SHISEIDO SHEER AND PERFECT COMPACT (REFILL) I00- octinoxate, octocrylene, and titanium dioxide powder SHISEIDO SHEER AND PERFECT COMPACT (REFILL) I20- octinoxate, octocrylene, and titanium dioxide powder SHISEIDO SHEER AND PERFECT COMPACT (REFILL) I40- octinoxate, octocrylene, and titanium dioxide powder SHISEIDO SHEER AND PERFECT COMPACT- REFILL ....... octocrylene, and titanium dioxide powder SHISEIDO SHEER AND PERFECT COMPACT (REFILL) D10- octinoxate, octocrylene, and titanium dioxide powder SHISEIDO SHEER AND PERFECT COMPACT (REFILL) D20- octinoxate, octocrylene, and titanium dioxide powder SHISEIDO SHEER AND PERFECT COMPACT (REFILL) D30- octinoxate, octocrylene, and titanium dioxide powder

SHISEIDO SHEER AND PERFECT COMPACT (REFILL) by

Drug Labeling and Warnings

SHISEIDO SHEER AND PERFECT COMPACT (REFILL) 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
OCTOCRYLENE 2.0%	Sunscreen
TITANIUM DIOXIDE 6.2%	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

TALC ∙ SYNTHETIC FLUORPHLOGOPITE ∙ NYLON-12 ∙ POLYMETHYL METHACRYLATE ∙ SILICA ∙ VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER ∙ METHYL METHACRYLATE CROSSPOLYMER ∙ CETYL ETHYLHEXANOATE ∙ SORBITAN SESQUIISOSTEARATE ∙ DIPENTAERYTHRITYL HEXAHYDROXYSTEARATE ∙ PEG/PPG-36/41 DIMETHYL ETHER ∙ ALUMINUM HYDROXIDE ∙ ALUMINUM DISTEARATE ∙ TRIETHOXYSILYLETHYL POLYDIMETHYLSILOXYETHYL HEXYL DIMETHICONE ∙ METHICONE ∙ CALCIUM STEARATE ∙ HYDROGEN DIMETHICONE ∙ POLYSILICONE-2 ∙ TOCOPHEROL ∙ BARIUM SULFATE ∙ CITRIC ACID ∙ SODIUM PHOSPHATE ∙ BHT ∙ TETRADECENE ∙ ALUMINA ∙ CHLORPHENESIN ∙ MICA ∙ BISMUTH OXYCHLORIDE ∙ TITANIUM DIOXIDE ∙ IRON OXIDES ∙ ZINC OXIDE ∙

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 - 10 g Tray Carton - I 00

SHI SEIDO

I 00

Sheer and Perfect
Compact (Refill)
Evens tone, Smoothes pores,
Oil-free

BROAD SPECTRUM
SPF 21
sunscreen

10g NET WT. .35 OZ.

PRINCIPAL DISPLAY PANEL - 10 g Tray Carton - I 20

SHI SEIDO

I 20

Sheer and Perfect
Compact (Refill)
Evens tone, Smoothes pores,
Oil-free

BROAD SPECTRUM
SPF 21
sunscreen

10g NET WT. .35 OZ.

PRINCIPAL DISPLAY PANEL - 10 g Tray Carton - I 40

SHI SEIDO

I 40

Sheer and Perfect
Compact (Refill)
Evens tone, Smoothes pores,
Oil-free

BROAD SPECTRUM
SPF 21
sunscreen

10g NET WT. .35 OZ.

PRINCIPAL DISPLAY PANEL - 10 g Tray Carton - I 60

SHI SEIDO

I 60

Sheer and Perfect
Compact (Refill)
Evens tone, Smoothes pores,
Oil-free

BROAD SPECTRUM
SPF 21
sunscreen

10g NET WT. .35 OZ.

PRINCIPAL DISPLAY PANEL - 10 g Tray Carton - I 100

SHI SEIDO

I 100

Sheer and Perfect
Compact (Refill)
Evens tone, Smoothes pores,
Oil-free

BROAD SPECTRUM
SPF 21
sunscreen

10g NET WT. .35 OZ.

