SHISEIDO THE MAKEUP FOUNDATION  I00- titanium dioxide stick 
SHISEIDO THE MAKEUP FOUNDATION  I20- titanium dioxide stick 
SHISEIDO THE MAKEUP FOUNDATION  I40- titanium dioxide stick 
SHISEIDO THE MAKEUP FOUNDATION  I60- titanium dioxide stick 
SHISEIDO THE MAKEUP FOUNDATION  B20- titanium dioxide stick 
SHISEIDO THE MAKEUP FOUNDATION  B40- titanium dioxide stick 
SHISEIDO THE MAKEUP FOUNDATION  B60- titanium dioxide stick 
SHISEIDO THE MAKEUP FOUNDATION  O20- titanium dioxide stick 
SHISEIDO THE MAKEUP FOUNDATION  O40- titanium dioxide stick 
SHISEIDO THE MAKEUP FOUNDATION  O60- titanium dioxide stick 
SHISEIDO CO., LTD.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

SHISEIDO THE MAKEUP STICK FOUNDATION

Drug Facts

Active ingredient

TITANIUM DIOXIDE 4.1%

Purpose

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

CYCLOMETHICONE • TRIETHYLHEXANOIN • MICA • TITANIUM DIOXIDE • KAOLIN • DIMETHICONE • CERESIN • SORBITAN SESQUIISOSTEARATE • IRON OXIDES • COPERNICIA CERIFERA (CARNAUBA) WAX • EUPHORBIA CERIFERA (CANDELILLA) WAX • ALUMINUM HYDROXIDE • ALUMINUM DISTEARATE • FRAGRANCE • PHYTOSTERYL/OCTYLDODECYL LAUROYL GLUTAMATE • TOCOPHEROL • TOCOPHERYL ACETATE • POLYMETHYL METHACRYLATE • SODIUM CARBONATE • ULTRAMARINES • ZINC OXIDE • RED 30

Other information

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

Questions or comments?

Call toll free 1-800-906-7503

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

PRINCIPAL DISPLAY PANEL - 10 g Carton I 00

SHISEIDO

I 00

The Makeup

Stick Foundation
BROAD SPECTRUM
SPF 17
sunscreen

10g NET WT. .35 OZ.

Principal Display Panel - 10 g Carton I 00

PRINCIPAL DISPLAY PANEL - 10 g Carton I 20

SHISEIDO

I 20

The Makeup

Stick Foundation
BROAD SPECTRUM
SPF 17
sunscreen

10g NET WT. .35 OZ.

Principal Display Panel - 10 g Carton I 20

PRINCIPAL DISPLAY PANEL - 10 g Carton I 40

SHISEIDO

I 40

The Makeup

Stick Foundation
BROAD SPECTRUM
SPF 17
sunscreen

10g NET WT. .35 OZ.

Principal Display Panel - 10 g Carton I 40

PRINCIPAL DISPLAY PANEL - 10 g Carton I 60

SHISEIDO

I 60

The Makeup

Stick Foundation
BROAD SPECTRUM
SPF 17
sunscreen

10g NET WT. .35 OZ.

Principal Display Panel - 10 g Carton I 60

PRINCIPAL DISPLAY PANEL - 10 g Carton B 20

SHISEIDO

B 20

The Makeup

Stick Foundation
BROAD SPECTRUM
SPF 17
sunscreen

10g NET WT. .35 OZ.

Principal Display Panel - 10 g Carton B 20

PRINCIPAL DISPLAY PANEL - 10 g Carton B 40

SHISEIDO

B 40

The Makeup

Stick Foundation
BROAD SPECTRUM
SPF 17
sunscreen

10g NET WT. .35 OZ.

Principal Display Panel - 10 g Carton B 40

PRINCIPAL DISPLAY PANEL - 10 g Carton B 60

SHISEIDO

B 60

The Makeup

Stick Foundation
BROAD SPECTRUM
SPF 17
sunscreen

10g NET WT. .35 OZ.

Principal Display Panel - 10 g Carton B 60

PRINCIPAL DISPLAY PANEL - 10 g Carton O 20

SHISEIDO

O 20

The Makeup

Stick Foundation
BROAD SPECTRUM
SPF 17
sunscreen

10g NET WT. .35 OZ.

Principal Display Panel - 10 g Carton O 20

PRINCIPAL DISPLAY PANEL - 10 g Carton O 40

SHISEIDO

O 40

The Makeup

Stick Foundation
BROAD SPECTRUM
SPF 17
sunscreen

10g NET WT. .35 OZ.

Principal Display Panel - 10 g Carton O 40

PRINCIPAL DISPLAY PANEL - 10 g Carton O 60

SHISEIDO

O 60

The Makeup

Stick Foundation
BROAD SPECTRUM
SPF 17
sunscreen

10g NET WT. .35 OZ.

