Label: SHISEIDO SYNCHRO SKIN GLOW LUMINIZING FLUID FOUNDATION NEUTRAL 1- octinoxate and titanium dioxide liquid
SHISEIDO SYNCHRO SKIN GLOW LUMINIZING FLUID FOUNDATION NEUTRAL 2- octinoxate and titanium dioxide liquid
SHISEIDO SYNCHRO SKIN GLOW LUMINIZING FLUID FOUNDATION NEUTRAL 3- octinoxate and titanium dioxide liquid
SHISEIDO SYNCHRO SKIN GLOW LUMINIZING FLUID FOUNDATION NEUTRAL 4- octinoxate and titanium dioxide liquid
SHISEIDO SYNCHRO SKIN GLOW LUMINIZING FLUID FOUNDATION NEUTRAL 5- octinoxate and titanium dioxide liquid
SHISEIDO SYNCHRO SKIN GLOW LUMINIZING FLUID FOUNDATION ROSE 2- octinoxate and titanium dioxide liquid
SHISEIDO SYNCHRO SKIN GLOW LUMINIZING FLUID FOUNDATION ROSE 3- octinoxate and titanium dioxide liquid
SHISEIDO SYNCHRO SKIN GLOW LUMINIZING FLUID FOUNDATION ROSE 4- octinoxate and titanium dioxide liquid
SHISEIDO SYNCHRO SKIN GLOW LUMINIZING FLUID FOUNDATION ROSE 5- octinoxate and titanium dioxide liquid
SHISEIDO SYNCHRO SKIN GLOW LUMINIZING FLUID FOUNDATION GOLDEN 2- octinoxate and titanium dioxide liquid
SHISEIDO SYNCHRO SKIN GLOW LUMINIZING FLUID FOUNDATION GOLDEN 3- octinoxate and titanium dioxide liquid
SHISEIDO SYNCHRO SKIN GLOW LUMINIZING FLUID FOUNDATION GOLDEN 4- octinoxate and titanium dioxide liquid
SHISEIDO SYNCHRO SKIN GLOW LUMINIZING FLUID FOUNDATION GOLDEN 5- octinoxate and titanium dioxide liquid
-
NDC Code(s):
58411-302-10,
58411-303-10,
58411-304-10,
58411-305-10, view more58411-306-10, 58411-307-10, 58411-308-10, 58411-309-10, 58411-310-10, 58411-311-10, 58411-312-10, 58411-313-10, 58411-314-10
- Packager: SHISEIDO AMERICAS CORPORATION
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not 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 December 13, 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
- helps prevent sunburn
- if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun
- Warnings
-
Directions
- apply liberally 15 minutes before sun exposure
- use a water resistant sunscreen if swimming or sweating
- reapply at least every 2 hours
-
Sun Protection Measures.
Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including:
- limit time in the sun, especially from 10 a.m. – 2 p.m.
- wear long-sleeve shirts, pants, hats, and sunglasses
- children under 6 months: Ask a doctor
-
Inactive Ingredients
WATER•CYCLOPENTASILOXANE•GLYCERIN•BUTYLENE GLYCOL•CYCLOMETHICONE•DIPHENYLSILOXY PHENYL TRIMETHICONE•SYNTHETIC FLUORPHLOGOPITE•SD ALCOHOL 40-B•DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER•SODIUM GLUTAMATE•LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE•PEG-10 DIMETHICONE•SORBITAN SESQUIISOSTEARATE•ISOPROPYL MYRISTATE•BARIUM SULFATE•BIS-BUTYLDIMETHICONE POLYGLYCERYL-3•ARGANIA SPINOSA KERNEL OIL•POLYQUATERNIUM-51•NYLON-12•THYMUS SERPYLLUM EXTRACT•SODIUM ACETYLATED HYALURONATE•VACCINIUM MACROCARPON (CRANBERRY) SEED OIL•CITRUS JUNOS SEED EXTRACT•DISTEARDIMONIUM HECTORITE•ALUMINUM HYDROXIDE•STEARIC ACID•ALUMINA•TRIETHOXYSILYLETHYL POLYDIMETHYLSILOXYETHYL DIMETHICONE•SODIUM CITRATE•TRIETHOXYCAPRYLYLSILANE•POLYSILICONE-2•TRISODIUM EDTA•ALCOHOL•DIMETHICONE•TOCOPHEROL•CITRIC ACID•HYDROGEN DIMETHICONE(ONLY IN:GOLDEN 5•NEUTRAL 4, 5•ROSE 4, 5)•BHT•SODIUM METABISULFITE•HYDRATED SILICA•DIMETHICONE/PEG-10/15 CROSSPOLYMER•TIN OXIDE•POLYMETHYLSILSESQUIOXANE•DIPROPYLENE GLYCOL•DIISOSTEARYL MALATE•GLYCERYL DIISOSTEARATE•HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL•ROSMARINUS OFFICINALIS (ROSEMARY) LEAF EXTRACT•SODIUM DEHYDROACETATE•METHYLPARABEN•ETHYLPARABEN•PHENOXYETHANOL•FRAGRANCE•TITANIUM DIOXIDE•IRON OXIDES•MICA•RED 27•
- Other information
- Questions or comments?
- PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - Neutral 1
- PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - Neutral 2
- PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - Neutral 3
- PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - Neutral 4
- PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - Neutral 5
- PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - Rose 2
- PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - Rose 3
- PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - Rose 4
- PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - Rose 5
- PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - Golden 2
- PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - Golden 3
- PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - Golden 4
- PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - Golden 5
-
INGREDIENTS AND APPEARANCE
SHISEIDO SYNCHRO SKIN GLOW LUMINIZING FLUID FOUNDATION NEUTRAL 1
octinoxate and titanium dioxide liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-302 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 1655 mg in 30 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 676 mg in 30 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) GLYCERIN (UNII: PDC6A3C0OX) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) CYCLOMETHICONE (UNII: NMQ347994Z) DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) MONOSODIUM GLUTAMATE (UNII: W81N5U6R6U) LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) BARIUM SULFATE (UNII: 25BB7EKE2E) ARGAN OIL (UNII: 4V59G5UW9X) POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J) NYLON-12 (UNII: 446U8J075B) THYMUS SERPYLLUM (UNII: 86H4S6K51N) SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93) CRANBERRY SEED OIL (UNII: 73KDS3BW5E) CITRUS JUNOS SEED (UNII: UY43O1Q45N) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) STEARIC ACID (UNII: 4ELV7Z65AP) ALUMINUM OXIDE (UNII: LMI26O6933) SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) EDETATE TRISODIUM (UNII: 420IP921MB) ALCOHOL (UNII: 3K9958V90M) DIMETHICONE (UNII: 92RU3N3Y1O) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) SODIUM METABISULFITE (UNII: 4VON5FNS3C) HYDRATED SILICA (UNII: Y6O7T4G8P9) STANNIC OXIDE (UNII: KM7N50LOS6) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) DIPROPYLENE GLYCOL (UNII: E107L85C40) DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ) GLYCERYL DIISOSTEARATE (UNII: 68BAV42LRC) SUNFLOWER OIL (UNII: 3W1JG795YI) ROSEMARY (UNII: IJ67X351P9) SODIUM DEHYDROACETATE (UNII: 8W46YN971G) METHYLPARABEN (UNII: A2I8C7HI9T) ETHYLPARABEN (UNII: 14255EXE39) PHENOXYETHANOL (UNII: HIE492ZZ3T) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) MICA (UNII: V8A1AW0880) D&C RED NO. 27 (UNII: 2LRS185U6K) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-302-10 1 in 1 CARTON 02/01/2017 1 30 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 02/01/2017 SHISEIDO SYNCHRO SKIN GLOW LUMINIZING FLUID FOUNDATION NEUTRAL 2
octinoxate and titanium dioxide liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-303 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 1655 mg in 30 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 676 mg in 30 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) GLYCERIN (UNII: PDC6A3C0OX) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) CYCLOMETHICONE (UNII: NMQ347994Z) DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) MONOSODIUM GLUTAMATE (UNII: W81N5U6R6U) LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) BARIUM SULFATE (UNII: 25BB7EKE2E) ARGAN OIL (UNII: 4V59G5UW9X) POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J) NYLON-12 (UNII: 446U8J075B) THYMUS SERPYLLUM (UNII: 86H4S6K51N) SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93) CRANBERRY SEED OIL (UNII: 73KDS3BW5E) CITRUS JUNOS SEED (UNII: UY43O1Q45N) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) STEARIC ACID (UNII: 4ELV7Z65AP) ALUMINUM