SHISEIDO PERFECT REFINING FOUNDATION I00- octinoxate and titanium dioxide cream SHISEIDO PERFECT REFINING FOUNDATION I20- octinoxate and titanium dioxide cream SHISEIDO PERFECT REFINING FOUNDATION I40- octinoxate and titanium dioxide cream SHISEIDO PERFECT REFINING FOUNDATION I60- octinoxate and titanium dioxide cream SHISEIDO PERFECT REFINING FOUNDATION I100- octinoxate and titanium dioxide cream SHISEIDO PERFECT REFINING FOUNDATION B00- octinoxate and titanium dioxide cream SHISEIDO PERFECT REFINING FOUNDATION B20- octinoxate and titanium dioxide cream SHISEIDO PERFECT REFINING FOUNDATION B40- octinoxate and titanium dioxide cream SHISEIDO PERFECT REFINING FOUNDATION B60- octinoxate and titanium dioxide cream SHISEIDO PERFECT REFINING FOUNDATION B100- octinoxate and titanium dioxide cream SHISEIDO PERFECT REFINING FOUNDATION O00- octinoxate and titanium dioxide cream SHISEIDO PERFECT REFINING FOUNDATION O20- octinoxate and titanium dioxide cream SHISEIDO PERFECT REFINING FOUNDATION O40- octinoxate and titanium dioxide cream SHISEIDO PERFECT REFINING FOUNDATION O60- octinoxate and titanium dioxide cream SHISEIDO PERFECT REFINING FOUNDATION O80- octinoxate and titanium dioxide cream

SHISEIDO PERFECT REFINING FOUNDATION by

Drug Labeling and Warnings

SHISEIDO PERFECT REFINING FOUNDATION by is a Otc medication manufactured, distributed, or labeled by SHISEIDO AMERICA INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients		Purpose
OCTINOXATE	1.9%	Sunscreen
TITANIUM DIOXIDE	4.1%	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, NYLON-12, SD ALCOHOL 40-B, DIETHYLHEXYL SUCCINATE, GLYCERIN, LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE, PEG-10 DIMETHICONE, ERYTHRITOL, XYLITOL, SODIUM GLUTAMATE, POLYGLYCERYL-2 DIISOSTEARATE, PEG/PPG-36/41 DIMETHYL ETHER, SODIUM HYALURONATE, LAVANDULA ANGUSTIFOLIA (LAVENDER) OIL, PAEONIA ALBIFLORA ROOT EXTRACT, ALUMINUM HYDROXIDE, ALUMINUM DISTEARATE, ALUMINA, DISTEARDIMONIUM HECTORITE, TRIETHOXYCAPRYLYLSILANE, POLYSILICONE-2, VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER, BUTYLENE GLYCOL, TOCOPHEROL, DIPENTAERYTHRITYL HEXAHYDROXYSTEARATE, BARIUM SULFATE, SODIUM METABISULFITE, BHT, METHICONE, HYDROGEN DIMETHICONE, TETRADECENE, PHENOXYETHANOL, BENZOIC ACID, TITANIUM DIOXIDE, IRON OXIDES, ZINC OXIDE, 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 B 00 Tube Carton

SHISEIDO

B 00

Perfect Refining
Foundation

All-Day Flawless,
Optimal Moisture

BROAD SPECTRUM
SPF 15
sunscreen

30mL 1FL. OZ.

PRINCIPAL DISPLAY PANEL - 30mL B 20 Tube Carton

SHISEIDO

B 20

Perfect Refining
Foundation

All-Day Flawless,
Optimal Moisture

BROAD SPECTRUM
SPF 15
sunscreen

30mL 1FL. OZ.

PRINCIPAL DISPLAY PANEL - 30mL B 40 Tube Carton

SHISEIDO

B 40

Perfect Refining
Foundation

All-Day Flawless,
Optimal Moisture

BROAD SPECTRUM
SPF 15
sunscreen

30mL 1FL. OZ.