PRINCIPAL DISPLAY PANEL - 10 g Tray Carton - B 00

SHI SEIDO

B 00

Sheer and Perfect
Compact (Refill)
Evens tone, Smoothes pores,
Oil-free

BROAD SPECTRUM
SPF 21
sunscreen

10g NET WT. .35 OZ.

PRINCIPAL DISPLAY PANEL - 10 g Tray Carton - B 20

SHI SEIDO

B 20

Sheer and Perfect
Compact (Refill)
Evens tone, Smoothes pores,
Oil-free

BROAD SPECTRUM
SPF 21
sunscreen

10g NET WT. .35 OZ.

PRINCIPAL DISPLAY PANEL - 10 g Tray Carton - B 40

SHI SEIDO

B 40

Sheer and Perfect
Compact (Refill)
Evens tone, Smoothes pores,
Oil-free

BROAD SPECTRUM
SPF 21
sunscreen

10g NET WT. .35 OZ.

PRINCIPAL DISPLAY PANEL - 10 g Tray Carton - B 60

SHI SEIDO

B 60

Sheer and Perfect
Compact (Refill)
Evens tone, Smoothes pores,
Oil-free

BROAD SPECTRUM
SPF 21
sunscreen

10g NET WT. .35 OZ.

PRINCIPAL DISPLAY PANEL - 10 g Tray Carton - B 100

SHI SEIDO

B 100

Sheer and Perfect
Compact (Refill)
Evens tone, Smoothes pores,
Oil-free

BROAD SPECTRUM
SPF 21
sunscreen

10g NET WT. .35 OZ.

PRINCIPAL DISPLAY PANEL - 10 g Tray Carton - O 00

SHI SEIDO

O 00

Sheer and Perfect
Compact (Refill)
Evens tone, Smoothes pores,
Oil-free

BROAD SPECTRUM
SPF 21
sunscreen

10g NET WT. .35 OZ.

PRINCIPAL DISPLAY PANEL - 10 g Tray Carton - O 20

SHI SEIDO

O 20

Sheer and Perfect
Compact (Refill)
Evens tone, Smoothes pores,
Oil-free

BROAD SPECTRUM
SPF 21
sunscreen

10g NET WT. .35 OZ.

PRINCIPAL DISPLAY PANEL - 10 g Tray Carton - O 40

SHI SEIDO

O 40

Sheer and Perfect
Compact (Refill)
Evens tone, Smoothes pores,
Oil-free

BROAD SPECTRUM
SPF 21
sunscreen

10g NET WT. .35 OZ.

PRINCIPAL DISPLAY PANEL - 10 g Tray Carton - O 60

SHI SEIDO

O 60

Sheer and Perfect
Compact (Refill)
Evens tone, Smoothes pores,
Oil-free

BROAD SPECTRUM
SPF 21
sunscreen

10g NET WT. .35 OZ.

PRINCIPAL DISPLAY PANEL - 10 g Tray Carton - O 80

SHI SEIDO

O 80

Sheer and Perfect
Compact (Refill)
Evens tone, Smoothes pores,
Oil-free

BROAD SPECTRUM
SPF 21
sunscreen

10g NET WT. .35 OZ.

PRINCIPAL DISPLAY PANEL - 10 g Tray Carton - D 10

SHI SEIDO

D 10

Sheer and Perfect
Compact (Refill)
Evens tone, Smoothes pores,
Oil-free

BROAD SPECTRUM
SPF 21
sunscreen

10g NET WT. .35 OZ.

PRINCIPAL DISPLAY PANEL - 10 g Tray Carton - D 20

SHI SEIDO

D 20

Sheer and Perfect
Compact (Refill)
Evens tone, Smoothes pores,
Oil-free

BROAD SPECTRUM
SPF 21
sunscreen

10g NET WT. .35 OZ.

PRINCIPAL DISPLAY PANEL - 10 g Tray Carton - D 30

SHI SEIDO

D 30

Sheer and Perfect
Compact (Refill)
Evens tone, Smoothes pores,
Oil-free

BROAD SPECTRUM
SPF 21
sunscreen

10g NET WT. .35 OZ.