OXIDE (UNII: LMI26O6933) SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) EDETATE TRISODIUM (UNII: 420IP921MB) ALCOHOL (UNII: 3K9958V90M) DIMETHICONE (UNII: 92RU3N3Y1O) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) SODIUM METABISULFITE (UNII: 4VON5FNS3C) HYDRATED SILICA (UNII: Y6O7T4G8P9) STANNIC OXIDE (UNII: KM7N50LOS6) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) DIPROPYLENE GLYCOL (UNII: E107L85C40) DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ) GLYCERYL DIISOSTEARATE (UNII: 68BAV42LRC) SUNFLOWER OIL (UNII: 3W1JG795YI) ROSEMARY (UNII: IJ67X351P9) SODIUM DEHYDROACETATE (UNII: 8W46YN971G) METHYLPARABEN (UNII: A2I8C7HI9T) ETHYLPARABEN (UNII: 14255EXE39) PHENOXYETHANOL (UNII: HIE492ZZ3T) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) MICA (UNII: V8A1AW0880) D&C RED NO. 27 (UNII: 2LRS185U6K) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-303-10 1 in 1 CARTON 02/01/2017 1 30 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 02/01/2017 SHISEIDO SYNCHRO SKIN GLOW LUMINIZING FLUID FOUNDATION NEUTRAL 3
octinoxate and titanium dioxide liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-304 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 1655 mg in 30 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 676 mg in 30 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) GLYCERIN (UNII: PDC6A3C0OX) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) CYCLOMETHICONE (UNII: NMQ347994Z) DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) MONOSODIUM GLUTAMATE (UNII: W81N5U6R6U) LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) BARIUM SULFATE (UNII: 25BB7EKE2E) ARGAN OIL (UNII: 4V59G5UW9X) POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J) NYLON-12 (UNII: 446U8J075B) THYMUS SERPYLLUM (UNII: 86H4S6K51N) SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93) CRANBERRY SEED OIL (UNII: 73KDS3BW5E) CITRUS JUNOS SEED (UNII: UY43O1Q45N) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) STEARIC ACID (UNII: 4ELV7Z65AP) ALUMINUM OXIDE (UNII: LMI26O6933) SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) EDETATE TRISODIUM (UNII: 420IP921MB) ALCOHOL (UNII: 3K9958V90M) DIMETHICONE (UNII: 92RU3N3Y1O) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) SODIUM METABISULFITE (UNII: 4VON5FNS3C) HYDRATED SILICA (UNII: Y6O7T4G8P9) STANNIC OXIDE (UNII: KM7N50LOS6) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) DIPROPYLENE GLYCOL (UNII: E107L85C40) DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ) GLYCERYL DIISOSTEARATE (UNII: 68BAV42LRC) SUNFLOWER OIL (UNII: 3W1JG795YI) ROSEMARY (UNII: IJ67X351P9) SODIUM DEHYDROACETATE (UNII: 8W46YN971G) METHYLPARABEN (UNII: A2I8C7HI9T) ETHYLPARABEN (UNII: 14255EXE39) PHENOXYETHANOL (UNII: HIE492ZZ3T) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) MICA (UNII: V8A1AW0880) D&C RED NO. 27 (UNII: 2LRS185U6K) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-304-10 1 in 1 CARTON 02/01/2017 1 30 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 02/01/2017 SHISEIDO SYNCHRO SKIN GLOW LUMINIZING FLUID FOUNDATION NEUTRAL 4
octinoxate and titanium dioxide liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-305 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 676 mg in 30 mL OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 1655 mg in 30 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) GLYCERIN (UNII: PDC6A3C0OX) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) CYCLOMETHICONE (UNII: NMQ347994Z) DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) MONOSODIUM GLUTAMATE (UNII: W81N5U6R6U) LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) BARIUM SULFATE (UNII: 25BB7EKE2E) ARGAN OIL (UNII: 4V59G5UW9X) POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J) NYLON-12 (UNII: 446U8J075B) THYMUS SERPYLLUM (UNII: 86H4S6K51N) SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93) CRANBERRY SEED OIL (UNII: 73KDS3BW5E) CITRUS JUNOS SEED (UNII: UY43O1Q45N) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) STEARIC ACID (UNII: 4ELV7Z65AP) ALUMINUM OXIDE (UNII: LMI26O6933) SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) EDETATE TRISODIUM (UNII: 420IP921MB) ALCOHOL (UNII: 3K9958V90M) DIMETHICONE (UNII: 92RU3N3Y1O) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) SODIUM METABISULFITE (UNII: 4VON5FNS3C) HYDRATED SILICA (UNII: Y6O7T4G8P9) STANNIC OXIDE (UNII: KM7N50LOS6) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) DIPROPYLENE GLYCOL (UNII: E107L85C40) DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ) GLYCERYL DIISOSTEARATE (UNII: 68BAV42LRC) SUNFLOWER OIL (UNII: 3W1JG795YI) ROSEMARY (UNII: IJ67X351P9) SODIUM DEHYDROACETATE (UNII: 8W46YN971G) METHYLPARABEN (UNII: A2I8C7HI9T) ETHYLPARABEN (UNII: 14255EXE39) PHENOXYETHANOL (UNII: HIE492ZZ3T) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) MICA (UNII: V8A1AW0880) D&C RED NO. 27 (UNII: 2LRS185U6K) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-305-10 1 in 1 CARTON 02/01/2017 1 30 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 02/01/2017 SHISEIDO SYNCHRO SKIN GLOW LUMINIZING FLUID FOUNDATION NEUTRAL 5
octinoxate and titanium dioxide liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-306 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 1655 mg in 30 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 676 mg in 30 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) GLYCERIN (UNII: PDC6A3C0OX) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) CYCLOMETHICONE (UNII: NMQ347994Z) DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) MONOSODIUM GLUTAMATE (UNII: W81N5U6R6U) LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) BARIUM SULFATE (UNII: 25BB7EKE2E) ARGAN OIL (UNII: 4V59G5UW9X) POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J) NYLON-12 (UNII: 446U8J075B) THYMUS SERPYLLUM (UNII: 86H4S6K51N) SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93) CRANBERRY SEED OIL (UNII: 73KDS3BW5E) CITRUS JUNOS SEED (UNII: UY43O1Q45N) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) STEARIC ACID (UNII: 4ELV7Z65AP) ALUMINUM OXIDE (UNII: LMI26O6933) SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) EDETATE TRISODIUM (UNII: 420IP921MB) ALCOHOL (UNII: 3K9958V90M) DIMETHICONE (UNII: 92RU3N3Y1O) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) SODIUM METABISULFITE (UNII: 4VON5FNS3C) HYDRATED SILICA (UNII: Y6O7T4G8P9) STANNIC OXIDE (UNII: KM7N50LOS6) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) DIPROPYLENE GLYCOL (UNII: E107L85C40) DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ) GLYCERYL DIISOSTEARATE (UNII: 68BAV42LRC) SUNFLOWER OIL (UNII: 3W1JG795YI) ROSEMARY (UNII: IJ67X351P9) SODIUM DEHYDROACETATE (UNII: 8W46YN971G) METHYLPARABEN (UNII: A2I8C7HI9T) ETHYLPARABEN (UNII: 14255EXE39) PHENOXYETHANOL (UNII: HIE492ZZ3T) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) MICA (UNII: V8A1AW0880) D&C RED NO. 27 (UNII: 2LRS185U6K) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-306-10 1 in 1 CARTON 02/01/2017 1 30 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 02/01/2017 SHISEIDO SYNCHRO SKIN GLOW LUMINIZING FLUID FOUNDATION ROSE 2
octinoxate and titanium dioxide liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-307 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 1655 mg in 30 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 676 mg in 30 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) GLYCERIN (UNII: PDC6A3C0OX) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) CYCLOMETHICONE (UNII: NMQ347994Z) DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) MONOSODIUM GLUTAMATE (UNII: W81N5U6R6U) LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) BARIUM SULFATE (UNII: 25BB7EKE2E) ARGAN OIL (UNII: 4V59G5UW9X) POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J) NYLON-12 (UNII: 446U8J075B) THYMUS SERPYLLUM (UNII: 86H4S6K51N) SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93) CRANBERRY