Label: SHISEIDO SYNCHRO SKIN LASTING FOUNDATION NEUTRAL 1- octinoxate and titanium dioxide liquid
SHISEIDO SYNCHRO SKIN LASTING FOUNDATION NEUTRAL 2- octinoxate and titanium dioxide liquid
SHISEIDO SYNCHRO SKIN LASTING FOUNDATION NEUTRAL 3- octinoxate and titanium dioxide liquid
SHISEIDO SYNCHRO SKIN LASTING FOUNDATION NEUTRAL 4- octinoxate and titanium dioxide liquid
SHISEIDO SYNCHRO SKIN LASTING FOUNDATION ROSE 2- octinoxate and titanium dioxide liquid
SHISEIDO SYNCHRO SKIN LASTING FOUNDATION ROSE 3- octinoxate and titanium dioxide liquid
SHISEIDO SYNCHRO SKIN LASTING FOUNDATION ROSE 4- octinoxate and titanium dioxide liquid
SHISEIDO SYNCHRO SKIN LASTING FOUNDATION GOLDEN 2- octinoxate and titanium dioxide liquid
SHISEIDO SYNCHRO SKIN LASTING FOUNDATION GOLDEN 3- octinoxate and titanium dioxide liquid
SHISEIDO SYNCHRO SKIN LASTING FOUNDATION GOLDEN 4- octinoxate and titanium dioxide liquid
SHISEIDO SYNCHRO SKIN LASTING FOUNDATION GOLDEN 5- octinoxate and titanium dioxide liquid
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NDC Code(s):
58411-261-10,
58411-262-10,
58411-263-10,
58411-264-10, view more58411-265-10, 58411-266-10, 58411-267-10, 58411-268-10, 58411-269-10, 58411-270-10, 58411-271-10
- Packager: SHISEIDO AMERICAS CORPORATION
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated October 23, 2023
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
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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
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Directions
For sunscreen use:
- 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
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Inactive Ingredients
DIMETHICONE∙WATER∙TRIFLUOROPROPYLDIMETHYL/TRIMETHYLSILOXYSILICATE∙CAPRYLIC/CAPRIC TRIGLYCERIDE∙DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER∙PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE∙SD ALCOHOL 40-B∙MAGNESIUM MYRISTATE∙NYLON-12∙DIPHENYL DIMETHICONE/VINYL DIPHENYL DIMETHICONE/SILSESQUIOXANE CROSSPOLYMER∙DISTEARDIMONIUM HECTORITE∙POLYQUATERNIUM-51∙THYMUS SERPILLUM EXTRACT∙ALUMINUM HYDROXIDE∙ALUMINUM DISTEARATE∙POLYSILICONE-2∙GLYCERIN∙BHT∙ALCOHOL∙BUTYLENE GLYCOL∙TOCOPHEROL∙METHYL METHACRYLATE CROSSPOLYMER∙HYPERICUM ERECTUM FLOWER/LEAF/STEM EXTRACT∙TALC∙DIMETHICONE/PEG-10/15 CROSSPOLYMER∙SILICA∙ALUMINA∙POLYMETHYLSILSESQUIOXANE∙DIISOSTEARYL MALATE∙GLYCERYL DIISOSTEARATE∙DIPROPYLENE GLYCOL∙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 - 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 - 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
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INGREDIENTS AND APPEARANCE
SHISEIDO SYNCHRO SKIN LASTING FOUNDATION NEUTRAL 1
octinoxate and titanium dioxide liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-261 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 911 mg in 30 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 754 mg in 30 mL Inactive Ingredients Ingredient Name Strength DIMETHICONE (UNII: 92RU3N3Y1O) WATER (UNII: 059QF0KO0R) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F) MAGNESIUM MYRISTATE (UNII: Z1917F0578) NYLON-12 (UNII: 446U8J075B) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) THYMUS SERPYLLUM (UNII: 86H4S6K51N) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI) GLYCERIN (UNII: PDC6A3C0OX) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) ALCOHOL (UNII: 3K9958V90M) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) HYPERICUM ERECTUM FLOWERING TOP (UNII: IT0296HQDC) TALC (UNII: 7SEV7J4R1U) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) ALUMINUM OXIDE (UNII: LMI26O6933) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ) GLYCERYL DIISOSTEARATE (UNII: 68BAV42LRC) DIPROPYLENE GLYCOL (UNII: E107L85C40) 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:58411-261-10 1 in 1 CARTON 02/01/2016 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 drug M020 02/01/2016 SHISEIDO SYNCHRO SKIN LASTING FOUNDATION NEUTRAL 2