PRINCIPAL DISPLAY PANEL - 30mL B 60 Tube Carton

SHISEIDO

B 60

Perfect Refining
Foundation

All-Day Flawless,
Optimal Moisture

BROAD SPECTRUM
SPF 15
sunscreen

30mL 1FL. OZ.

PRINCIPAL DISPLAY PANEL - 30mL B 100 Tube Carton

SHISEIDO

B 100

Perfect Refining
Foundation

All-Day Flawless,
Optimal Moisture

BROAD SPECTRUM
SPF 15
sunscreen

30mL 1FL. OZ.

PRINCIPAL DISPLAY PANEL - 30mL I 00 Tube Carton

SHISEIDO

I 00

Perfect Refining
Foundation

All-Day Flawless,
Optimal Moisture

BROAD SPECTRUM
SPF 15
sunscreen

30mL 1FL. OZ.

PRINCIPAL DISPLAY PANEL - 30mL I 20 Tube Carton

SHISEIDO

I 20

Perfect Refining
Foundation

All-Day Flawless,
Optimal Moisture

BROAD SPECTRUM
SPF 15
sunscreen

30mL 1FL. OZ.

PRINCIPAL DISPLAY PANEL - 30mL I 40 Tube Carton

SHISEIDO

I 40

Perfect Refining
Foundation

All-Day Flawless,
Optimal Moisture

BROAD SPECTRUM
SPF 15
sunscreen

30mL 1FL. OZ.

PRINCIPAL DISPLAY PANEL - 30mL I 60 Tube Carton

SHISEIDO

I 60

Perfect Refining
Foundation

All-Day Flawless,
Optimal Moisture

BROAD SPECTRUM
SPF 15
sunscreen

30mL 1FL. OZ.

PRINCIPAL DISPLAY PANEL - 30mL I 100 Tube Carton

SHISEIDO

I 100

Perfect Refining
Foundation

All-Day Flawless,
Optimal Moisture

BROAD SPECTRUM
SPF 15
sunscreen

30mL 1FL. OZ.

PRINCIPAL DISPLAY PANEL - 30mL O 00 Tube Carton

SHISEIDO

O 00

Perfect Refining
Foundation

All-Day Flawless,
Optimal Moisture

BROAD SPECTRUM
SPF 15
sunscreen

30mL 1FL. OZ.

PRINCIPAL DISPLAY PANEL - 30mL O 20 Tube Carton

SHISEIDO

O 20

Perfect Refining
Foundation

All-Day Flawless,
Optimal Moisture

BROAD SPECTRUM
SPF 15
sunscreen

30mL 1FL. OZ.

PRINCIPAL DISPLAY PANEL - 30mL O 40 Tube Carton

SHISEIDO

O 40

Perfect Refining
Foundation

All-Day Flawless,
Optimal Moisture

BROAD SPECTRUM
SPF 15
sunscreen

30mL 1FL. OZ.

PRINCIPAL DISPLAY PANEL - 30mL O 60 Tube Carton

SHISEIDO

O 60

Perfect Refining
Foundation

All-Day Flawless,
Optimal Moisture

BROAD SPECTRUM
SPF 15
sunscreen

30mL 1FL. OZ.

PRINCIPAL DISPLAY PANEL - 30mL O 80 Tube Carton

SHISEIDO

O 80

Perfect Refining
Foundation

All-Day Flawless,
Optimal Moisture

BROAD SPECTRUM
SPF 15
sunscreen

30mL 1FL. OZ.

