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

United States - English - NLM (National Library of Medicine)

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Active ingredient:
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51), TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)
Available from:
SHISEIDO CO., LTD.
INN (International Name):
Octinoxate
Composition:
Octinoxate 382 mg in 9.8 g
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
- helps prevent sunburn
Authorization status:
OTC monograph not final
Authorization number:
52685-394-30, 52685-395-30, 52685-396-30, 52685-397-30, 52685-398-30, 52685-399-30, 52685-400-30, 52685-401-30, 52685-402-30, 52685-403-30, 52685-404-30, 52685-405-30, 52685-406-30, 52685-407-30, 52685-408-30, 52685-409-30, 52685-410-30

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

Us e

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?

Call toll free 1-800-906-7503

Manufactured by

SHISEIDO CO., LTD. 7-5-5 GINZA TOKYO

PRINCIPAL DISPLAY PANEL - 9.8 g Carton B 00

SHI SEIDO

B 00

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 B 20

SHI SEIDO

B 20

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 B40

SHI SEIDO

B40

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 B 60

SHI SEIDO

B 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 B 100

SHI SEIDO

B 100

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 I 00

SHI SEIDO

I 00

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 I 20

SHI SEIDO

I 20

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 I 40

SHI SEIDO

I 40

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 I 60

SHI SEIDO

I 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 I 100

SHI SEIDO

I 100

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 O 00

SHI SEIDO

O 00

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 O 20

SHI SEIDO

O 20

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 O 40

SHI SEIDO

O 40

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 O 60

SHI SEIDO

O 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 O 80

SHI SEIDO

O 80

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 40

SHI SEIDO

WB 40

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

SHI SEIDO

WB 60

Sheer Matifying

Compact (Refill)

Long-lasting,

Oil-free Foundation

BROAD SPECTRUM

SPF 21

sunscreen

9.8g NET WT. .34 OZ.

SHISEIDO SHEER MATIFYING COMPACT (REFILL) I00

octinoxate and titanium dioxide powder

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:526 8 5-39 4

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

O CTINO XATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)

OCTINOXATE

38 2 mg in 9 .8 g

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP) (TITANIUM DIOXIDE - UNII:15FIX9 V2JP)

TITANIUM DIOXIDE

58 8 mg in 9 .8 g

Inactive Ingredients

Ingredient Name

Stre ng th

TALC (UNII: 7SEV7J4R1U)

FERRIC O XIDE RED (UNII: 1K0 9 F3G6 75)

FERRIC O XIDE YELLO W (UNII: EX438 O2MRT)

FERRO SO FERRIC O XIDE (UNII: XM0 M8 7F357)

ZINC O XIDE (UNII: SOI2LOH54Z)

BARIUM SULFATE (UNII: 25BB7EKE2E)

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

CETYL ETHYLHEXANO ATE (UNII: 1346 47WMX4)

DIISO STEARYL MALATE (UNII: QBS8 A3XZGQ)

NYLO N-12 (UNII: 446 U8 J0 75B)

ALUMINUM HYDRO XIDE (UNII: 5QB0 T2IUN0 )

DIMETHICO NE (UNII: 9 2RU3N3Y1O)

ALUMINUM DISTEARATE (UNII: 7P1HP1B9 UI)

CHLO RPHENESIN (UNII: I6 70 DAL4SZ)

METHICO NE ( 2 0 CST) (UNII: 6 777U11MKT)

.ALPHA.-TO CO PHERO L (UNII: H4N8 55PNZ1)

BUTYLATED HYDRO XYTO LUENE (UNII: 1P9 D0 Z171K)

MICA (UNII: V8 A1AW0 8 8 0 )

TETRADECENE (UNII: FW2348 1S7S)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:526 8 5-39 4-30

1 in 1 CARTON

0 3/0 1/20 12

1

9 .8 g in 1 TRAY; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt352

0 3/0 1/20 12

SHISEIDO SHEER MATIFYING COMPACT (REFILL) I20

octinoxate and titanium dioxide powder

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:526 8 5-39 5

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

O CTINO XATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)

OCTINOXATE

38 2 mg in 9 .8 g

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP) (TITANIUM DIOXIDE - UNII:15FIX9 V2JP)

TITANIUM DIOXIDE

58 8 mg in 9 .8 g

Inactive Ingredients

Ingredient Name

Stre ng th

TALC (UNII: 7SEV7J4R1U)

FERRIC O XIDE RED (UNII: 1K0 9 F3G6 75)

FERRIC O XIDE YELLO W (UNII: EX438 O2MRT)

FERRO SO FERRIC O XIDE (UNII: XM0 M8 7F357)

