SHISEIDO SHEER AND PERFECT FOUNDATION I00- octinoxate and titanium dioxide emulsion SHISEIDO SHEER AND PERFECT FOUNDATION I20- octinoxate and titanium dioxide emulsion SHISEIDO SHEER AND PERFECT FOUNDATION I40- octinoxate and titanium dioxide emulsion SHISEIDO SHEER AND PERFECT FOUNDATION I60- octinoxate and titanium dioxide emulsion

SHISEIDO SHEER AND PERFECT FOUNDATION by

Drug Labeling and Warnings

SHISEIDO SHEER AND PERFECT 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

ACTIVE INGREDIENTS:	Purpose
OCTINOXATE 2.9%	Sunscreen
TITANIUM DIOXIDE 5.2%	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

WATER, DIMETHICONE, CYCLOMETHICONE, SD ALCOHOL 40-B, NYLON-12, GLYCERIN, PEG-10 DIMETHICONE, DIPHENYLSILOXY PHENYL TRIMETHICONE, DIETHYLHEXYL SUCCINATE, POLYGLYCERYL-2 DIISOSTEARATE, ERYTHRITOL, XYLITOL, GLYCYL GLYCINE, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, SODIUM HYALURONATE, PAEONIA ALBIFLORA ROOT EXTRACT, PEG/PPG-36/41 DIMETHYL ETHER, ZINGIBER AROMATICUS EXTRACT, DIMETHICONE/PEG-10/15 CROSSPOLYMER, ALUMINUM HYDROXIDE, ALUMINUM DISTEARATE, DISODIUM EDTA, ALUMINA, POLYSILICONE-2, SODIUM CITRATE, TRIETHOXYCAPRYLYLSILANE, BHT, ALCOHOL, BUTYLENE GLYCOL, TOCOPHEROL, CITRIC ACID, DIPROPYLENE GLYCOL, BARIUM SULFATE, SODIUM METABISULFITE, METHICONE, TETRADECENE, DIPENTAERYTHRITYL HEXAHYDROXYSTEARATE, PHENOXYETHANOL, SODIUM DEHYDROACETATE, BENZOIC ACID, FRAGRANCE, IRON OXIDES, TITANIUM DIOXIDE, 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

PRINCIPAL DISPLAY PANEL - 30mL Bottle Carton - I00

SHISEIDO

I00

Sheer and Perfect
Foundation
Evens tone,
Freshens skin,
Oil-free

BROAD SPECTRUM
SPF 18
sunscreen

30mL 1 FL. OZ.

PRINCIPAL DISPLAY PANEL - 30mL Bottle Carton - I20

SHISEIDO

I20

Sheer and Perfect
Foundation
Evens tone,
Freshens skin,
Oil-free

BROAD SPECTRUM
SPF 18
sunscreen

30mL 1 FL. OZ.

PRINCIPAL DISPLAY PANEL - 30mL Bottle Carton - I40

SHISEIDO

I40

Sheer and Perfect
Foundation
Evens tone,
Freshens skin,
Oil-free

BROAD SPECTRUM
SPF 18
sunscreen

30mL 1 FL. OZ.

PRINCIPAL DISPLAY PANEL - 30mL Bottle Carton - I60

SHISEIDO

I60

Sheer and Perfect
Foundation
Evens tone,
Freshens skin,
Oil-free

BROAD SPECTRUM
SPF 18
sunscreen

30mL 1 FL. OZ.

PRINCIPAL DISPLAY PANEL - 30mL Bottle Carton - I100

SHISEIDO

I100

Sheer and Perfect
Foundation
Evens tone,
Freshens skin,
Oil-free

BROAD SPECTRUM
SPF 18
sunscreen

30mL 1 FL. OZ.

PRINCIPAL DISPLAY PANEL - 30mL Bottle Carton - B00

SHISEIDO

B00

Sheer and Perfect
Foundation
Evens tone,
Freshens skin,
Oil-free

BROAD SPECTRUM
SPF 18
sunscreen

30mL 1 FL. OZ.

PRINCIPAL DISPLAY PANEL - 30mL Bottle Carton - B20

SHISEIDO

B20

Sheer and Perfect
Foundation
Evens tone,
Freshens skin,
Oil-free

BROAD SPECTRUM
SPF 18
sunscreen

30mL 1 FL. OZ.

PRINCIPAL DISPLAY PANEL - 30mL Bottle Carton - B40

SHISEIDO

B40

Sheer and Perfect
Foundation
Evens tone,
Freshens skin,
Oil-free

BROAD SPECTRUM
SPF 18
sunscreen

30mL 1 FL. OZ.

PRINCIPAL DISPLAY PANEL - 30mL Bottle Carton - B60

SHISEIDO

B60

Sheer and Perfect
Foundation
Evens tone,
Freshens skin,
Oil-free

BROAD SPECTRUM
SPF 18
sunscreen

30mL 1 FL. OZ.

