SHISEIDO SHEER MATIFYING COMPACT (REFILL) I00- octinoxate and titanium dioxide powder
SHISEIDO SHEER MATIFYING COMPACT (REFILL) I20- octinoxate and titanium dioxide powder
SHISEIDO SHEER MATIFYING COMPACT (REFILL) I40- octinoxate and titanium dioxide powder
SHISEIDO SHEER MATIFYING COMPACT (REFILL) I60- octinoxate and titanium dioxide powder
SHISEIDO SHEER MATIFYING COMPACT (REFILL) B20- octinoxate and titanium dioxide powder
SHISEIDO SHEER MATIFYING COMPACT (REFILL) B40- octinoxate and titanium dioxide powder
SHISEIDO SHEER MATIFYING COMPACT (REFILL) B60- octinoxate and titanium dioxide powder
SHISEIDO SHEER MATIFYING COMPACT (REFILL) O20- octinoxate and titanium dioxide powder
SHISEIDO SHEER MATIFYING COMPACT (REFILL) O40- octinoxate and titanium dioxide powder
SHISEIDO SHEER MATIFYING COMPACT (REFILL) O60- octinoxate and titanium dioxide powder
SHISEIDO SHEER MATIFYING COMPACT (REFILL) O80- octinoxate and titanium dioxide powder
SHISEIDO SHEER MATIFYING COMPACT (REFILL) B00- octinoxate and titanium dioxide powder
SHISEIDO SHEER MATIFYING COMPACT (REFILL) B100- octinoxate and titanium dioxide powder
SHISEIDO SHEER MATIFYING COMPACT (REFILL) I100- octinoxate and titanium dioxide powder
SHISEIDO SHEER MATIFYING COMPACT (REFILL) O00- octinoxate and titanium dioxide powder
SHISEIDO SHEER MATIFYING COMPACT (REFILL) WB40- octinoxate and titanium dioxide powder
SHISEIDO SHEER MATIFYING COMPACT (REFILL) WB60- octinoxate and titanium dioxide powder
SHISEIDO CO., LTD.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

SHISEIDO SHEER MATIFYING COMPACT

Drug Facts

Active ingredients	Purpose
OCTINOXATE 3.9%	Sunscreen
TITANIUM DIOXIDE 6.0%	Sunscreen

Use

helps prevent sunburn

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

TALC • SYNTHETIC FLUORPHLOGOPITE • VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER • BARIUM SULFATE • DIPHENYLSILOXY PHENYL • TRIMETHICONE • SILICA • METHYL METHACRYLATE CROSSPOLYMER • DIMETHYLENECYCLOHEXANE BIS-HYDROXYSTEARAMIDE • CETYL ETHYLHEXANOATE • DIPHENYL DIMETHICONE/VINYL DIPHENYL DIMETHICONE/SILSESQUIOXANE CROSSPOLYMER • HEXAMETHYLENE BIS-HYDROXYSTEARAMIDE • DIISOSTEARYL MALATE • NYLON-12 • PEG/PPG-36/41 DIMETHYL ETHER • POLYSILICONE-2 • SORBITAN SESQUIISOSTEARATE • DIMETHICONE • ALUMINUM HYDROXIDE • ALUMINUM DISTEARATE • DIMETHICONE/METHICONE COPOLYMER • METHICONE • TOCOPHEROL • DIPENTAERYTHRITYL HEXAHYDROXYSTEARATE • BHT • TETRADECENE • CHLORPHENESIN • ZINC OXIDE • TITANIUM DIOXIDE • IRON OXIDES • MICA

Other information

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

Questions or comments?

9.8g NET WT. .34 OZ.

Principal Display Panel - 9.8 g Carton WB 40

PRINCIPAL DISPLAY PANEL - 9.8 g Carton WB 60

SHISEIDO

WB 60

Sheer Matifying
Compact (Refill)
Long-lasting,
Oil-free Foundation

BROAD SPECTRUM
SPF 21
sunscreen

9.8g NET WT. .34 OZ.

