FDA.reportPublic FDA data

SHISEIDO ULTIMATE SUN PROTECTION CREAM N SPF 55•PA+++ FOR FACE

Manufacturer
SHISEIDO AMERICA INC.
Effective date
2010-01-27
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:54:26

Label at a glance#

ProductSHISEIDO SUNCARE ULTIMATE
Active ingredientOctinoxate, Titanium Dioxide, Zinc Oxide
Label structure10 sections

Indications and uses

helps prevent sunburn higher SPF gives more sunburn protection retains SPF after 80 minutes of activity in the water

Dosage and administration

apply generously to face before sun exposure. children under 6 months of age: ask a doctor. reapply as needed or after towel drying, swimming or perspiring.

Storage and handling

high sun protection product. Sun alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risks of skin aging, skin cancer, and other harmful effects of the sun. Broad spectrum sunscreen; provides protection against UVA and UVB radiation.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredientsPurpose
OCTINOXATE 7.4%Sunscreen
TITANIUM DIOXIDE 2.2%Sunscreen
ZINC OXIDE 16.3%Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • helps prevent sunburn
  • higher SPF gives more sunburn protection
  • retains SPF after 80 minutes of activity in the water

Warnings

WARNINGS SECTION

For external use only

When using this product

OTC - WHEN USING SECTION

  • keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • rash or irritation develops and lasts.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • apply generously to face before sun exposure.
  • children under 6 months of age: ask a doctor.
  • reapply as needed or after towel drying, swimming or perspiring.

Other information

STORAGE AND HANDLING SECTION

  • high sun protection product.
  • Sun alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risks of skin aging, skin cancer, and other harmful effects of the sun.
  • Broad spectrum sunscreen; provides protection against UVA and UVB radiation.

Inactive ingredients

INACTIVE INGREDIENT SECTION

CYCLOMETHICONE, WATER, BUTYLENE GLYCOL, DIMETHICONE, POLYMETHYLSILSESQUIOXANE, PEG-10 DIMETHICONE, POLYBUTYLENE GLYCOL/PPG-9/1 COPOLYMER, TRIMETHYLSILOXYSILICATE, DISTEARDIMONIUM HECTORITE, GLYCERIN, XYLITOL, METHYL GLUCETH-10, SCUTELLARIA BAICALENSIS ROOT EXTRACT, ONONIS SPINOSA ROOT EXTRACT, ECTOIN, HYDROGENATED POLYDECENE, CYCLOPENTASILOXANE, TRIETHOXYCAPRYLYLSILANE, ALUMINUM HYDROXIDE, STEARIC ACID, ACRYLATES/DIMETHICONE COPOLYMER, ISOSTEARIC ACID, TRISODIUM EDTA, BHT, SYZYGIUM JAMBOS LEAF EXTRACT, TOCOPHEROL, PHENOXYETHANOL, FRAGRANCE

Questions?

OTC - QUESTIONS SECTION

1-800-906-7503

SPL UNCLASSIFIED SECTION

SHISEIDO AMERICA INC.
NEW YORK, N.Y. 10022
MADE IN U.S.A.
SHISEIDO DIST.
NEW YORK • PARIS • MILANO
GLO. 12627

www.shiseido.com

PRINCIPAL DISPLAY PANEL - 50mL Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SHISEIDO

Anti-Aging Suncare
UVA and UVB Protection

55
Ultimate
Sun Protection
Cream N

SPF 55•PA+++

For Face

VERY WATER-RESISTANT

SUNSCREEN

50mL NET WT. 2 OZ.

Principal Display Panel - 50mL Carton
Principal Display Panel - 50mL Carton

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52686-225-602023-09-26C16284748780-19d75b9d0-2062-f424-e053-dadaa90a57ceSHISEIDO ULTIMATE SUN PROTECTION CREAM N SPF 55•PA+++ FOR FACE
52686-225-602020-01-31C16284748780-19d75b9d0-2062-f424-e053-dadaa90a57ceSHISEIDO ULTIMATE SUN PROTECTION CREAM N SPF 55•PA+++ FOR FACE

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
OctinoxateACTIVE INGREDIENT4Y5P7MUD511
Titanium DioxideACTIVE INGREDIENT15FIX9V2JP1
Zinc OxideACTIVE INGREDIENTSOI2LOH54Z1
OctinoxateACTIVE MOIETY4Y5P7MUD511
TitaniumACTIVE MOIETYD1JT611TNE1
ZincACTIVE MOIETYJ41CSQ7QDS1

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
52686-22552686-225-60

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
Octinoxate4Y5P7MUD51ACTIB
Titanium Dioxide15FIX9V2JPACTIB
Zinc OxideSOI2LOH54ZACTIB

Source Document#

Source XML · Source PDF

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
9592488e-6afb-4aa2-99d3-9d4a7bc7488fff5d98e7-2e78-4d77-82cd-c759a6514b592023-09-26WarningsExact identifier
spl set id: ff5d98e7-2e78-4d77-82cd-c759a6514b59

Reported adverse events (FAERS/openFDA)#

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