ZINC O XIDE (UNII: SOI2LOH54Z)

BARIUM SULFATE (UNII: 25BB7EKE2E)

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

CETYL ETHYLHEXANO ATE (UNII: 1346 47WMX4)

DIISO STEARYL MALATE (UNII: QBS8 A3XZGQ)

NYLO N-12 (UNII: 446 U8 J0 75B)

ALUMINUM HYDRO XIDE (UNII: 5QB0 T2IUN0 )

DIMETHICO NE (UNII: 9 2RU3N3Y1O)

ALUMINUM DISTEARATE (UNII: 7P1HP1B9 UI)

CHLO RPHENESIN (UNII: I6 70 DAL4SZ)

METHICO NE ( 2 0 CST) (UNII: 6 777U11MKT)

.ALPHA.-TO CO PHERO L (UNII: H4N8 55PNZ1)

BUTYLATED HYDRO XYTO LUENE (UNII: 1P9 D0 Z171K)

MICA (UNII: V8 A1AW0 8 8 0 )

TETRADECENE (UNII: FW2348 1S7S)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:526 8 5-39 5-30

1 in 1 CARTON

0 3/0 1/20 12

1

9 .8 g in 1 TRAY; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt352

0 3/0 1/20 12

SHISEIDO SHEER MATIFYING COMPACT (REFILL) I40

octinoxate and titanium dioxide powder

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:526 8 5-39 6

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

O CTINO XATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)

OCTINOXATE

38 2 mg in 9 .8 g

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP) (TITANIUM DIOXIDE - UNII:15FIX9 V2JP)

TITANIUM DIOXIDE

58 8 mg in 9 .8 g

Inactive Ingredients

Ingredient Name

Stre ng th

TALC (UNII: 7SEV7J4R1U)

FERRIC O XIDE RED (UNII: 1K0 9 F3G6 75)

FERRIC O XIDE YELLO W (UNII: EX438 O2MRT)

FERRO SO FERRIC O XIDE (UNII: XM0 M8 7F357)

ZINC O XIDE (UNII: SOI2LOH54Z)

BARIUM SULFATE (UNII: 25BB7EKE2E)

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

CETYL ETHYLHEXANO ATE (UNII: 1346 47WMX4)

DIISO STEARYL MALATE (UNII: QBS8 A3XZGQ)

NYLO N-12 (UNII: 446 U8 J0 75B)

ALUMINUM HYDRO XIDE (UNII: 5QB0 T2IUN0 )

DIMETHICO NE (UNII: 9 2RU3N3Y1O)

ALUMINUM DISTEARATE (UNII: 7P1HP1B9 UI)

CHLO RPHENESIN (UNII: I6 70 DAL4SZ)

METHICO NE ( 2 0 CST) (UNII: 6 777U11MKT)

.ALPHA.-TO CO PHERO L (UNII: H4N8 55PNZ1)

BUTYLATED HYDRO XYTO LUENE (UNII: 1P9 D0 Z171K)

MICA (UNII: V8 A1AW0 8 8 0 )

TETRADECENE (UNII: FW2348 1S7S)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:526 8 5-39 6 -30

1 in 1 CARTON

0 3/0 1/20 12

1

9 .8 g in 1 TRAY; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt352

0 3/0 1/20 12

SHISEIDO SHEER MATIFYING COMPACT (REFILL) I60

octinoxate and titanium dioxide powder

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:526 8 5-39 7

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

O CTINO XATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)

OCTINOXATE

38 2 mg in 9 .8 g

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP) (TITANIUM DIOXIDE - UNII:15FIX9 V2JP)

TITANIUM DIOXIDE

58 8 mg in 9 .8 g

Inactive Ingredients

Ingredient Name

Stre ng th

TALC (UNII: 7SEV7J4R1U)

FERRIC O XIDE RED (UNII: 1K0 9 F3G6 75)

FERRIC O XIDE YELLO W (UNII: EX438 O2MRT)

FERRO SO FERRIC O XIDE (UNII: XM0 M8 7F357)

ZINC O XIDE (UNII: SOI2LOH54Z)

BARIUM SULFATE (UNII: 25BB7EKE2E)

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

CETYL ETHYLHEXANO ATE (UNII: 1346 47WMX4)

DIISO STEARYL MALATE (UNII: QBS8 A3XZGQ)

NYLO N-12 (UNII: 446 U8 J0 75B)

ALUMINUM HYDRO XIDE (UNII: 5QB0 T2IUN0 )

DIMETHICO NE (UNII: 9 2RU3N3Y1O)

ALUMINUM DISTEARATE (UNII: 7P1HP1B9 UI)