PRINCIPAL DISPLAY PANEL - 30mL Bottle Carton - B100

SHISEIDO

B100

Sheer and Perfect
Foundation
Evens tone,
Freshens skin,
Oil-free

BROAD SPECTRUM
SPF 18
sunscreen

30mL 1 FL. OZ.

PRINCIPAL DISPLAY PANEL - 30mL Bottle Carton - O00

SHISEIDO

O00

Sheer and Perfect
Foundation
Evens tone,
Freshens skin,
Oil-free

BROAD SPECTRUM
SPF 18
sunscreen

30mL 1 FL. OZ.

PRINCIPAL DISPLAY PANEL - 30mL Bottle Carton - O20

SHISEIDO

O20

Sheer and Perfect
Foundation
Evens tone,
Freshens skin,
Oil-free

BROAD SPECTRUM
SPF 18
sunscreen

30mL 1 FL. OZ.

PRINCIPAL DISPLAY PANEL - 30mL Bottle Carton - O40

SHISEIDO

O40

Sheer and Perfect
Foundation
Evens tone,
Freshens skin,
Oil-free

BROAD SPECTRUM
SPF 18
sunscreen

30mL 1 FL. OZ.

PRINCIPAL DISPLAY PANEL - 30mL Bottle Carton - O60

SHISEIDO

O60

Sheer and Perfect
Foundation
Evens tone,
Freshens skin,
Oil-free

BROAD SPECTRUM
SPF 18
sunscreen

30mL 1 FL. OZ.

PRINCIPAL DISPLAY PANEL - 30mL Bottle Carton - O80

SHISEIDO

O80

Sheer and Perfect
Foundation
Evens tone,
Freshens skin,
Oil-free

BROAD SPECTRUM
SPF 18
sunscreen

30mL 1 FL. OZ.

PRINCIPAL DISPLAY PANEL - 30mL Bottle Carton - D10

SHISEIDO

D10

Sheer and Perfect
Foundation
Evens tone,
Freshens skin,
Oil-free

BROAD SPECTRUM
SPF 18
sunscreen

30mL 1 FL. OZ.

PRINCIPAL DISPLAY PANEL - 30mL Bottle Carton - D20

SHISEIDO

D20

Sheer and Perfect
Foundation
Evens tone,
Freshens skin,
Oil-free

BROAD SPECTRUM
SPF 18
sunscreen

30mL 1 FL. OZ.

PRINCIPAL DISPLAY PANEL - 30mL Bottle Carton - D30

SHISEIDO

D30

Sheer and Perfect
Foundation
Evens tone,
Freshens skin,
Oil-free

BROAD SPECTRUM
SPF 18
sunscreen

30mL 1 FL. OZ.

INGREDIENTS AND APPEARANCE

SHISEIDO SHEER AND PERFECT FOUNDATION  I00
octinoxate and titanium dioxide emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-103
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	948 mg  in 32.7 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	1700 mg  in 32.7 g

Inactive Ingredients
Ingredient Name	Strength
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
MICA (UNII: V8A1AW0880)
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
CYCLOMETHICONE (UNII: NMQ347994Z)
NYLON-12 (UNII: 446U8J075B)
GLYCERIN (UNII: PDC6A3C0OX)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
DIETHYLHEXYL SUCCINATE (UNII: 69W9UMG3P8)
POLYGLYCERYL-2 DIISOSTEARATE (UNII: DG195GP57P)
ERYTHRITOL (UNII: RA96B954X6)
XYLITOL (UNII: VCQ006KQ1E)
DIGLYCINE (UNII: 10525P22U0)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
PAEONIA LACTIFLORA ROOT (UNII: 3Z3866YW6P)
PEG/PPG-36/41 DIMETHYL ETHER (UNII: GZ406N3R9F)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)
EDETATE DISODIUM (UNII: 7FLD91C86K)
ALUMINUM OXIDE (UNII: LMI26O6933)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
ALCOHOL (UNII: 3K9958V90M)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
BARIUM SULFATE (UNII: 25BB7EKE2E)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
METHICONE (20 CST) (UNII: 6777U11MKT)
TETRADECENE (UNII: FW23481S7S)
DIPENTAERYTHRITYL HEXAHYDROXYSTEARATE (UNII: 74J1X57U42)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
BENZOIC ACID (UNII: 8SKN0B0MIM)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-103-10	1 in 1 CARTON	08/01/2013
1		32.7 g in 1 BOTTLE; 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	08/01/2013

