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 AMERICA INC.

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SHISEIDO PURENESS MATIFYING COMPACT OIL-FREE (REFILL)

Drug Facts

ACTIVE INGREDIENTSPurpose
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

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 - 10 LIGHT IVORY

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- 20 LIGHT BEIGE

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 - 30 NATURAL IVORY

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 - 40 NATURAL BEIGE

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 - 50 DEEP IVORY

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.

PRINCIPAL DISPLAY PANEL - 11g Tray Carton - 60 NATURAL BEIGE
SHISEIDO PURENESS MATIFYING COMPACT OIL-FREE (REFILL)   10
octinoxate and titanium dioxide powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52686-302
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE209 mg  in 11 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE198 mg  in 11 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52686-302-301 in 1 CARTON09/01/200208/01/2015
111 g in 1 TRAY; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02009/01/200208/01/2015
SHISEIDO PURENESS MATIFYING COMPACT OIL-FREE (REFILL)   20
octinoxate and titanium dioxide powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52686-303
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE209 mg  in 11 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE198 mg  in 11 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52686-303-301 in 1 CARTON09/01/200208/01/2015
111 g in 1 TRAY; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02009/01/200208/01/2015
SHISEIDO PURENESS MATIFYING COMPACT OIL-FREE (REFILL)   30
octinoxate and titanium dioxide powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52686-304
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE209 mg  in 11 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE198 mg  in 11 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52686-304-301 in 1 CARTON09/01/200208/01/2015
111 g in 1 TRAY; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02009/01/200208/01/2015
SHISEIDO PURENESS MATIFYING COMPACT OIL-FREE (REFILL)   40
octinoxate and titanium dioxide powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52686-305
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE209 mg  in 11 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE198 mg  in 11 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52686-305-301 in 1 CARTON09/01/200208/01/2015
111 g in 1 TRAY; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02009/01/200208/01/2015
SHISEIDO PURENESS MATIFYING COMPACT OIL-FREE (REFILL)   50
octinoxate and titanium dioxide powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52686-306
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE209 mg  in 11 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE198 mg  in 11 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52686-306-301 in 1 CARTON09/01/200209/30/2020
111 g in 1 TRAY; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02009/01/200209/30/2020
SHISEIDO PURENESS MATIFYING COMPACT OIL-FREE (REFILL)   60
octinoxate and titanium dioxide powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52686-307
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE209 mg  in 11 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE198 mg  in 11 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52686-307-301 in 1 CARTON09/01/200208/01/2015
111 g in 1 TRAY; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02009/01/200208/01/2015
Labeler - SHISEIDO AMERICA INC. (782677132)
Establishment
NameAddressID/FEIBusiness Operations
SHISEIDO AMERICA INC.782677132MANUFACTURE(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)

Revised: 10/2023
Document Id: f15b9510-8869-4281-98c5-1f5281376dee
Set id: bc60460c-202e-434d-958d-98e30eb98cd1
Version: 3
Effective Time: 20231022
 
SHISEIDO AMERICA INC.