INGREDIENTS AND APPEARANCE

SHISEIDO SHEER AND PERFECT COMPACT (REFILL)  I00
octinoxate, octocrylene, and titanium dioxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-207
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	290 mg  in 10 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	200 mg  in 10 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	620 mg  in 10 g

Inactive Ingredients
Ingredient Name	Strength
TALC (UNII: 7SEV7J4R1U)
NYLON-12 (UNII: 446U8J075B)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CETYL ETHYLHEXANOATE (UNII: 134647WMX4)
DIPENTAERYTHRITYL HEXAHYDROXYSTEARATE (UNII: 74J1X57U42)
PEG/PPG-36/41 DIMETHYL ETHER (UNII: GZ406N3R9F)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)
METHICONE (20 CST) (UNII: 6777U11MKT)
CALCIUM STEARATE (UNII: 776XM7047L)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
BARIUM SULFATE (UNII: 25BB7EKE2E)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SODIUM PHOSPHATE (UNII: SE337SVY37)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
TETRADECENE (UNII: FW23481S7S)
ALUMINUM OXIDE (UNII: LMI26O6933)
CHLORPHENESIN (UNII: I670DAL4SZ)
MICA (UNII: V8A1AW0880)
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
ZINC OXIDE (UNII: SOI2LOH54Z)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-207-30	1 in 1 CARTON	09/01/2014
1		10 g in 1 TRAY; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	09/01/2014

SHISEIDO SHEER AND PERFECT COMPACT (REFILL)  I20
octinoxate, octocrylene, and titanium dioxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-208
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	290 mg  in 10 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	200 mg  in 10 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	620 mg  in 10 g

Inactive Ingredients
Ingredient Name	Strength
TALC (UNII: 7SEV7J4R1U)
NYLON-12 (UNII: 446U8J075B)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CETYL ETHYLHEXANOATE (UNII: 134647WMX4)
DIPENTAERYTHRITYL HEXAHYDROXYSTEARATE (UNII: 74J1X57U42)
PEG/PPG-36/41 DIMETHYL ETHER (UNII: GZ406N3R9F)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)
METHICONE (20 CST) (UNII: 6777U11MKT)
CALCIUM STEARATE (UNII: 776XM7047L)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
BARIUM SULFATE (UNII: 25BB7EKE2E)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SODIUM PHOSPHATE (UNII: SE337SVY37)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
TETRADECENE (UNII: FW23481S7S)
ALUMINUM OXIDE (UNII: LMI26O6933)
CHLORPHENESIN (UNII: I670DAL4SZ)
MICA (UNII: V8A1AW0880)
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
ZINC OXIDE (UNII: SOI2LOH54Z)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-208-30	1 in 1 CARTON	09/01/2014
1		10 g in 1 TRAY; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	09/01/2014

SHISEIDO SHEER AND PERFECT COMPACT (REFILL)  I40
octinoxate, octocrylene, and titanium dioxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-209
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	290 mg  in 10 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	200 mg  in 10 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	620 mg  in 10 g

Inactive Ingredients
Ingredient Name	Strength
TALC (UNII: 7SEV7J4R1U)
NYLON-12 (UNII: 446U8J075B)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CETYL ETHYLHEXANOATE (UNII: 134647WMX4)
DIPENTAERYTHRITYL HEXAHYDROXYSTEARATE (UNII: 74J1X57U42)
PEG/PPG-36/41 DIMETHYL ETHER (UNII: GZ406N3R9F)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)
METHICONE (20 CST) (UNII: 6777U11MKT)
CALCIUM STEARATE (UNII: 776XM7047L)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
BARIUM SULFATE (UNII: 25BB7EKE2E)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SODIUM PHOSPHATE (UNII: SE337SVY37)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
TETRADECENE (UNII: FW23481S7S)
ALUMINUM OXIDE (UNII: LMI26O6933)
CHLORPHENESIN (UNII: I670DAL4SZ)
MICA (UNII: V8A1AW0880)
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
ZINC OXIDE (UNII: SOI2LOH54Z)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-209-30	1 in 1 CARTON	09/01/2014
1		10 g in 1 TRAY; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	09/01/2014

SHISEIDO SHEER AND PERFECT COMPACT (REFILL)  I60
octinoxate, octocrylene, and titanium dioxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-210
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	290 mg  in 10 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	200 mg  in 10 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	620 mg  in 10 g

