SHISEIDO PURENESS MATIFYING COMPACT OIL-FREE (REFILL) 10- octinoxate and titanium dioxide powder SHISEIDO PURENESS MATIFYING COMPACT OIL-FREE (REFILL) 20- octinoxate and titanium dioxide powder SHISEIDO PURENESS MATIFYING COMPACT OIL-FREE (REFILL) 30- octinoxate and titanium dioxide powder SHISEIDO PURENESS MATIFYING COMPACT OIL-FREE (REFILL) 40- octinoxate and titanium dioxide powder SHISEIDO PURENESS MATIFYING COMPACT OIL-FREE (REFILL) 50- octinoxate and titanium dioxide powder SHISEIDO PURENESS MATIFYING COMPACT OIL-FREE (REFILL) 60- octinoxate and titanium dioxide powder

SHISEIDO PURENESS MATIFYING COMPACT oil-FREE (REFILL) by

Drug Labeling and Warnings

SHISEIDO PURENESS MATIFYING COMPACT oil-FREE (REFILL) 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 1.8%	Sunscreen

Uses

• helps prevent sunburn
• if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

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, POLYMETHYL METHACRYLATE, DIMETHICONE, ZINC MYRISTATE, DIISOSTEARYL MALATE, SILICA, SORBITAN SESQUIISOSTEARATE, DIPHENYLSILOXY PHENYL TRIMETHICONE, METHICONE, TOCOPHEROL, BHT, ETHYLPARABEN, FRAGRANCE, MICA, ZINC OXIDE, IRON OXIDES, 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
SHISEIDO DIST. NEW YORK PARIS MILANO

PRINCIPAL DISPLAY PANEL - 11g Tray Carton - 10 LIGHT IVORY

SHISEIDO

Pureness

Matifying Compact
Oil-Free
<Foundation> (Refill)

BROAD SPECTRUM
SPF 16

sunscreen

11g NET WT. .38 OZ.

PRINCIPAL DISPLAY PANEL - 11g Tray Carton - 20 LIGHT BEIGE

SHISEIDO

Pureness

Matifying Compact
Oil-Free
<Foundation> (Refill)

BROAD SPECTRUM
SPF 16

sunscreen

11g NET WT. .38 OZ.

PRINCIPAL DISPLAY PANEL - 11g Tray Carton - 30 NATURAL IVORY

SHISEIDO

Pureness

Matifying Compact
Oil-Free
<Foundation> (Refill)

BROAD SPECTRUM
SPF 16

sunscreen

11g NET WT. .38 OZ.

PRINCIPAL DISPLAY PANEL - 11g Tray Carton - 40 NATURAL BEIGE

SHISEIDO

Pureness

Matifying Compact
Oil-Free
<Foundation> (Refill)

BROAD SPECTRUM
SPF 16

sunscreen

11g NET WT. .38 OZ.

PRINCIPAL DISPLAY PANEL - 11g Tray Carton - 50 DEEP IVORY

SHISEIDO

Pureness

Matifying Compact
Oil-Free
<Foundation> (Refill)

BROAD SPECTRUM
SPF 16

sunscreen

11g NET WT. .38 OZ.

PRINCIPAL DISPLAY PANEL - 11g Tray Carton - 60 NATURAL BEIGE

SHISEIDO

Pureness

Matifying Compact
Oil-Free
<Foundation> (Refill)

BROAD SPECTRUM
SPF 16

sunscreen

11g NET WT. .38 OZ.

INGREDIENTS AND APPEARANCE

SHISEIDO PURENESS MATIFYING COMPACT OIL-FREE (REFILL)   10
octinoxate and titanium dioxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52686-302
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	209 mg  in 11 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	198 mg  in 11 g

Inactive Ingredients
Ingredient Name	Strength
TALC (UNII: 7SEV7J4R1U)
ZINC OXIDE (UNII: SOI2LOH54Z)
DIMETHICONE (UNII: 92RU3N3Y1O)
ZINC MYRISTATE (UNII: K09A9E2GGO)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
MICA (UNII: V8A1AW0880)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
ETHYLPARABEN (UNII: 14255EXE39)
METHICONE (20 CST) (UNII: 6777U11MKT)
TOCOPHEROL (UNII: R0ZB2556P8)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52686-302-30	1 in 1 CARTON	09/01/2002
1		11 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	09/01/2002

SHISEIDO PURENESS MATIFYING COMPACT OIL-FREE (REFILL)   20
octinoxate and titanium dioxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52686-303
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	209 mg  in 11 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	198 mg  in 11 g