SHISEIDO SHEER AND PERFECT FOUNDATION  I20
octinoxate and titanium dioxide emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-104
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	948 mg  in 32.7 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	1700 mg  in 32.7 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
CYCLOMETHICONE (UNII: NMQ347994Z)
NYLON-12 (UNII: 446U8J075B)
GLYCERIN (UNII: PDC6A3C0OX)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
DIETHYLHEXYL SUCCINATE (UNII: 69W9UMG3P8)
POLYGLYCERYL-2 DIISOSTEARATE (UNII: DG195GP57P)
ERYTHRITOL (UNII: RA96B954X6)
XYLITOL (UNII: VCQ006KQ1E)
DIGLYCINE (UNII: 10525P22U0)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
PAEONIA LACTIFLORA ROOT (UNII: 3Z3866YW6P)
PEG/PPG-36/41 DIMETHYL ETHER (UNII: GZ406N3R9F)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)
EDETATE DISODIUM (UNII: 7FLD91C86K)
ALUMINUM OXIDE (UNII: LMI26O6933)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
ALCOHOL (UNII: 3K9958V90M)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
BARIUM SULFATE (UNII: 25BB7EKE2E)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
METHICONE (20 CST) (UNII: 6777U11MKT)
TETRADECENE (UNII: FW23481S7S)
DIPENTAERYTHRITYL HEXAHYDROXYSTEARATE (UNII: 74J1X57U42)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
BENZOIC ACID (UNII: 8SKN0B0MIM)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
MICA (UNII: V8A1AW0880)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-104-10	1 in 1 CARTON	08/01/2013
1		32.7 g in 1 BOTTLE; 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	08/01/2013

SHISEIDO SHEER AND PERFECT FOUNDATION  I40
octinoxate and titanium dioxide emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-105
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	948 mg  in 32.7 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	1700 mg  in 32.7 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
CYCLOMETHICONE (UNII: NMQ347994Z)
NYLON-12 (UNII: 446U8J075B)
GLYCERIN (UNII: PDC6A3C0OX)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
DIETHYLHEXYL SUCCINATE (UNII: 69W9UMG3P8)
POLYGLYCERYL-2 DIISOSTEARATE (UNII: DG195GP57P)
ERYTHRITOL (UNII: RA96B954X6)
XYLITOL (UNII: VCQ006KQ1E)
DIGLYCINE (UNII: 10525P22U0)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
PAEONIA LACTIFLORA ROOT (UNII: 3Z3866YW6P)
PEG/PPG-36/41 DIMETHYL ETHER (UNII: GZ406N3R9F)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)
EDETATE DISODIUM (UNII: 7FLD91C86K)
ALUMINUM OXIDE (UNII: LMI26O6933)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
ALCOHOL (UNII: 3K9958V90M)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
BARIUM SULFATE (UNII: 25BB7EKE2E)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
METHICONE (20 CST) (UNII: 6777U11MKT)
TETRADECENE (UNII: FW23481S7S)
DIPENTAERYTHRITYL HEXAHYDROXYSTEARATE (UNII: 74J1X57U42)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
BENZOIC ACID (UNII: 8SKN0B0MIM)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
MICA (UNII: V8A1AW0880)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-105-10	1 in 1 CARTON	08/01/2013
1		32.7 g in 1 BOTTLE; 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	08/01/2013

SHISEIDO SHEER AND PERFECT FOUNDATION  I60
octinoxate and titanium dioxide emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-106
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	948 mg  in 32.7 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	1700 mg  in 32.7 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
CYCLOMETHICONE (UNII: NMQ347994Z)
NYLON-12 (UNII: 446U8J075B)
GLYCERIN (UNII: PDC6A3C0OX)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
DIETHYLHEXYL SUCCINATE (UNII: 69W9UMG3P8)
POLYGLYCERYL-2 DIISOSTEARATE (UNII: DG195GP57P)
ERYTHRITOL (UNII: RA96B954X6)
XYLITOL (UNII: VCQ006KQ1E)
DIGLYCINE (UNII: 10525P22U0)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
PAEONIA LACTIFLORA ROOT (UNII: 3Z3866YW6P)
PEG/PPG-36/41 DIMETHYL ETHER (UNII: GZ406N3R9F)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)
EDETATE DISODIUM (UNII: 7FLD91C86K)
ALUMINUM OXIDE (UNII: LMI26O6933)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
ALCOHOL (UNII: 3K9958V90M)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
BARIUM SULFATE (UNII: 25BB7EKE2E)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
METHICONE (20 CST) (UNII: 6777U11MKT)
TETRADECENE (UNII: FW23481S7S)
DIPENTAERYTHRITYL HEXAHYDROXYSTEARATE (UNII: 74J1X57U42)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
BENZOIC ACID (UNII: 8SKN0B0MIM)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
MICA (UNII: V8A1AW0880)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-106-10	1 in 1 CARTON	08/01/2013
1		32.7 g in 1 BOTTLE; 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	08/01/2013