Inactive Ingredients
Ingredient Name	Strength
TALC (UNII: 7SEV7J4R1U)
NYLON-12 (UNII: 446U8J075B)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CETYL ETHYLHEXANOATE (UNII: 134647WMX4)
DIPENTAERYTHRITYL HEXAHYDROXYSTEARATE (UNII: 74J1X57U42)
PEG/PPG-36/41 DIMETHYL ETHER (UNII: GZ406N3R9F)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)
METHICONE (20 CST) (UNII: 6777U11MKT)
CALCIUM STEARATE (UNII: 776XM7047L)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
BARIUM SULFATE (UNII: 25BB7EKE2E)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SODIUM PHOSPHATE (UNII: SE337SVY37)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
TETRADECENE (UNII: FW23481S7S)
ALUMINUM OXIDE (UNII: LMI26O6933)
CHLORPHENESIN (UNII: I670DAL4SZ)
MICA (UNII: V8A1AW0880)
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
ZINC OXIDE (UNII: SOI2LOH54Z)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-210-30	1 in 1 CARTON	09/01/2014
1		10 g in 1 TRAY; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	09/01/2014

SHISEIDO SHEER AND PERFECT COMPACT (REFILL)  I100
octinoxate, octocrylene, and titanium dioxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-211
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	290 mg  in 10 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	200 mg  in 10 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	620 mg  in 10 g

Inactive Ingredients
Ingredient Name	Strength
TALC (UNII: 7SEV7J4R1U)
NYLON-12 (UNII: 446U8J075B)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CETYL ETHYLHEXANOATE (UNII: 134647WMX4)
DIPENTAERYTHRITYL HEXAHYDROXYSTEARATE (UNII: 74J1X57U42)
PEG/PPG-36/41 DIMETHYL ETHER (UNII: GZ406N3R9F)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)
METHICONE (20 CST) (UNII: 6777U11MKT)
CALCIUM STEARATE (UNII: 776XM7047L)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
BARIUM SULFATE (UNII: 25BB7EKE2E)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SODIUM PHOSPHATE (UNII: SE337SVY37)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
TETRADECENE (UNII: FW23481S7S)
ALUMINUM OXIDE (UNII: LMI26O6933)
CHLORPHENESIN (UNII: I670DAL4SZ)
MICA (UNII: V8A1AW0880)
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
ZINC OXIDE (UNII: SOI2LOH54Z)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-211-30	1 in 1 CARTON	09/01/2014
1		10 g in 1 TRAY; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	09/01/2014

SHISEIDO SHEER AND PERFECT COMPACT (REFILL)  B00
octinoxate, octocrylene, and titanium dioxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-212
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	290 mg  in 10 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	200 mg  in 10 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	620 mg  in 10 g

Inactive Ingredients
Ingredient Name	Strength
TALC (UNII: 7SEV7J4R1U)
NYLON-12 (UNII: 446U8J075B)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CETYL ETHYLHEXANOATE (UNII: 134647WMX4)
DIPENTAERYTHRITYL HEXAHYDROXYSTEARATE (UNII: 74J1X57U42)
PEG/PPG-36/41 DIMETHYL ETHER (UNII: GZ406N3R9F)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)
METHICONE (20 CST) (UNII: 6777U11MKT)
CALCIUM STEARATE (UNII: 776XM7047L)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
BARIUM SULFATE (UNII: 25BB7EKE2E)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SODIUM PHOSPHATE (UNII: SE337SVY37)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
TETRADECENE (UNII: FW23481S7S)
ALUMINUM OXIDE (UNII: LMI26O6933)
CHLORPHENESIN (UNII: I670DAL4SZ)
MICA (UNII: V8A1AW0880)
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
ZINC OXIDE (UNII: SOI2LOH54Z)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-212-30	1 in 1 CARTON	09/01/2014
1		10 g in 1 TRAY; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	09/01/2014

SHISEIDO SHEER AND PERFECT COMPACT (REFILL)  B20
octinoxate, octocrylene, and titanium dioxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-213
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	290 mg  in 10 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	200 mg  in 10 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	620 mg  in 10 g