CHLO RPHENESIN (UNII: I6 70 DAL4SZ)

METHICO NE ( 2 0 CST) (UNII: 6 777U11MKT)

.ALPHA.-TO CO PHERO L (UNII: H4N8 55PNZ1)

BUTYLATED HYDRO XYTO LUENE (UNII: 1P9 D0 Z171K)

MICA (UNII: V8 A1AW0 8 8 0 )

TETRADECENE (UNII: FW2348 1S7S)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:526 8 5-39 7-30

1 in 1 CARTON

0 3/0 1/20 12

1

9 .8 g in 1 TRAY; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt352

0 3/0 1/20 12

SHISEIDO SHEER MATIFYING COMPACT (REFILL) B20

octinoxate and titanium dioxide powder

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:526 8 5-39 8

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

O CTINO XATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)

OCTINOXATE

38 2 mg in 9 .8 g

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP) (TITANIUM DIOXIDE - UNII:15FIX9 V2JP)

TITANIUM DIOXIDE

58 8 mg in 9 .8 g

Inactive Ingredients

Ingredient Name

Stre ng th

TALC (UNII: 7SEV7J4R1U)

FERRIC O XIDE RED (UNII: 1K0 9 F3G6 75)

FERRIC O XIDE YELLO W (UNII: EX438 O2MRT)

FERRO SO FERRIC O XIDE (UNII: XM0 M8 7F357)

ZINC O XIDE (UNII: SOI2LOH54Z)

BARIUM SULFATE (UNII: 25BB7EKE2E)

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

CETYL ETHYLHEXANO ATE (UNII: 1346 47WMX4)

DIISO STEARYL MALATE (UNII: QBS8 A3XZGQ)

NYLO N-12 (UNII: 446 U8 J0 75B)

ALUMINUM HYDRO XIDE (UNII: 5QB0 T2IUN0 )

DIMETHICO NE (UNII: 9 2RU3N3Y1O)

ALUMINUM DISTEARATE (UNII: 7P1HP1B9 UI)

CHLO RPHENESIN (UNII: I6 70 DAL4SZ)

METHICO NE ( 2 0 CST) (UNII: 6 777U11MKT)

.ALPHA.-TO CO PHERO L (UNII: H4N8 55PNZ1)

BUTYLATED HYDRO XYTO LUENE (UNII: 1P9 D0 Z171K)

MICA (UNII: V8 A1AW0 8 8 0 )

TETRADECENE (UNII: FW2348 1S7S)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:526 8 5-39 8 -30

1 in 1 CARTON

0 3/0 1/20 12

1

9 .8 g in 1 TRAY; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt352

0 3/0 1/20 12

SHISEIDO SHEER MATIFYING COMPACT (REFILL) B40

octinoxate and titanium dioxide powder

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:526 8 5-39 9

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP) (TITANIUM DIOXIDE - UNII:15FIX9 V2JP)

TITANIUM DIOXIDE

58 8 mg in 9 .8 g

O CTINO XATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)

OCTINOXATE

38 2 mg in 9 .8 g

Inactive Ingredients

Ingredient Name

Stre ng th

TALC (UNII: 7SEV7J4R1U)

FERRIC O XIDE RED (UNII: 1K0 9 F3G6 75)

FERRIC O XIDE YELLO W (UNII: EX438 O2MRT)

FERRO SO FERRIC O XIDE (UNII: XM0 M8 7F357)

ZINC O XIDE (UNII: SOI2LOH54Z)

BARIUM SULFATE (UNII: 25BB7EKE2E)

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

CETYL ETHYLHEXANO ATE (UNII: 1346 47WMX4)

DIISO STEARYL MALATE (UNII: QBS8 A3XZGQ)

NYLO N-12 (UNII: 446 U8 J0 75B)

ALUMINUM HYDRO XIDE (UNII: 5QB0 T2IUN0 )

DIMETHICO NE (UNII: 9 2RU3N3Y1O)

ALUMINUM DISTEARATE (UNII: 7P1HP1B9 UI)

CHLO RPHENESIN (UNII: I6 70 DAL4SZ)

METHICO NE ( 2 0 CST) (UNII: 6 777U11MKT)

.ALPHA.-TO CO PHERO L (UNII: H4N8 55PNZ1)

BUTYLATED HYDRO XYTO LUENE (UNII: 1P9 D0 Z171K)

MICA (UNII: V8 A1AW0 8 8 0 )

TETRADECENE (UNII: FW2348 1S7S)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:526 8 5-39 9 -30

1 in 1 CARTON

0 3/0 1/20 12

1

9 .8 g in 1 TRAY; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt352

0 3/0 1/20 12

SHISEIDO SHEER MATIFYING COMPACT (REFILL) B60

octinoxate and titanium dioxide powder

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:526 8 5-40 0

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

O CTINO XATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)