Principal Display Panel - 10 g Carton O 60
SHISEIDO THE MAKEUP FOUNDATION   I00
titanium dioxide stick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52685-422
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE410 mg  in 10 g
Inactive Ingredients
Ingredient NameStrength
CYCLOMETHICONE (UNII: NMQ347994Z)  
TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)  
MICA (UNII: V8A1AW0880)  
KAOLIN (UNII: 24H4NWX5CO)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
CERESIN (UNII: Q1LS2UJO3A)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
CANDELILLA WAX (UNII: WL0328HX19)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)  
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
SODIUM CARBONATE (UNII: 45P3261C7T)  
ZINC OXIDE (UNII: SOI2LOH54Z)  
D&C RED NO. 30 (UNII: 2S42T2808B)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52685-422-211 in 1 CARTON01/01/200103/01/2023
110 g in 1 CONTAINER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35201/01/200103/01/2023
SHISEIDO THE MAKEUP FOUNDATION   I20
titanium dioxide stick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52685-423
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE410 mg  in 10 g
Inactive Ingredients
Ingredient NameStrength
CYCLOMETHICONE (UNII: NMQ347994Z)  
TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)  
MICA (UNII: V8A1AW0880)  
KAOLIN (UNII: 24H4NWX5CO)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
CERESIN (UNII: Q1LS2UJO3A)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
CANDELILLA WAX (UNII: WL0328HX19)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)  
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
SODIUM CARBONATE (UNII: 45P3261C7T)  
ZINC OXIDE (UNII: SOI2LOH54Z)  
D&C RED NO. 30 (UNII: 2S42T2808B)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52685-423-211 in 1 CARTON01/01/200103/01/2023
110 g in 1 CONTAINER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35201/01/200103/01/2023
SHISEIDO THE MAKEUP FOUNDATION   I40
titanium dioxide stick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52685-424
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE410 mg  in 10 g
Inactive Ingredients
Ingredient NameStrength
CYCLOMETHICONE (UNII: NMQ347994Z)  
TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)  
MICA (UNII: V8A1AW0880)  
KAOLIN (UNII: 24H4NWX5CO)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
CERESIN (UNII: Q1LS2UJO3A)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
CANDELILLA WAX (UNII: WL0328HX19)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)  
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
SODIUM CARBONATE (UNII: 45P3261C7T)  
ZINC OXIDE (UNII: SOI2LOH54Z)  
D&C RED NO. 30 (UNII: 2S42T2808B)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52685-424-211 in 1 CARTON01/01/200103/01/2023
110 g in 1 CONTAINER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35201/01/200103/01/2023
SHISEIDO THE MAKEUP FOUNDATION   I60
titanium dioxide stick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52685-425
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE410 mg  in 10 g
Inactive Ingredients
Ingredient NameStrength
CYCLOMETHICONE (UNII: NMQ347994Z)  
TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)  
MICA (UNII: V8A1AW0880)  
KAOLIN (UNII: 24H4NWX5CO)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
CERESIN (UNII: Q1LS2UJO3A)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
CANDELILLA WAX (UNII: WL0328HX19)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)  
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
SODIUM CARBONATE (UNII: 45P3261C7T)  
ZINC OXIDE (UNII: SOI2LOH54Z)  
D&C RED NO. 30 (UNII: 2S42T2808B)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52685-425-211 in 1 CARTON01/01/200101/31/2018
110 g in 1 CONTAINER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35201/01/200101/31/2018
SHISEIDO THE MAKEUP FOUNDATION   B20
titanium dioxide stick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52685-426
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE410 mg  in 10 g
Inactive Ingredients
Ingredient NameStrength
CYCLOMETHICONE (UNII: NMQ347994Z)  
TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)  
MICA (UNII: V8A1AW0880)  
KAOLIN (UNII: 24H4NWX5CO)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
CERESIN (UNII: Q1LS2UJO3A)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
CANDELILLA WAX (UNII: WL0328HX19)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)  
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
SODIUM CARBONATE (UNII: 45P3261C7T)  
ZINC OXIDE (UNII: SOI2LOH54Z)  
D&C RED NO. 30 (UNII: 2S42T2808B)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52685-426-211 in 1 CARTON01/01/200112/31/2017
110 g in 1 CONTAINER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35201/01/200112/31/2017
SHISEIDO THE MAKEUP FOUNDATION   B40
titanium dioxide stick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52685-427
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE410 mg  in 10 g
Inactive Ingredients
Ingredient NameStrength
