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 AMERICAS CORPORATION

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SHISEIDO THE MAKEUP STICK FOUNDATION

Drug Facts

Active ingredients

Titanium Dioxide 4.1%

Purpose

Sunscreen

Uses

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:

Inactive Ingredients

CYCLOHEXASILOXANE ∙ TRIETHYLHEXANOIN ∙ DIMETHICONE ∙ KAOLIN ∙ CYCLOPENTASILOXANE ∙ PARAFFIN ∙ SORBITAN SESQUIISOSTEARATE ∙ EUPHORBIA CERIFERA (CANDELILLA) WAX ∙ PHYTOSTERYL/OCTYLDODECYL LAUROYL GLUTAMATE ∙ TOCOPHERYL ACETATE ∙ POLYMETHYL METHACRYLATE ∙ COPERNICIA CERIFERA (CARNAUBA) WAX ∙ ALUMINUM HYDROXIDE ∙ STEARIC ACID ∙ MICROCRYSTALLINE WAX ∙ ALUMINA ∙ GLYCERIN ∙ TOCOPHEROL ∙ ZINC OXIDE ∙ BHT ∙ FRAGRANCE ∙ MICA ∙ TITANIUM DIOXIDE ∙ IRON OXIDES ∙ ULTRAMARINES ∙

Other information

Protect this product in this container from excessive heat and direct sun.

Questions or comments?

Call toll free 1-800-906-7503

PRINCIPAL DISPLAY PANEL - 10 g Cartridge Carton - I 20

I 20

SHISEIDO

The Makeup

Stick Foundation
BROAD SPECTRUM
SPF 20
sunscreen

10g NET WT. .35 OZ.

PRINCIPAL DISPLAY PANEL - 10 g Cartridge Carton - I 20

PRINCIPAL DISPLAY PANEL - 10 g Cartridge Carton - I 40

I 40

SHISEIDO

The Makeup

Stick Foundation
BROAD SPECTRUM
SPF 20
sunscreen

10g NET WT. .35 OZ.

PRINCIPAL DISPLAY PANEL - 10 g Cartridge Carton - I 40

PRINCIPAL DISPLAY PANEL - 10 g Cartridge Carton - I 60

I 60

SHISEIDO

The Makeup

Stick Foundation
BROAD SPECTRUM
SPF 20
sunscreen

10g NET WT. .35 OZ.

PRINCIPAL DISPLAY PANEL - 10 g Cartridge Carton - I 60

PRINCIPAL DISPLAY PANEL - 10 g Cartridge Carton - B 20

B 20

SHISEIDO

The Makeup

Stick Foundation
BROAD SPECTRUM
SPF 20
sunscreen

10g NET WT. .35 OZ.

PRINCIPAL DISPLAY PANEL - 10 g Cartridge Carton - B 20

PRINCIPAL DISPLAY PANEL - 10 g Cartridge Carton - B 40

B 40

SHISEIDO

The Makeup

Stick Foundation
BROAD SPECTRUM
SPF 20
sunscreen

10g NET WT. .35 OZ.

PRINCIPAL DISPLAY PANEL - 10 g Cartridge Carton - B 40

PRINCIPAL DISPLAY PANEL - 10 g Cartridge Carton - B 60

B 60

SHISEIDO

The Makeup

Stick Foundation
BROAD SPECTRUM
SPF 20
sunscreen

10g NET WT. .35 OZ.