OCTINOXATE

38 2 mg in 9 .8 g

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP) (TITANIUM DIOXIDE - UNII:15FIX9 V2JP)

TITANIUM DIOXIDE

58 8 mg in 9 .8 g

Inactive Ingredients

Ingredient Name

Stre ng th

TALC (UNII: 7SEV7J4R1U)

FERRIC O XIDE RED (UNII: 1K0 9 F3G6 75)

FERRIC O XIDE YELLO W (UNII: EX438 O2MRT)

FERRO SO FERRIC O XIDE (UNII: XM0 M8 7F357)

ZINC O XIDE (UNII: SOI2LOH54Z)

BARIUM SULFATE (UNII: 25BB7EKE2E)

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

CETYL ETHYLHEXANO ATE (UNII: 1346 47WMX4)

DIISO STEARYL MALATE (UNII: QBS8 A3XZGQ)

NYLO N-12 (UNII: 446 U8 J0 75B)

ALUMINUM HYDRO XIDE (UNII: 5QB0 T2IUN0 )

DIMETHICO NE (UNII: 9 2RU3N3Y1O)

ALUMINUM DISTEARATE (UNII: 7P1HP1B9 UI)

CHLO RPHENESIN (UNII: I6 70 DAL4SZ)

METHICO NE ( 2 0 CST) (UNII: 6 777U11MKT)

.ALPHA.-TO CO PHERO L (UNII: H4N8 55PNZ1)

BUTYLATED HYDRO XYTO LUENE (UNII: 1P9 D0 Z171K)

MICA (UNII: V8 A1AW0 8 8 0 )

TETRADECENE (UNII: FW2348 1S7S)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:526 8 5-40 0 -30

1 in 1 CARTON

0 3/0 1/20 12

1

9 .8 g in 1 TRAY; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt352

0 3/0 1/20 12

SHISEIDO SHEER MATIFYING COMPACT (REFILL) O20

octinoxate and titanium dioxide powder

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:526 8 5-40 1

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

O CTINO XATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)

OCTINOXATE

38 2 mg in 9 .8 g

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP) (TITANIUM DIOXIDE - UNII:15FIX9 V2JP)

TITANIUM DIOXIDE

58 8 mg in 9 .8 g

Inactive Ingredients

Ingredient Name

Stre ng th

TALC (UNII: 7SEV7J4R1U)

FERRIC O XIDE RED (UNII: 1K0 9 F3G6 75)

FERRIC O XIDE YELLO W (UNII: EX438 O2MRT)

FERRO SO FERRIC O XIDE (UNII: XM0 M8 7F357)

ZINC O XIDE (UNII: SOI2LOH54Z)

BARIUM SULFATE (UNII: 25BB7EKE2E)

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

CETYL ETHYLHEXANO ATE (UNII: 1346 47WMX4)

DIISO STEARYL MALATE (UNII: QBS8 A3XZGQ)

NYLO N-12 (UNII: 446 U8 J0 75B)

ALUMINUM HYDRO XIDE (UNII: 5QB0 T2IUN0 )

DIMETHICO NE (UNII: 9 2RU3N3Y1O)

ALUMINUM DISTEARATE (UNII: 7P1HP1B9 UI)

CHLO RPHENESIN (UNII: I6 70 DAL4SZ)

METHICO NE ( 2 0 CST) (UNII: 6 777U11MKT)

.ALPHA.-TO CO PHERO L (UNII: H4N8 55PNZ1)

BUTYLATED HYDRO XYTO LUENE (UNII: 1P9 D0 Z171K)

MICA (UNII: V8 A1AW0 8 8 0 )

TETRADECENE (UNII: FW2348 1S7S)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:526 8 5-40 1-30

1 in 1 CARTON

0 3/0 1/20 12

1

9 .8 g in 1 TRAY; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt352

0 3/0 1/20 12

SHISEIDO SHEER MATIFYING COMPACT (REFILL) O40

octinoxate and titanium dioxide powder

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:526 8 5-40 2

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

O CTINO XATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)

OCTINOXATE

38 2 mg in 9 .8 g

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP) (TITANIUM DIOXIDE - UNII:15FIX9 V2JP)

TITANIUM DIOXIDE

58 8 mg in 9 .8 g

Inactive Ingredients

Ingredient Name

Stre ng th

TALC (UNII: 7SEV7J4R1U)

FERRIC O XIDE RED (UNII: 1K0 9 F3G6 75)

FERRIC O XIDE YELLO W (UNII: EX438 O2MRT)

