SHISEIDO SYNCHRO SKIN TINTED 1 VERY LIGHT- octinoxate and titanium dioxide cream SHISEIDO SYNCHRO SKIN TINTED 2 LIGHT- octinoxate and titanium dioxide cream SHISEIDO SYNCHRO SKIN TINTED 3 MEDIUM- octinoxate and titanium dioxide cream SHISEIDO SYNCHRO SKIN TINTED 4 MEDIUM DARK- octinoxate and titanium dioxide cream SHISEIDO SYNCHRO SKIN TINTED 5 DARK- octinoxate and titanium dioxide cream

SHISEIDO SYNCHRO SKIN TINTED by

Drug Labeling and Warnings

SHISEIDO SYNCHRO SKIN TINTED 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

Drug Facts

ACTIVE INGREDIENT

Active ingredients	Purpose
OCTINOXATE 2.9%	Sunscreen
TITANIUM DIOXIDE 6.1%	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.

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

Inactive Ingredients

WATERISOHEXADECANEPROPANEDIOLISOPROPYL MYRISTATETREHALOSEISODODECANEISOSTEARIC ACIDGLYCERINSILICAPOLYQUATERNIUM-51THYMUS SERPYLLUM EXTRACTSODIUM ACETYLATED HYALURONATECAMELLIA SINENSIS LEAF EXTRACTMETHYL METHACRYLATE/ACRYLONITRILE COPOLYMERDIMETHICONE/VINYL DIMETHICONE CROSSPOLYMERPEG-60 GLYCERYL ISOSTEARATEAGARSORBITAN SESQUIISOSTEARATECELLULOSE GUMALUMINUM HYDROXIDEPOLYSILICONE-2SODIUM CITRATEALCOHOLMAGNESIUM HYDROXIDESUCCINOGLYCANBHTBUTYLENE GLYCOLTOCOPHEROLCITRIC ACIDMETHYL METHACRYLATE CROSSPOLYMERSODIUM METABISULFITEHYPERICUM ERECTUM FLOWER/LEAF/STEM EXTRACTTALCALUMINAPOLYMETHYLSILSESQUIOXANEISOBUTANEISOPENTANEPHENOXYETHANOLTITANIUM DIOXIDEIRON OXIDESMICA

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 - 40 mL Tube Carton - 1 Very Light

SHISEIDO
GINZA TOKYO

SYNCHRO SKIN

Tinted Gel Cream

Oil Free

BROAD SPECTRUM

SPF 30

Sunscreen

40mL NET WT. 1.5 OZ.

PRINCIPAL DISPLAY PANEL - 40 mL Tube Carton - 2 Light

SHISEIDO
GINZA TOKYO

SYNCHRO SKIN

Tinted Gel Cream

Oil Free

BROAD SPECTRUM

SPF 30

Sunscreen

40mL NET WT. 1.5 OZ.

PRINCIPAL DISPLAY PANEL - 40 mL Tube Carton - 3 Medium

SHISEIDO
GINZA TOKYO

SYNCHRO SKIN

Tinted Gel Cream

Oil Free

BROAD SPECTRUM

SPF 30

Sunscreen

40mL NET WT. 1.5 OZ.

PRINCIPAL DISPLAY PANEL - 40 mL Tube Carton - 4 Medium Dark

SHISEIDO
GINZA TOKYO

SYNCHRO SKIN

Tinted Gel Cream

Oil Free

BROAD SPECTRUM

SPF 30

Sunscreen

40mL NET WT. 1.5 OZ.

PRINCIPAL DISPLAY PANEL - 40 mL Tube Carton - 5 Dark

SHISEIDO
GINZA TOKYO

SYNCHRO SKIN

Tinted Gel Cream

Oil Free

BROAD SPECTRUM

SPF 30

Sunscreen

40mL NET WT. 1.5 OZ.

INGREDIENTS AND APPEARANCE

SHISEIDO SYNCHRO SKIN TINTED  1 VERY LIGHT
octinoxate and titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-440
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	1248 mg  in 40 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	2625 mg  in 40 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ISOHEXADECANE (UNII: 918X1OUF1E)
PROPANEDIOL (UNII: 5965N8W85T)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
TREHALOSE (UNII: B8WCK70T7I)
ISODODECANE (UNII: A8289P68Y2)
ISOSTEARIC ACID (UNII: X33R8U0062)
GLYCERIN (UNII: PDC6A3C0OX)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J)
THYMUS SERPYLLUM (UNII: 86H4S6K51N)
SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
PEG-60 GLYCERYL ISOSTEARATE (UNII: WQP0973914)
AGAR, UNSPECIFIED (UNII: 89T13OHQ2B)
SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
ALCOHOL (UNII: 3K9958V90M)
MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
HYPERICUM ERECTUM FLOWERING TOP (UNII: IT0296HQDC)
TALC (UNII: 7SEV7J4R1U)
ALUMINUM OXIDE (UNII: LMI26O6933)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
ISOBUTANE (UNII: BXR49TP611)
ISOPENTANE (UNII: ZH67814I0O)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-440-60	1 in 1 CARTON	06/01/2018
1		40 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	06/01/2018