octinoxate and titanium dioxide liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-262 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 911 mg in 30 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 754 mg in 30 mL Inactive Ingredients Ingredient Name Strength DIMETHICONE (UNII: 92RU3N3Y1O) WATER (UNII: 059QF0KO0R) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F) MAGNESIUM MYRISTATE (UNII: Z1917F0578) NYLON-12 (UNII: 446U8J075B) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) THYMUS SERPYLLUM (UNII: 86H4S6K51N) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI) GLYCERIN (UNII: PDC6A3C0OX) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) ALCOHOL (UNII: 3K9958V90M) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) HYPERICUM ERECTUM FLOWERING TOP (UNII: IT0296HQDC) TALC (UNII: 7SEV7J4R1U) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) ALUMINUM OXIDE (UNII: LMI26O6933) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ) GLYCERYL DIISOSTEARATE (UNII: 68BAV42LRC) DIPROPYLENE GLYCOL (UNII: E107L85C40) 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:58411-262-10 1 in 1 CARTON 02/01/2016 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 drug M020 02/01/2016 SHISEIDO SYNCHRO SKIN LASTING FOUNDATION NEUTRAL 3
octinoxate and titanium dioxide liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-263 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 911 mg in 30 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 754 mg in 30 mL Inactive Ingredients Ingredient Name Strength DIMETHICONE (UNII: 92RU3N3Y1O) WATER (UNII: 059QF0KO0R) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F) MAGNESIUM MYRISTATE (UNII: Z1917F0578) NYLON-12 (UNII: 446U8J075B) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) THYMUS SERPYLLUM (UNII: 86H4S6K51N) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI) GLYCERIN (UNII: PDC6A3C0OX) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) ALCOHOL (UNII: 3K9958V90M) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) HYPERICUM ERECTUM FLOWERING TOP (UNII: IT0296HQDC) TALC (UNII: 7SEV7J4R1U) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) ALUMINUM OXIDE (UNII: LMI26O6933) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ) GLYCERYL DIISOSTEARATE (UNII: 68BAV42LRC) DIPROPYLENE GLYCOL (UNII: E107L85C40) 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:58411-263-10 1 in 1 CARTON 02/01/2016 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 drug M020 02/01/2016 SHISEIDO SYNCHRO SKIN LASTING FOUNDATION NEUTRAL 4
octinoxate and titanium dioxide liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-264 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 911 mg in 30 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 754 mg in 30 mL Inactive Ingredients Ingredient Name Strength DIMETHICONE (UNII: 92RU3N3Y1O) WATER (UNII: 059QF0KO0R) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F) MAGNESIUM MYRISTATE (UNII: Z1917F0578) NYLON-12 (UNII: 446U8J075B) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) THYMUS SERPYLLUM (UNII: 86H4S6K51N) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI) GLYCERIN (UNII: PDC6A3C0OX) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) ALCOHOL (UNII: 3K9958V90M) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) HYPERICUM ERECTUM FLOWERING TOP (UNII: IT0296HQDC) TALC (UNII: 7SEV7J4R1U) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) ALUMINUM OXIDE (UNII: LMI26O6933) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ) GLYCERYL DIISOSTEARATE (UNII: 68BAV42LRC) DIPROPYLENE GLYCOL (UNII: E107L85C40) 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:58411-264-10 1 in 1 CARTON 02/01/2016 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 drug M020 02/01/2016 SHISEIDO SYNCHRO SKIN LASTING FOUNDATION ROSE 2
octinoxate and titanium dioxide liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-265 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 911 mg in 30 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 754 mg in 30 mL Inactive Ingredients Ingredient Name Strength DIMETHICONE (UNII: 92RU3N3Y1O) WATER (UNII: 059QF0KO0R) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F) MAGNESIUM MYRISTATE (UNII: Z1917F0578) NYLON-12 (UNII: 446U8J075B) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) THYMUS SERPYLLUM (UNII: 86H4S6K51N) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI) GLYCERIN (UNII: PDC6A3C0OX) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) ALCOHOL (UNII: 3K9958V90M) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) HYPERICUM ERECTUM FLOWERING TOP (UNII: IT0296HQDC) TALC (UNII: 7SEV7J4R1U) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) ALUMINUM OXIDE (UNII: LMI26O6933) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ) GLYCERYL DIISOSTEARATE (UNII: 68BAV42LRC) DIPROPYLENE GLYCOL (UNII: E107L85C40) 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:58411-265-10 1 in 1 CARTON 02/01/2016 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 drug M020 02/01/2016 SHISEIDO SYNCHRO SKIN LASTING FOUNDATION ROSE 3
