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
SHISEIDO SYNCHRO SKIN GLOW LUMINIZING FLUID FOUNDATION by
Drug Labeling and Warnings
SHISEIDO SYNCHRO SKIN GLOW LUMINIZING FLUID FOUNDATION by is a Otc medication manufactured, distributed, or labeled by SHISEIDO AMERICAS CORPORATION, SHISEIDO AMERICA INC.. Drug facts, warnings, and ingredients follow.
Drug Details [pdf]
- 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
WATERCYCLOPENTASILOXANEGLYCERINBUTYLENE GLYCOLCYCLOMETHICONEDIPHENYLSILOXY PHENYL TRIMETHICONESYNTHETIC FLUORPHLOGOPITESD ALCOHOL 40-BDIMETHICONE/VINYL DIMETHICONE CROSSPOLYMERSODIUM GLUTAMATELAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONEPEG-10 DIMETHICONESORBITAN SESQUIISOSTEARATEISOPROPYL MYRISTATEBARIUM SULFATEBIS-BUTYLDIMETHICONE POLYGLYCERYL-3ARGANIA SPINOSA KERNEL OILPOLYQUATERNIUM-51NYLON-12THYMUS SERPYLLUM EXTRACTSODIUM ACETYLATED HYALURONATEVACCINIUM MACROCARPON (CRANBERRY) SEED OILCITRUS JUNOS SEED EXTRACTDISTEARDIMONIUM HECTORITEALUMINUM HYDROXIDESTEARIC ACIDALUMINATRIETHOXYSILYLETHYL POLYDIMETHYLSILOXYETHYL DIMETHICONESODIUM CITRATETRIETHOXYCAPRYLYLSILANEPOLYSILICONE-2TRISODIUM EDTAALCOHOLDIMETHICONETOCOPHEROLCITRIC ACIDHYDROGEN DIMETHICONE(ONLY IN:GOLDEN 5NEUTRAL 4, 5ROSE 4, 5)BHTSODIUM METABISULFITEHYDRATED SILICADIMETHICONE/PEG-10/15 CROSSPOLYMERTIN OXIDEPOLYMETHYLSILSESQUIOXANEDIPROPYLENE GLYCOLDIISOSTEARYL MALATEGLYCERYL DIISOSTEARATEHELIANTHUS ANNUUS (SUNFLOWER) SEED OILROSMARINUS OFFICINALIS (ROSEMARY) LEAF EXTRACTSODIUM DEHYDROACETATEMETHYLPARABENETHYLPARABENPHENOXYETHANOLFRAGRANCETITANIUM DIOXIDEIRON OXIDESMICARED 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)
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