FERRO SO FERRIC O XIDE (UNII: XM0 M8 7F357)

ZINC O XIDE (UNII: SOI2LOH54Z)

BARIUM SULFATE (UNII: 25BB7EKE2E)

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

CETYL ETHYLHEXANO ATE (UNII: 1346 47WMX4)

DIISO STEARYL MALATE (UNII: QBS8 A3XZGQ)

NYLO N-12 (UNII: 446 U8 J0 75B)

ALUMINUM HYDRO XIDE (UNII: 5QB0 T2IUN0 )

DIMETHICO NE (UNII: 9 2RU3N3Y1O)

ALUMINUM DISTEARATE (UNII: 7P1HP1B9 UI)

CHLO RPHENESIN (UNII: I6 70 DAL4SZ)

METHICO NE ( 2 0 CST) (UNII: 6 777U11MKT)

.ALPHA.-TO CO PHERO L (UNII: H4N8 55PNZ1)

BUTYLATED HYDRO XYTO LUENE (UNII: 1P9 D0 Z171K)

MICA (UNII: V8 A1AW0 8 8 0 )

TETRADECENE (UNII: FW2348 1S7S)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:526 8 5-40 2-30

1 in 1 CARTON

0 3/0 1/20 12

1

9 .8 g in 1 TRAY; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt352

0 3/0 1/20 12

SHISEIDO SHEER MATIFYING COMPACT (REFILL) O60

octinoxate and titanium dioxide powder

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:526 8 5-40 3

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

O CTINO XATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)

OCTINOXATE

38 2 mg in 9 .8 g

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP) (TITANIUM DIOXIDE - UNII:15FIX9 V2JP)

TITANIUM DIOXIDE

58 8 mg in 9 .8 g

Inactive Ingredients

Ingredient Name

Stre ng th

TALC (UNII: 7SEV7J4R1U)

FERRIC O XIDE RED (UNII: 1K0 9 F3G6 75)

FERRIC O XIDE YELLO W (UNII: EX438 O2MRT)

FERRO SO FERRIC O XIDE (UNII: XM0 M8 7F357)

ZINC O XIDE (UNII: SOI2LOH54Z)

BARIUM SULFATE (UNII: 25BB7EKE2E)

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

CETYL ETHYLHEXANO ATE (UNII: 1346 47WMX4)

DIISO STEARYL MALATE (UNII: QBS8 A3XZGQ)

NYLO N-12 (UNII: 446 U8 J0 75B)

ALUMINUM HYDRO XIDE (UNII: 5QB0 T2IUN0 )

DIMETHICO NE (UNII: 9 2RU3N3Y1O)

ALUMINUM DISTEARATE (UNII: 7P1HP1B9 UI)

CHLO RPHENESIN (UNII: I6 70 DAL4SZ)

METHICO NE ( 2 0 CST) (UNII: 6 777U11MKT)

.ALPHA.-TO CO PHERO L (UNII: H4N8 55PNZ1)

BUTYLATED HYDRO XYTO LUENE (UNII: 1P9 D0 Z171K)

MICA (UNII: V8 A1AW0 8 8 0 )

TETRADECENE (UNII: FW2348 1S7S)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:526 8 5-40 3-30

1 in 1 CARTON

0 3/0 1/20 12

1

9 .8 g in 1 TRAY; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt352

0 3/0 1/20 12

SHISEIDO SHEER MATIFYING COMPACT (REFILL) O80

octinoxate and titanium dioxide powder

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:526 8 5-40 4

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

O CTINO XATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)

OCTINOXATE

38 2 mg in 9 .8 g

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP) (TITANIUM DIOXIDE - UNII:15FIX9 V2JP)

TITANIUM DIOXIDE

58 8 mg in 9 .8 g

Inactive Ingredients

Ingredient Name

Stre ng th

TALC (UNII: 7SEV7J4R1U)

FERRIC O XIDE RED (UNII: 1K0 9 F3G6 75)

FERRIC O XIDE YELLO W (UNII: EX438 O2MRT)

FERRO SO FERRIC O XIDE (UNII: XM0 M8 7F357)

ZINC O XIDE (UNII: SOI2LOH54Z)

BARIUM SULFATE (UNII: 25BB7EKE2E)

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

CETYL ETHYLHEXANO ATE (UNII: 1346 47WMX4)

DIISO STEARYL MALATE (UNII: QBS8 A3XZGQ)

NYLO N-12 (UNII: 446 U8 J0 75B)

ALUMINUM HYDRO XIDE (UNII: 5QB0 T2IUN0 )

DIMETHICO NE (UNII: 9 2RU3N3Y1O)