INGREDIENTS AND APPEARANCE

SHISEIDO PERFECT REFINING FOUNDATION  I00
octinoxate and titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52686-232
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.63555 g  in 33.45 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	1.37145 g  in 33.45 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
CYCLOMETHICONE (UNII: NMQ347994Z)
NYLON-12 (UNII: 446U8J075B)
DIETHYLHEXYL SUCCINATE (UNII: 69W9UMG3P8)
GLYCERIN (UNII: PDC6A3C0OX)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
ERYTHRITOL (UNII: RA96B954X6)
MONOSODIUM GLUTAMATE (UNII: W81N5U6R6U)
XYLITOL (UNII: VCQ006KQ1E)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)
ALUMINUM OXIDE (UNII: LMI26O6933)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
PEG/PPG-36/41 DIMETHYL ETHER (UNII: GZ406N3R9F)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
DIPENTAERYTHRITYL HEXAHYDROXYSTEARATE (UNII: 74J1X57U42)
BARIUM SULFATE (UNII: 25BB7EKE2E)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
LAVENDER OIL (UNII: ZBP1YXW0H8)
PAEONIA LACTIFLORA ROOT (UNII: 3Z3866YW6P)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
METHICONE (20 CST) (UNII: 6777U11MKT)
TETRADECENE (UNII: FW23481S7S)
BENZOIC ACID (UNII: 8SKN0B0MIM)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
ZINC OXIDE (UNII: SOI2LOH54Z)
MICA (UNII: V8A1AW0880)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52686-232-60	1 in 1 CARTON	02/01/2011
1		33.45 g in 1 TUBE; 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	02/01/2011

SHISEIDO PERFECT REFINING FOUNDATION  I20
octinoxate and titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52686-233
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.63555 g  in 33.45 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	1.37145 g  in 33.45 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
CYCLOMETHICONE (UNII: NMQ347994Z)
NYLON-12 (UNII: 446U8J075B)
DIETHYLHEXYL SUCCINATE (UNII: 69W9UMG3P8)
GLYCERIN (UNII: PDC6A3C0OX)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
ERYTHRITOL (UNII: RA96B954X6)
MONOSODIUM GLUTAMATE (UNII: W81N5U6R6U)
XYLITOL (UNII: VCQ006KQ1E)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)
ALUMINUM OXIDE (UNII: LMI26O6933)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
PEG/PPG-36/41 DIMETHYL ETHER (UNII: GZ406N3R9F)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
DIPENTAERYTHRITYL HEXAHYDROXYSTEARATE (UNII: 74J1X57U42)
BARIUM SULFATE (UNII: 25BB7EKE2E)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
LAVENDER OIL (UNII: ZBP1YXW0H8)
PAEONIA LACTIFLORA ROOT (UNII: 3Z3866YW6P)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
METHICONE (20 CST) (UNII: 6777U11MKT)
TETRADECENE (UNII: FW23481S7S)
BENZOIC ACID (UNII: 8SKN0B0MIM)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
ZINC OXIDE (UNII: SOI2LOH54Z)
MICA (UNII: V8A1AW0880)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52686-233-60	1 in 1 CARTON	02/01/2011
1		33.45 g in 1 TUBE; 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	02/01/2011

SHISEIDO PERFECT REFINING FOUNDATION  I40
octinoxate and titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52686-234
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.63555 g  in 33.45 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	1.37145 g  in 33.45 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
CYCLOMETHICONE (UNII: NMQ347994Z)
NYLON-12 (UNII: 446U8J075B)
DIETHYLHEXYL SUCCINATE (UNII: 69W9UMG3P8)
GLYCERIN (UNII: PDC6A3C0OX)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
ERYTHRITOL (UNII: RA96B954X6)
MONOSODIUM GLUTAMATE (UNII: W81N5U6R6U)
XYLITOL (UNII: VCQ006KQ1E)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)
ALUMINUM OXIDE (UNII: LMI26O6933)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
PEG/PPG-36/41 DIMETHYL ETHER (UNII: GZ406N3R9F)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
DIPENTAERYTHRITYL HEXAHYDROXYSTEARATE (UNII: 74J1X57U42)
BARIUM SULFATE (UNII: 25BB7EKE2E)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
LAVENDER OIL (UNII: ZBP1YXW0H8)
PAEONIA LACTIFLORA ROOT (UNII: 3Z3866YW6P)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
METHICONE (20 CST) (UNII: 6777U11MKT)
TETRADECENE (UNII: FW23481S7S)
BENZOIC ACID (UNII: 8SKN0B0MIM)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
ZINC OXIDE (UNII: SOI2LOH54Z)
MICA (UNII: V8A1AW0880)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52686-234-60	1 in 1 CARTON	02/01/2011
1		33.45 g in 1 TUBE; 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	02/01/2011