SEED OIL (UNII: 73KDS3BW5E) CITRUS JUNOS SEED (UNII: UY43O1Q45N) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) STEARIC ACID (UNII: 4ELV7Z65AP) ALUMINUM OXIDE (UNII: LMI26O6933) SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) EDETATE TRISODIUM (UNII: 420IP921MB) ALCOHOL (UNII: 3K9958V90M) DIMETHICONE (UNII: 92RU3N3Y1O) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) SODIUM METABISULFITE (UNII: 4VON5FNS3C) HYDRATED SILICA (UNII: Y6O7T4G8P9) STANNIC OXIDE (UNII: KM7N50LOS6) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) DIPROPYLENE GLYCOL (UNII: E107L85C40) DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ) GLYCERYL DIISOSTEARATE (UNII: 68BAV42LRC) SUNFLOWER OIL (UNII: 3W1JG795YI) ROSEMARY (UNII: IJ67X351P9) SODIUM DEHYDROACETATE (UNII: 8W46YN971G) METHYLPARABEN (UNII: A2I8C7HI9T) ETHYLPARABEN (UNII: 14255EXE39) PHENOXYETHANOL (UNII: HIE492ZZ3T) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) MICA (UNII: V8A1AW0880) D&C RED NO. 27 (UNII: 2LRS185U6K) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-307-10 1 in 1 CARTON 02/01/2017 1 30 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 02/01/2017 SHISEIDO SYNCHRO SKIN GLOW LUMINIZING FLUID FOUNDATION ROSE 3
octinoxate and titanium dioxide liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-308 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 1655 mg in 30 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 676 mg in 30 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) GLYCERIN (UNII: PDC6A3C0OX) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) CYCLOMETHICONE (UNII: NMQ347994Z) DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) MONOSODIUM GLUTAMATE (UNII: W81N5U6R6U) LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) BARIUM SULFATE (UNII: 25BB7EKE2E) ARGAN OIL (UNII: 4V59G5UW9X) POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J) NYLON-12 (UNII: 446U8J075B) THYMUS SERPYLLUM (UNII: 86H4S6K51N) SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93) CRANBERRY SEED OIL (UNII: 73KDS3BW5E) CITRUS JUNOS SEED (UNII: UY43O1Q45N) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) STEARIC ACID (UNII: 4ELV7Z65AP) ALUMINUM OXIDE (UNII: LMI26O6933) SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) EDETATE TRISODIUM (UNII: 420IP921MB) ALCOHOL (UNII: 3K9958V90M) DIMETHICONE (UNII: 92RU3N3Y1O) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) SODIUM METABISULFITE (UNII: 4VON5FNS3C) HYDRATED SILICA (UNII: Y6O7T4G8P9) STANNIC OXIDE (UNII: KM7N50LOS6) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) DIPROPYLENE GLYCOL (UNII: E107L85C40) DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ) GLYCERYL DIISOSTEARATE (UNII: 68BAV42LRC) SUNFLOWER OIL (UNII: 3W1JG795YI) ROSEMARY (UNII: IJ67X351P9) SODIUM DEHYDROACETATE (UNII: 8W46YN971G) METHYLPARABEN (UNII: A2I8C7HI9T) ETHYLPARABEN (UNII: 14255EXE39) PHENOXYETHANOL (UNII: HIE492ZZ3T) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) MICA (UNII: V8A1AW0880) D&C RED NO. 27 (UNII: 2LRS185U6K) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-308-10 1 in 1 CARTON 02/01/2017 1 30 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 02/01/2017 SHISEIDO SYNCHRO SKIN GLOW LUMINIZING FLUID FOUNDATION ROSE 4
octinoxate and titanium dioxide liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-309 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 1655 mg in 30 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 676 mg in 30 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) GLYCERIN (UNII: PDC6A3C0OX) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) CYCLOMETHICONE (UNII: NMQ347994Z) DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) MONOSODIUM GLUTAMATE (UNII: W81N5U6R6U) LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) BARIUM SULFATE (UNII: 25BB7EKE2E) ARGAN OIL (UNII: 4V59G5UW9X) POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J) NYLON-12 (UNII: 446U8J075B) THYMUS SERPYLLUM (UNII: 86H4S6K51N) SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93) CRANBERRY SEED OIL (UNII: 73KDS3BW5E) CITRUS JUNOS SEED (UNII: UY43O1Q45N) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) STEARIC ACID (UNII: 4ELV7Z65AP) ALUMINUM OXIDE (UNII: LMI26O6933) SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) EDETATE TRISODIUM (UNII: 420IP921MB) ALCOHOL (UNII: 3K9958V90M) DIMETHICONE (UNII: 92RU3N3Y1O) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) SODIUM METABISULFITE (UNII: 4VON5FNS3C) HYDRATED SILICA (UNII: Y6O7T4G8P9) STANNIC OXIDE (UNII: KM7N50LOS6) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) DIPROPYLENE GLYCOL (UNII: E107L85C40) DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ) GLYCERYL DIISOSTEARATE (UNII: 68BAV42LRC) SUNFLOWER OIL (UNII: 3W1JG795YI) ROSEMARY (UNII: IJ67X351P9) SODIUM DEHYDROACETATE (UNII: 8W46YN971G) METHYLPARABEN (UNII: A2I8C7HI9T) ETHYLPARABEN (UNII: 14255EXE39) PHENOXYETHANOL (UNII: HIE492ZZ3T) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) MICA (UNII: V8A1AW0880) D&C RED NO. 27 (UNII: 2LRS185U6K) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-309-10 1 in 1 CARTON 02/01/2017 1 30 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 02/01/2017 SHISEIDO SYNCHRO SKIN GLOW LUMINIZING FLUID FOUNDATION ROSE 5
octinoxate and titanium dioxide liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-310 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 1655 mg in 30 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 676 mg in 30 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) GLYCERIN (UNII: PDC6A3C0OX) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) CYCLOMETHICONE (UNII: NMQ347994Z) DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) MONOSODIUM GLUTAMATE (UNII: W81N5U6R6U) LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) BARIUM SULFATE (UNII: 25BB7EKE2E) ARGAN OIL (UNII: 4V59G5UW9X) POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J) NYLON-12 (UNII: 446U8J075B) THYMUS SERPYLLUM (UNII: 86H4S6K51N) SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93) CRANBERRY SEED OIL (UNII: 73KDS3BW5E) CITRUS JUNOS SEED (UNII: UY43O1Q45N) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) STEARIC ACID (UNII: 4ELV7Z65AP) ALUMINUM OXIDE (UNII: LMI26O6933) SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) EDETATE TRISODIUM (UNII: 420IP921MB) ALCOHOL (UNII: 3K9958V90M) DIMETHICONE (UNII: 92RU3N3Y1O) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) SODIUM METABISULFITE (UNII: 4VON5FNS3C) HYDRATED SILICA (UNII: Y6O7T4G8P9) STANNIC OXIDE (UNII: KM7N50LOS6) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) DIPROPYLENE GLYCOL (UNII: E107L85C40) DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ) GLYCERYL DIISOSTEARATE (UNII: 68BAV42LRC) SUNFLOWER OIL (UNII: 3W1JG795YI) ROSEMARY (UNII: IJ67X351P9) SODIUM DEHYDROACETATE (UNII: 8W46YN971G) METHYLPARABEN (UNII: A2I8C7HI9T) ETHYLPARABEN (UNII: 14255EXE39) PHENOXYETHANOL (UNII: HIE492ZZ3T) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) MICA (UNII: V8A1AW0880) D&C RED NO. 27 (UNII: 2LRS185U6K) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-310-10 1 in 1 CARTON 02/01/2017 1 30 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 02/01/2017 SHISEIDO SYNCHRO SKIN GLOW LUMINIZING FLUID FOUNDATION GOLDEN 2
