FDA.reportPublic FDA data

SHISEIDO WHITE LUCENT BRIGHTENING PROTECTIVE CREAM W SPF 15 • PA++

Manufacturer
SHISEIDO AMERICA INC.
Effective date
2018-12-19
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-02 00:40:24

Label at a glance#

ProductSHISEIDO WHITE LUCENT
Active ingredientENSULIZOLE, OCTINOXATE, TITANIUM DIOXIDE
Label structure9 sections

Indications and uses

helps prevent sunburn higher SPF gives more sunburn protection

Dosage and administration

apply smoothly to face before sun exposure and as needed. children under 6 months of age: ask a doctor.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredientsPurpose
ENSULIZOLE 2.5%Sunscreen
OCTINOXATE 7.4%Sunscreen
TITANIUM DIOXIDE 1.9%Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • helps prevent sunburn
  • higher SPF gives more sunburn protection

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 smoothly to face before sun exposure and as needed.
  • children under 6 months of age: ask a doctor.

Inactive ingredients

INACTIVE INGREDIENT SECTION

WATER, BUTYLENE GLYCOL, GLYCERIN, DIPROPYLENE GLYCOL, HYDROGENATED POLYDECENE, PENTAERYTHRITYL TETRAETHYLHEXANOATE, DIMETHICONE, SD ALCOHOL 40-B, BEHENYL ALCOHOL, POLYBUTYLENE GLYCOL/PPG-9/1 COPOLYMER, TRANEXAMIC ACID, BEHENETH-20, TRIETHANOLAMINE, SILICA, XANTHAN GUM, PEG/PPG-14/7 DIMETHYL ETHER, ERYTHRITOL, PEG/PPG-17/4 DIMETHYL ETHER, 2-O-ETHYL ASCORBIC ACID, GLUCOSYL HESPERIDIN, PHYTOSTERYL/OCTYLDODECYL LAUROYL GLUTAMATE, SODIUM HYALURONATE, STEARYL ALCOHOL, HYDROGENATED PALM OIL, ELAEIS GUINEENSIS (PALM) KERNEL OIL, ELAEIS GUINEENSIS (PALM) OIL, SODIUM METAPHOSPHATE, TRISODIUM EDTA, CELLULOSE GUM, ALUMINUM HYDROXIDE, BHT, SODIUM METABISULFITE, TOCOPHEROL, CITRIC ACID, PHENOXYETHANOL, FRAGRANCE, IRON OXIDES

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. 10394

www.shiseido.com

PRINCIPAL DISPLAY PANEL - 50 mL Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SHISEIDO

WHITE LUCENT

Brightening
Protective Cream w
SPF 15 • PA++
SUNSCREEN

50mL NET WT. 1.8 OZ.

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52686-227-502023-09-27C16284748780-19d75b9d0-c424-f424-e053-dadaa90a57ceSHISEIDO WHITE LUCENT BRIGHTENING PROTECTIVE CREAM W SPF 15 • PA++
52686-227-502020-01-31C16284748780-19d75b9d0-c424-f424-e053-dadaa90a57ceSHISEIDO WHITE LUCENT BRIGHTENING PROTECTIVE CREAM W SPF 15 • PA++

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
EnsulizoleACTIVE INGREDIENT9YQ9DI1W421
OctinoxateACTIVE INGREDIENT4Y5P7MUD511
Titanium DioxideACTIVE INGREDIENT15FIX9V2JP1
EnsulizoleACTIVE MOIETY9YQ9DI1W421
OctinoxateACTIVE MOIETY4Y5P7MUD511
Titanium DioxideACTIVE MOIETY15FIX9V2JP1

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
52686-22752686-227-50

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
ENSULIZOLE9YQ9DI1W42ACTIB
OCTINOXATE4Y5P7MUD51ACTIB
TITANIUM DIOXIDE15FIX9V2JPACTIB
WATER059QF0KO0RIACT

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
7c16fb28-c5e5-447d-ae22-8f97d3c47f2c32802c1d-db4c-4a04-b03e-feaa4e9b429a2023-09-27WarningsExact identifier
spl set id: 32802c1d-db4c-4a04-b03e-feaa4e9b429a

Reported adverse events (FAERS/openFDA)#

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