SHISEIDO PERFECT REFINING FOUNDATION  I60
octinoxate and titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52686-235
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.63555 g  in 33.45 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	1.37145 g  in 33.45 g

Inactive Ingredients
Ingredient Name	Strength
XYLITOL (UNII: VCQ006KQ1E)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)
ALUMINUM OXIDE (UNII: LMI26O6933)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
PEG/PPG-36/41 DIMETHYL ETHER (UNII: GZ406N3R9F)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
DIPENTAERYTHRITYL HEXAHYDROXYSTEARATE (UNII: 74J1X57U42)
BARIUM SULFATE (UNII: 25BB7EKE2E)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
LAVENDER OIL (UNII: ZBP1YXW0H8)
PAEONIA LACTIFLORA ROOT (UNII: 3Z3866YW6P)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
METHICONE (20 CST) (UNII: 6777U11MKT)
TETRADECENE (UNII: FW23481S7S)
BENZOIC ACID (UNII: 8SKN0B0MIM)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
ZINC OXIDE (UNII: SOI2LOH54Z)
MICA (UNII: V8A1AW0880)
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
CYCLOMETHICONE (UNII: NMQ347994Z)
NYLON-12 (UNII: 446U8J075B)
DIETHYLHEXYL SUCCINATE (UNII: 69W9UMG3P8)
GLYCERIN (UNII: PDC6A3C0OX)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
ERYTHRITOL (UNII: RA96B954X6)
MONOSODIUM GLUTAMATE (UNII: W81N5U6R6U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52686-235-60	1 in 1 CARTON	02/01/2011
1		33.45 g in 1 TUBE; 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	02/01/2011

SHISEIDO PERFECT REFINING FOUNDATION  I100
octinoxate and titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52686-236
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.63555 g  in 33.45 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	1.37145 g  in 33.45 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
CYCLOMETHICONE (UNII: NMQ347994Z)
NYLON-12 (UNII: 446U8J075B)
DIETHYLHEXYL SUCCINATE (UNII: 69W9UMG3P8)
GLYCERIN (UNII: PDC6A3C0OX)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
ERYTHRITOL (UNII: RA96B954X6)
MONOSODIUM GLUTAMATE (UNII: W81N5U6R6U)
XYLITOL (UNII: VCQ006KQ1E)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)
ALUMINUM OXIDE (UNII: LMI26O6933)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
PEG/PPG-36/41 DIMETHYL ETHER (UNII: GZ406N3R9F)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
DIPENTAERYTHRITYL HEXAHYDROXYSTEARATE (UNII: 74J1X57U42)
BARIUM SULFATE (UNII: 25BB7EKE2E)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
LAVENDER OIL (UNII: ZBP1YXW0H8)
PAEONIA LACTIFLORA ROOT (UNII: 3Z3866YW6P)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
METHICONE (20 CST) (UNII: 6777U11MKT)
TETRADECENE (UNII: FW23481S7S)
BENZOIC ACID (UNII: 8SKN0B0MIM)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
ZINC OXIDE (UNII: SOI2LOH54Z)
MICA (UNII: V8A1AW0880)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52686-236-60	1 in 1 CARTON	02/01/2011
1		33.45 g in 1 TUBE; 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	02/01/2011

