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 by

Drug Labeling and Warnings

SHISEIDO THE MAKEUP FOUNDATION by is a Otc medication manufactured, distributed, or labeled by SHISEIDO AMERICAS CORPORATION, SHISEIDO AMERICAS INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

Titanium Dioxide 4.1%

Purpose

Sunscreen

Uses

• 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
• children under 6 months: ask a doctor
• 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

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 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 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 - 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 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 60

B 60

SHISEIDO

The Makeup

Stick Foundation
BROAD SPECTRUM
SPF 20
sunscreen

10g NET WT. .35 OZ.

INGREDIENTS AND APPEARANCE

SHISEIDO THE MAKEUP FOUNDATION   I20
titanium dioxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-458
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	400 mg  in 10 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-458-20	1 in 1 CARTON	01/01/2018
1		10 g in 1 CARTRIDGE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	01/01/2018

SHISEIDO THE MAKEUP FOUNDATION   I40
titanium dioxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-459
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	400 mg  in 10 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-459-20	1 in 1 CARTON	01/01/2018
1		10 g in 1 CARTRIDGE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	01/01/2018

SHISEIDO THE MAKEUP FOUNDATION   I60
titanium dioxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-460
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	400 mg  in 10 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-460-20	1 in 1 CARTON	01/01/2018
1		10 g in 1 CARTRIDGE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	01/01/2018

SHISEIDO THE MAKEUP FOUNDATION   B20
titanium dioxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-461
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	400 mg  in 10 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-461-20	1 in 1 CARTON	01/01/2018
1		10 g in 1 CARTRIDGE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	01/01/2018

SHISEIDO THE MAKEUP FOUNDATION   B40
titanium dioxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-462
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	400 mg  in 10 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-462-20	1 in 1 CARTON	01/01/2018
1		10 g in 1 CARTRIDGE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	01/01/2018

SHISEIDO THE MAKEUP FOUNDATION   B60
titanium dioxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-534
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	400 mg  in 10 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-534-20	1 in 1 CARTON	01/01/2018
1		10 g in 1 CARTRIDGE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	01/01/2018

Labeler - SHISEIDO AMERICAS CORPORATION (193691821)

Establishment
Name	Address	ID/FEI	Business Operations
SHISEIDO AMERICAS INC.		782677132	MANUFACTURE(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)