Principal Display Panel - 9.8 g Carton WB 60

SHISEIDO SHEER MATIFYING COMPACT (REFILL) I00
octinoxate and titanium dioxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:52685-394
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	382 mg in 9.8 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	588 mg in 9.8 g

Ingredient Name	Strength
Inactive Ingredients
TALC (UNII: 7SEV7J4R1U)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
ZINC OXIDE (UNII: SOI2LOH54Z)
BARIUM SULFATE (UNII: 25BB7EKE2E)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CETYL ETHYLHEXANOATE (UNII: 134647WMX4)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
NYLON-12 (UNII: 446U8J075B)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
DIMETHICONE (UNII: 92RU3N3Y1O)
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)
CHLORPHENESIN (UNII: I670DAL4SZ)
METHICONE (20 CST) (UNII: 6777U11MKT)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
MICA (UNII: V8A1AW0880)
1-TETRADECENE (UNII: FW23481S7S)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:52685-394-30	1 in 1 CARTON	03/01/2012	02/28/2022
1		9.8 g in 1 TRAY; 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	03/01/2012	02/28/2022

SHISEIDO SHEER MATIFYING COMPACT (REFILL) I20
octinoxate and titanium dioxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:52685-395
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	382 mg in 9.8 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	588 mg in 9.8 g

Ingredient Name	Strength
Inactive Ingredients
TALC (UNII: 7SEV7J4R1U)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
ZINC OXIDE (UNII: SOI2LOH54Z)
BARIUM SULFATE (UNII: 25BB7EKE2E)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CETYL ETHYLHEXANOATE (UNII: 134647WMX4)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
NYLON-12 (UNII: 446U8J075B)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
DIMETHICONE (UNII: 92RU3N3Y1O)
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)
CHLORPHENESIN (UNII: I670DAL4SZ)
METHICONE (20 CST) (UNII: 6777U11MKT)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
MICA (UNII: V8A1AW0880)
1-TETRADECENE (UNII: FW23481S7S)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:52685-395-30	1 in 1 CARTON	03/01/2012	02/28/2021
1		9.8 g in 1 TRAY; 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	03/01/2012	02/28/2021

SHISEIDO SHEER MATIFYING COMPACT (REFILL) I40
octinoxate and titanium dioxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:52685-396
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	382 mg in 9.8 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	588 mg in 9.8 g

Ingredient Name	Strength
Inactive Ingredients
TALC (UNII: 7SEV7J4R1U)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
ZINC OXIDE (UNII: SOI2LOH54Z)
BARIUM SULFATE (UNII: 25BB7EKE2E)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CETYL ETHYLHEXANOATE (UNII: 134647WMX4)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
NYLON-12 (UNII: 446U8J075B)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
DIMETHICONE (UNII: 92RU3N3Y1O)
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)
CHLORPHENESIN (UNII: I670DAL4SZ)
METHICONE (20 CST) (UNII: 6777U11MKT)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
MICA (UNII: V8A1AW0880)
1-TETRADECENE (UNII: FW23481S7S)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:52685-396-30	1 in 1 CARTON	03/01/2012	02/28/2022
1		9.8 g in 1 TRAY; 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	03/01/2012	02/28/2022

SHISEIDO SHEER MATIFYING COMPACT (REFILL) I60
octinoxate and titanium dioxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:52685-397
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	382 mg in 9.8 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	588 mg in 9.8 g

Ingredient Name	Strength
Inactive Ingredients
TALC (UNII: 7SEV7J4R1U)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
ZINC OXIDE (UNII: SOI2LOH54Z)
BARIUM SULFATE (UNII: 25BB7EKE2E)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CETYL ETHYLHEXANOATE (UNII: 134647WMX4)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
NYLON-12 (UNII: 446U8J075B)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
DIMETHICONE (UNII: 92RU3N3Y1O)
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)
CHLORPHENESIN (UNII: I670DAL4SZ)
METHICONE (20 CST) (UNII: 6777U11MKT)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
MICA (UNII: V8A1AW0880)
1-TETRADECENE (UNII: FW23481S7S)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:52685-397-30	1 in 1 CARTON	03/01/2012	02/28/2021
1		9.8 g in 1 TRAY; 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	03/01/2012	02/28/2021

SHISEIDO SHEER MATIFYING COMPACT (REFILL) B20
octinoxate and titanium dioxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:52685-398
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	382 mg in 9.8 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	588 mg in 9.8 g

Ingredient Name	Strength
Inactive Ingredients
TALC (UNII: 7SEV7J4R1U)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
ZINC OXIDE (UNII: SOI2LOH54Z)
BARIUM SULFATE (UNII: 25BB7EKE2E)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CETYL ETHYLHEXANOATE (UNII: 134647WMX4)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
NYLON-12 (UNII: 446U8J075B)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
DIMETHICONE (UNII: 92RU3N3Y1O)
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)
CHLORPHENESIN (UNII: I670DAL4SZ)
METHICONE (20 CST) (UNII: 6777U11MKT)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
MICA (UNII: V8A1AW0880)
1-TETRADECENE (UNII: FW23481S7S)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:52685-398-30	1 in 1 CARTON	03/01/2012	02/28/2021
1		9.8 g in 1 TRAY; 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	03/01/2012	02/28/2021