SHISEIDO PERFECT REFINING FOUNDATION  B00
octinoxate and titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52686-237
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.63555 g  in 33.45 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	1.37145 g  in 33.45 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
CYCLOMETHICONE (UNII: NMQ347994Z)
NYLON-12 (UNII: 446U8J075B)
DIETHYLHEXYL SUCCINATE (UNII: 69W9UMG3P8)
GLYCERIN (UNII: PDC6A3C0OX)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
ERYTHRITOL (UNII: RA96B954X6)
MONOSODIUM GLUTAMATE (UNII: W81N5U6R6U)
XYLITOL (UNII: VCQ006KQ1E)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)
ALUMINUM OXIDE (UNII: LMI26O6933)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
PEG/PPG-36/41 DIMETHYL ETHER (UNII: GZ406N3R9F)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
DIPENTAERYTHRITYL HEXAHYDROXYSTEARATE (UNII: 74J1X57U42)
BARIUM SULFATE (UNII: 25BB7EKE2E)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
LAVENDER OIL (UNII: ZBP1YXW0H8)
PAEONIA LACTIFLORA ROOT (UNII: 3Z3866YW6P)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
METHICONE (20 CST) (UNII: 6777U11MKT)
TETRADECENE (UNII: FW23481S7S)
BENZOIC ACID (UNII: 8SKN0B0MIM)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
ZINC OXIDE (UNII: SOI2LOH54Z)
MICA (UNII: V8A1AW0880)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52686-237-60	1 in 1 CARTON	02/01/2011
1		33.45 g in 1 TUBE; 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	02/01/2011

SHISEIDO PERFECT REFINING FOUNDATION  B20
octinoxate and titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52686-238
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.63555 g  in 33.45 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	1.37145 g  in 33.45 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
CYCLOMETHICONE (UNII: NMQ347994Z)
NYLON-12 (UNII: 446U8J075B)
DIETHYLHEXYL SUCCINATE (UNII: 69W9UMG3P8)
GLYCERIN (UNII: PDC6A3C0OX)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
ERYTHRITOL (UNII: RA96B954X6)
MONOSODIUM GLUTAMATE (UNII: W81N5U6R6U)
XYLITOL (UNII: VCQ006KQ1E)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)
ALUMINUM OXIDE (UNII: LMI26O6933)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
PEG/PPG-36/41 DIMETHYL ETHER (UNII: GZ406N3R9F)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
DIPENTAERYTHRITYL HEXAHYDROXYSTEARATE (UNII: 74J1X57U42)
BARIUM SULFATE (UNII: 25BB7EKE2E)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
LAVENDER OIL (UNII: ZBP1YXW0H8)
PAEONIA LACTIFLORA ROOT (UNII: 3Z3866YW6P)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
METHICONE (20 CST) (UNII: 6777U11MKT)
TETRADECENE (UNII: FW23481S7S)
BENZOIC ACID (UNII: 8SKN0B0MIM)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
ZINC OXIDE (UNII: SOI2LOH54Z)
MICA (UNII: V8A1AW0880)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52686-238-60	1 in 1 CARTON	02/01/2011
1		33.45 g in 1 TUBE; 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	02/01/2011

SHISEIDO PERFECT REFINING FOUNDATION  B40
octinoxate and titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52686-239
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.63555 g  in 33.45 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	1.37145 g  in 33.45 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
CYCLOMETHICONE (UNII: NMQ347994Z)
NYLON-12 (UNII: 446U8J075B)
DIETHYLHEXYL SUCCINATE (UNII: 69W9UMG3P8)
GLYCERIN (UNII: PDC6A3C0OX)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
ERYTHRITOL (UNII: RA96B954X6)
MONOSODIUM GLUTAMATE (UNII: W81N5U6R6U)
XYLITOL (UNII: VCQ006KQ1E)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)
ALUMINUM OXIDE (UNII: LMI26O6933)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
PEG/PPG-36/41 DIMETHYL ETHER (UNII: GZ406N3R9F)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
DIPENTAERYTHRITYL HEXAHYDROXYSTEARATE (UNII: 74J1X57U42)
BARIUM SULFATE (UNII: 25BB7EKE2E)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
LAVENDER OIL (UNII: ZBP1YXW0H8)
PAEONIA LACTIFLORA ROOT (UNII: 3Z3866YW6P)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
METHICONE (20 CST) (UNII: 6777U11MKT)
TETRADECENE (UNII: FW23481S7S)
BENZOIC ACID (UNII: 8SKN0B0MIM)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
ZINC OXIDE (UNII: SOI2LOH54Z)
MICA (UNII: V8A1AW0880)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52686-239-60	1 in 1 CARTON	02/01/2011
1		33.45 g in 1 TUBE; 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	02/01/2011