PRINCIPAL DISPLAY PANEL - 10 g Cartridge Carton - B 60
SHISEIDO THE MAKEUP FOUNDATION   I20
titanium dioxide stick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-458
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE400 mg  in 10 g
Inactive Ingredients
Ingredient NameStrength
CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
KAOLIN (UNII: 24H4NWX5CO)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
PARAFFIN (UNII: I9O0E3H2ZE)  
SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9)  
CANDELILLA WAX (UNII: WL0328HX19)  
PHYTOSTERYL/OCTYLDODECYL LAUROYL GLUTAMATE (UNII: 65954KGO9Q)  
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
GLYCERIN (UNII: PDC6A3C0OX)  
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
ZINC OXIDE (UNII: SOI2LOH54Z)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
MICA (UNII: V8A1AW0880)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58411-458-201 in 1 CARTON01/01/2018
110 g in 1 CARTRIDGE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02001/01/2018
SHISEIDO THE MAKEUP FOUNDATION   I40
titanium dioxide stick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-459
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE400 mg  in 10 g
Inactive Ingredients
Ingredient NameStrength
CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
KAOLIN (UNII: 24H4NWX5CO)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
PARAFFIN (UNII: I9O0E3H2ZE)  
SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9)  
CANDELILLA WAX (UNII: WL0328HX19)  
PHYTOSTERYL/OCTYLDODECYL LAUROYL GLUTAMATE (UNII: 65954KGO9Q)  
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
GLYCERIN (UNII: PDC6A3C0OX)  
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
ZINC OXIDE (UNII: SOI2LOH54Z)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
MICA (UNII: V8A1AW0880)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58411-459-201 in 1 CARTON01/01/2018
110 g in 1 CARTRIDGE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02001/01/2018
SHISEIDO THE MAKEUP FOUNDATION   I60
titanium dioxide stick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-460
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE400 mg  in 10 g
Inactive Ingredients
Ingredient NameStrength
CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
KAOLIN (UNII: 24H4NWX5CO)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
PARAFFIN (UNII: I9O0E3H2ZE)  
SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9)  
CANDELILLA WAX (UNII: WL0328HX19)  
PHYTOSTERYL/OCTYLDODECYL LAUROYL GLUTAMATE (UNII: 65954KGO9Q)  
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
GLYCERIN (UNII: PDC6A3C0OX)  
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
ZINC OXIDE (UNII: SOI2LOH54Z)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
MICA (UNII: V8A1AW0880)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58411-460-201 in 1 CARTON01/01/2018
110 g in 1 CARTRIDGE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02001/01/2018
SHISEIDO THE MAKEUP FOUNDATION   B20
titanium dioxide stick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-461
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE400 mg  in 10 g
Inactive Ingredients
Ingredient NameStrength
CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
KAOLIN (UNII: 24H4NWX5CO)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
PARAFFIN (UNII: I9O0E3H2ZE)  
SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9)  
CANDELILLA WAX (UNII: WL0328HX19)  
PHYTOSTERYL/OCTYLDODECYL LAUROYL GLUTAMATE (UNII: 65954KGO9Q)  
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
GLYCERIN (UNII: PDC6A3C0OX)  
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
ZINC OXIDE (UNII: SOI2LOH54Z)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
MICA (UNII: V8A1AW0880)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58411-461-201 in 1 CARTON01/01/2018
110 g in 1 CARTRIDGE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02001/01/2018
SHISEIDO THE MAKEUP FOUNDATION   B40
titanium dioxide stick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-462
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE400 mg  in 10 g
Inactive Ingredients
Ingredient NameStrength
CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
KAOLIN (UNII: 24H4NWX5CO)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
PARAFFIN (UNII: I9O0E3H2ZE)  
SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9)  
CANDELILLA WAX (UNII: WL0328HX19)  
PHYTOSTERYL/OCTYLDODECYL LAUROYL GLUTAMATE (UNII: 65954KGO9Q)  
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
GLYCERIN (UNII: PDC6A3C0OX)  
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
ZINC OXIDE (UNII: SOI2LOH54Z)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
MICA (UNII: V8A1AW0880)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58411-462-201 in 1 CARTON01/01/2018
110 g in 1 CARTRIDGE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02001/01/2018
SHISEIDO THE MAKEUP FOUNDATION   B60
titanium dioxide stick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-534
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE400 mg  in 10 g
Inactive Ingredients
Ingredient NameStrength
CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
KAOLIN (UNII: 24H4NWX5CO)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
PARAFFIN (UNII: I9O0E3H2ZE)  
SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9)  
CANDELILLA WAX (UNII: WL0328HX19)  
PHYTOSTERYL/OCTYLDODECYL LAUROYL GLUTAMATE (UNII: 65954KGO9Q)  
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
GLYCERIN (UNII: PDC6A3C0OX)  
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
ZINC OXIDE (UNII: SOI2LOH54Z)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
MICA (UNII: V8A1AW0880)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58411-534-201 in 1 CARTON01/01/201801/31/2022
110 g in 1 CARTRIDGE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02001/01/201801/31/2022
Labeler - SHISEIDO AMERICAS CORPORATION (193691821)
Establishment
NameAddressID/FEIBusiness Operations
SHISEIDO AMERICAS INC.782677132MANUFACTURE(58411-458, 58411-459, 58411-460, 58411-461, 58411-462, 58411-534) , ANALYSIS(58411-458, 58411-459, 58411-460, 58411-461, 58411-462, 58411-534)

Revised: 12/2023
Document Id: 9bffdf19-7980-4cda-8f64-a645985c957f
Set id: 3c024fe9-2983-4857-a55a-13406158e3a9
Version: 2
Effective Time: 20231229
 
SHISEIDO AMERICAS CORPORATION