FDA.reportPublic FDA data

SHISEIDO ULTIMATE SUN PROTECTION LOTION N SPF 60 • PA+++ FOR FACE/BODY

Manufacturer
SHISEIDO AMERICA INC.
Effective date
2010-01-28
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:54:25

Label at a glance#

ProductSHISEIDO SUNCARE ULTIMATE
Active ingredientEnsulizole, Octinoxate, 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 and body before sun exposure. children under 6 months of age: ask a doctor. reapply as needed or after towel drying, swimming or perspiring.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredientsPurpose
ENSULIZOLE 2.0%Sunscreen
OCTINOXATE 7.4%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 and body before sun exposure.
  • children under 6 months of age: ask a doctor.
  • reapply as needed or after towel drying, swimming or perspiring.

Other information

SPL UNCLASSIFIED 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, CETYL ETHYLHEXANOATE, POLYMETHYLSILSESQUIOXANE, SD ALCOHOL 40-B, POLYBUTYLENE GLYCOL/PPG-9/1 COPOLYMER, OCTORYLENE, TRIMETHYLSILOXYSILICATE, LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE, TRIETHANOLAMINE, GLYCERIN, XYLITOL, METHYL GLUCETH-10, SCUTELLARIA BAICALENSIS ROOT EXTRACT, ECTOIN, CYCLOPENTASILOXANE, TRIETHOXYCAPRYLYLSILANE, ISOSTEARIC ACID, ACRYLATES/DIMETHICONE COPOLYMER, 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. 12628

www.shiseido.com

PRINCIPAL DISPLAY PANEL - 100 mL Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SHISEIDO

Anti-Aging Suncare
UVA and UVB Protection

60

Ultimate
Sun Protection Lotion N

SPF 60 • PA+++

For Face/Body

VERY WATER-RESISTANT

SUNSCREEN

100mL 3.3 FL. OZ.

Principal Display Panel - 100 mL Carton
Principal Display Panel - 100 mL Carton

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52686-226-102023-09-26C16284748780-19d75b9d1-1b5a-f424-e053-dadaa90a57ceSHISEIDO ULTIMATE SUN PROTECTION LOTION N SPF 60 • PA+++ FOR FACE/BODY
52686-226-102020-01-31C16284748780-19d75b9d1-1b5a-f424-e053-dadaa90a57ceSHISEIDO ULTIMATE SUN PROTECTION LOTION N SPF 60 • PA+++ FOR FACE/BODY

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
EnsulizoleACTIVE INGREDIENT9YQ9DI1W421
OctinoxateACTIVE INGREDIENT4Y5P7MUD511
Zinc OxideACTIVE INGREDIENTSOI2LOH54Z1
EnsulizoleACTIVE MOIETY9YQ9DI1W421
OctinoxateACTIVE MOIETY4Y5P7MUD511
ZincACTIVE MOIETYJ41CSQ7QDS1

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
52686-22652686-226-10

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
Ensulizole9YQ9DI1W42ACTIB
Octinoxate4Y5P7MUD51ACTIB
Zinc OxideSOI2LOH54ZACTIB

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
de1a531b-1c85-4302-b22d-7bff624ac022923e6371-23f9-4b8c-92ed-f6694e2cca452023-09-26WarningsExact identifier
spl set id: 923e6371-23f9-4b8c-92ed-f6694e2cca45

Reported adverse events (FAERS/openFDA)#

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