SHISEIDO PERFECT REFINING FOUNDATION  B60
octinoxate and titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52686-240
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.63555 g  in 33.45 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	1.37145 g  in 33.45 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
CYCLOMETHICONE (UNII: NMQ347994Z)
NYLON-12 (UNII: 446U8J075B)
DIETHYLHEXYL SUCCINATE (UNII: 69W9UMG3P8)
GLYCERIN (UNII: PDC6A3C0OX)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
ERYTHRITOL (UNII: RA96B954X6)
MONOSODIUM GLUTAMATE (UNII: W81N5U6R6U)
XYLITOL (UNII: VCQ006KQ1E)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)
ALUMINUM OXIDE (UNII: LMI26O6933)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
PEG/PPG-36/41 DIMETHYL ETHER (UNII: GZ406N3R9F)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
DIPENTAERYTHRITYL HEXAHYDROXYSTEARATE (UNII: 74J1X57U42)
BARIUM SULFATE (UNII: 25BB7EKE2E)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
LAVENDER OIL (UNII: ZBP1YXW0H8)
PAEONIA LACTIFLORA ROOT (UNII: 3Z3866YW6P)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
METHICONE (20 CST) (UNII: 6777U11MKT)
TETRADECENE (UNII: FW23481S7S)
BENZOIC ACID (UNII: 8SKN0B0MIM)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
ZINC OXIDE (UNII: SOI2LOH54Z)
MICA (UNII: V8A1AW0880)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52686-240-60	1 in 1 CARTON	02/01/2011
1		33.45 g in 1 TUBE; 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	02/01/2011

SHISEIDO PERFECT REFINING FOUNDATION  B100
octinoxate and titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52686-241
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.63555 g  in 33.45 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	1.37145 g  in 33.45 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
CYCLOMETHICONE (UNII: NMQ347994Z)
NYLON-12 (UNII: 446U8J075B)
DIETHYLHEXYL SUCCINATE (UNII: 69W9UMG3P8)
GLYCERIN (UNII: PDC6A3C0OX)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
ERYTHRITOL (UNII: RA96B954X6)
MONOSODIUM GLUTAMATE (UNII: W81N5U6R6U)
XYLITOL (UNII: VCQ006KQ1E)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)
ALUMINUM OXIDE (UNII: LMI26O6933)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
PEG/PPG-36/41 DIMETHYL ETHER (UNII: GZ406N3R9F)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
DIPENTAERYTHRITYL HEXAHYDROXYSTEARATE (UNII: 74J1X57U42)
BARIUM SULFATE (UNII: 25BB7EKE2E)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
LAVENDER OIL (UNII: ZBP1YXW0H8)
PAEONIA LACTIFLORA ROOT (UNII: 3Z3866YW6P)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
METHICONE (20 CST) (UNII: 6777U11MKT)
TETRADECENE (UNII: FW23481S7S)
BENZOIC ACID (UNII: 8SKN0B0MIM)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
ZINC OXIDE (UNII: SOI2LOH54Z)
MICA (UNII: V8A1AW0880)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52686-241-60	1 in 1 CARTON	02/01/2011
1		33.45 g in 1 TUBE; 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	02/01/2011