ALUMINUM DISTEARATE (UNII: 7P1HP1B9 UI)

CHLO RPHENESIN (UNII: I6 70 DAL4SZ)

METHICO NE ( 2 0 CST) (UNII: 6 777U11MKT)

.ALPHA.-TO CO PHERO L (UNII: H4N8 55PNZ1)

BUTYLATED HYDRO XYTO LUENE (UNII: 1P9 D0 Z171K)

MICA (UNII: V8 A1AW0 8 8 0 )

TETRADECENE (UNII: FW2348 1S7S)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:526 8 5-40 4-30

1 in 1 CARTON

0 3/0 1/20 12

1

9 .8 g in 1 TRAY; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt352

0 3/0 1/20 12

SHISEIDO SHEER MATIFYING COMPACT (REFILL) B00

octinoxate and titanium dioxide powder

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:526 8 5-40 5

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

O CTINO XATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)

OCTINOXATE

38 2 mg in 9 .8 g

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP) (TITANIUM DIOXIDE - UNII:15FIX9 V2JP)

TITANIUM DIOXIDE

58 8 mg in 9 .8 g

Inactive Ingredients

Ingredient Name

Stre ng th

TALC (UNII: 7SEV7J4R1U)

FERRIC O XIDE RED (UNII: 1K0 9 F3G6 75)

FERRIC O XIDE YELLO W (UNII: EX438 O2MRT)

FERRO SO FERRIC O XIDE (UNII: XM0 M8 7F357)

ZINC O XIDE (UNII: SOI2LOH54Z)

BARIUM SULFATE (UNII: 25BB7EKE2E)

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

CETYL ETHYLHEXANO ATE (UNII: 1346 47WMX4)

DIISO STEARYL MALATE (UNII: QBS8 A3XZGQ)

NYLO N-12 (UNII: 446 U8 J0 75B)

ALUMINUM HYDRO XIDE (UNII: 5QB0 T2IUN0 )

DIMETHICO NE (UNII: 9 2RU3N3Y1O)

ALUMINUM DISTEARATE (UNII: 7P1HP1B9 UI)

CHLO RPHENESIN (UNII: I6 70 DAL4SZ)

METHICO NE ( 2 0 CST) (UNII: 6 777U11MKT)

.ALPHA.-TO CO PHERO L (UNII: H4N8 55PNZ1)

BUTYLATED HYDRO XYTO LUENE (UNII: 1P9 D0 Z171K)

MICA (UNII: V8 A1AW0 8 8 0 )

TETRADECENE (UNII: FW2348 1S7S)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:526 8 5-40 5-30

1 in 1 CARTON

0 3/0 1/20 12

1

9 .8 g in 1 TRAY; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt352

0 3/0 1/20 12

SHISEIDO SHEER MATIFYING COMPACT (REFILL) B100

octinoxate and titanium dioxide powder

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:526 8 5-40 6

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

O CTINO XATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)

OCTINOXATE

38 2 mg in 9 .8 g

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP) (TITANIUM DIOXIDE - UNII:15FIX9 V2JP)

TITANIUM DIOXIDE

58 8 mg in 9 .8 g

Inactive Ingredients

Ingredient Name

Stre ng th

TALC (UNII: 7SEV7J4R1U)

FERRIC O XIDE RED (UNII: 1K0 9 F3G6 75)

FERRIC O XIDE YELLO W (UNII: EX438 O2MRT)

FERRO SO FERRIC O XIDE (UNII: XM0 M8 7F357)

ZINC O XIDE (UNII: SOI2LOH54Z)

BARIUM SULFATE (UNII: 25BB7EKE2E)

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

CETYL ETHYLHEXANO ATE (UNII: 1346 47WMX4)

DIISO STEARYL MALATE (UNII: QBS8 A3XZGQ)

NYLO N-12 (UNII: 446 U8 J0 75B)

ALUMINUM HYDRO XIDE (UNII: 5QB0 T2IUN0 )

DIMETHICO NE (UNII: 9 2RU3N3Y1O)

ALUMINUM DISTEARATE (UNII: 7P1HP1B9 UI)

CHLO RPHENESIN (UNII: I6 70 DAL4SZ)

METHICO NE ( 2 0 CST) (UNII: 6 777U11MKT)

.ALPHA.-TO CO PHERO L (UNII: H4N8 55PNZ1)

BUTYLATED HYDRO XYTO LUENE (UNII: 1P9 D0 Z171K)

MICA (UNII: V8 A1AW0 8 8 0 )

TETRADECENE (UNII: FW2348 1S7S)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:526 8 5-40 6 -30