octinoxate and titanium dioxide liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-266 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 911 mg in 30 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 754 mg in 30 mL Inactive Ingredients Ingredient Name Strength DIMETHICONE (UNII: 92RU3N3Y1O) WATER (UNII: 059QF0KO0R) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F) MAGNESIUM MYRISTATE (UNII: Z1917F0578) NYLON-12 (UNII: 446U8J075B) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) THYMUS SERPYLLUM (UNII: 86H4S6K51N) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI) GLYCERIN (UNII: PDC6A3C0OX) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) ALCOHOL (UNII: 3K9958V90M) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) HYPERICUM ERECTUM FLOWERING TOP (UNII: IT0296HQDC) TALC (UNII: 7SEV7J4R1U) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) ALUMINUM OXIDE (UNII: LMI26O6933) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ) GLYCERYL DIISOSTEARATE (UNII: 68BAV42LRC) DIPROPYLENE GLYCOL (UNII: E107L85C40) 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:58411-266-10 1 in 1 CARTON 02/01/2016 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 drug M020 02/01/2016 SHISEIDO SYNCHRO SKIN LASTING FOUNDATION ROSE 4
octinoxate and titanium dioxide liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-267 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 911 mg in 30 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 754 mg in 30 mL Inactive Ingredients Ingredient Name Strength DIMETHICONE (UNII: 92RU3N3Y1O) WATER (UNII: 059QF0KO0R) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F) MAGNESIUM MYRISTATE (UNII: Z1917F0578) NYLON-12 (UNII: 446U8J075B) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) THYMUS SERPYLLUM (UNII: 86H4S6K51N) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI) GLYCERIN (UNII: PDC6A3C0OX) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) ALCOHOL (UNII: 3K9958V90M) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) HYPERICUM ERECTUM FLOWERING TOP (UNII: IT0296HQDC) TALC (UNII: 7SEV7J4R1U) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) ALUMINUM OXIDE (UNII: LMI26O6933) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ) GLYCERYL DIISOSTEARATE (UNII: 68BAV42LRC) DIPROPYLENE GLYCOL (UNII: E107L85C40) 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:58411-267-10 1 in 1 CARTON 02/01/2016 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 drug M020 02/01/2016 SHISEIDO SYNCHRO SKIN LASTING FOUNDATION GOLDEN 2
octinoxate and titanium dioxide liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-268 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 911 mg in 30 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 754 mg in 30 mL Inactive Ingredients Ingredient Name Strength DIMETHICONE (UNII: 92RU3N3Y1O) WATER (UNII: 059QF0KO0R) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F) MAGNESIUM MYRISTATE (UNII: Z1917F0578) NYLON-12 (UNII: 446U8J075B) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) THYMUS SERPYLLUM (UNII: 86H4S6K51N) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI) GLYCERIN (UNII: PDC6A3C0OX) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) ALCOHOL (UNII: 3K9958V90M) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) HYPERICUM ERECTUM FLOWERING TOP (UNII: IT0296HQDC) TALC (UNII: 7SEV7J4R1U) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) ALUMINUM OXIDE (UNII: LMI26O6933) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ) GLYCERYL DIISOSTEARATE (UNII: 68BAV42LRC) DIPROPYLENE GLYCOL (UNII: E107L85C40) 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:58411-268-10 1 in 1 CARTON 02/01/2016 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 drug M020 02/01/2016 SHISEIDO SYNCHRO SKIN LASTING FOUNDATION GOLDEN 3