octinoxate and titanium dioxide liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-311 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 1655 mg in 30 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 676 mg in 30 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) GLYCERIN (UNII: PDC6A3C0OX) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) CYCLOMETHICONE (UNII: NMQ347994Z) DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) MONOSODIUM GLUTAMATE (UNII: W81N5U6R6U) LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) BARIUM SULFATE (UNII: 25BB7EKE2E) ARGAN OIL (UNII: 4V59G5UW9X) POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J) NYLON-12 (UNII: 446U8J075B) THYMUS SERPYLLUM (UNII: 86H4S6K51N) SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93) CRANBERRY SEED OIL (UNII: 73KDS3BW5E) CITRUS JUNOS SEED (UNII: UY43O1Q45N) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) STEARIC ACID (UNII: 4ELV7Z65AP) ALUMINUM OXIDE (UNII: LMI26O6933) SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) EDETATE TRISODIUM (UNII: 420IP921MB) ALCOHOL (UNII: 3K9958V90M) DIMETHICONE (UNII: 92RU3N3Y1O) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) SODIUM METABISULFITE (UNII: 4VON5FNS3C) HYDRATED SILICA (UNII: Y6O7T4G8P9) STANNIC OXIDE (UNII: KM7N50LOS6) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) DIPROPYLENE GLYCOL (UNII: E107L85C40) DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ) GLYCERYL DIISOSTEARATE (UNII: 68BAV42LRC) SUNFLOWER OIL (UNII: 3W1JG795YI) ROSEMARY (UNII: IJ67X351P9) SODIUM DEHYDROACETATE (UNII: 8W46YN971G) METHYLPARABEN (UNII: A2I8C7HI9T) ETHYLPARABEN (UNII: 14255EXE39) PHENOXYETHANOL (UNII: HIE492ZZ3T) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) MICA (UNII: V8A1AW0880) D&C RED NO. 27 (UNII: 2LRS185U6K) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-311-10 1 in 1 CARTON 02/01/2017 1 30 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 02/01/2017 SHISEIDO SYNCHRO SKIN GLOW LUMINIZING FLUID FOUNDATION GOLDEN 3
octinoxate and titanium dioxide liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-312 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 1655 mg in 30 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 676 mg in 30 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) GLYCERIN (UNII: PDC6A3C0OX) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) CYCLOMETHICONE (UNII: NMQ347994Z) DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) MONOSODIUM GLUTAMATE (UNII: W81N5U6R6U) LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) BARIUM SULFATE (UNII: 25BB7EKE2E) ARGAN OIL (UNII: 4V59G5UW9X) POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J) NYLON-12 (UNII: 446U8J075B) THYMUS SERPYLLUM (UNII: 86H4S6K51N) SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93) CRANBERRY SEED OIL (UNII: 73KDS3BW5E) CITRUS JUNOS SEED (UNII: UY43O1Q45N) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) STEARIC ACID (UNII: 4ELV7Z65AP) ALUMINUM OXIDE (UNII: LMI26O6933) SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) EDETATE TRISODIUM (UNII: 420IP921MB) ALCOHOL (UNII: 3K9958V90M) DIMETHICONE (UNII: 92RU3N3Y1O) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) SODIUM METABISULFITE (UNII: 4VON5FNS3C) HYDRATED SILICA (UNII: Y6O7T4G8P9) STANNIC OXIDE (UNII: KM7N50LOS6) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) DIPROPYLENE GLYCOL (UNII: E107L85C40) DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ) GLYCERYL DIISOSTEARATE (UNII: 68BAV42LRC) SUNFLOWER OIL (UNII: 3W1JG795YI) ROSEMARY (UNII: IJ67X351P9) SODIUM DEHYDROACETATE (UNII: 8W46YN971G) METHYLPARABEN (UNII: A2I8C7HI9T) ETHYLPARABEN (UNII: 14255EXE39) PHENOXYETHANOL (UNII: HIE492ZZ3T) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) MICA (UNII: V8A1AW0880) D&C RED NO. 27 (UNII: 2LRS185U6K) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-312-10 1 in 1 CARTON 02/01/2017 1 30 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 02/01/2017 SHISEIDO SYNCHRO SKIN GLOW LUMINIZING FLUID FOUNDATION GOLDEN 4
