FDA.reportPublic FDA data

SHISEIDO ULTIMATE SUN PROTECTOR CREAM

Manufacturer
SHISEIDO AMERICAS CORPORATION | Shiseido America Inc.
Effective date
2026-01-05
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:31:21

Label at a glance#

ProductSHISEIDO ULTIMATE SUN PROTECTOR
Active ingredientOCTISALATE, TITANIUM DIOXIDE, OCTOCRYLENE, ZINC OXIDE
Label structure9 sections

Indications and 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

Dosage and administration

For sunscreen use: apply liberally 15 minutes before sun exposure reapply: after 80 minutes of swimming or sweating immediately after towel drying at least every two 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: l...

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

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredientsPurpose
Octisalate 5.0%Sunscreen
Octocrylene 7.0%Sunscreen
Titanium Dioxide 3.8%Sunscreen
Zinc Oxide 19.4%Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • 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

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.

Flammable

SPL UNCLASSIFIED SECTION

Do not use near heat, flame, or while smoking.

Directions

DOSAGE & ADMINISTRATION SECTION

For sunscreen use:

  • apply liberally 15 minutes before sun exposure
  • reapply:
    • after 80 minutes of swimming or sweating
    • immediately after towel drying
    • at least every two 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

INACTIVE INGREDIENT SECTION

WATER▪DIMETHICONE▪SD ALCOHOL 40-B▪ISOPROPYL MYRISTATE▪PEG/PPG-9/2 DIMETHYL ETHER▪METHYL METHACRYLATE CROSSPOLYMER▪LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE▪GLYCERIN▪ISOHEXADECANE▪POLYBUTYLENE GLYCOL/PPG-9/1 COPOLYMER▪ISODODECANE▪TRIMETHYLSILOXYSILICATE▪DISTEARDIMONIUM HECTORITE▪DEXTRIN PALMITATE▪PEG/PPG-14/7 DIMETHYL ETHER▪SAXIFRAGA SARMENTOSA EXTRACT▪SCUTELLARIA BAICALENSIS ROOT EXTRACT▪CAMELLIA SINENSIS LEAF EXTRACT▪ONONIS SPINOSA ROOT EXTRACT▪SODIUM HYALURONATE▪SOPHORA ANGUSTIFOLIA ROOT EXTRACT▪ALUMINUM HYDROXIDE▪SILICA▪HYDROGEN DIMETHICONE▪STEARIC ACID▪SORBITAN SESQUIISOSTEARATE▪CARBOXYDECYL TRISILOXANE▪TRISODIUM EDTA▪BUTYLENE GLYCOL▪ALCOHOL▪POLYMETHYLSILSESQUIOXANE▪TALC▪TOCOPHEROL▪BHT▪SODIUM METABISULFITE▪PEG-6▪SYZYGIUM JAMBOS LEAF EXTRACT▪PHENOXYETHANOL▪FRAGRANCE▪

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 - 50 mL Tube Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SHISEIDO
GINZA TOKYO

Ultimate
Sun Protector Cream

50+

SynchroShield
WetForce × HeatForce

BROAD SPECTRUM
SPF 50+

For Face

WATER RESISTANT
(80 MINUTES)

SUNSCREEN

50mL NET WT. 2 OZ.

PRINCIPAL DISPLAY PANEL - 50 mL Tube Label
PRINCIPAL DISPLAY PANEL - 50 mL Tube Label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58411-480-60SHISEIDO ULTIMATE SUN PROTECTOR1 in 1 CARTONCREAM13
58411-480-60SHISEIDO ULTIMATE SUN PROTECTOR50 mL in 1 TUBECREAM503

Products#

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

DailyMed product names page 1 of 2 · 46 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58411-48058411-480-60

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 44 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
DIMETHICONE92RU3N3Y1OIACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
PEG/PPG-9/2 DIMETHYL ETHERLM6Q66468XIACT
METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMEREG97988M5QIACT
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE25G622K2RAIACT
GLYCERINPDC6A3C0OXIACT
ISOHEXADECANE918X1OUF1EIACT
ISODODECANEA8289P68Y2IACT
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8)5041RX63GNIACT
DISTEARDIMONIUM HECTORITEX687XDK09LIACT
DEXTRIN PALMITATE (CORN; 20000 MW)89B2BSF9I3IACT
PEG/PPG-14/7 DIMETHYL ETHER6DNW9T7YT2IACT
SAXIFRAGA STOLONIFERA LEAFO3TMV4903HIACT
SCUTELLARIA BAICALENSIS ROOT7J95K7ID2SIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
ONONIS SPINOSA ROOTFD2FMC53M1IACT
HYALURONATE SODIUMYSE9PPT4THIACT
SOPHORA FLAVESCENS ROOTIYR6K8KQ5KIACT
ALUMINUM HYDROXIDE5QB0T2IUN0IACT
SILICON DIOXIDEETJ7Z6XBU4IACT
HYDROGEN DIMETHICONE (13 CST)4QGR4P2YOIIACT
STEARIC ACID4ELV7Z65APIACT
SORBITAN SESQUIISOSTEARATEVU97D01BF9IACT
EDETATE TRISODIUM420IP921MBIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
ALCOHOL3K9958V90MIACT
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS)59Z907ZB69IACT
TALC7SEV7J4R1UIACT
.ALPHA.-TOCOPHEROLH4N855PNZ1IACT
BUTYLATED HYDROXYTOLUENE1P9D0Z171KIACT
SODIUM METABISULFITE4VON5FNS3CIACT
POLYETHYLENE GLYCOL 3005655G9Y8AQIACT
SYZYGIUM JAMBOS LEAF407Z4W5LFFIACT
PHENOXYETHANOLHIE492ZZ3TIACT
SODIUM POLYMETAPHOSPHATEP1BM4ZH95LIACT
.ALPHA.-CELLULOSEI355QGZ19AIACT
FERRIC OXIDE RED1K09F3G675IACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
FERROSOFERRIC OXIDEXM0M87F357IACT

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 ULTIMATE SUN PROTECTOROCTISALATE, TITANIUM DIOXIDE, OCTOCRYLENE, AND ZINC OXIDESHISEIDO AMERICAS CORPORATIONc656792a-e1ed-478d-b501-9bdc92d16eca2026-01-05WarningsExact identifier
ndc (package): 58411-480-60
ndc (product): 58411-480
ndc11 (package): 58411048060
spl id: 47a95b3e-c698-9007-e063-6394a90afe66
spl set id: c656792a-e1ed-478d-b501-9bdc92d16eca

Reported adverse events (FAERS/openFDA)#

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