SHISEIDO SYNCHRO SKIN TINTED  2 LIGHT
octinoxate and titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-441
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	1248 mg  in 40 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	2625 mg  in 40 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ISOHEXADECANE (UNII: 918X1OUF1E)
PROPANEDIOL (UNII: 5965N8W85T)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
TREHALOSE (UNII: B8WCK70T7I)
ISODODECANE (UNII: A8289P68Y2)
ISOSTEARIC ACID (UNII: X33R8U0062)
GLYCERIN (UNII: PDC6A3C0OX)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J)
THYMUS SERPYLLUM (UNII: 86H4S6K51N)
SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
PEG-60 GLYCERYL ISOSTEARATE (UNII: WQP0973914)
AGAR, UNSPECIFIED (UNII: 89T13OHQ2B)
SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
ALCOHOL (UNII: 3K9958V90M)
MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
HYPERICUM ERECTUM FLOWERING TOP (UNII: IT0296HQDC)
TALC (UNII: 7SEV7J4R1U)
ALUMINUM OXIDE (UNII: LMI26O6933)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
ISOBUTANE (UNII: BXR49TP611)
ISOPENTANE (UNII: ZH67814I0O)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-441-60	1 in 1 CARTON	06/01/2018
1		40 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	06/01/2018

SHISEIDO SYNCHRO SKIN TINTED  3 MEDIUM
octinoxate and titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-442
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	1248 mg  in 40 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	2625 mg  in 40 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ISOHEXADECANE (UNII: 918X1OUF1E)
PROPANEDIOL (UNII: 5965N8W85T)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
TREHALOSE (UNII: B8WCK70T7I)
ISODODECANE (UNII: A8289P68Y2)
ISOSTEARIC ACID (UNII: X33R8U0062)
GLYCERIN (UNII: PDC6A3C0OX)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J)
THYMUS SERPYLLUM (UNII: 86H4S6K51N)
SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
PEG-60 GLYCERYL ISOSTEARATE (UNII: WQP0973914)
AGAR, UNSPECIFIED (UNII: 89T13OHQ2B)
SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
ALCOHOL (UNII: 3K9958V90M)
MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
HYPERICUM ERECTUM FLOWERING TOP (UNII: IT0296HQDC)
TALC (UNII: 7SEV7J4R1U)
ALUMINUM OXIDE (UNII: LMI26O6933)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
ISOBUTANE (UNII: BXR49TP611)
ISOPENTANE (UNII: ZH67814I0O)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-442-60	1 in 1 CARTON	06/01/2018
1		40 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	06/01/2018

SHISEIDO SYNCHRO SKIN TINTED  4 MEDIUM DARK
octinoxate and titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-443
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	1248 mg  in 40 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	2625 mg  in 40 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ISOHEXADECANE (UNII: 918X1OUF1E)
PROPANEDIOL (UNII: 5965N8W85T)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
TREHALOSE (UNII: B8WCK70T7I)
ISODODECANE (UNII: A8289P68Y2)
ISOSTEARIC ACID (UNII: X33R8U0062)
GLYCERIN (UNII: PDC6A3C0OX)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J)
THYMUS SERPYLLUM (UNII: 86H4S6K51N)
SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
PEG-60 GLYCERYL ISOSTEARATE (UNII: WQP0973914)
AGAR, UNSPECIFIED (UNII: 89T13OHQ2B)
SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
ALCOHOL (UNII: 3K9958V90M)
MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
HYPERICUM ERECTUM FLOWERING TOP (UNII: IT0296HQDC)
TALC (UNII: 7SEV7J4R1U)
ALUMINUM OXIDE (UNII: LMI26O6933)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
ISOBUTANE (UNII: BXR49TP611)
ISOPENTANE (UNII: ZH67814I0O)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-443-60	1 in 1 CARTON	06/01/2018
1		40 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	06/01/2018

SHISEIDO SYNCHRO SKIN TINTED  5 DARK
octinoxate and titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-444
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	1248 mg  in 40 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	2625 mg  in 40 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ISOHEXADECANE (UNII: 918X1OUF1E)
PROPANEDIOL (UNII: 5965N8W85T)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
TREHALOSE (UNII: B8WCK70T7I)
ISODODECANE (UNII: A8289P68Y2)
ISOSTEARIC ACID (UNII: X33R8U0062)
GLYCERIN (UNII: PDC6A3C0OX)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J)
THYMUS SERPYLLUM (UNII: 86H4S6K51N)
SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
PEG-60 GLYCERYL ISOSTEARATE (UNII: WQP0973914)
AGAR, UNSPECIFIED (UNII: 89T13OHQ2B)
SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
ALCOHOL (UNII: 3K9958V90M)
MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
HYPERICUM ERECTUM FLOWERING TOP (UNII: IT0296HQDC)
TALC (UNII: 7SEV7J4R1U)
ALUMINUM OXIDE (UNII: LMI26O6933)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
ISOBUTANE (UNII: BXR49TP611)
ISOPENTANE (UNII: ZH67814I0O)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-444-60	1 in 1 CARTON	06/01/2018
1		40 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	06/01/2018

Labeler - SHISEIDO AMERICAS CORPORATION (193691821)

Establishment
Name	Address	ID/FEI	Business Operations
SHISEIDO AMERICA INC.		782677132	MANUFACTURE(58411-440, 58411-441, 58411-442, 58411-443, 58411-444) , ANALYSIS(58411-440, 58411-441, 58411-442, 58411-443, 58411-444)