SHISEIDO SHEER MATIFYING COMPACT (REFILL) B40
octinoxate and titanium dioxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:52685-399
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	588 mg in 9.8 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	382 mg in 9.8 g

Ingredient Name	Strength
Inactive Ingredients
TALC (UNII: 7SEV7J4R1U)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
ZINC OXIDE (UNII: SOI2LOH54Z)
BARIUM SULFATE (UNII: 25BB7EKE2E)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CETYL ETHYLHEXANOATE (UNII: 134647WMX4)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
NYLON-12 (UNII: 446U8J075B)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
DIMETHICONE (UNII: 92RU3N3Y1O)
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)
CHLORPHENESIN (UNII: I670DAL4SZ)
METHICONE (20 CST) (UNII: 6777U11MKT)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
MICA (UNII: V8A1AW0880)
1-TETRADECENE (UNII: FW23481S7S)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:52685-399-30	1 in 1 CARTON	03/01/2012	02/28/2022
1		9.8 g in 1 TRAY; 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	03/01/2012	02/28/2022

SHISEIDO SHEER MATIFYING COMPACT (REFILL) B60
octinoxate and titanium dioxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:52685-400
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	382 mg in 9.8 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	588 mg in 9.8 g

Ingredient Name	Strength
Inactive Ingredients
TALC (UNII: 7SEV7J4R1U)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
ZINC OXIDE (UNII: SOI2LOH54Z)
BARIUM SULFATE (UNII: 25BB7EKE2E)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CETYL ETHYLHEXANOATE (UNII: 134647WMX4)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
NYLON-12 (UNII: 446U8J075B)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
DIMETHICONE (UNII: 92RU3N3Y1O)
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)
CHLORPHENESIN (UNII: I670DAL4SZ)
METHICONE (20 CST) (UNII: 6777U11MKT)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
MICA (UNII: V8A1AW0880)
1-TETRADECENE (UNII: FW23481S7S)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:52685-400-30	1 in 1 CARTON	03/01/2012	01/31/2018
1		9.8 g in 1 TRAY; 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	03/01/2012	01/31/2018

SHISEIDO SHEER MATIFYING COMPACT (REFILL) O20
octinoxate and titanium dioxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:52685-401
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	382 mg in 9.8 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	588 mg in 9.8 g

Ingredient Name	Strength
Inactive Ingredients
TALC (UNII: 7SEV7J4R1U)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
ZINC OXIDE (UNII: SOI2LOH54Z)
BARIUM SULFATE (UNII: 25BB7EKE2E)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CETYL ETHYLHEXANOATE (UNII: 134647WMX4)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
NYLON-12 (UNII: 446U8J075B)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
DIMETHICONE (UNII: 92RU3N3Y1O)
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)
CHLORPHENESIN (UNII: I670DAL4SZ)
METHICONE (20 CST) (UNII: 6777U11MKT)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
MICA (UNII: V8A1AW0880)
1-TETRADECENE (UNII: FW23481S7S)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:52685-401-30	1 in 1 CARTON	03/01/2012	01/31/2018
1		9.8 g in 1 TRAY; 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	03/01/2012	01/31/2018

SHISEIDO SHEER MATIFYING COMPACT (REFILL) O40
octinoxate and titanium dioxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:52685-402
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	382 mg in 9.8 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	588 mg in 9.8 g

Ingredient Name	Strength
Inactive Ingredients
TALC (UNII: 7SEV7J4R1U)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
ZINC OXIDE (UNII: SOI2LOH54Z)
BARIUM SULFATE (UNII: 25BB7EKE2E)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CETYL ETHYLHEXANOATE (UNII: 134647WMX4)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
NYLON-12 (UNII: 446U8J075B)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
DIMETHICONE (UNII: 92RU3N3Y1O)
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)
CHLORPHENESIN (UNII: I670DAL4SZ)
METHICONE (20 CST) (UNII: 6777U11MKT)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
MICA (UNII: V8A1AW0880)
1-TETRADECENE (UNII: FW23481S7S)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:52685-402-30	1 in 1 CARTON	03/01/2012	02/28/2022
1		9.8 g in 1 TRAY; 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	03/01/2012	02/28/2022

SHISEIDO SHEER MATIFYING COMPACT (REFILL) O60
octinoxate and titanium dioxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:52685-403
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	382 mg in 9.8 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	588 mg in 9.8 g