1 in 1 CARTON

0 3/0 1/20 12

1

9 .8 g in 1 TRAY; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt352

0 3/0 1/20 12

SHISEIDO SHEER MATIFYING COMPACT (REFILL) I100

octinoxate and titanium dioxide powder

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:526 8 5-40 7

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

O CTINO XATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)

OCTINOXATE

38 2 mg in 9 .8 g

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP) (TITANIUM DIOXIDE - UNII:15FIX9 V2JP)

TITANIUM DIOXIDE

58 8 mg in 9 .8 g

Inactive Ingredients

Ingredient Name

Stre ng th

TALC (UNII: 7SEV7J4R1U)

FERRIC O XIDE RED (UNII: 1K0 9 F3G6 75)

FERRIC O XIDE YELLO W (UNII: EX438 O2MRT)

FERRO SO FERRIC O XIDE (UNII: XM0 M8 7F357)

ZINC O XIDE (UNII: SOI2LOH54Z)

BARIUM SULFATE (UNII: 25BB7EKE2E)

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

CETYL ETHYLHEXANO ATE (UNII: 1346 47WMX4)

DIISO STEARYL MALATE (UNII: QBS8 A3XZGQ)

NYLO N-12 (UNII: 446 U8 J0 75B)

ALUMINUM HYDRO XIDE (UNII: 5QB0 T2IUN0 )

DIMETHICO NE (UNII: 9 2RU3N3Y1O)

ALUMINUM DISTEARATE (UNII: 7P1HP1B9 UI)

CHLO RPHENESIN (UNII: I6 70 DAL4SZ)

METHICO NE ( 2 0 CST) (UNII: 6 777U11MKT)

.ALPHA.-TO CO PHERO L (UNII: H4N8 55PNZ1)

BUTYLATED HYDRO XYTO LUENE (UNII: 1P9 D0 Z171K)

MICA (UNII: V8 A1AW0 8 8 0 )

TETRADECENE (UNII: FW2348 1S7S)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:526 8 5-40 7-30

1 in 1 CARTON

0 3/0 1/20 12

1

9 .8 g in 1 TRAY; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt352

0 3/0 1/20 12

SHISEIDO SHEER MATIFYING COMPACT (REFILL) O00

octinoxate and titanium dioxide powder

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:526 8 5-40 8

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

O CTINO XATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)

OCTINOXATE

38 2 mg in 9 .8 g

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP) (TITANIUM DIOXIDE - UNII:15FIX9 V2JP)

TITANIUM DIOXIDE

58 8 mg in 9 .8 g

Inactive Ingredients

Ingredient Name

Stre ng th

TALC (UNII: 7SEV7J4R1U)

FERRIC O XIDE RED (UNII: 1K0 9 F3G6 75)

FERRIC O XIDE YELLO W (UNII: EX438 O2MRT)

FERRO SO FERRIC O XIDE (UNII: XM0 M8 7F357)

ZINC O XIDE (UNII: SOI2LOH54Z)

BARIUM SULFATE (UNII: 25BB7EKE2E)

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

CETYL ETHYLHEXANO ATE (UNII: 1346 47WMX4)

DIISO STEARYL MALATE (UNII: QBS8 A3XZGQ)

NYLO N-12 (UNII: 446 U8 J0 75B)

ALUMINUM HYDRO XIDE (UNII: 5QB0 T2IUN0 )

DIMETHICO NE (UNII: 9 2RU3N3Y1O)

ALUMINUM DISTEARATE (UNII: 7P1HP1B9 UI)

CHLO RPHENESIN (UNII: I6 70 DAL4SZ)

METHICO NE ( 2 0 CST) (UNII: 6 777U11MKT)

.ALPHA.-TO CO PHERO L (UNII: H4N8 55PNZ1)

BUTYLATED HYDRO XYTO LUENE (UNII: 1P9 D0 Z171K)

MICA (UNII: V8 A1AW0 8 8 0 )

TETRADECENE (UNII: FW2348 1S7S)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:526 8 5-40 8 -30

1 in 1 CARTON

0 3/0 1/20 12

1

9 .8 g in 1 TRAY; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt352

0 3/0 1/20 12

SHISEIDO SHEER MATIFYING COMPACT (REFILL) WB40

octinoxate and titanium dioxide powder

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:526 8 5-40 9

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

O CTINO XATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)

OCTINOXATE

38 2 mg in 9 .8 g

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP) (TITANIUM DIOXIDE - UNII:15FIX9 V2JP)

TITANIUM DIOXIDE

58 8 mg in 9 .8 g

Inactive Ingredients

Ingredient Name

Stre ng th

TALC (UNII: 7SEV7J4R1U)

FERRIC O XIDE RED (UNII: 1K0 9 F3G6 75)

