SHISEIDO PERFECT REFINING FOUNDATION D10- octinoxate and titanium dioxide cream SHISEIDO PERFECT REFINING FOUNDATION D20- octinoxate and titanium dioxide cream SHISEIDO PERFECT REFINING FOUNDATION D30- 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 2.9%	Sunscreen
TITANIUM DIOXIDE 5.8%	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, POLYGLYCERYL-2 DIISOSTEARATE, PEG/PPG-36/41 DIMETHYL ETHER, SODIUM HYALURONATE, LAVANDULA ANGUSTIFOLIA (LAVENDER) OIL, PAEONIA ALBIFLORA ROOT EXTRACT, ALUMINUM HYDROXIDE, ALUMINUM DISTEARATE, TRISODIUM EDTA, DISTEARDIMONIUM HECTORITE, POLYSILICONE-2, VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER, BUTYLENE GLYCOL, TOCOPHEROL, DIPENTAERYTHRITYL HEXAHYDROXYSTEARATE, BARIUM SULFATE, SODIUM METABISULFITE, BHT, METHICONE, TETRADECENE, HYDROGEN DIMETHICONE, ALUMINA, PHENOXYETHANOL, BENZOIC ACID, IRON OXIDES, ZINC OXIDE, MICA, TITANIUM DIOXIDE,

Other information

• protect this product in this container from excessive heat and direct sun.

Questions or comments?

Call toll free 1-800-906-7503

SPL UNCLASSIFIED SECTION

SHISEIDO AMERICA INC.
NEW YORK, N.Y. 10022

PRINCIPAL DISPLAY PANEL - 30mL D 10 Tube Carton

SHISEIDO

D 10

Perfect Refining
Foundation

All-Day Flawless,
Optimal Moisture

BROAD SPECTRUM
SPF 15
sunscreen

30mL 1 FL. OZ.

PRINCIPAL DISPLAY PANEL - 30mL D 20 Tube Carton

SHISEIDO

D 20

Perfect Refining
Foundation

All-Day Flawless,
Optimal Moisture

BROAD SPECTRUM
SPF 15
sunscreen

30mL 1 FL. OZ.

PRINCIPAL DISPLAY PANEL - 30mL D 30 Tube Carton

SHISEIDO

D 30

Perfect Refining
Foundation

All-Day Flawless,
Optimal Moisture

BROAD SPECTRUM
SPF 15
sunscreen

30mL 1 FL. OZ.

INGREDIENTS AND APPEARANCE

SHISEIDO PERFECT REFINING FOUNDATION  D10
octinoxate and titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52686-277
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	983 mg  in 33.9 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	1966 mg  in 33.9 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
CYCLOMETHICONE (UNII: NMQ347994Z)
NYLON-12 (UNII: 446U8J075B)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
DIETHYLHEXYL SUCCINATE (UNII: 69W9UMG3P8)
GLYCERIN (UNII: PDC6A3C0OX)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
ERYTHRITOL (UNII: RA96B954X6)
XYLITOL (UNII: VCQ006KQ1E)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
EDETATE TRISODIUM (UNII: 420IP921MB)
PEG/PPG-36/41 DIMETHYL ETHER (UNII: GZ406N3R9F)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
ZINC OXIDE (UNII: SOI2LOH54Z)
MICA (UNII: V8A1AW0880)
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)
ALUMINUM OXIDE (UNII: LMI26O6933)
BENZOIC ACID (UNII: 8SKN0B0MIM)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52686-277-60	1 in 1 CARTON	02/01/2011
1		33.9 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  D20
octinoxate and titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52686-278
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	983 mg  in 33.9 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	1966 mg  in 33.9 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
CYCLOMETHICONE (UNII: NMQ347994Z)
NYLON-12 (UNII: 446U8J075B)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
DIETHYLHEXYL SUCCINATE (UNII: 69W9UMG3P8)
GLYCERIN (UNII: PDC6A3C0OX)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
ERYTHRITOL (UNII: RA96B954X6)
XYLITOL (UNII: VCQ006KQ1E)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
EDETATE TRISODIUM (UNII: 420IP921MB)
PEG/PPG-36/41 DIMETHYL ETHER (UNII: GZ406N3R9F)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
ZINC OXIDE (UNII: SOI2LOH54Z)
MICA (UNII: V8A1AW0880)
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)
ALUMINUM OXIDE (UNII: LMI26O6933)
BENZOIC ACID (UNII: 8SKN0B0MIM)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52686-278-60	1 in 1 CARTON	02/01/2011
1		33.9 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  D30
octinoxate and titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52686-279
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	983 mg  in 33.9 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	1966 mg  in 33.9 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
CYCLOMETHICONE (UNII: NMQ347994Z)
NYLON-12 (UNII: 446U8J075B)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
DIETHYLHEXYL SUCCINATE (UNII: 69W9UMG3P8)
GLYCERIN (UNII: PDC6A3C0OX)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
ERYTHRITOL (UNII: RA96B954X6)
XYLITOL (UNII: VCQ006KQ1E)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
EDETATE TRISODIUM (UNII: 420IP921MB)
PEG/PPG-36/41 DIMETHYL ETHER (UNII: GZ406N3R9F)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
ZINC OXIDE (UNII: SOI2LOH54Z)
MICA (UNII: V8A1AW0880)
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)
ALUMINUM OXIDE (UNII: LMI26O6933)
BENZOIC ACID (UNII: 8SKN0B0MIM)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52686-279-60	1 in 1 CARTON	02/01/2011
1		33.9 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(52686-277, 52686-278, 52686-279) , analysis(52686-277, 52686-278, 52686-279)