Inactive Ingredients
Ingredient Name	Strength
TALC (UNII: 7SEV7J4R1U)
BARIUM SULFATE (UNII: 25BB7EKE2E)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SODIUM PHOSPHATE (UNII: SE337SVY37)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
TETRADECENE (UNII: FW23481S7S)
ALUMINUM OXIDE (UNII: LMI26O6933)
CHLORPHENESIN (UNII: I670DAL4SZ)
NYLON-12 (UNII: 446U8J075B)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CETYL ETHYLHEXANOATE (UNII: 134647WMX4)
DIPENTAERYTHRITYL HEXAHYDROXYSTEARATE (UNII: 74J1X57U42)
PEG/PPG-36/41 DIMETHYL ETHER (UNII: GZ406N3R9F)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)
METHICONE (20 CST) (UNII: 6777U11MKT)
CALCIUM STEARATE (UNII: 776XM7047L)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
MICA (UNII: V8A1AW0880)
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
ZINC OXIDE (UNII: SOI2LOH54Z)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-213-30	1 in 1 CARTON	09/01/2014
1		10 g in 1 TRAY; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	09/01/2014

SHISEIDO SHEER AND PERFECT COMPACT (REFILL)  B40
octinoxate, octocrylene, and titanium dioxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-214
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	290 mg  in 10 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	200 mg  in 10 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	620 mg  in 10 g

Inactive Ingredients
Ingredient Name	Strength
TALC (UNII: 7SEV7J4R1U)
NYLON-12 (UNII: 446U8J075B)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CETYL ETHYLHEXANOATE (UNII: 134647WMX4)
DIPENTAERYTHRITYL HEXAHYDROXYSTEARATE (UNII: 74J1X57U42)
PEG/PPG-36/41 DIMETHYL ETHER (UNII: GZ406N3R9F)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)
METHICONE (20 CST) (UNII: 6777U11MKT)
CALCIUM STEARATE (UNII: 776XM7047L)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
BARIUM SULFATE (UNII: 25BB7EKE2E)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SODIUM PHOSPHATE (UNII: SE337SVY37)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
TETRADECENE (UNII: FW23481S7S)
ALUMINUM OXIDE (UNII: LMI26O6933)
CHLORPHENESIN (UNII: I670DAL4SZ)
MICA (UNII: V8A1AW0880)
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
ZINC OXIDE (UNII: SOI2LOH54Z)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-214-30	1 in 1 CARTON	09/01/2014
1		10 g in 1 TRAY; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	09/01/2014

SHISEIDO SHEER AND PERFECT COMPACT (REFILL)  B60
octinoxate, octocrylene, and titanium dioxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-215
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	290 mg  in 10 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	200 mg  in 10 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	620 mg  in 10 g

Inactive Ingredients
Ingredient Name	Strength
TALC (UNII: 7SEV7J4R1U)
NYLON-12 (UNII: 446U8J075B)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CETYL ETHYLHEXANOATE (UNII: 134647WMX4)
DIPENTAERYTHRITYL HEXAHYDROXYSTEARATE (UNII: 74J1X57U42)
PEG/PPG-36/41 DIMETHYL ETHER (UNII: GZ406N3R9F)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)
METHICONE (20 CST) (UNII: 6777U11MKT)
CALCIUM STEARATE (UNII: 776XM7047L)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
BARIUM SULFATE (UNII: 25BB7EKE2E)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SODIUM PHOSPHATE (UNII: SE337SVY37)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
TETRADECENE (UNII: FW23481S7S)
ALUMINUM OXIDE (UNII: LMI26O6933)
CHLORPHENESIN (UNII: I670DAL4SZ)
MICA (UNII: V8A1AW0880)
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
ZINC OXIDE (UNII: SOI2LOH54Z)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-215-30	1 in 1 CARTON	09/01/2014
1		10 g in 1 TRAY; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	09/01/2014

SHISEIDO SHEER AND PERFECT COMPACT (REFILL)  B100
octinoxate, octocrylene, and titanium dioxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-216
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	290 mg  in 10 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	200 mg  in 10 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	620 mg  in 10 g

