SHISEIDO THE MAKEUP SHEER MATIFYING COMPACT (REFILL)- octinoxate and titanium dioxide powder SHISEIDO THE MAKEUP SHEER MATIFYING COMPACT (REFILL)- octinoxate and titanium dioxide powder SHISEIDO THE MAKEUP SHEER MATIFYING COMPACT (REFILL)- octinoxate and titanium dioxide powder SHISEIDO THE MAKEUP SHEER MATIFYING COMPACT (REFILL)- octinoxate and titanium dioxide powder

SHISEIDO THE MAKEUP SHEER MATIFYING COMPACT (REFILL) by

Drug Labeling and Warnings

SHISEIDO THE MAKEUP SHEER MATIFYING COMPACT (REFILL) by is a Otc medication manufactured, distributed, or labeled by SHISEIDO CO., LTD.. 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

Uses

• helps prevent sunburn
• higher SPF gives more sunburn protection

Warnings

For external use only.

When using this product

• keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if

• rash or irritation develops and lasts.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• apply evenly before sun exposure and as needed.
• children under 6 months of age: 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
ALUMINUM HYDROXIDE
SORBITAN SESQUIISOSTEARATE
DIMETHICONE
ALUMINUM DISTEARATE
POLYSILICONE-2
METHICONE
DIMETHICONE/METHICONE COPOLYMER
TOCOPHEROL
DIPENTAERYTHRITYL HEXAHYDROXYSTEARATE
BHT
TETRADECENE
CHLORPHENESIN
TITANIUM DIOXIDE
IRON OXIDES
ZINC OXIDE
MICA

Questions?

1-800-906-7503

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 9.8g Tray Carton (B 00)

SHISEIDO

B 00

Sheer Matifying
Compact (Refill)
Long-lasting,
Oil-free Foundation

SPF 22
sunscreen

9.8g NET WT. .34 OZ.

PRINCIPAL DISPLAY PANEL - 9.8g Tray Carton (B 100)

SHISEIDO

B 100

Sheer Matifying
Compact (Refill)
Long-lasting,
Oil-free Foundation

SPF 22
sunscreen

9.8g NET WT. .34 OZ.

PRINCIPAL DISPLAY PANEL - 9.8g Tray Carton (I 100)

SHISEIDO

I 100

Sheer Matifying
Compact (Refill)
Long-lasting,
Oil-free Foundation

SPF 22
sunscreen

9.8g NET WT. .34 OZ.

PRINCIPAL DISPLAY PANEL - 9.8g Tray Carton (O 00)

SHISEIDO

O 00

Sheer Matifying
Compact (Refill)
Long-lasting,
Oil-free Foundation

SPF 22
sunscreen

9.8g NET WT. .34 OZ.

INGREDIENTS AND APPEARANCE

SHISEIDO THE MAKEUP SHEER MATIFYING COMPACT (REFILL)   B00
octinoxate and titanium dioxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52685-348
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)
BARIUM SULFATE (UNII: 25BB7EKE2E)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CETYL ETHYLHEXANOATE (UNII: 134647WMX4)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
DIMETHICONE (UNII: 92RU3N3Y1O)
ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
CHLORPHENESIN (UNII: I670DAL4SZ)
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: 52685-348-30	1 in 1 CARTON
1		9.8 g in 1 TRAY

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	08/01/2011

SHISEIDO THE MAKEUP SHEER MATIFYING COMPACT (REFILL)   B100
octinoxate and titanium dioxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52685-349
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)
BARIUM SULFATE (UNII: 25BB7EKE2E)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CETYL ETHYLHEXANOATE (UNII: 134647WMX4)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
DIMETHICONE (UNII: 92RU3N3Y1O)
ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
CHLORPHENESIN (UNII: I670DAL4SZ)
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: 52685-349-30	1 in 1 CARTON
1		9.8 g in 1 TRAY

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	08/01/2011

SHISEIDO THE MAKEUP SHEER MATIFYING COMPACT (REFILL)   I00
octinoxate and titanium dioxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52685-350
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)
BARIUM SULFATE (UNII: 25BB7EKE2E)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CETYL ETHYLHEXANOATE (UNII: 134647WMX4)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
DIMETHICONE (UNII: 92RU3N3Y1O)
ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
CHLORPHENESIN (UNII: I670DAL4SZ)
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: 52685-350-30	1 in 1 CARTON
1		9.8 g in 1 TRAY

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	08/01/2011

SHISEIDO THE MAKEUP SHEER MATIFYING COMPACT (REFILL)   O00
octinoxate and titanium dioxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52685-351
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)
BARIUM SULFATE (UNII: 25BB7EKE2E)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CETYL ETHYLHEXANOATE (UNII: 134647WMX4)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
DIMETHICONE (UNII: 92RU3N3Y1O)
ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
CHLORPHENESIN (UNII: I670DAL4SZ)
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: 52685-351-30	1 in 1 CARTON
1		9.8 g in 1 TRAY

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	08/01/2011

Labeler - SHISEIDO CO., LTD. (690536453)

Establishment
Name	Address	ID/FEI	Business Operations
SHISEIDO CO., LTD.		690536453	ANALYSIS, MANUFACTURE