SHISEIDO SHEER AND PERFECT FOUNDATION  I100
octinoxate and titanium dioxide emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-107
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	948 mg  in 32.7 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	1700 mg  in 32.7 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
CYCLOMETHICONE (UNII: NMQ347994Z)
NYLON-12 (UNII: 446U8J075B)
GLYCERIN (UNII: PDC6A3C0OX)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
DIETHYLHEXYL SUCCINATE (UNII: 69W9UMG3P8)
POLYGLYCERYL-2 DIISOSTEARATE (UNII: DG195GP57P)
ERYTHRITOL (UNII: RA96B954X6)
XYLITOL (UNII: VCQ006KQ1E)
DIGLYCINE (UNII: 10525P22U0)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
PAEONIA LACTIFLORA ROOT (UNII: 3Z3866YW6P)
PEG/PPG-36/41 DIMETHYL ETHER (UNII: GZ406N3R9F)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)
EDETATE DISODIUM (UNII: 7FLD91C86K)
ALUMINUM OXIDE (UNII: LMI26O6933)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
ALCOHOL (UNII: 3K9958V90M)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
BARIUM SULFATE (UNII: 25BB7EKE2E)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
METHICONE (20 CST) (UNII: 6777U11MKT)
TETRADECENE (UNII: FW23481S7S)
DIPENTAERYTHRITYL HEXAHYDROXYSTEARATE (UNII: 74J1X57U42)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
BENZOIC ACID (UNII: 8SKN0B0MIM)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
MICA (UNII: V8A1AW0880)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-107-10	1 in 1 CARTON	08/01/2013
1		32.7 g in 1 BOTTLE; 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	08/01/2013

SHISEIDO SHEER AND PERFECT FOUNDATION  B00
octinoxate and titanium dioxide emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-108
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	948 mg  in 32.7 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	1700 mg  in 32.7 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
CYCLOMETHICONE (UNII: NMQ347994Z)
NYLON-12 (UNII: 446U8J075B)
GLYCERIN (UNII: PDC6A3C0OX)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
DIETHYLHEXYL SUCCINATE (UNII: 69W9UMG3P8)
POLYGLYCERYL-2 DIISOSTEARATE (UNII: DG195GP57P)
ERYTHRITOL (UNII: RA96B954X6)
XYLITOL (UNII: VCQ006KQ1E)
DIGLYCINE (UNII: 10525P22U0)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
PAEONIA LACTIFLORA ROOT (UNII: 3Z3866YW6P)
PEG/PPG-36/41 DIMETHYL ETHER (UNII: GZ406N3R9F)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)
EDETATE DISODIUM (UNII: 7FLD91C86K)
ALUMINUM OXIDE (UNII: LMI26O6933)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
ALCOHOL (UNII: 3K9958V90M)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
BARIUM SULFATE (UNII: 25BB7EKE2E)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
METHICONE (20 CST) (UNII: 6777U11MKT)
TETRADECENE (UNII: FW23481S7S)
DIPENTAERYTHRITYL HEXAHYDROXYSTEARATE (UNII: 74J1X57U42)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
BENZOIC ACID (UNII: 8SKN0B0MIM)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
MICA (UNII: V8A1AW0880)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-108-10	1 in 1 CARTON	08/01/2013
1		32.7 g in 1 BOTTLE; 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	08/01/2013

SHISEIDO SHEER AND PERFECT FOUNDATION  B20
octinoxate and titanium dioxide emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-109
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	948 mg  in 32.7 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	1700 mg  in 32.7 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
CYCLOMETHICONE (UNII: NMQ347994Z)
NYLON-12 (UNII: 446U8J075B)
GLYCERIN (UNII: PDC6A3C0OX)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
DIETHYLHEXYL SUCCINATE (UNII: 69W9UMG3P8)
POLYGLYCERYL-2 DIISOSTEARATE (UNII: DG195GP57P)
ERYTHRITOL (UNII: RA96B954X6)
XYLITOL (UNII: VCQ006KQ1E)
DIGLYCINE (UNII: 10525P22U0)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
PAEONIA LACTIFLORA ROOT (UNII: 3Z3866YW6P)
PEG/PPG-36/41 DIMETHYL ETHER (UNII: GZ406N3R9F)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)
EDETATE DISODIUM (UNII: 7FLD91C86K)
ALUMINUM OXIDE (UNII: LMI26O6933)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
ALCOHOL (UNII: 3K9958V90M)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
BARIUM SULFATE (UNII: 25BB7EKE2E)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
METHICONE (20 CST) (UNII: 6777U11MKT)
TETRADECENE (UNII: FW23481S7S)
DIPENTAERYTHRITYL HEXAHYDROXYSTEARATE (UNII: 74J1X57U42)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
BENZOIC ACID (UNII: 8SKN0B0MIM)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
MICA (UNII: V8A1AW0880)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-109-10	1 in 1 CARTON	08/01/2013
1		32.7 g in 1 BOTTLE; 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	08/01/2013