Inactive Ingredients
Ingredient Name	Strength
TALC (UNII: 7SEV7J4R1U)
NYLON-12 (UNII: 446U8J075B)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CETYL ETHYLHEXANOATE (UNII: 134647WMX4)
DIPENTAERYTHRITYL HEXAHYDROXYSTEARATE (UNII: 74J1X57U42)
PEG/PPG-36/41 DIMETHYL ETHER (UNII: GZ406N3R9F)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)
METHICONE (20 CST) (UNII: 6777U11MKT)
CALCIUM STEARATE (UNII: 776XM7047L)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
BARIUM SULFATE (UNII: 25BB7EKE2E)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SODIUM PHOSPHATE (UNII: SE337SVY37)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
TETRADECENE (UNII: FW23481S7S)
ALUMINUM OXIDE (UNII: LMI26O6933)
CHLORPHENESIN (UNII: I670DAL4SZ)
MICA (UNII: V8A1AW0880)
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
ZINC OXIDE (UNII: SOI2LOH54Z)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-216-30	1 in 1 CARTON	09/01/2014
1		10 g in 1 TRAY; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	09/01/2014

SHISEIDO SHEER AND PERFECT COMPACT (REFILL)  O00
octinoxate, octocrylene, and titanium dioxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-217
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	290 mg  in 10 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	200 mg  in 10 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	620 mg  in 10 g

Inactive Ingredients
Ingredient Name	Strength
TALC (UNII: 7SEV7J4R1U)
NYLON-12 (UNII: 446U8J075B)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CETYL ETHYLHEXANOATE (UNII: 134647WMX4)
DIPENTAERYTHRITYL HEXAHYDROXYSTEARATE (UNII: 74J1X57U42)
PEG/PPG-36/41 DIMETHYL ETHER (UNII: GZ406N3R9F)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)
METHICONE (20 CST) (UNII: 6777U11MKT)
CALCIUM STEARATE (UNII: 776XM7047L)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
BARIUM SULFATE (UNII: 25BB7EKE2E)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SODIUM PHOSPHATE (UNII: SE337SVY37)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
TETRADECENE (UNII: FW23481S7S)
ALUMINUM OXIDE (UNII: LMI26O6933)
CHLORPHENESIN (UNII: I670DAL4SZ)
MICA (UNII: V8A1AW0880)
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
ZINC OXIDE (UNII: SOI2LOH54Z)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-217-30	1 in 1 CARTON	09/01/2014
1		10 g in 1 TRAY; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	09/01/2014

SHISEIDO SHEER AND PERFECT COMPACT (REFILL)  O20
octinoxate, octocrylene, and titanium dioxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-218
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	290 mg  in 10 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	200 mg  in 10 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	620 mg  in 10 g

Inactive Ingredients
Ingredient Name	Strength
TALC (UNII: 7SEV7J4R1U)
NYLON-12 (UNII: 446U8J075B)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CETYL ETHYLHEXANOATE (UNII: 134647WMX4)
DIPENTAERYTHRITYL HEXAHYDROXYSTEARATE (UNII: 74J1X57U42)
PEG/PPG-36/41 DIMETHYL ETHER (UNII: GZ406N3R9F)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)
METHICONE (20 CST) (UNII: 6777U11MKT)
CALCIUM STEARATE (UNII: 776XM7047L)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
BARIUM SULFATE (UNII: 25BB7EKE2E)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SODIUM PHOSPHATE (UNII: SE337SVY37)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
TETRADECENE (UNII: FW23481S7S)
ALUMINUM OXIDE (UNII: LMI26O6933)
CHLORPHENESIN (UNII: I670DAL4SZ)
MICA (UNII: V8A1AW0880)
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
ZINC OXIDE (UNII: SOI2LOH54Z)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-218-30	1 in 1 CARTON	09/01/2014
1		10 g in 1 TRAY; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	09/01/2014

SHISEIDO SHEER AND PERFECT COMPACT (REFILL)  O40
octinoxate, octocrylene, and titanium dioxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-219
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	290 mg  in 10 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	200 mg  in 10 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	620 mg  in 10 g

