FDA.reportPublic FDA data

SHISEIDO ULTIMATE SUN PROTECTOR

Manufacturer
Shiseido Americas Corporation | Shiseido America Inc.
Effective date
2026-02-04
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:37:02

Label at a glance#

ProductSHISEIDO ULTIMATE SUN PROTECTOR
Active ingredientOCTOCRYLENE, OCTISALATE, ZINC OXIDE
Label structure14 sections

Indications and uses

helps prevent sunburn

Dosage and administration

apply liberally 15 minutes before sun exposure reapply:    after 80 minutes of swimming or sweating    immediately after towel drying    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...

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 - PURPOSE SECTION

Active ingredients Purpose
 Octisalate 3.0%Sunscreen   
 Octocrylene 3.0%
 Zinc Oxide 19.4%

Uses

INDICATIONS & USAGE SECTION

  • helps prevent sunburn

Warnings

WARNINGS SECTION

For external use only

OTC - DO NOT USE SECTION

Do not useon 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.

WARNINGS SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • apply liberally 15 minutes before sun exposure
  • reapply:
  •    after 80 minutes of swimming or sweating
  •    immediately after towel drying
  •    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. - 2p.m.
  • wear long-sleeve shirts, pant, hats, and sunglasses
  • children under 6 months: Ask a doctor

INACTIVE INGREDIENT SECTION

WATER･DIISOPROPYL SEBACATE･ISOPROPYL MYRISTATE･ALCOHOL DENAT.･PEG/PPG-9/2 DIMETHYL ETHER･GLYCERIN･ALCOHOL･PPG-3 DIPIVALATE･TALC･POLYGLYCERYL-6 POLYRICINOLEATE･SILICA･DEXTRIN PALMITATE･DEXTRIN PALMITATE/ETHYLHEXANOATE･ACRYLAMIDES/DMAPA ACRYLATES/METHOXY PEG METHACRYLATE COPOLYMER･DIPOTASSIUM GLYCYRRHIZATE･AMINOETHANESULFINIC ACID･PEG/PPG-14/7 DIMETHYL ETHER･SAXIFRAGA SARMENTOSA EXTRACT･CAMELLIA SINENSIS LEAF EXTRACT･EUCHEUMA SERRA/GRATELOUPIA SPARSA/SACCHARINA ANGUSTATA/ULVA LINZA/UNDARIA PINNATIFIDA EXTRACT･SODIUM HYALURONATE･SOPHORA ANGUSTIFOLIA ROOT EXTRACT･SACCHARINA ANGUSTATA/UNDARIA PINNATIFIDA EXTRACT･HYDROGEN DIMETHICONE･DIMETHYLACRYLAMIDE/SODIUM ACRYLOYLDIMETHYLTAURATE CROSSPOLYMER･HYDROXYPROPYL METHYLCELLULOSE STEAROXY ETHER･SUCCINOGLYCAN･TOCOPHEROL･BHT･BUTYLENE GLYCOL･STEARIC ACID･SODIUM METABISULFITE･PEG-6･BIS-BUTYLDIMETHICONE POLYGLYCERYL-3･SYZYGIUM JAMBOS LEAF EXTRACT･CHLORPHENESIN･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- 50mL Tube

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SHISEIDO

GINZA TOKYO

Ultimate Sun Protector Cream

SPF 50

Advanced Protection & Age Defense

BROAD SPECTRUM SPF 50

WATER RESISTANT (80 MINUTES) 

SUNSCREEN

image descriptionimage description

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ZINC CATION Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58411-971-60SHISEIDO ULTIMATE SUN PROTECTOR1 in 1 BOXCREAM12
58411-971-60SHISEIDO ULTIMATE SUN PROTECTOR50 mL in 1 TUBECREAM502

Products#

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

DailyMed product names page 1 of 1 · 33 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58411-97158411-971-60

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 29 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
DIISOPROPYL SEBACATEJ8T3X564IHIACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
ALCOHOL3K9958V90MIACT
PEG/PPG-9/2 DIMETHYL ETHERLM6Q66468XIACT
GLYCERINPDC6A3C0OXIACT
TALC7SEV7J4R1UIACT
POLYGLYCERYL-6 POLYRICINOLEATEYPM0ZOC2HRIACT
SILICAETJ7Z6XBU4IACT
DEXTRIN PALMITATE (CORN; 20000 MW)89B2BSF9I3IACT
DIPOTASSIUM GLYCYRRHIZATECA2Y0FE3FXIACT
AMINOETHANESULFINIC ACID5L08GE4332IACT
PEG/PPG-14/7 DIMETHYL ETHER6DNW9T7YT2IACT
SAXIFRAGA STOLONIFERA LEAFO3TMV4903HIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
SODIUM HYALURONATEYSE9PPT4THIACT
SOPHORA FLAVESCENS ROOTIYR6K8KQ5KIACT
HYDROGEN DIMETHICONE (13 CST)4QGR4P2YOIIACT
HYPROMELLOSE 2208 0.45% STEAROXY ETHERMG58AH4FJ8IACT
SUCCINOGLYCAN (AGROBACTERIUM TUMEFACIENS)YP632MQS35IACT
TOCOPHEROLR0ZB2556P8IACT
BHT1P9D0Z171KIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
STEARIC ACID4ELV7Z65APIACT
SODIUM METABISULFITE4VON5FNS3CIACT
CHLORPHENESINI670DAL4SZIACT
OCTOCRYLENE5A68WGF6WMACTIB
OCTISALATE4X49Y0596WACTIB
ZINC OXIDESOI2LOH54ZACTIM

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, OCTOCRYLENE, ZINC OXIDEShiseido Americas Corporationce6a28c1-56e6-4105-bc9d-9d1986ead4202026-02-04WarningsExact identifier
ndc (package): 58411-971-60
ndc (product): 58411-971
ndc11 (package): 58411097160
spl id: 4a041a52-40c7-099d-e063-6394a90a766e
spl set id: ce6a28c1-56e6-4105-bc9d-9d1986ead420

Reported adverse events (FAERS/openFDA)#

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