SHISEIDO SHEER AND PERFECT FOUNDATION  B40
octinoxate and titanium dioxide emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-110
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	948 mg  in 32.7 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	1700 mg  in 32.7 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
CYCLOMETHICONE (UNII: NMQ347994Z)
NYLON-12 (UNII: 446U8J075B)
GLYCERIN (UNII: PDC6A3C0OX)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
DIETHYLHEXYL SUCCINATE (UNII: 69W9UMG3P8)
POLYGLYCERYL-2 DIISOSTEARATE (UNII: DG195GP57P)
ERYTHRITOL (UNII: RA96B954X6)
XYLITOL (UNII: VCQ006KQ1E)
DIGLYCINE (UNII: 10525P22U0)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
PAEONIA LACTIFLORA ROOT (UNII: 3Z3866YW6P)
PEG/PPG-36/41 DIMETHYL ETHER (UNII: GZ406N3R9F)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)
EDETATE DISODIUM (UNII: 7FLD91C86K)
ALUMINUM OXIDE (UNII: LMI26O6933)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
ALCOHOL (UNII: 3K9958V90M)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
BARIUM SULFATE (UNII: 25BB7EKE2E)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
METHICONE (20 CST) (UNII: 6777U11MKT)
TETRADECENE (UNII: FW23481S7S)
DIPENTAERYTHRITYL HEXAHYDROXYSTEARATE (UNII: 74J1X57U42)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
BENZOIC ACID (UNII: 8SKN0B0MIM)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
MICA (UNII: V8A1AW0880)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-110-10	1 in 1 CARTON	08/01/2013
1		32.7 g in 1 BOTTLE; 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	08/01/2013

SHISEIDO SHEER AND PERFECT FOUNDATION  B60
octinoxate and titanium dioxide emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-111
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	948 mg  in 32.7 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	1700 mg  in 32.7 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
CYCLOMETHICONE (UNII: NMQ347994Z)
NYLON-12 (UNII: 446U8J075B)
GLYCERIN (UNII: PDC6A3C0OX)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
DIETHYLHEXYL SUCCINATE (UNII: 69W9UMG3P8)
POLYGLYCERYL-2 DIISOSTEARATE (UNII: DG195GP57P)
ERYTHRITOL (UNII: RA96B954X6)
XYLITOL (UNII: VCQ006KQ1E)
DIGLYCINE (UNII: 10525P22U0)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
PAEONIA LACTIFLORA ROOT (UNII: 3Z3866YW6P)
PEG/PPG-36/41 DIMETHYL ETHER (UNII: GZ406N3R9F)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)
EDETATE DISODIUM (UNII: 7FLD91C86K)
ALUMINUM OXIDE (UNII: LMI26O6933)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
ALCOHOL (UNII: 3K9958V90M)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
BARIUM SULFATE (UNII: 25BB7EKE2E)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
METHICONE (20 CST) (UNII: 6777U11MKT)
TETRADECENE (UNII: FW23481S7S)
DIPENTAERYTHRITYL HEXAHYDROXYSTEARATE (UNII: 74J1X57U42)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
BENZOIC ACID (UNII: 8SKN0B0MIM)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
MICA (UNII: V8A1AW0880)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-111-10	1 in 1 CARTON	08/01/2013
1		32.7 g in 1 BOTTLE; 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	08/01/2013

SHISEIDO SHEER AND PERFECT FOUNDATION  B100
octinoxate and titanium dioxide emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-112
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	948 mg  in 32.7 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	1700 mg  in 32.7 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
CYCLOMETHICONE (UNII: NMQ347994Z)
NYLON-12 (UNII: 446U8J075B)
GLYCERIN (UNII: PDC6A3C0OX)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
DIETHYLHEXYL SUCCINATE (UNII: 69W9UMG3P8)
POLYGLYCERYL-2 DIISOSTEARATE (UNII: DG195GP57P)
ERYTHRITOL (UNII: RA96B954X6)
XYLITOL (UNII: VCQ006KQ1E)
DIGLYCINE (UNII: 10525P22U0)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
PAEONIA LACTIFLORA ROOT (UNII: 3Z3866YW6P)
PEG/PPG-36/41 DIMETHYL ETHER (UNII: GZ406N3R9F)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)
EDETATE DISODIUM (UNII: 7FLD91C86K)
ALUMINUM OXIDE (UNII: LMI26O6933)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
ALCOHOL (UNII: 3K9958V90M)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
BARIUM SULFATE (UNII: 25BB7EKE2E)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
METHICONE (20 CST) (UNII: 6777U11MKT)
TETRADECENE (UNII: FW23481S7S)
DIPENTAERYTHRITYL HEXAHYDROXYSTEARATE (UNII: 74J1X57U42)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
BENZOIC ACID (UNII: 8SKN0B0MIM)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
MICA (UNII: V8A1AW0880)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-112-10	1 in 1 CARTON	08/01/2013
1		32.7 g in 1 BOTTLE; 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	08/01/2013

