SHISEIDO THE MAKEUP FOUNDATION I00- titanium dioxide stick SHISEIDO THE MAKEUP FOUNDATION I20- titanium dioxide stick SHISEIDO THE MAKEUP FOUNDATION I40- titanium dioxide stick SHISEIDO THE MAKEUP FOUNDATION I60- titanium dioxide stick SHISEIDO THE MAKEUP FOUNDATION B20- titanium dioxide stick SHISEIDO THE MAKEUP FOUNDATION B40- titanium dioxide stick SHISEIDO THE MAKEUP FOUNDATION B60- titanium dioxide stick SHISEIDO THE MAKEUP FOUNDATION O20- titanium dioxide stick SHISEIDO THE MAKEUP FOUNDATION O40- titanium dioxide stick SHISEIDO THE MAKEUP FOUNDATION O60- titanium dioxide stick

SHISEIDO THE MAKEUP FOUNDATION by

Drug Labeling and Warnings

SHISEIDO THE MAKEUP FOUNDATION 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

TITANIUM DIOXIDE 4.1%

Purpose

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

CYCLOMETHICONE∙TRIETHYLHEXANOIN∙DIMETHICONE∙KAOLIN∙CERESIN∙SORBITAN SESQUIISOSTEARATE∙EUPHORBIA CERIFERA (CANDELILLA) WAX∙PHYTOSTERYL/OCTYLDODECYL LAUROYL GLUTAMATE∙TOCOPHERYL ACETATE∙POLYMETHYL METHACRYLATE∙COPERNICIA CERIFERA (CARNAUBA) WAX∙ALUMINUM HYDROXIDE∙ALUMINUM DISTEARATE∙TOCOPHEROL∙SODIUM CARBONATE∙FRAGRANCE∙MICA∙TITANIUM DIOXIDE∙IRON OXIDES∙ULTRAMARINES∙ZINC OXIDE∙RED 30∙

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 Container Carton - I 00

SHI SEIDO

I 00

The Makeup

Stick Foundation

BROAD SPECTRUM
SPF 17
sunscreen

10g NET WT. .35 OZ.

PRINCIPAL DISPLAY PANEL - 10 g Container Carton - I 20

SHI SEIDO

I 20

The Makeup

Stick Foundation

BROAD SPECTRUM
SPF 17
sunscreen

10g NET WT. .35 OZ.

PRINCIPAL DISPLAY PANEL - 10 g Container Carton - I 40

SHI SEIDO

I 40

The Makeup

Stick Foundation

BROAD SPECTRUM
SPF 17
sunscreen

10g NET WT. .35 OZ.

PRINCIPAL DISPLAY PANEL - 10 g Container Carton - I 60

SHI SEIDO

I 60

The Makeup

Stick Foundation

BROAD SPECTRUM
SPF 17
sunscreen

10g NET WT. .35 OZ.

PRINCIPAL DISPLAY PANEL - 10 g Container Carton - B 20

SHI SEIDO

B 20

The Makeup

Stick Foundation

BROAD SPECTRUM
SPF 17
sunscreen

10g NET WT. .35 OZ.

PRINCIPAL DISPLAY PANEL - 10 g Container Carton - B 40

SHI SEIDO

B 40

The Makeup

Stick Foundation

BROAD SPECTRUM
SPF 17
sunscreen

10g NET WT. .35 OZ.

PRINCIPAL DISPLAY PANEL - 10 g Container Carton - B 60

SHI SEIDO

B 60

The Makeup

Stick Foundation

BROAD SPECTRUM
SPF 17
sunscreen

10g NET WT. .35 OZ.

PRINCIPAL DISPLAY PANEL - 10 g Container Carton - O 20

SHI SEIDO

O 20

The Makeup

Stick Foundation

BROAD SPECTRUM
SPF 17
sunscreen

10g NET WT. .35 OZ.

PRINCIPAL DISPLAY PANEL - 10 g Container Carton - O 40

SHI SEIDO

O 40

The Makeup

Stick Foundation

BROAD SPECTRUM
SPF 17
sunscreen

10g NET WT. .35 OZ.

PRINCIPAL DISPLAY PANEL - 10 g Container Carton - O 60

SHI SEIDO

O 60

The Makeup

Stick Foundation

BROAD SPECTRUM
SPF 17
sunscreen

10g NET WT. .35 OZ.