SHISEIDO PERFECT REFINING FOUNDATION  O00
octinoxate and titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52686-242
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.63555 g  in 33.45 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	1.37145 g  in 33.45 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
CYCLOMETHICONE (UNII: NMQ347994Z)
NYLON-12 (UNII: 446U8J075B)
DIETHYLHEXYL SUCCINATE (UNII: 69W9UMG3P8)
GLYCERIN (UNII: PDC6A3C0OX)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
ERYTHRITOL (UNII: RA96B954X6)
MONOSODIUM GLUTAMATE (UNII: W81N5U6R6U)
XYLITOL (UNII: VCQ006KQ1E)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)
ALUMINUM OXIDE (UNII: LMI26O6933)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
PEG/PPG-36/41 DIMETHYL ETHER (UNII: GZ406N3R9F)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
DIPENTAERYTHRITYL HEXAHYDROXYSTEARATE (UNII: 74J1X57U42)
BARIUM SULFATE (UNII: 25BB7EKE2E)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
LAVENDER OIL (UNII: ZBP1YXW0H8)
PAEONIA LACTIFLORA ROOT (UNII: 3Z3866YW6P)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
METHICONE (20 CST) (UNII: 6777U11MKT)
TETRADECENE (UNII: FW23481S7S)
BENZOIC ACID (UNII: 8SKN0B0MIM)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
ZINC OXIDE (UNII: SOI2LOH54Z)
MICA (UNII: V8A1AW0880)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52686-242-60	1 in 1 CARTON	02/01/2011
1		33.45 g in 1 TUBE; 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	02/01/2011

SHISEIDO PERFECT REFINING FOUNDATION  O20
octinoxate and titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52686-243
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.63555 g  in 33.45 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	1.37145 g  in 33.45 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
CYCLOMETHICONE (UNII: NMQ347994Z)
NYLON-12 (UNII: 446U8J075B)
DIETHYLHEXYL SUCCINATE (UNII: 69W9UMG3P8)
GLYCERIN (UNII: PDC6A3C0OX)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
ERYTHRITOL (UNII: RA96B954X6)
MONOSODIUM GLUTAMATE (UNII: W81N5U6R6U)
XYLITOL (UNII: VCQ006KQ1E)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)
ALUMINUM OXIDE (UNII: LMI26O6933)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
PEG/PPG-36/41 DIMETHYL ETHER (UNII: GZ406N3R9F)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
DIPENTAERYTHRITYL HEXAHYDROXYSTEARATE (UNII: 74J1X57U42)
BARIUM SULFATE (UNII: 25BB7EKE2E)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
LAVENDER OIL (UNII: ZBP1YXW0H8)
PAEONIA LACTIFLORA ROOT (UNII: 3Z3866YW6P)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
METHICONE (20 CST) (UNII: 6777U11MKT)
TETRADECENE (UNII: FW23481S7S)
BENZOIC ACID (UNII: 8SKN0B0MIM)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
ZINC OXIDE (UNII: SOI2LOH54Z)
MICA (UNII: V8A1AW0880)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52686-243-60	1 in 1 CARTON	02/01/2011
1		33.45 g in 1 TUBE; 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	02/01/2011

SHISEIDO PERFECT REFINING FOUNDATION  O40
octinoxate and titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52686-244
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.63555 g  in 33.45 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	1.37145 g  in 33.45 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
CYCLOMETHICONE (UNII: NMQ347994Z)
NYLON-12 (UNII: 446U8J075B)
DIETHYLHEXYL SUCCINATE (UNII: 69W9UMG3P8)
GLYCERIN (UNII: PDC6A3C0OX)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
ERYTHRITOL (UNII: RA96B954X6)
MONOSODIUM GLUTAMATE (UNII: W81N5U6R6U)
XYLITOL (UNII: VCQ006KQ1E)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)
ALUMINUM OXIDE (UNII: LMI26O6933)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
PEG/PPG-36/41 DIMETHYL ETHER (UNII: GZ406N3R9F)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
DIPENTAERYTHRITYL HEXAHYDROXYSTEARATE (UNII: 74J1X57U42)
BARIUM SULFATE (UNII: 25BB7EKE2E)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
LAVENDER OIL (UNII: ZBP1YXW0H8)
PAEONIA LACTIFLORA ROOT (UNII: 3Z3866YW6P)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
METHICONE (20 CST) (UNII: 6777U11MKT)
TETRADECENE (UNII: FW23481S7S)
BENZOIC ACID (UNII: 8SKN0B0MIM)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
ZINC OXIDE (UNII: SOI2LOH54Z)
MICA (UNII: V8A1AW0880)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52686-244-60	1 in 1 CARTON	02/01/2011
1		33.45 g in 1 TUBE; 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	02/01/2011