Inactive Ingredients
Ingredient Name	Strength
TALC (UNII: 7SEV7J4R1U)
ZINC OXIDE (UNII: SOI2LOH54Z)
DIMETHICONE (UNII: 92RU3N3Y1O)
ZINC MYRISTATE (UNII: K09A9E2GGO)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
MICA (UNII: V8A1AW0880)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
ETHYLPARABEN (UNII: 14255EXE39)
METHICONE (20 CST) (UNII: 6777U11MKT)
TOCOPHEROL (UNII: R0ZB2556P8)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52686-303-30	1 in 1 CARTON	09/01/2002
1		11 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	09/01/2002

SHISEIDO PURENESS MATIFYING COMPACT OIL-FREE (REFILL)   30
octinoxate and titanium dioxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52686-304
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	209 mg  in 11 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	198 mg  in 11 g

Inactive Ingredients
Ingredient Name	Strength
TALC (UNII: 7SEV7J4R1U)
ZINC OXIDE (UNII: SOI2LOH54Z)
DIMETHICONE (UNII: 92RU3N3Y1O)
ZINC MYRISTATE (UNII: K09A9E2GGO)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
MICA (UNII: V8A1AW0880)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
ETHYLPARABEN (UNII: 14255EXE39)
METHICONE (20 CST) (UNII: 6777U11MKT)
TOCOPHEROL (UNII: R0ZB2556P8)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52686-304-30	1 in 1 CARTON	09/01/2002
1		11 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	09/01/2002

SHISEIDO PURENESS MATIFYING COMPACT OIL-FREE (REFILL)   40
octinoxate and titanium dioxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52686-305
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	209 mg  in 11 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	198 mg  in 11 g

Inactive Ingredients
Ingredient Name	Strength
TALC (UNII: 7SEV7J4R1U)
ZINC OXIDE (UNII: SOI2LOH54Z)
DIMETHICONE (UNII: 92RU3N3Y1O)
ZINC MYRISTATE (UNII: K09A9E2GGO)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
MICA (UNII: V8A1AW0880)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
ETHYLPARABEN (UNII: 14255EXE39)
METHICONE (20 CST) (UNII: 6777U11MKT)
TOCOPHEROL (UNII: R0ZB2556P8)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52686-305-30	1 in 1 CARTON	09/01/2002
1		11 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	09/01/2002

SHISEIDO PURENESS MATIFYING COMPACT OIL-FREE (REFILL)   50
octinoxate and titanium dioxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52686-306
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	209 mg  in 11 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	198 mg  in 11 g

Inactive Ingredients
Ingredient Name	Strength
TALC (UNII: 7SEV7J4R1U)
ZINC OXIDE (UNII: SOI2LOH54Z)
DIMETHICONE (UNII: 92RU3N3Y1O)
ZINC MYRISTATE (UNII: K09A9E2GGO)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
MICA (UNII: V8A1AW0880)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
ETHYLPARABEN (UNII: 14255EXE39)
METHICONE (20 CST) (UNII: 6777U11MKT)
TOCOPHEROL (UNII: R0ZB2556P8)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52686-306-30	1 in 1 CARTON	09/01/2002
1		11 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	09/01/2002

SHISEIDO PURENESS MATIFYING COMPACT OIL-FREE (REFILL)   60
octinoxate and titanium dioxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52686-307
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	209 mg  in 11 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	198 mg  in 11 g

Inactive Ingredients
Ingredient Name	Strength
TALC (UNII: 7SEV7J4R1U)
ZINC OXIDE (UNII: SOI2LOH54Z)
DIMETHICONE (UNII: 92RU3N3Y1O)
ZINC MYRISTATE (UNII: K09A9E2GGO)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
MICA (UNII: V8A1AW0880)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
ETHYLPARABEN (UNII: 14255EXE39)
METHICONE (20 CST) (UNII: 6777U11MKT)
TOCOPHEROL (UNII: R0ZB2556P8)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52686-307-30	1 in 1 CARTON	09/01/2002
1		11 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	09/01/2002

Labeler - SHISEIDO AMERICA INC. (782677132)

Establishment
Name	Address	ID/FEI	Business Operations
SHISEIDO AMERICA INC.		782677132	MANUFACTURE(52686-302, 52686-303, 52686-304, 52686-305, 52686-306, 52686-307) , ANALYSIS(52686-302, 52686-303, 52686-304, 52686-305, 52686-306, 52686-307)