CYCLOMETHICONE (UNII: NMQ347994Z)  
TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)  
MICA (UNII: V8A1AW0880)  
KAOLIN (UNII: 24H4NWX5CO)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
CERESIN (UNII: Q1LS2UJO3A)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
CANDELILLA WAX (UNII: WL0328HX19)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)  
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
SODIUM CARBONATE (UNII: 45P3261C7T)  
ZINC OXIDE (UNII: SOI2LOH54Z)  
D&C RED NO. 30 (UNII: 2S42T2808B)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52685-427-211 in 1 CARTON01/01/200101/31/2018
110 g in 1 CONTAINER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35201/01/200101/31/2018
SHISEIDO THE MAKEUP FOUNDATION   B60
titanium dioxide stick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52685-428
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE410 mg  in 10 g
Inactive Ingredients
Ingredient NameStrength
CYCLOMETHICONE (UNII: NMQ347994Z)  
TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)  
MICA (UNII: V8A1AW0880)  
KAOLIN (UNII: 24H4NWX5CO)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
CERESIN (UNII: Q1LS2UJO3A)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
CANDELILLA WAX (UNII: WL0328HX19)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)  
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
SODIUM CARBONATE (UNII: 45P3261C7T)  
ZINC OXIDE (UNII: SOI2LOH54Z)  
D&C RED NO. 30 (UNII: 2S42T2808B)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52685-428-211 in 1 CARTON01/01/200102/28/2022
110 g in 1 CONTAINER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35201/01/200102/28/2022
SHISEIDO THE MAKEUP FOUNDATION   O20
titanium dioxide stick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52685-429
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE410 mg  in 10 g
Inactive Ingredients
Ingredient NameStrength
CYCLOMETHICONE (UNII: NMQ347994Z)  
TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)  
MICA (UNII: V8A1AW0880)  
KAOLIN (UNII: 24H4NWX5CO)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
CERESIN (UNII: Q1LS2UJO3A)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
CANDELILLA WAX (UNII: WL0328HX19)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)  
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
SODIUM CARBONATE (UNII: 45P3261C7T)  
ZINC OXIDE (UNII: SOI2LOH54Z)  
D&C RED NO. 30 (UNII: 2S42T2808B)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52685-429-211 in 1 CARTON01/01/200102/28/2022
110 g in 1 CONTAINER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35201/01/200102/28/2022
SHISEIDO THE MAKEUP FOUNDATION   O40
titanium dioxide stick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52685-430
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE410 mg  in 10 g
Inactive Ingredients
Ingredient NameStrength
CYCLOMETHICONE (UNII: NMQ347994Z)  
TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)  
MICA (UNII: V8A1AW0880)  
KAOLIN (UNII: 24H4NWX5CO)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
CERESIN (UNII: Q1LS2UJO3A)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
CANDELILLA WAX (UNII: WL0328HX19)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)  
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
SODIUM CARBONATE (UNII: 45P3261C7T)  
ZINC OXIDE (UNII: SOI2LOH54Z)  
D&C RED NO. 30 (UNII: 2S42T2808B)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52685-430-211 in 1 CARTON01/01/200102/28/2022
110 g in 1 CONTAINER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35201/01/200102/28/2022
SHISEIDO THE MAKEUP FOUNDATION   O60
titanium dioxide stick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52685-431
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE410 mg  in 10 g
Inactive Ingredients
Ingredient NameStrength
CYCLOMETHICONE (UNII: NMQ347994Z)  
TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)  
MICA (UNII: V8A1AW0880)  
KAOLIN (UNII: 24H4NWX5CO)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
CERESIN (UNII: Q1LS2UJO3A)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
CANDELILLA WAX (UNII: WL0328HX19)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)  
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
SODIUM CARBONATE (UNII: 45P3261C7T)  
ZINC OXIDE (UNII: SOI2LOH54Z)  
D&C RED NO. 30 (UNII: 2S42T2808B)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52685-431-211 in 1 CARTON01/01/200101/01/2020
110 g in 1 CONTAINER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35201/01/200101/01/2020
Labeler - SHISEIDO CO., LTD. (690536453)
Establishment
NameAddressID/FEIBusiness Operations
SHISEIDO CO., LTD.695589382MANUFACTURE(52685-422, 52685-423, 52685-424, 52685-425, 52685-426, 52685-427, 52685-428, 52685-429, 52685-430, 52685-431) , ANALYSIS(52685-422, 52685-423, 52685-424, 52685-425, 52685-426, 52685-427, 52685-428, 52685-429, 52685-430, 52685-431)

Revised: 9/2023
Document Id: cffad0db-1bbd-45b4-81c3-7eaf31b63b71
Set id: 686c4608-deb5-41f1-ba73-d30c90cd106f
Version: 2
Effective Time: 20230921
 
SHISEIDO CO., LTD.