SHISEIDO SHEER AND PERFECT FOUNDATION  O00
octinoxate and titanium dioxide emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-113
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	948 mg  in 32.7 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	1700 mg  in 32.7 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
CYCLOMETHICONE (UNII: NMQ347994Z)
NYLON-12 (UNII: 446U8J075B)
GLYCERIN (UNII: PDC6A3C0OX)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
DIETHYLHEXYL SUCCINATE (UNII: 69W9UMG3P8)
POLYGLYCERYL-2 DIISOSTEARATE (UNII: DG195GP57P)
ERYTHRITOL (UNII: RA96B954X6)
XYLITOL (UNII: VCQ006KQ1E)
DIGLYCINE (UNII: 10525P22U0)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
PAEONIA LACTIFLORA ROOT (UNII: 3Z3866YW6P)
PEG/PPG-36/41 DIMETHYL ETHER (UNII: GZ406N3R9F)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)
EDETATE DISODIUM (UNII: 7FLD91C86K)
ALUMINUM OXIDE (UNII: LMI26O6933)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
ALCOHOL (UNII: 3K9958V90M)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
BARIUM SULFATE (UNII: 25BB7EKE2E)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
METHICONE (20 CST) (UNII: 6777U11MKT)
TETRADECENE (UNII: FW23481S7S)
DIPENTAERYTHRITYL HEXAHYDROXYSTEARATE (UNII: 74J1X57U42)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
BENZOIC ACID (UNII: 8SKN0B0MIM)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
MICA (UNII: V8A1AW0880)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-113-10	1 in 1 CARTON	08/01/2013
1		32.7 g in 1 BOTTLE; 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	08/01/2013

SHISEIDO SHEER AND PERFECT FOUNDATION  O20
octinoxate and titanium dioxide emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-114
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	948 mg  in 32.7 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	1700 mg  in 32.7 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
CYCLOMETHICONE (UNII: NMQ347994Z)
NYLON-12 (UNII: 446U8J075B)
GLYCERIN (UNII: PDC6A3C0OX)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
DIETHYLHEXYL SUCCINATE (UNII: 69W9UMG3P8)
POLYGLYCERYL-2 DIISOSTEARATE (UNII: DG195GP57P)
ERYTHRITOL (UNII: RA96B954X6)
XYLITOL (UNII: VCQ006KQ1E)
DIGLYCINE (UNII: 10525P22U0)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
PAEONIA LACTIFLORA ROOT (UNII: 3Z3866YW6P)
PEG/PPG-36/41 DIMETHYL ETHER (UNII: GZ406N3R9F)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)
EDETATE DISODIUM (UNII: 7FLD91C86K)
ALUMINUM OXIDE (UNII: LMI26O6933)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
ALCOHOL (UNII: 3K9958V90M)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
BARIUM SULFATE (UNII: 25BB7EKE2E)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
METHICONE (20 CST) (UNII: 6777U11MKT)
TETRADECENE (UNII: FW23481S7S)
DIPENTAERYTHRITYL HEXAHYDROXYSTEARATE (UNII: 74J1X57U42)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
BENZOIC ACID (UNII: 8SKN0B0MIM)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
MICA (UNII: V8A1AW0880)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-114-10	1 in 1 CARTON	08/01/2013
1		32.7 g in 1 BOTTLE; 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	08/01/2013

SHISEIDO SHEER AND PERFECT FOUNDATION  O40
octinoxate and titanium dioxide emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-115
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	948 mg  in 32.7 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	1700 mg  in 32.7 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
CYCLOMETHICONE (UNII: NMQ347994Z)
NYLON-12 (UNII: 446U8J075B)
GLYCERIN (UNII: PDC6A3C0OX)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
DIETHYLHEXYL SUCCINATE (UNII: 69W9UMG3P8)
POLYGLYCERYL-2 DIISOSTEARATE (UNII: DG195GP57P)
ERYTHRITOL (UNII: RA96B954X6)
XYLITOL (UNII: VCQ006KQ1E)
DIGLYCINE (UNII: 10525P22U0)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
PAEONIA LACTIFLORA ROOT (UNII: 3Z3866YW6P)
PEG/PPG-36/41 DIMETHYL ETHER (UNII: GZ406N3R9F)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)
EDETATE DISODIUM (UNII: 7FLD91C86K)
ALUMINUM OXIDE (UNII: LMI26O6933)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
ALCOHOL (UNII: 3K9958V90M)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
BARIUM SULFATE (UNII: 25BB7EKE2E)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
METHICONE (20 CST) (UNII: 6777U11MKT)
TETRADECENE (UNII: FW23481S7S)
DIPENTAERYTHRITYL HEXAHYDROXYSTEARATE (UNII: 74J1X57U42)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
BENZOIC ACID (UNII: 8SKN0B0MIM)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
MICA (UNII: V8A1AW0880)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-115-10	1 in 1 CARTON	08/01/2013
1		32.7 g in 1 BOTTLE; 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	08/01/2013