octinoxate and titanium dioxide liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-313 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 1655 mg in 30 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 676 mg in 30 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) GLYCERIN (UNII: PDC6A3C0OX) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) CYCLOMETHICONE (UNII: NMQ347994Z) DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) MONOSODIUM GLUTAMATE (UNII: W81N5U6R6U) LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) BARIUM SULFATE (UNII: 25BB7EKE2E) ARGAN OIL (UNII: 4V59G5UW9X) POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J) NYLON-12 (UNII: 446U8J075B) THYMUS SERPYLLUM (UNII: 86H4S6K51N) SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93) CRANBERRY SEED OIL (UNII: 73KDS3BW5E) CITRUS JUNOS SEED (UNII: UY43O1Q45N) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) STEARIC ACID (UNII: 4ELV7Z65AP) ALUMINUM OXIDE (UNII: LMI26O6933) SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) EDETATE TRISODIUM (UNII: 420IP921MB) ALCOHOL (UNII: 3K9958V90M) DIMETHICONE (UNII: 92RU3N3Y1O) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) SODIUM METABISULFITE (UNII: 4VON5FNS3C) HYDRATED SILICA (UNII: Y6O7T4G8P9) STANNIC OXIDE (UNII: KM7N50LOS6) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) DIPROPYLENE GLYCOL (UNII: E107L85C40) DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ) GLYCERYL DIISOSTEARATE (UNII: 68BAV42LRC) SUNFLOWER OIL (UNII: 3W1JG795YI) ROSEMARY (UNII: IJ67X351P9) SODIUM DEHYDROACETATE (UNII: 8W46YN971G) METHYLPARABEN (UNII: A2I8C7HI9T) ETHYLPARABEN (UNII: 14255EXE39) PHENOXYETHANOL (UNII: HIE492ZZ3T) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) MICA (UNII: V8A1AW0880) D&C RED NO. 27 (UNII: 2LRS185U6K) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-313-10 1 in 1 CARTON 02/01/2017 1 30 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 02/01/2017 SHISEIDO SYNCHRO SKIN GLOW LUMINIZING FLUID FOUNDATION GOLDEN 5
octinoxate and titanium dioxide liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-314 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 1655 mg in 30 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 676 mg in 30 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) GLYCERIN (UNII: PDC6A3C0OX) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) CYCLOMETHICONE (UNII: NMQ347994Z) DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) MONOSODIUM GLUTAMATE (UNII: W81N5U6R6U) LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) BARIUM SULFATE (UNII: 25BB7EKE2E) ARGAN OIL (UNII: 4V59G5UW9X) POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J) NYLON-12 (UNII: 446U8J075B) THYMUS SERPYLLUM (UNII: 86H4S6K51N) SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93) CRANBERRY SEED OIL (UNII: 73KDS3BW5E) CITRUS JUNOS SEED (UNII: UY43O1Q45N) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) STEARIC ACID (UNII: 4ELV7Z65AP) ALUMINUM OXIDE (UNII: LMI26O6933) SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) EDETATE TRISODIUM (UNII: 420IP921MB) ALCOHOL (UNII: 3K9958V90M) DIMETHICONE (UNII: 92RU3N3Y1O) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) SODIUM METABISULFITE (UNII: 4VON5FNS3C) HYDRATED SILICA (UNII: Y6O7T4G8P9) STANNIC OXIDE (UNII: KM7N50LOS6) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) DIPROPYLENE GLYCOL (UNII: E107L85C40) DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ) GLYCERYL DIISOSTEARATE (UNII: 68BAV42LRC) SUNFLOWER OIL (UNII: 3W1JG795YI) ROSEMARY (UNII: IJ67X351P9) SODIUM DEHYDROACETATE (UNII: 8W46YN971G) METHYLPARABEN (UNII: A2I8C7HI9T) ETHYLPARABEN (UNII: 14255EXE39) PHENOXYETHANOL (UNII: HIE492ZZ3T) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) MICA (UNII: V8A1AW0880) D&C RED NO. 27 (UNII: 2LRS185U6K) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-314-10 1 in 1 CARTON 02/01/2017 1 30 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 02/01/2017 Labeler - SHISEIDO AMERICAS CORPORATION (193691821) Establishment Name Address ID/FEI Business Operations SHISEIDO AMERICA INC. 782677132 manufacture(58411-302, 58411-303, 58411-304, 58411-305, 58411-306, 58411-307, 58411-308, 58411-309, 58411-310, 58411-311, 58411-312, 58411-313, 58411-314) , analysis(58411-302, 58411-303, 58411-304, 58411-305, 58411-306, 58411-307, 58411-308, 58411-309, 58411-310, 58411-311, 58411-312, 58411-313, 58411-314)
