FDA.reportPublic FDA data

SHISEIDO THE MAKEUP FOUNDATION

Manufacturer
SHISEIDO AMERICAS CORPORATION | Shiseido America Inc.
Effective date
2026-01-05
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:31:28

Label at a glance#

ProductSHISEIDO THE MAKEUP FOUNDATION I20
Active ingredientTITANIUM DIOXIDE
Label structure15 sections

Indications and uses

helps prevent sunburn

Dosage and administration

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 me...

Storage and handling

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

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Titanium Dioxide 4.1%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • helps prevent sunburn

Warnings

WARNINGS SECTION

For external use only

OTC - DO NOT USE SECTION

Do not use on damaged or broken skin

OTC - WHEN USING SECTION

When using this productkeep out of eyes. Rinse with water to remove.

OTC - STOP USE SECTION

Stop use and ask a doctorif rash occurs.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

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

INACTIVE INGREDIENT SECTION

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

STORAGE AND HANDLING SECTION

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

Questions or comments?

OTC - QUESTIONS SECTION

Call toll free 1-800-906-7503

PRINCIPAL DISPLAY PANEL - 10 g Cartridge Carton - I 20

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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 20

PRINCIPAL DISPLAY PANEL - 10 g Cartridge Carton - I 40

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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 40

PRINCIPAL DISPLAY PANEL - 10 g Cartridge Carton - I 60

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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 - I 60

PRINCIPAL DISPLAY PANEL - 10 g Cartridge Carton - B 20

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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 20

PRINCIPAL DISPLAY PANEL - 10 g Cartridge Carton - B 40

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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 40

PRINCIPAL DISPLAY PANEL - 10 g Cartridge Carton - B 60

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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
PRINCIPAL DISPLAY PANEL - 10 g Cartridge Carton - B 60

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58411-534-202023-12-29C16284748780-1ba0f9c33-167a-a910-e053-dadaa90a0b85SHISEIDO THE MAKEUP STICK FOUNDATION
58411-534-202021-01-29C16284748780-1ba0f9c33-167a-a910-e053-dadaa90a0b85SHISEIDO THE MAKEUP STICK FOUNDATION

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58411-458-20SHISEIDO THE MAKEUP FOUNDATIONI2010 g in 1 CARTRIDGESTICK104
58411-458-20SHISEIDO THE MAKEUP FOUNDATIONI201 in 1 CARTONSTICK14
58411-459-20SHISEIDO THE MAKEUP FOUNDATIONI401 in 1 CARTONSTICK14
58411-459-20SHISEIDO THE MAKEUP FOUNDATIONI4010 g in 1 CARTRIDGESTICK104
58411-460-20SHISEIDO THE MAKEUP FOUNDATIONI601 in 1 CARTONSTICK14
58411-460-20SHISEIDO THE MAKEUP FOUNDATIONI6010 g in 1 CARTRIDGESTICK104
58411-461-20SHISEIDO THE MAKEUP FOUNDATIONB2010 g in 1 CARTRIDGESTICK104
58411-461-20SHISEIDO THE MAKEUP FOUNDATIONB201 in 1 CARTONSTICK14
58411-462-20SHISEIDO THE MAKEUP FOUNDATIONB401 in 1 CARTONSTICK14
58411-462-20SHISEIDO THE MAKEUP FOUNDATIONB4010 g in 1 CARTRIDGESTICK104
58411-534-20SHISEIDO THE MAKEUP FOUNDATIONB601 in 1 CARTONSTICK14
58411-534-20SHISEIDO THE MAKEUP FOUNDATIONB6010 g in 1 CARTRIDGESTICK104

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 31 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58411-45858411-458-20
58411-45958411-459-20
58411-46058411-460-20
58411-46158411-461-20
58411-46258411-462-20
58411-53458411-534-20

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 4 · 150 matching rows.

Name, UNII, Kind table
NameUNIIKind
CYCLOMETHICONE 6XHK3U310BAIACT
TRIETHYLHEXANOIN7K3W1BIU6KIACT
DIMETHICONE92RU3N3Y1OIACT
KAOLIN24H4NWX5COIACT
CYCLOMETHICONE 50THT5PCI0RIACT
PARAFFINI9O0E3H2ZEIACT
SORBITAN SESQUIISOSTEARATEVU97D01BF9IACT
CANDELILLA WAXWL0328HX19IACT
PHYTOSTERYL/OCTYLDODECYL LAUROYL GLUTAMATE65954KGO9QIACT
.ALPHA.-TOCOPHEROL ACETATE, DL-WR1WPI7EW8IACT
POLY(METHYL METHACRYLATE; 450000 MW)Z47NNT4J11IACT
CARNAUBA WAXR12CBM0EIZIACT
ALUMINUM HYDROXIDE5QB0T2IUN0IACT
STEARIC ACID4ELV7Z65APIACT
MICROCRYSTALLINE WAXXOF597Q3KYIACT
ALUMINUM OXIDELMI26O6933IACT
GLYCERINPDC6A3C0OXIACT
.ALPHA.-TOCOPHEROLH4N855PNZ1IACT
ZINC OXIDESOI2LOH54ZIACT
BUTYLATED HYDROXYTOLUENE1P9D0Z171KIACT
MICAV8A1AW0880IACT
FERRIC OXIDE RED1K09F3G675IACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
FERROSOFERRIC OXIDEXM0M87F357IACT
TITANIUM DIOXIDE15FIX9V2JPACTIB
CYCLOMETHICONE 6XHK3U310BAIACT
TRIETHYLHEXANOIN7K3W1BIU6KIACT
DIMETHICONE92RU3N3Y1OIACT
KAOLIN24H4NWX5COIACT
CYCLOMETHICONE 50THT5PCI0RIACT
PARAFFINI9O0E3H2ZEIACT
SORBITAN SESQUIISOSTEARATEVU97D01BF9IACT
CANDELILLA WAXWL0328HX19IACT
PHYTOSTERYL/OCTYLDODECYL LAUROYL GLUTAMATE65954KGO9QIACT
.ALPHA.-TOCOPHEROL ACETATE, DL-WR1WPI7EW8IACT
POLY(METHYL METHACRYLATE; 450000 MW)Z47NNT4J11IACT
CARNAUBA WAXR12CBM0EIZIACT
ALUMINUM HYDROXIDE5QB0T2IUN0IACT
STEARIC ACID4ELV7Z65APIACT
MICROCRYSTALLINE WAXXOF597Q3KYIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SHISEIDO THE MAKEUP FOUNDATION I20TITANIUM DIOXIDESHISEIDO AMERICAS CORPORATION3c024fe9-2983-4857-a55a-13406158e3a92026-01-05WarningsExact identifier
ndc (package): 58411-461-20
ndc (package): 58411-534-20
ndc (package): 58411-458-20
ndc (package): 58411-462-20
ndc (package): 58411-459-20
ndc (package): 58411-460-20
ndc (product): 58411-534
ndc (product): 58411-460
ndc (product): 58411-459
ndc (product): 58411-462
ndc (product): 58411-461
ndc (product): 58411-458
ndc11 (package): 58411053420
ndc11 (package): 58411046020
ndc11 (package): 58411045920
ndc11 (package): 58411046120
ndc11 (package): 58411045820
ndc11 (package): 58411046220
spl id: 47abe7b4-317b-901b-e063-6394a90a63f2
spl set id: 3c024fe9-2983-4857-a55a-13406158e3a9

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.