Drug Facts

Active ingredients	Purpose
OCTINOXATE 4.9%	Sunscreen
TITANIUM DIOXIDE 2.0%	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, flame or while smoking.

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

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 1

SHI SEIDO
GINZA TOKYO

SYNCHRO SKIN
GLOW

Luminizing
Fluid Foundation

BROAD SPECTRUM
SPF 20

Sunscreen

30mL 1 FL. OZ.

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - Neutral 1

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - Neutral 2

SHI SEIDO
GINZA TOKYO

SYNCHRO SKIN
GLOW

Luminizing
Fluid Foundation

BROAD SPECTRUM
SPF 20

Sunscreen

30mL 1 FL. OZ.

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - Neutral 2

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - Neutral 3

SHI SEIDO
GINZA TOKYO

SYNCHRO SKIN
GLOW

Luminizing
Fluid Foundation

BROAD SPECTRUM
SPF 20

Sunscreen

30mL 1 FL. OZ.

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - Neutral 3

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - Neutral 4

SHI SEIDO
GINZA TOKYO

SYNCHRO SKIN
GLOW

Luminizing
Fluid Foundation

BROAD SPECTRUM
SPF 20

Sunscreen

30mL 1 FL. OZ.

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - Neutral 4

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - Neutral 5

SHI SEIDO
GINZA TOKYO

SYNCHRO SKIN
GLOW

Luminizing
Fluid Foundation

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 2

SHI SEIDO
GINZA TOKYO

SYNCHRO SKIN
GLOW

Luminizing
Fluid Foundation

BROAD SPECTRUM
SPF 20

Sunscreen

30mL 1 FL. OZ.

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - Rose 2

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - Rose 3

SHI SEIDO
GINZA TOKYO

SYNCHRO SKIN
GLOW

Luminizing
Fluid Foundation

BROAD SPECTRUM
SPF 20

Sunscreen

30mL 1 FL. OZ.

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - Rose 3

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - Rose 4

SHI SEIDO
GINZA TOKYO

SYNCHRO SKIN
GLOW

Luminizing
Fluid Foundation

BROAD SPECTRUM
SPF 20

Sunscreen

30mL 1 FL. OZ.

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - Rose 4

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - Rose 5

SHI SEIDO
GINZA TOKYO

SYNCHRO SKIN
GLOW

Luminizing
Fluid Foundation

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 2

SHI SEIDO
GINZA TOKYO

SYNCHRO SKIN
GLOW

Luminizing
Fluid Foundation

BROAD SPECTRUM
SPF 20

Sunscreen

30mL 1 FL. OZ.

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - Golden 2

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - Golden 3

SHI SEIDO
GINZA TOKYO

SYNCHRO SKIN
GLOW

Luminizing
Fluid Foundation

BROAD SPECTRUM
SPF 20

Sunscreen

30mL 1 FL. OZ.

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - Golden 3

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - Golden 4

SHI SEIDO
GINZA TOKYO

SYNCHRO SKIN
GLOW

Luminizing
Fluid Foundation

BROAD SPECTRUM
SPF 20

Sunscreen

30mL 1 FL. OZ.

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - Golden 4

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - Golden 5

SHI SEIDO
GINZA TOKYO

SYNCHRO SKIN
GLOW

Luminizing
Fluid Foundation

BROAD SPECTRUM
SPF 20

Sunscreen

30mL 1 FL. OZ.

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - Golden 5

SHISEIDO SYNCHRO SKIN GLOW LUMINIZING FLUID FOUNDATION NEUTRAL 1
octinoxate and titanium dioxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58411-302
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	02/01/2017

SHISEIDO SYNCHRO SKIN GLOW LUMINIZING FLUID FOUNDATION NEUTRAL 2
octinoxate and titanium dioxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58411-303
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	02/01/2017

SHISEIDO SYNCHRO SKIN GLOW LUMINIZING FLUID FOUNDATION NEUTRAL 3
octinoxate and titanium dioxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58411-304
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	02/01/2017

SHISEIDO SYNCHRO SKIN GLOW LUMINIZING FLUID FOUNDATION NEUTRAL 4
octinoxate and titanium dioxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58411-305
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	02/01/2017

SHISEIDO SYNCHRO SKIN GLOW LUMINIZING FLUID FOUNDATION NEUTRAL 5
octinoxate and titanium dioxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58411-306
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	02/01/2017

SHISEIDO SYNCHRO SKIN GLOW LUMINIZING FLUID FOUNDATION ROSE 2
octinoxate and titanium dioxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58411-307
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	02/01/2017

SHISEIDO SYNCHRO SKIN GLOW LUMINIZING FLUID FOUNDATION ROSE 3
octinoxate and titanium dioxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58411-308
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	02/01/2017

SHISEIDO SYNCHRO SKIN GLOW LUMINIZING FLUID FOUNDATION ROSE 4
octinoxate and titanium dioxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58411-309
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	02/01/2017

SHISEIDO SYNCHRO SKIN GLOW LUMINIZING FLUID FOUNDATION ROSE 5
octinoxate and titanium dioxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58411-310
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	02/01/2017

SHISEIDO SYNCHRO SKIN GLOW LUMINIZING FLUID FOUNDATION GOLDEN 2
octinoxate and titanium dioxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58411-311
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	02/01/2017

SHISEIDO SYNCHRO SKIN GLOW LUMINIZING FLUID FOUNDATION GOLDEN 3
octinoxate and titanium dioxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58411-312
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	02/01/2017

SHISEIDO SYNCHRO SKIN GLOW LUMINIZING FLUID FOUNDATION GOLDEN 4
octinoxate and titanium dioxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58411-313
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	02/01/2017

SHISEIDO SYNCHRO SKIN GLOW LUMINIZING FLUID FOUNDATION GOLDEN 5
octinoxate and titanium dioxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58411-314
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	02/01/2017

Labeler - SHISEIDO AMERICAS CORPORATION (193691821)

Name	Address	ID/FEI	Business Operations
Establishment
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)