INGREDIENTS AND APPEARANCE

SHISEIDO THE MAKEUP FOUNDATION  I00
titanium dioxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-182
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	410 mg  in 10 g

Inactive Ingredients
Ingredient Name	Strength
CYCLOMETHICONE (UNII: NMQ347994Z)
TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)
MICA (UNII: V8A1AW0880)
KAOLIN (UNII: 24H4NWX5CO)
DIMETHICONE (UNII: 92RU3N3Y1O)
CERESIN (UNII: Q1LS2UJO3A)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
CARNAUBA WAX (UNII: R12CBM0EIZ)
CANDELILLA WAX (UNII: WL0328HX19)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
SODIUM CARBONATE (UNII: 45P3261C7T)
ULTRAMARINE BLUE (UNII: I39WR998BI)
ZINC OXIDE (UNII: SOI2LOH54Z)
D&C RED NO. 30 (UNII: 2S42T2808B)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-182-20	1 in 1 CARTON	06/01/2014
1		10 g in 1 CONTAINER; 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	06/01/2014

SHISEIDO THE MAKEUP FOUNDATION  I20
titanium dioxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-183
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	410 mg  in 10 g

Inactive Ingredients
Ingredient Name	Strength
CYCLOMETHICONE (UNII: NMQ347994Z)
TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)
MICA (UNII: V8A1AW0880)
KAOLIN (UNII: 24H4NWX5CO)
DIMETHICONE (UNII: 92RU3N3Y1O)
CERESIN (UNII: Q1LS2UJO3A)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
CARNAUBA WAX (UNII: R12CBM0EIZ)
CANDELILLA WAX (UNII: WL0328HX19)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
SODIUM CARBONATE (UNII: 45P3261C7T)
ULTRAMARINE BLUE (UNII: I39WR998BI)
ZINC OXIDE (UNII: SOI2LOH54Z)
D&C RED NO. 30 (UNII: 2S42T2808B)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-183-20	1 in 1 CARTON	06/01/2014
1		10 g in 1 CONTAINER; 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	06/01/2014

SHISEIDO THE MAKEUP FOUNDATION  I40
titanium dioxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-184
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	410 mg  in 10 g

Inactive Ingredients
Ingredient Name	Strength
CYCLOMETHICONE (UNII: NMQ347994Z)
TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)
MICA (UNII: V8A1AW0880)
KAOLIN (UNII: 24H4NWX5CO)
DIMETHICONE (UNII: 92RU3N3Y1O)
CERESIN (UNII: Q1LS2UJO3A)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
CARNAUBA WAX (UNII: R12CBM0EIZ)
CANDELILLA WAX (UNII: WL0328HX19)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
SODIUM CARBONATE (UNII: 45P3261C7T)
ULTRAMARINE BLUE (UNII: I39WR998BI)
ZINC OXIDE (UNII: SOI2LOH54Z)
D&C RED NO. 30 (UNII: 2S42T2808B)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-184-20	1 in 1 CARTON	06/01/2014
1		10 g in 1 CONTAINER; 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	06/01/2014

SHISEIDO THE MAKEUP FOUNDATION  I60
titanium dioxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-185
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	410 mg  in 10 g

Inactive Ingredients
Ingredient Name	Strength
CYCLOMETHICONE (UNII: NMQ347994Z)
TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)
MICA (UNII: V8A1AW0880)
KAOLIN (UNII: 24H4NWX5CO)
DIMETHICONE (UNII: 92RU3N3Y1O)
CERESIN (UNII: Q1LS2UJO3A)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
CARNAUBA WAX (UNII: R12CBM0EIZ)
CANDELILLA WAX (UNII: WL0328HX19)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
SODIUM CARBONATE (UNII: 45P3261C7T)
ULTRAMARINE BLUE (UNII: I39WR998BI)
ZINC OXIDE (UNII: SOI2LOH54Z)
D&C RED NO. 30 (UNII: 2S42T2808B)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-185-20	1 in 1 CARTON	06/01/2014
1		10 g in 1 CONTAINER; 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	06/01/2014

SHISEIDO THE MAKEUP FOUNDATION  B20
titanium dioxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-186
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	410 mg  in 10 g

Inactive Ingredients
Ingredient Name	Strength
CYCLOMETHICONE (UNII: NMQ347994Z)
TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)
MICA (UNII: V8A1AW0880)
KAOLIN (UNII: 24H4NWX5CO)
DIMETHICONE (UNII: 92RU3N3Y1O)
CERESIN (UNII: Q1LS2UJO3A)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
CARNAUBA WAX (UNII: R12CBM0EIZ)
CANDELILLA WAX (UNII: WL0328HX19)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
SODIUM CARBONATE (UNII: 45P3261C7T)
ULTRAMARINE BLUE (UNII: I39WR998BI)
ZINC OXIDE (UNII: SOI2LOH54Z)
D&C RED NO. 30 (UNII: 2S42T2808B)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-186-20	1 in 1 CARTON	06/01/2014
1		10 g in 1 CONTAINER; 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	06/01/2014

SHISEIDO THE MAKEUP FOUNDATION  B40
titanium dioxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-187
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	410 mg  in 10 g