Ingredient Name	Strength
Inactive Ingredients
TALC (UNII: 7SEV7J4R1U)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
ZINC OXIDE (UNII: SOI2LOH54Z)
BARIUM SULFATE (UNII: 25BB7EKE2E)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CETYL ETHYLHEXANOATE (UNII: 134647WMX4)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
NYLON-12 (UNII: 446U8J075B)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
DIMETHICONE (UNII: 92RU3N3Y1O)
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)
CHLORPHENESIN (UNII: I670DAL4SZ)
METHICONE (20 CST) (UNII: 6777U11MKT)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
MICA (UNII: V8A1AW0880)
1-TETRADECENE (UNII: FW23481S7S)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:52685-403-30	1 in 1 CARTON	03/01/2012	03/01/2023
1		9.8 g in 1 TRAY; 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	03/01/2012	03/01/2023

SHISEIDO SHEER MATIFYING COMPACT (REFILL) O80
octinoxate and titanium dioxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:52685-404
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	382 mg in 9.8 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	588 mg in 9.8 g

Ingredient Name	Strength
Inactive Ingredients
TALC (UNII: 7SEV7J4R1U)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
ZINC OXIDE (UNII: SOI2LOH54Z)
BARIUM SULFATE (UNII: 25BB7EKE2E)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CETYL ETHYLHEXANOATE (UNII: 134647WMX4)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
NYLON-12 (UNII: 446U8J075B)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
DIMETHICONE (UNII: 92RU3N3Y1O)
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)
CHLORPHENESIN (UNII: I670DAL4SZ)
METHICONE (20 CST) (UNII: 6777U11MKT)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
MICA (UNII: V8A1AW0880)
1-TETRADECENE (UNII: FW23481S7S)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:52685-404-30	1 in 1 CARTON	03/01/2012	03/01/2023
1		9.8 g in 1 TRAY; 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	03/01/2012	03/01/2023

SHISEIDO SHEER MATIFYING COMPACT (REFILL) B00
octinoxate and titanium dioxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:52685-405
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	382 mg in 9.8 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	588 mg in 9.8 g

Ingredient Name	Strength
Inactive Ingredients
TALC (UNII: 7SEV7J4R1U)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
ZINC OXIDE (UNII: SOI2LOH54Z)
BARIUM SULFATE (UNII: 25BB7EKE2E)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CETYL ETHYLHEXANOATE (UNII: 134647WMX4)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
NYLON-12 (UNII: 446U8J075B)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
DIMETHICONE (UNII: 92RU3N3Y1O)
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)
CHLORPHENESIN (UNII: I670DAL4SZ)
METHICONE (20 CST) (UNII: 6777U11MKT)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
MICA (UNII: V8A1AW0880)
1-TETRADECENE (UNII: FW23481S7S)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:52685-405-30	1 in 1 CARTON	03/01/2012	03/01/2023
1		9.8 g in 1 TRAY; 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	03/01/2012	03/01/2023

SHISEIDO SHEER MATIFYING COMPACT (REFILL) B100
octinoxate and titanium dioxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:52685-406
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	382 mg in 9.8 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	588 mg in 9.8 g

Ingredient Name	Strength
Inactive Ingredients
TALC (UNII: 7SEV7J4R1U)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
ZINC OXIDE (UNII: SOI2LOH54Z)
BARIUM SULFATE (UNII: 25BB7EKE2E)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CETYL ETHYLHEXANOATE (UNII: 134647WMX4)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
NYLON-12 (UNII: 446U8J075B)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
DIMETHICONE (UNII: 92RU3N3Y1O)
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)
CHLORPHENESIN (UNII: I670DAL4SZ)
METHICONE (20 CST) (UNII: 6777U11MKT)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
MICA (UNII: V8A1AW0880)
1-TETRADECENE (UNII: FW23481S7S)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:52685-406-30	1 in 1 CARTON	03/01/2012	03/01/2023
1		9.8 g in 1 TRAY; 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	03/01/2012	03/01/2023

SHISEIDO SHEER MATIFYING COMPACT (REFILL) I100
octinoxate and titanium dioxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:52685-407
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	382 mg in 9.8 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	588 mg in 9.8 g