Inactive Ingredients
Ingredient Name	Strength
TALC (UNII: 7SEV7J4R1U)
NYLON-12 (UNII: 446U8J075B)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CETYL ETHYLHEXANOATE (UNII: 134647WMX4)
DIPENTAERYTHRITYL HEXAHYDROXYSTEARATE (UNII: 74J1X57U42)
PEG/PPG-36/41 DIMETHYL ETHER (UNII: GZ406N3R9F)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)
METHICONE (20 CST) (UNII: 6777U11MKT)
CALCIUM STEARATE (UNII: 776XM7047L)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
BARIUM SULFATE (UNII: 25BB7EKE2E)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SODIUM PHOSPHATE (UNII: SE337SVY37)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
TETRADECENE (UNII: FW23481S7S)
ALUMINUM OXIDE (UNII: LMI26O6933)
CHLORPHENESIN (UNII: I670DAL4SZ)
MICA (UNII: V8A1AW0880)
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
ZINC OXIDE (UNII: SOI2LOH54Z)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-219-30	1 in 1 CARTON	09/01/2014
1		10 g in 1 TRAY; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	09/01/2014

SHISEIDO SHEER AND PERFECT COMPACT (REFILL)  O60
octinoxate, octocrylene, and titanium dioxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-220
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	290 mg  in 10 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	200 mg  in 10 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	620 mg  in 10 g

Inactive Ingredients
Ingredient Name	Strength
TALC (UNII: 7SEV7J4R1U)
NYLON-12 (UNII: 446U8J075B)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CETYL ETHYLHEXANOATE (UNII: 134647WMX4)
DIPENTAERYTHRITYL HEXAHYDROXYSTEARATE (UNII: 74J1X57U42)
PEG/PPG-36/41 DIMETHYL ETHER (UNII: GZ406N3R9F)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)
METHICONE (20 CST) (UNII: 6777U11MKT)
CALCIUM STEARATE (UNII: 776XM7047L)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
BARIUM SULFATE (UNII: 25BB7EKE2E)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SODIUM PHOSPHATE (UNII: SE337SVY37)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
TETRADECENE (UNII: FW23481S7S)
ALUMINUM OXIDE (UNII: LMI26O6933)
CHLORPHENESIN (UNII: I670DAL4SZ)
MICA (UNII: V8A1AW0880)
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
ZINC OXIDE (UNII: SOI2LOH54Z)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-220-30	1 in 1 CARTON	09/01/2014
1		10 g in 1 TRAY; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	09/01/2014

SHISEIDO SHEER AND PERFECT COMPACT (REFILL)  O80
octinoxate, octocrylene, and titanium dioxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-221
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	290 mg  in 10 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	200 mg  in 10 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	620 mg  in 10 g

Inactive Ingredients
Ingredient Name	Strength
TALC (UNII: 7SEV7J4R1U)
NYLON-12 (UNII: 446U8J075B)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CETYL ETHYLHEXANOATE (UNII: 134647WMX4)
DIPENTAERYTHRITYL HEXAHYDROXYSTEARATE (UNII: 74J1X57U42)
PEG/PPG-36/41 DIMETHYL ETHER (UNII: GZ406N3R9F)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)
METHICONE (20 CST) (UNII: 6777U11MKT)
CALCIUM STEARATE (UNII: 776XM7047L)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
BARIUM SULFATE (UNII: 25BB7EKE2E)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SODIUM PHOSPHATE (UNII: SE337SVY37)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
TETRADECENE (UNII: FW23481S7S)
ALUMINUM OXIDE (UNII: LMI26O6933)
CHLORPHENESIN (UNII: I670DAL4SZ)
MICA (UNII: V8A1AW0880)
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
ZINC OXIDE (UNII: SOI2LOH54Z)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-221-30	1 in 1 CARTON	09/01/2014
1		10 g in 1 TRAY; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	09/01/2014

SHISEIDO SHEER AND PERFECT COMPACT (REFILL)  D10
octinoxate, octocrylene, and titanium dioxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-222
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	290 mg  in 10 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	200 mg  in 10 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	620 mg  in 10 g