octinoxate and titanium dioxide liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-269 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 911 mg in 30 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 754 mg in 30 mL Inactive Ingredients Ingredient Name Strength DIMETHICONE (UNII: 92RU3N3Y1O) WATER (UNII: 059QF0KO0R) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F) MAGNESIUM MYRISTATE (UNII: Z1917F0578) NYLON-12 (UNII: 446U8J075B) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) THYMUS SERPYLLUM (UNII: 86H4S6K51N) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI) GLYCERIN (UNII: PDC6A3C0OX) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) ALCOHOL (UNII: 3K9958V90M) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) HYPERICUM ERECTUM FLOWERING TOP (UNII: IT0296HQDC) TALC (UNII: 7SEV7J4R1U) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) ALUMINUM OXIDE (UNII: LMI26O6933) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ) GLYCERYL DIISOSTEARATE (UNII: 68BAV42LRC) DIPROPYLENE GLYCOL (UNII: E107L85C40) 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:58411-269-10 1 in 1 CARTON 02/01/2016 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 drug M020 02/01/2016 SHISEIDO SYNCHRO SKIN LASTING FOUNDATION GOLDEN 4
octinoxate and titanium dioxide liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-270 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 911 mg in 30 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 754 mg in 30 mL Inactive Ingredients Ingredient Name Strength DIMETHICONE (UNII: 92RU3N3Y1O) WATER (UNII: 059QF0KO0R) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F) MAGNESIUM MYRISTATE (UNII: Z1917F0578) NYLON-12 (UNII: 446U8J075B) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) THYMUS SERPYLLUM (UNII: 86H4S6K51N) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI) GLYCERIN (UNII: PDC6A3C0OX) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) ALCOHOL (UNII: 3K9958V90M) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) HYPERICUM ERECTUM FLOWERING TOP (UNII: IT0296HQDC) TALC (UNII: 7SEV7J4R1U) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) ALUMINUM OXIDE (UNII: LMI26O6933) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ) GLYCERYL DIISOSTEARATE (UNII: 68BAV42LRC) DIPROPYLENE GLYCOL (UNII: E107L85C40) 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:58411-270-10 1 in 1 CARTON 02/01/2016 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 drug M020 02/01/2016 SHISEIDO SYNCHRO SKIN LASTING FOUNDATION GOLDEN 5
octinoxate and titanium dioxide liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-271 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 911 mg in 30 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 754 mg in 30 mL Inactive Ingredients Ingredient Name Strength DIMETHICONE (UNII: 92RU3N3Y1O) WATER (UNII: 059QF0KO0R) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F) MAGNESIUM MYRISTATE (UNII: Z1917F0578) NYLON-12 (UNII: 446U8J075B) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) THYMUS SERPYLLUM (UNII: 86H4S6K51N) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI) GLYCERIN (UNII: PDC6A3C0OX) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) ALCOHOL (UNII: 3K9958V90M) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) HYPERICUM ERECTUM FLOWERING TOP (UNII: IT0296HQDC) TALC (UNII: 7SEV7J4R1U) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) ALUMINUM OXIDE (UNII: LMI26O6933) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ) GLYCERYL DIISOSTEARATE (UNII: 68BAV42LRC) DIPROPYLENE GLYCOL (UNII: E107L85C40) 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:58411-271-10 1 in 1 CARTON 02/01/2016 01/08/2021 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 drug M020 02/01/2016 01/08/2021 Labeler - SHISEIDO AMERICAS CORPORATION (193691821) Establishment Name Address ID/FEI Business Operations SHISEIDO AMERICA INC. 782677132 manufacture(58411-261, 58411-262, 58411-263, 58411-264, 58411-265, 58411-266, 58411-267, 58411-268, 58411-269, 58411-270, 58411-271) , analysis(58411-261, 58411-262, 58411-263, 58411-264, 58411-265, 58411-266, 58411-267, 58411-268, 58411-269, 58411-270, 58411-271)
