SHISEIDO SHEER MATIFYING COMPACT (REFILL) D10- octinoxate and titanium dioxide powder SHISEIDO SHEER MATIFYING COMPACT (REFILL) D20- octinoxate and titanium dioxide powder SHISEIDO SHEER MATIFYING COMPACT (REFILL) D30- octinoxate and titanium dioxide powder

SHISEIDO SHEER MATIFYING COMPACT (REFILL) by

Drug Labeling and Warnings

SHISEIDO SHEER MATIFYING COMPACT (REFILL) by is a Otc medication manufactured, distributed, or labeled by SHISEIDO CO., LTD., SHISEIDO AMERICA INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients		Purpose
OCTINOXATE	3.9%	Sunscreen
TITANIUM DIOXIDE	6.0％	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

TALC, SYNTHETIC FLUORPHLOGOPITE, VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER, BARIUM SULFATE, DIPHENYLSILOXY PHENYL, TRIMETHICONE, SILICA, METHYL METHACRYLATE CROSSPOLYMER, DIMETHYLENECYCLOHEXANE BIS-HYDROXYSTEARAMIDE, CETYL ETHYLHEXANOATE, DIPHENYL DIMETHICONE/VINYL DIPHENYL DIMETHICONE/SILSESQUIOXANE CROSSPOLYMER, HEXAMETHYLENE BIS-HYDROXYSTEARAMIDE, DIISOSTEARYL MALATE, NYLON-12, PEG/PPG-36/41 DIMETHYL ETHER, POLYSILICONE-2, SORBITAN SESQUIISOSTEARATE, DIMETHICONE, ALUMINUM HYDROXIDE, ALUMINUM DISTEARATE, DIMETHICONE/METHICONE COPOLYMER, METHICONE, TOCOPHEROL, DIPENTAERYTHRITYL HEXAHYDROXYSTEARATE, BHT, TETRADECENE, CHLORPHENESIN, ZINC OXIDE, TITANIUM DIOXIDE, IRON OXIDES, 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

SPL UNCLASSIFIED SECTION

Manufactured by
SHISEIDO CO.,LTD. 7-5-5 GINZA TOKYO

PRINCIPAL DISPLAY PANEL - 9.8g D 10 Tray Carton

SHI SEIDO

D 10

Sheer Matifying
Compact (Refill)

Long-lasting,
Oil-free Foundation

BROAD SPECTRUM
SPF 21
sunscreen

9.8g NET WT. .34 OZ.

PRINCIPAL DISPLAY PANEL - 9.8g D 20 Tray Carton

SHI SEIDO

D 20

Sheer Matifying
Compact (Refill)

Long-lasting,
Oil-free Foundation

BROAD SPECTRUM
SPF 21
sunscreen

9.8g NET WT. .34 OZ.

PRINCIPAL DISPLAY PANEL - 9.8g D 30 Tray Carton

SHI SEIDO

D 30

Sheer Matifying
Compact (Refill)

Long-lasting,
Oil-free Foundation

BROAD SPECTRUM
SPF 21
sunscreen

9.8g NET WT. .34 OZ.

INGREDIENTS AND APPEARANCE

SHISEIDO SHEER MATIFYING COMPACT (REFILL)  D10
octinoxate and titanium dioxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52685-455
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	382 mg  in 9.8 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	588 mg  in 9.8 g

Inactive Ingredients
Ingredient Name	Strength
TALC (UNII: 7SEV7J4R1U)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
ZINC OXIDE (UNII: SOI2LOH54Z)
BARIUM SULFATE (UNII: 25BB7EKE2E)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CETYL ETHYLHEXANOATE (UNII: 134647WMX4)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
NYLON-12 (UNII: 446U8J075B)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
DIMETHICONE (UNII: 92RU3N3Y1O)
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)
CHLORPHENESIN (UNII: I670DAL4SZ)
METHICONE (20 CST) (UNII: 6777U11MKT)
PEG/PPG-36/41 DIMETHYL ETHER (UNII: GZ406N3R9F)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
DIPENTAERYTHRITYL HEXAHYDROXYSTEARATE (UNII: 74J1X57U42)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
MICA (UNII: V8A1AW0880)
TETRADECENE (UNII: FW23481S7S)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52685-455-30	1 in 1 CARTON	08/01/2012
1		9.8 g in 1 TRAY; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	08/01/2012

SHISEIDO SHEER MATIFYING COMPACT (REFILL)  D20
octinoxate and titanium dioxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52685-456
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	382 mg  in 9.8 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	588 mg  in 9.8 g

Inactive Ingredients
Ingredient Name	Strength
TALC (UNII: 7SEV7J4R1U)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
ZINC OXIDE (UNII: SOI2LOH54Z)
BARIUM SULFATE (UNII: 25BB7EKE2E)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CETYL ETHYLHEXANOATE (UNII: 134647WMX4)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
NYLON-12 (UNII: 446U8J075B)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
DIMETHICONE (UNII: 92RU3N3Y1O)
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)
CHLORPHENESIN (UNII: I670DAL4SZ)
METHICONE (20 CST) (UNII: 6777U11MKT)
PEG/PPG-36/41 DIMETHYL ETHER (UNII: GZ406N3R9F)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
DIPENTAERYTHRITYL HEXAHYDROXYSTEARATE (UNII: 74J1X57U42)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
MICA (UNII: V8A1AW0880)
TETRADECENE (UNII: FW23481S7S)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52685-456-30	1 in 1 CARTON	08/01/2012
1		9.8 g in 1 TRAY; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	08/01/2012

SHISEIDO SHEER MATIFYING COMPACT (REFILL)  D30
octinoxate and titanium dioxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52685-457
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	382 mg  in 9.8 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	588 mg  in 9.8 g

Inactive Ingredients
Ingredient Name	Strength
TALC (UNII: 7SEV7J4R1U)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
ZINC OXIDE (UNII: SOI2LOH54Z)
BARIUM SULFATE (UNII: 25BB7EKE2E)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CETYL ETHYLHEXANOATE (UNII: 134647WMX4)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
NYLON-12 (UNII: 446U8J075B)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
DIMETHICONE (UNII: 92RU3N3Y1O)
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)
CHLORPHENESIN (UNII: I670DAL4SZ)
METHICONE (20 CST) (UNII: 6777U11MKT)
PEG/PPG-36/41 DIMETHYL ETHER (UNII: GZ406N3R9F)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
DIPENTAERYTHRITYL HEXAHYDROXYSTEARATE (UNII: 74J1X57U42)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
MICA (UNII: V8A1AW0880)
TETRADECENE (UNII: FW23481S7S)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52685-457-30	1 in 1 CARTON	08/01/2012
1		9.8 g in 1 TRAY; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	08/01/2012

Labeler - SHISEIDO CO., LTD. (690536453)

Establishment
Name	Address	ID/FEI	Business Operations
SHISEIDO AMERICA INC.		782677132	manufacture(52685-455, 52685-456, 52685-457) , analysis(52685-455, 52685-456, 52685-457)