ZA4V) BIS-HYDROXYETHOXYPROPYL DIMETHICONE (37 CST) (UNII: 7K226YI89Y) IRVINGIA GABONENSIS SEED BUTTER (UNII: 8Y12O726LX) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) CYCLOMETHICONE 6 (UNII: XHK3U310BA) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) CHLORPHENESIN (UNII: I670DAL4SZ) LAUROYL LYSINE (UNII: 113171Q70B) SEDUM ROSEUM ROOT (UNII: 3S5ITS5ULN) PROPYLENE CARBONATE (UNII: 8D08K3S51E) HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI) PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS) POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7) HYDROGENATED COCO-GLYCERIDES (UNII: XDD37N2GPR) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN) CAPRYLYL GLYCOL (UNII: 00YIU5438U) OCTYLDODECANOL (UNII: 461N1O614Y) BORON NITRIDE (UNII: 2U4T60A6YD) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) ALUMINUM OXIDE (UNII: LMI26O6933) CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) ALANYL GLUTAMINE (UNII: U5JDO2770Z) FERRIC OXIDE RED (UNII: 1K09F3G675) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:43596-0181-1 30 g in 1 TUBE; Type 0: Not a Combination Product 11/12/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 11/12/2020 LBEL MOUSSE MATIFFIANT MATTE FINISH MOUSSE FOUNDATION SPF 15 MEDIUM 6
octinoxate, titanium dioxide, zinc oxide pasteProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:43596-0182 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 2.44 g in 100 g OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 6.5 g in 100 g ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 1.57 g in 100 g Inactive Ingredients Ingredient Name Strength MICA (UNII: V8A1AW0880) DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6) PHENOXYETHANOL (UNII: HIE492ZZ3T) CARNOSINE (UNII: 8HO6PVN24W) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) HEXYL LAURATE (UNII: 4CG9F9W01Q) DIMETHICONOL (14000 CST) (UNII: M2HW98ZA4V) BIS-HYDROXYETHOXYPROPYL DIMETHICONE (37 CST) (UNII: 7K226YI89Y) IRVINGIA GABONENSIS SEED BUTTER (UNII: 8Y12O726LX) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) CYCLOMETHICONE 6 (UNII: XHK3U310BA) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) CHLORPHENESIN (UNII: I670DAL4SZ) LAUROYL LYSINE (UNII: 113171Q70B) SEDUM ROSEUM ROOT (UNII: 3S5ITS5ULN) PROPYLENE CARBONATE (UNII: 8D08K3S51E) HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI) PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS) POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7) HYDROGENATED COCO-GLYCERIDES (UNII: XDD37N2GPR) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN) CAPRYLYL GLYCOL (UNII: 00YIU5438U) OCTYLDODECANOL (UNII: 461N1O614Y) BORON NITRIDE (UNII: 2U4T60A6YD) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) ALUMINUM OXIDE (UNII: LMI26O6933) CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) ALANYL GLUTAMINE (UNII: U5JDO2770Z) FERRIC OXIDE RED (UNII: 1K09F3G675) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:43596-0182-1 30 g in 1 TUBE; Type 0: Not a Combination Product 11/12/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 11/12/2020 Labeler - Ventura Corporation LTD (602751344) Establishment Name Address ID/FEI Business Operations Bel Star S.A. (Colombia) 880160197 manufacture(43596-0174, 43596-0175, 43596-0176, 43596-0177, 43596-0178, 43596-0179, 43596-0180, 43596-0181, 43596-0182)