Inactive Ingredients
Ingredient Name	Strength
CYCLOMETHICONE (UNII: NMQ347994Z)
TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)
MICA (UNII: V8A1AW0880)
KAOLIN (UNII: 24H4NWX5CO)
DIMETHICONE (UNII: 92RU3N3Y1O)
CERESIN (UNII: Q1LS2UJO3A)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
CARNAUBA WAX (UNII: R12CBM0EIZ)
CANDELILLA WAX (UNII: WL0328HX19)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
SODIUM CARBONATE (UNII: 45P3261C7T)
ULTRAMARINE BLUE (UNII: I39WR998BI)
ZINC OXIDE (UNII: SOI2LOH54Z)
D&C RED NO. 30 (UNII: 2S42T2808B)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-187-20	1 in 1 CARTON	06/01/2014
1		10 g in 1 CONTAINER; 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	06/01/2014

SHISEIDO THE MAKEUP FOUNDATION  B60
titanium dioxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-188
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	410 mg  in 10 g

Inactive Ingredients
Ingredient Name	Strength
CYCLOMETHICONE (UNII: NMQ347994Z)
TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)
MICA (UNII: V8A1AW0880)
KAOLIN (UNII: 24H4NWX5CO)
DIMETHICONE (UNII: 92RU3N3Y1O)
CERESIN (UNII: Q1LS2UJO3A)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
CARNAUBA WAX (UNII: R12CBM0EIZ)
CANDELILLA WAX (UNII: WL0328HX19)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
SODIUM CARBONATE (UNII: 45P3261C7T)
ULTRAMARINE BLUE (UNII: I39WR998BI)
ZINC OXIDE (UNII: SOI2LOH54Z)
D&C RED NO. 30 (UNII: 2S42T2808B)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-188-20	1 in 1 CARTON	06/01/2014
1		10 g in 1 CONTAINER; 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	06/01/2014

SHISEIDO THE MAKEUP FOUNDATION  O20
titanium dioxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-189
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	410 mg  in 10 g

Inactive Ingredients
Ingredient Name	Strength
CYCLOMETHICONE (UNII: NMQ347994Z)
TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)
MICA (UNII: V8A1AW0880)
KAOLIN (UNII: 24H4NWX5CO)
DIMETHICONE (UNII: 92RU3N3Y1O)
CERESIN (UNII: Q1LS2UJO3A)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
CARNAUBA WAX (UNII: R12CBM0EIZ)
CANDELILLA WAX (UNII: WL0328HX19)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
SODIUM CARBONATE (UNII: 45P3261C7T)
ULTRAMARINE BLUE (UNII: I39WR998BI)
ZINC OXIDE (UNII: SOI2LOH54Z)
D&C RED NO. 30 (UNII: 2S42T2808B)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-189-20	1 in 1 CARTON	06/01/2014
1		10 g in 1 CONTAINER; 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	06/01/2014

SHISEIDO THE MAKEUP FOUNDATION  O40
titanium dioxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-190
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	410 mg  in 10 g

Inactive Ingredients
Ingredient Name	Strength
CYCLOMETHICONE (UNII: NMQ347994Z)
TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)
MICA (UNII: V8A1AW0880)
KAOLIN (UNII: 24H4NWX5CO)
DIMETHICONE (UNII: 92RU3N3Y1O)
CERESIN (UNII: Q1LS2UJO3A)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
CARNAUBA WAX (UNII: R12CBM0EIZ)
CANDELILLA WAX (UNII: WL0328HX19)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
SODIUM CARBONATE (UNII: 45P3261C7T)
ULTRAMARINE BLUE (UNII: I39WR998BI)
ZINC OXIDE (UNII: SOI2LOH54Z)
D&C RED NO. 30 (UNII: 2S42T2808B)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-190-20	1 in 1 CARTON	06/01/2014
1		10 g in 1 CONTAINER; 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	06/01/2014

SHISEIDO THE MAKEUP FOUNDATION  O60
titanium dioxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-191
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	410 mg  in 10 g

Inactive Ingredients
Ingredient Name	Strength
CYCLOMETHICONE (UNII: NMQ347994Z)
TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)
MICA (UNII: V8A1AW0880)
KAOLIN (UNII: 24H4NWX5CO)
DIMETHICONE (UNII: 92RU3N3Y1O)
CERESIN (UNII: Q1LS2UJO3A)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
CARNAUBA WAX (UNII: R12CBM0EIZ)
CANDELILLA WAX (UNII: WL0328HX19)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
SODIUM CARBONATE (UNII: 45P3261C7T)
ULTRAMARINE BLUE (UNII: I39WR998BI)
ZINC OXIDE (UNII: SOI2LOH54Z)
D&C RED NO. 30 (UNII: 2S42T2808B)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-191-20	1 in 1 CARTON	06/01/2014
1		10 g in 1 CONTAINER; 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	06/01/2014

Labeler - SHISEIDO AMERICAS CORPORATION (193691821)

Establishment
Name	Address	ID/FEI	Business Operations
SHISEIDO AMERICA INC.		782677132	manufacture(58411-182, 58411-183, 58411-184, 58411-185, 58411-186, 58411-187, 58411-188, 58411-189, 58411-190, 58411-191) , analysis(58411-182, 58411-183, 58411-184, 58411-185, 58411-186, 58411-187, 58411-188, 58411-189, 58411-190, 58411-191)