SHISEIDO SHEER AND PERFECT FOUNDATION  O60
octinoxate and titanium dioxide emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-116
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	948 mg  in 32.7 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	1700 mg  in 32.7 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
CYCLOMETHICONE (UNII: NMQ347994Z)
NYLON-12 (UNII: 446U8J075B)
GLYCERIN (UNII: PDC6A3C0OX)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
DIETHYLHEXYL SUCCINATE (UNII: 69W9UMG3P8)
POLYGLYCERYL-2 DIISOSTEARATE (UNII: DG195GP57P)
ERYTHRITOL (UNII: RA96B954X6)
XYLITOL (UNII: VCQ006KQ1E)
DIGLYCINE (UNII: 10525P22U0)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
PAEONIA LACTIFLORA ROOT (UNII: 3Z3866YW6P)
PEG/PPG-36/41 DIMETHYL ETHER (UNII: GZ406N3R9F)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)
EDETATE DISODIUM (UNII: 7FLD91C86K)
ALUMINUM OXIDE (UNII: LMI26O6933)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
ALCOHOL (UNII: 3K9958V90M)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
BARIUM SULFATE (UNII: 25BB7EKE2E)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
METHICONE (20 CST) (UNII: 6777U11MKT)
TETRADECENE (UNII: FW23481S7S)
DIPENTAERYTHRITYL HEXAHYDROXYSTEARATE (UNII: 74J1X57U42)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
BENZOIC ACID (UNII: 8SKN0B0MIM)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
MICA (UNII: V8A1AW0880)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-116-10	1 in 1 CARTON	08/01/2013
1		32.7 g in 1 BOTTLE; 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	08/01/2013

SHISEIDO SHEER AND PERFECT FOUNDATION  O80
octinoxate and titanium dioxide emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-117
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	948 mg  in 32.7 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	1700 mg  in 32.7 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
CYCLOMETHICONE (UNII: NMQ347994Z)
NYLON-12 (UNII: 446U8J075B)
GLYCERIN (UNII: PDC6A3C0OX)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
DIETHYLHEXYL SUCCINATE (UNII: 69W9UMG3P8)
POLYGLYCERYL-2 DIISOSTEARATE (UNII: DG195GP57P)
ERYTHRITOL (UNII: RA96B954X6)
XYLITOL (UNII: VCQ006KQ1E)
DIGLYCINE (UNII: 10525P22U0)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
PAEONIA LACTIFLORA ROOT (UNII: 3Z3866YW6P)
PEG/PPG-36/41 DIMETHYL ETHER (UNII: GZ406N3R9F)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)
EDETATE DISODIUM (UNII: 7FLD91C86K)
ALUMINUM OXIDE (UNII: LMI26O6933)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
ALCOHOL (UNII: 3K9958V90M)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
BARIUM SULFATE (UNII: 25BB7EKE2E)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
METHICONE (20 CST) (UNII: 6777U11MKT)
TETRADECENE (UNII: FW23481S7S)
DIPENTAERYTHRITYL HEXAHYDROXYSTEARATE (UNII: 74J1X57U42)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
BENZOIC ACID (UNII: 8SKN0B0MIM)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
MICA (UNII: V8A1AW0880)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-117-10	1 in 1 CARTON	08/01/2013
1		32.7 g in 1 BOTTLE; 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	08/01/2013

SHISEIDO SHEER AND PERFECT FOUNDATION  D10
octinoxate and titanium dioxide emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-118
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	948 mg  in 32.7 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	1700 mg  in 32.7 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
CYCLOMETHICONE (UNII: NMQ347994Z)
NYLON-12 (UNII: 446U8J075B)
GLYCERIN (UNII: PDC6A3C0OX)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
DIETHYLHEXYL SUCCINATE (UNII: 69W9UMG3P8)
POLYGLYCERYL-2 DIISOSTEARATE (UNII: DG195GP57P)
ERYTHRITOL (UNII: RA96B954X6)
XYLITOL (UNII: VCQ006KQ1E)
DIGLYCINE (UNII: 10525P22U0)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
PAEONIA LACTIFLORA ROOT (UNII: 3Z3866YW6P)
PEG/PPG-36/41 DIMETHYL ETHER (UNII: GZ406N3R9F)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)
EDETATE DISODIUM (UNII: 7FLD91C86K)
ALUMINUM OXIDE (UNII: LMI26O6933)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
ALCOHOL (UNII: 3K9958V90M)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
BARIUM SULFATE (UNII: 25BB7EKE2E)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
METHICONE (20 CST) (UNII: 6777U11MKT)
TETRADECENE (UNII: FW23481S7S)
DIPENTAERYTHRITYL HEXAHYDROXYSTEARATE (UNII: 74J1X57U42)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
BENZOIC ACID (UNII: 8SKN0B0MIM)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
MICA (UNII: V8A1AW0880)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-118-10	1 in 1 CARTON	08/01/2013
1		32.7 g in 1 BOTTLE; 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	08/01/2013