Inactive Ingredients
Ingredient Name	Strength
TALC (UNII: 7SEV7J4R1U)
NYLON-12 (UNII: 446U8J075B)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CETYL ETHYLHEXANOATE (UNII: 134647WMX4)
DIPENTAERYTHRITYL HEXAHYDROXYSTEARATE (UNII: 74J1X57U42)
PEG/PPG-36/41 DIMETHYL ETHER (UNII: GZ406N3R9F)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)
METHICONE (20 CST) (UNII: 6777U11MKT)
CALCIUM STEARATE (UNII: 776XM7047L)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
BARIUM SULFATE (UNII: 25BB7EKE2E)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SODIUM PHOSPHATE (UNII: SE337SVY37)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
TETRADECENE (UNII: FW23481S7S)
ALUMINUM OXIDE (UNII: LMI26O6933)
CHLORPHENESIN (UNII: I670DAL4SZ)
MICA (UNII: V8A1AW0880)
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
ZINC OXIDE (UNII: SOI2LOH54Z)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-222-30	1 in 1 CARTON	09/01/2014
1		10 g in 1 TRAY; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	09/01/2014

SHISEIDO SHEER AND PERFECT COMPACT (REFILL)  D20
octinoxate, octocrylene, and titanium dioxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-223
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	290 mg  in 10 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	200 mg  in 10 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	620 mg  in 10 g

Inactive Ingredients
Ingredient Name	Strength
TALC (UNII: 7SEV7J4R1U)
NYLON-12 (UNII: 446U8J075B)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CETYL ETHYLHEXANOATE (UNII: 134647WMX4)
DIPENTAERYTHRITYL HEXAHYDROXYSTEARATE (UNII: 74J1X57U42)
PEG/PPG-36/41 DIMETHYL ETHER (UNII: GZ406N3R9F)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)
METHICONE (20 CST) (UNII: 6777U11MKT)
CALCIUM STEARATE (UNII: 776XM7047L)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
BARIUM SULFATE (UNII: 25BB7EKE2E)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SODIUM PHOSPHATE (UNII: SE337SVY37)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
TETRADECENE (UNII: FW23481S7S)
ALUMINUM OXIDE (UNII: LMI26O6933)
CHLORPHENESIN (UNII: I670DAL4SZ)
MICA (UNII: V8A1AW0880)
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
ZINC OXIDE (UNII: SOI2LOH54Z)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-223-30	1 in 1 CARTON	09/01/2014
1		10 g in 1 TRAY; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	09/01/2014

SHISEIDO SHEER AND PERFECT COMPACT (REFILL)  D30
octinoxate, octocrylene, and titanium dioxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-224
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	290 mg  in 10 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	200 mg  in 10 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	620 mg  in 10 g

Inactive Ingredients
Ingredient Name	Strength
TALC (UNII: 7SEV7J4R1U)
NYLON-12 (UNII: 446U8J075B)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CETYL ETHYLHEXANOATE (UNII: 134647WMX4)
DIPENTAERYTHRITYL HEXAHYDROXYSTEARATE (UNII: 74J1X57U42)
PEG/PPG-36/41 DIMETHYL ETHER (UNII: GZ406N3R9F)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)
METHICONE (20 CST) (UNII: 6777U11MKT)
CALCIUM STEARATE (UNII: 776XM7047L)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
BARIUM SULFATE (UNII: 25BB7EKE2E)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SODIUM PHOSPHATE (UNII: SE337SVY37)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
TETRADECENE (UNII: FW23481S7S)
ALUMINUM OXIDE (UNII: LMI26O6933)
CHLORPHENESIN (UNII: I670DAL4SZ)
MICA (UNII: V8A1AW0880)
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
ZINC OXIDE (UNII: SOI2LOH54Z)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-224-30	1 in 1 CARTON	09/01/2014
1		10 g in 1 TRAY; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	09/01/2014

Labeler - SHISEIDO AMERICAS CORPORATION (193691821)

Establishment
Name	Address	ID/FEI	Business Operations
SHISEIDO AMERICA INC.		782677132	manufacture(58411-207, 58411-208, 58411-209, 58411-210, 58411-211, 58411-212, 58411-213, 58411-214, 58411-215, 58411-216, 58411-217, 58411-218, 58411-219, 58411-220, 58411-221, 58411-222, 58411-223, 58411-224) , analysis(58411-207, 58411-208, 58411-209, 58411-210, 58411-211, 58411-212, 58411-213, 58411-214, 58411-215, 58411-216, 58411-217, 58411-218, 58411-219, 58411-220, 58411-221, 58411-222, 58411-223, 58411-224)