SHISEIDO PERFECT REFINING FOUNDATION  O60
octinoxate and titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52686-245
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.63555 g  in 33.45 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	1.37145 g  in 33.45 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
CYCLOMETHICONE (UNII: NMQ347994Z)
NYLON-12 (UNII: 446U8J075B)
DIETHYLHEXYL SUCCINATE (UNII: 69W9UMG3P8)
GLYCERIN (UNII: PDC6A3C0OX)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
ERYTHRITOL (UNII: RA96B954X6)
MONOSODIUM GLUTAMATE (UNII: W81N5U6R6U)
XYLITOL (UNII: VCQ006KQ1E)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)
ALUMINUM OXIDE (UNII: LMI26O6933)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
PEG/PPG-36/41 DIMETHYL ETHER (UNII: GZ406N3R9F)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
DIPENTAERYTHRITYL HEXAHYDROXYSTEARATE (UNII: 74J1X57U42)
BARIUM SULFATE (UNII: 25BB7EKE2E)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
LAVENDER OIL (UNII: ZBP1YXW0H8)
PAEONIA LACTIFLORA ROOT (UNII: 3Z3866YW6P)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
METHICONE (20 CST) (UNII: 6777U11MKT)
TETRADECENE (UNII: FW23481S7S)
BENZOIC ACID (UNII: 8SKN0B0MIM)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
ZINC OXIDE (UNII: SOI2LOH54Z)
MICA (UNII: V8A1AW0880)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52686-245-60	1 in 1 CARTON	02/01/2011
1		33.45 g in 1 TUBE; 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	02/01/2011

SHISEIDO PERFECT REFINING FOUNDATION  O80
octinoxate and titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52686-246
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.63555 g  in 33.45 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	1.37145 g  in 33.45 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
CYCLOMETHICONE (UNII: NMQ347994Z)
NYLON-12 (UNII: 446U8J075B)
DIETHYLHEXYL SUCCINATE (UNII: 69W9UMG3P8)
GLYCERIN (UNII: PDC6A3C0OX)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
ERYTHRITOL (UNII: RA96B954X6)
MONOSODIUM GLUTAMATE (UNII: W81N5U6R6U)
XYLITOL (UNII: VCQ006KQ1E)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)
ALUMINUM OXIDE (UNII: LMI26O6933)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
PEG/PPG-36/41 DIMETHYL ETHER (UNII: GZ406N3R9F)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
DIPENTAERYTHRITYL HEXAHYDROXYSTEARATE (UNII: 74J1X57U42)
BARIUM SULFATE (UNII: 25BB7EKE2E)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
LAVENDER OIL (UNII: ZBP1YXW0H8)
PAEONIA LACTIFLORA ROOT (UNII: 3Z3866YW6P)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
METHICONE (20 CST) (UNII: 6777U11MKT)
TETRADECENE (UNII: FW23481S7S)
BENZOIC ACID (UNII: 8SKN0B0MIM)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
ZINC OXIDE (UNII: SOI2LOH54Z)
MICA (UNII: V8A1AW0880)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52686-246-60	1 in 1 CARTON	02/01/2011
1		33.45 g in 1 TUBE; 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	02/01/2011

Labeler - SHISEIDO AMERICA INC. (782677132)

Establishment
Name	Address	ID/FEI	Business Operations
SHISEIDO AMERICA INC.		782677132	manufacture(52686-232, 52686-233, 52686-234, 52686-235, 52686-236, 52686-237, 52686-238, 52686-239, 52686-240, 52686-241, 52686-242, 52686-243, 52686-244, 52686-245, 52686-246) , analysis(52686-232, 52686-233, 52686-234, 52686-235, 52686-236, 52686-237, 52686-238, 52686-239, 52686-240, 52686-241, 52686-242, 52686-243, 52686-244, 52686-245, 52686-246)