FERRIC O XIDE YELLO W (UNII: EX438 O2MRT)

FERRO SO FERRIC O XIDE (UNII: XM0 M8 7F357)

ZINC O XIDE (UNII: SOI2LOH54Z)

BARIUM SULFATE (UNII: 25BB7EKE2E)

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

CETYL ETHYLHEXANO ATE (UNII: 1346 47WMX4)

DIISO STEARYL MALATE (UNII: QBS8 A3XZGQ)

NYLO N-12 (UNII: 446 U8 J0 75B)

ALUMINUM HYDRO XIDE (UNII: 5QB0 T2IUN0 )

DIMETHICO NE (UNII: 9 2RU3N3Y1O)

ALUMINUM DISTEARATE (UNII: 7P1HP1B9 UI)

CHLO RPHENESIN (UNII: I6 70 DAL4SZ)

METHICO NE ( 2 0 CST) (UNII: 6 777U11MKT)

.ALPHA.-TO CO PHERO L (UNII: H4N8 55PNZ1)

BUTYLATED HYDRO XYTO LUENE (UNII: 1P9 D0 Z171K)

MICA (UNII: V8 A1AW0 8 8 0 )

TETRADECENE (UNII: FW2348 1S7S)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:526 8 5-40 9 -30

1 in 1 CARTON

0 3/0 1/20 12

1

9 .8 g in 1 TRAY; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt352

0 3/0 1/20 12

SHISEIDO SHEER MATIFYING COMPACT (REFILL) WB60

octinoxate and titanium dioxide powder

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:526 8 5-410

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

O CTINO XATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)

OCTINOXATE

38 2 mg in 9 .8 g

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP) (TITANIUM DIOXIDE - UNII:15FIX9 V2JP)

TITANIUM DIOXIDE

58 8 mg in 9 .8 g

Inactive Ingredients

Ingredient Name

Stre ng th

TALC (UNII: 7SEV7J4R1U)

FERRIC O XIDE RED (UNII: 1K0 9 F3G6 75)

FERRIC O XIDE YELLO W (UNII: EX438 O2MRT)

FERRO SO FERRIC O XIDE (UNII: XM0 M8 7F357)

ZINC O XIDE (UNII: SOI2LOH54Z)

BARIUM SULFATE (UNII: 25BB7EKE2E)

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

CETYL ETHYLHEXANO ATE (UNII: 1346 47WMX4)

DIISO STEARYL MALATE (UNII: QBS8 A3XZGQ)

NYLO N-12 (UNII: 446 U8 J0 75B)

ALUMINUM HYDRO XIDE (UNII: 5QB0 T2IUN0 )

DIMETHICO NE (UNII: 9 2RU3N3Y1O)

ALUMINUM DISTEARATE (UNII: 7P1HP1B9 UI)

CHLO RPHENESIN (UNII: I6 70 DAL4SZ)

METHICO NE ( 2 0 CST) (UNII: 6 777U11MKT)

.ALPHA.-TO CO PHERO L (UNII: H4N8 55PNZ1)

BUTYLATED HYDRO XYTO LUENE (UNII: 1P9 D0 Z171K)

MICA (UNII: V8 A1AW0 8 8 0 )

TETRADECENE (UNII: FW2348 1S7S)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:526 8 5-410 -30

1 in 1 CARTON

0 3/0 1/20 12

1

9 .8 g in 1 TRAY; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt352

0 3/0 1/20 12

SHISEIDO CO., LTD.

Labeler -

SHISEIDO CO., LT D. (690536453)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

SHISEIDO

AMERICA

INC.

78 26 77132

manufacture(526 8 5-40 7, 526 8 5-39 4, 526 8 5-39 5, 526 8 5-39 6 , 526 8 5-39 7, 526 8 5-39 8 , 526 8 5-39 9 ,

526 8 5-40 0 , 526 8 5-40 1, 526 8 5-40 2, 526 8 5-40 3, 526 8 5-40 4, 526 8 5-40 5, 526 8 5-40 6 , 526 8 5-40 8 ,

526 8 5-40 9 , 526 8 5-410 ) , analysis(526 8 5-39 4, 526 8 5-39 5, 526 8 5-39 6 , 526 8 5-39 7, 526 8 5-39 8 ,

526 8 5-39 9 , 526 8 5-40 0 , 526 8 5-40 1, 526 8 5-40 2, 526 8 5-40 3, 526 8 5-40 4, 526 8 5-40 5, 526 8 5-40 6 ,

526 8 5-40 7, 526 8 5-40 8 , 526 8 5-40 9 , 526 8 5-410 )

Revised: 12/2018

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