SHISEIDO SYNCHRO SKIN LASTING LIQUID FOUNDATION NEUTRAL 5- octinoxate and titanium dioxide emulsion 
SHISEIDO SYNCHRO SKIN LASTING LIQUID FOUNDATION ROSE 5- octinoxate and titanium dioxide emulsion 
SHISEIDO SYNCHRO SKIN LASTING LIQUID FOUNDATION GOLDEN 5- octinoxate and titanium dioxide emulsion 
SHISEIDO AMERICAS CORPORATION

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SHISEIDO SYNCHRO SKIN LASTING LIQUID FOUNDATION

Drug Facts

Active ingredientsPurpose
OCTINOXATE 2.9 %Sunscreen
TITANIUM DIOXIDE 2.4 %Sunscreen

Uses

Warnings

For external use only

Do not use on damaged or broken skin

When using this product keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if rash occurs.

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Flammable; Do not use near heat, flam or white smoking.

Directions

For sunscreen use:

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

Protect this product in this container from excessive heat and direct sun.

Questions or comments?

Call toll free 1-800-906-7503

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - Neutral 5

SHISEIDO
GINZA TOKYO

SYNCHRO SKIN

Lasting
Liquid Foundation

Oil Free

BROAD SPECTRUM
SPF 20

Sunscreen

30mL 1 FL. OZ.

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - Neutral 5

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - Rose 5

SHISEIDO
GINZA TOKYO

SYNCHRO SKIN

Lasting
Liquid Foundation

Oil Free

BROAD SPECTRUM
SPF 20

Sunscreen

30mL 1 FL. OZ.

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - Rose 5

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - Golden 5

SHISEIDO
GINZA TOKYO

SYNCHRO SKIN

Lasting
Liquid Foundation

Oil Free

BROAD SPECTRUM
SPF 20

Sunscreen

30mL 1 FL. OZ.

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - Golden 5
SHISEIDO SYNCHRO SKIN LASTING LIQUID FOUNDATION NEUTRAL 5 
octinoxate and titanium dioxide emulsion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-624
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE1.31 g  in 30 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE1.09 g  in 30 mL
Inactive Ingredients
Ingredient NameStrength
DIMETHICONE (UNII: 92RU3N3Y1O)  
WATER (UNII: 059QF0KO0R)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)  
MAGNESIUM MYRISTATE (UNII: Z1917F0578)  
NYLON-12 (UNII: 446U8J075B)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
GLYCERIN (UNII: PDC6A3C0OX)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
ALCOHOL (UNII: 3K9958V90M)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EG97988M5Q)  
POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J)  
THYMUS SERPYLLUM WHOLE (UNII: 86H4S6K51N)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
HYPERICUM ERECTUM FLOWERING TOP (UNII: IT0296HQDC)  
TALC (UNII: 7SEV7J4R1U)  
MICA (UNII: V8A1AW0880)  
DIMETHICONE/PEG-10/15 CROSSPOLYMER (UNII: 21AS8B1BSS)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  
GLYCERYL DIISOSTEARATE (UNII: 68BAV42LRC)  
DIPROPYLENE GLYCOL (UNII: E107L85C40)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58411-624-101 in 1 CARTON01/01/2021
130 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH DRUGM02001/01/2021
SHISEIDO SYNCHRO SKIN LASTING LIQUID FOUNDATION ROSE 5 
octinoxate and titanium dioxide emulsion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-625
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE1.31 g  in 30 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE1.09 g  in 30 mL
Inactive Ingredients
Ingredient NameStrength
DIMETHICONE (UNII: 92RU3N3Y1O)  
WATER (UNII: 059QF0KO0R)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
MAGNESIUM MYRISTATE (UNII: Z1917F0578)  
NYLON-12 (UNII: 446U8J075B)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
GLYCERIN (UNII: PDC6A3C0OX)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
ALCOHOL (UNII: 3K9958V90M)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EG97988M5Q)  
POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J)  
THYMUS SERPYLLUM WHOLE (UNII: 86H4S6K51N)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
HYPERICUM ERECTUM FLOWERING TOP (UNII: IT0296HQDC)  
TALC (UNII: 7SEV7J4R1U)  
MICA (UNII: V8A1AW0880)  
DIMETHICONE/PEG-10/15 CROSSPOLYMER (UNII: 21AS8B1BSS)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  
GLYCERYL DIISOSTEARATE (UNII: 68BAV42LRC)  
DIPROPYLENE GLYCOL (UNII: E107L85C40)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58411-625-101 in 1 CARTON01/01/2021
130 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH DRUGM02001/01/2021
SHISEIDO SYNCHRO SKIN LASTING LIQUID FOUNDATION GOLDEN 5 
octinoxate and titanium dioxide emulsion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-626
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE1.31 g  in 30 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE1.09 g  in 30 mL
Inactive Ingredients
Ingredient NameStrength
DIMETHICONE (UNII: 92RU3N3Y1O)  
WATER (UNII: 059QF0KO0R)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)  
MAGNESIUM MYRISTATE (UNII: Z1917F0578)  
NYLON-12 (UNII: 446U8J075B)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
GLYCERIN (UNII: PDC6A3C0OX)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
ALCOHOL (UNII: 3K9958V90M)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EG97988M5Q)  
POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J)  
THYMUS SERPYLLUM WHOLE (UNII: 86H4S6K51N)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
HYPERICUM ERECTUM FLOWERING TOP (UNII: IT0296HQDC)  
TALC (UNII: 7SEV7J4R1U)  
MICA (UNII: V8A1AW0880)  
DIMETHICONE/PEG-10/15 CROSSPOLYMER (UNII: 21AS8B1BSS)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  
GLYCERYL DIISOSTEARATE (UNII: 68BAV42LRC)  
DIPROPYLENE GLYCOL (UNII: E107L85C40)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58411-626-101 in 1 CARTON01/01/2021
130 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH DRUGM02001/01/2021
Labeler - SHISEIDO AMERICAS CORPORATION (193691821)
Establishment
NameAddressID/FEIBusiness Operations
Shiseido America Inc.782677132ANALYSIS(58411-624, 58411-625, 58411-626) , MANUFACTURE(58411-624, 58411-625, 58411-626)

Revised: 1/2021
Document Id: 2c20f296-e118-4541-91f0-a0dfbef62d7a
Set id: 66c22f17-5418-42ff-97b2-33fa10f5eac3
Version: 5
Effective Time: 20210113
 
SHISEIDO AMERICAS CORPORATION