Ingredient Name	Strength
Inactive Ingredients
TALC (UNII: 7SEV7J4R1U)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
ZINC OXIDE (UNII: SOI2LOH54Z)
BARIUM SULFATE (UNII: 25BB7EKE2E)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CETYL ETHYLHEXANOATE (UNII: 134647WMX4)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
NYLON-12 (UNII: 446U8J075B)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
DIMETHICONE (UNII: 92RU3N3Y1O)
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)
CHLORPHENESIN (UNII: I670DAL4SZ)
METHICONE (20 CST) (UNII: 6777U11MKT)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
MICA (UNII: V8A1AW0880)
1-TETRADECENE (UNII: FW23481S7S)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:52685-407-30	1 in 1 CARTON	03/01/2012	03/01/2023
1		9.8 g in 1 TRAY; 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	03/01/2012	03/01/2023

SHISEIDO SHEER MATIFYING COMPACT (REFILL) O00
octinoxate and titanium dioxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:52685-408
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	382 mg in 9.8 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	588 mg in 9.8 g

Ingredient Name	Strength
Inactive Ingredients
TALC (UNII: 7SEV7J4R1U)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
ZINC OXIDE (UNII: SOI2LOH54Z)
BARIUM SULFATE (UNII: 25BB7EKE2E)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CETYL ETHYLHEXANOATE (UNII: 134647WMX4)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
NYLON-12 (UNII: 446U8J075B)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
DIMETHICONE (UNII: 92RU3N3Y1O)
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)
CHLORPHENESIN (UNII: I670DAL4SZ)
METHICONE (20 CST) (UNII: 6777U11MKT)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
MICA (UNII: V8A1AW0880)
1-TETRADECENE (UNII: FW23481S7S)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:52685-408-30	1 in 1 CARTON	03/01/2012	03/01/2023
1		9.8 g in 1 TRAY; 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	03/01/2012	03/01/2023

SHISEIDO SHEER MATIFYING COMPACT (REFILL) WB40
octinoxate and titanium dioxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:52685-409
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	382 mg in 9.8 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	588 mg in 9.8 g

Ingredient Name	Strength
Inactive Ingredients
TALC (UNII: 7SEV7J4R1U)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
ZINC OXIDE (UNII: SOI2LOH54Z)
BARIUM SULFATE (UNII: 25BB7EKE2E)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CETYL ETHYLHEXANOATE (UNII: 134647WMX4)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
NYLON-12 (UNII: 446U8J075B)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
DIMETHICONE (UNII: 92RU3N3Y1O)
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)
CHLORPHENESIN (UNII: I670DAL4SZ)
METHICONE (20 CST) (UNII: 6777U11MKT)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
MICA (UNII: V8A1AW0880)
1-TETRADECENE (UNII: FW23481S7S)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:52685-409-30	1 in 1 CARTON	03/01/2012	03/01/2023
1		9.8 g in 1 TRAY; 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	03/01/2012	03/01/2023

SHISEIDO SHEER MATIFYING COMPACT (REFILL) WB60
octinoxate and titanium dioxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:52685-410
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	382 mg in 9.8 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	588 mg in 9.8 g

Ingredient Name	Strength
Inactive Ingredients
TALC (UNII: 7SEV7J4R1U)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
ZINC OXIDE (UNII: SOI2LOH54Z)
BARIUM SULFATE (UNII: 25BB7EKE2E)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CETYL ETHYLHEXANOATE (UNII: 134647WMX4)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
NYLON-12 (UNII: 446U8J075B)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
DIMETHICONE (UNII: 92RU3N3Y1O)
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)
CHLORPHENESIN (UNII: I670DAL4SZ)
METHICONE (20 CST) (UNII: 6777U11MKT)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
MICA (UNII: V8A1AW0880)
1-TETRADECENE (UNII: FW23481S7S)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:52685-410-30	1 in 1 CARTON	03/01/2012	03/01/2023
1		9.8 g in 1 TRAY; 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	03/01/2012	03/01/2023

Labeler - SHISEIDO CO., LTD. (690536453)

Name	Address	ID/FEI	Business Operations
Establishment
SHISEIDO AMERICA INC.		782677132	manufacture(52685-407, 52685-394, 52685-395, 52685-396, 52685-397, 52685-398, 52685-399, 52685-400, 52685-401, 52685-402, 52685-403, 52685-404, 52685-405, 52685-406, 52685-408, 52685-409, 52685-410) , analysis(52685-394, 52685-395, 52685-396, 52685-397, 52685-398, 52685-399, 52685-400, 52685-401, 52685-402, 52685-403, 52685-404, 52685-405, 52685-406, 52685-407, 52685-408, 52685-409, 52685-410)

Revised: 9/2023

Document Id: 46aa4a3c-4229-478c-99a9-4f7d1e539000

Set id: 2c941a55-3d0e-41a1-8729-49b35d079045

Version: 3

Effective Time: 20230922

SHISEIDO CO., LTD.