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 SYNCHRO SKIN LASTING Liquid FOUNDATION Golden 5 by

Drug Labeling and Warnings

SHISEIDO SYNCHRO SKIN LASTING Liquid FOUNDATION Golden 5 by is a Otc medication manufactured, distributed, or labeled by SHISEIDO AMERICAS CORPORATION. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients	Purpose
OCTINOXATE 2.9 %	Sunscreen
TITANIUM DIOXIDE 2.4 %	Sunscreen

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

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:

• apply liberally 15 minutes before sun exposure
• use a water resistant sunscreen if swimming or sweating
• reapply at least every two 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

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 - 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 - Golden 5

SHISEIDO
GINZA TOKYO

SYNCHRO SKIN

Lasting
Liquid Foundation

Oil Free

BROAD SPECTRUM
SPF 20

Sunscreen

30mL 1 FL. OZ.

INGREDIENTS AND APPEARANCE

SHISEIDO SYNCHRO SKIN LASTING LIQUID FOUNDATION NEUTRAL 5 
octinoxate and titanium dioxide emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-624
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	1.31 g  in 30 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	1.09 g  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-624-10	1 in 1 CARTON	01/01/2021
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	01/01/2021

SHISEIDO SYNCHRO SKIN LASTING LIQUID FOUNDATION ROSE 5 
octinoxate and titanium dioxide emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-625
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	1.31 g  in 30 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	1.09 g  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-625-10	1 in 1 CARTON	01/01/2021
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	01/01/2021

SHISEIDO SYNCHRO SKIN LASTING LIQUID FOUNDATION GOLDEN 5 
octinoxate and titanium dioxide emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-626
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	1.31 g  in 30 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	1.09 g  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-626-10	1 in 1 CARTON	01/01/2021
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	01/01/2021

Labeler - SHISEIDO AMERICAS CORPORATION (193691821)

Establishment
Name	Address	ID/FEI	Business Operations
Shiseido America Inc.		782677132	ANALYSIS(58411-624, 58411-625, 58411-626) , MANUFACTURE(58411-624, 58411-625, 58411-626)