SHISEIDO SHEER AND PERFECT FOUNDATION  D20
octinoxate and titanium dioxide emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-119
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	948 mg  in 32.7 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	1700 mg  in 32.7 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
CYCLOMETHICONE (UNII: NMQ347994Z)
NYLON-12 (UNII: 446U8J075B)
GLYCERIN (UNII: PDC6A3C0OX)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
DIETHYLHEXYL SUCCINATE (UNII: 69W9UMG3P8)
POLYGLYCERYL-2 DIISOSTEARATE (UNII: DG195GP57P)
ERYTHRITOL (UNII: RA96B954X6)
XYLITOL (UNII: VCQ006KQ1E)
DIGLYCINE (UNII: 10525P22U0)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
PAEONIA LACTIFLORA ROOT (UNII: 3Z3866YW6P)
PEG/PPG-36/41 DIMETHYL ETHER (UNII: GZ406N3R9F)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)
EDETATE DISODIUM (UNII: 7FLD91C86K)
ALUMINUM OXIDE (UNII: LMI26O6933)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
ALCOHOL (UNII: 3K9958V90M)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
BARIUM SULFATE (UNII: 25BB7EKE2E)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
METHICONE (20 CST) (UNII: 6777U11MKT)
TETRADECENE (UNII: FW23481S7S)
DIPENTAERYTHRITYL HEXAHYDROXYSTEARATE (UNII: 74J1X57U42)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
BENZOIC ACID (UNII: 8SKN0B0MIM)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
MICA (UNII: V8A1AW0880)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-119-10	1 in 1 CARTON	08/01/2013
1		32.7 g in 1 BOTTLE; 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	08/01/2013

SHISEIDO SHEER AND PERFECT FOUNDATION  D30
octinoxate and titanium dioxide emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-120
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	948 mg  in 32.7 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	1700 mg  in 32.7 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
CYCLOMETHICONE (UNII: NMQ347994Z)
NYLON-12 (UNII: 446U8J075B)
GLYCERIN (UNII: PDC6A3C0OX)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
DIETHYLHEXYL SUCCINATE (UNII: 69W9UMG3P8)
POLYGLYCERYL-2 DIISOSTEARATE (UNII: DG195GP57P)
ERYTHRITOL (UNII: RA96B954X6)
XYLITOL (UNII: VCQ006KQ1E)
DIGLYCINE (UNII: 10525P22U0)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
PAEONIA LACTIFLORA ROOT (UNII: 3Z3866YW6P)
PEG/PPG-36/41 DIMETHYL ETHER (UNII: GZ406N3R9F)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)
EDETATE DISODIUM (UNII: 7FLD91C86K)
ALUMINUM OXIDE (UNII: LMI26O6933)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
ALCOHOL (UNII: 3K9958V90M)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
BARIUM SULFATE (UNII: 25BB7EKE2E)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
METHICONE (20 CST) (UNII: 6777U11MKT)
TETRADECENE (UNII: FW23481S7S)
DIPENTAERYTHRITYL HEXAHYDROXYSTEARATE (UNII: 74J1X57U42)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
BENZOIC ACID (UNII: 8SKN0B0MIM)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
MICA (UNII: V8A1AW0880)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-120-10	1 in 1 CARTON	08/01/2013
1		32.7 g in 1 BOTTLE; 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	08/01/2013

Labeler - SHISEIDO AMERICAS CORPORATION (193691821)

Establishment
Name	Address	ID/FEI	Business Operations
SHISEIDO AMERICA INC.		782677132	manufacture(58411-103, 58411-104, 58411-105, 58411-106, 58411-107, 58411-108, 58411-109, 58411-110, 58411-111, 58411-112, 58411-113, 58411-114, 58411-115, 58411-116, 58411-117, 58411-118, 58411-119, 58411-120) , analysis(58411-103, 58411-104, 58411-105, 58411-106, 58411-107, 58411-108, 58411-109, 58411-110, 58411-111, 58411-112, 58411-113, 58411-114, 58411-115, 58411-116, 58411-117, 58411-118, 58411-119, 58411-120)