FDA.reportPublic FDA data

SHISEIDO WHITE LUCENT

Manufacturer
SHISEIDO AMERICA INC. | Davlyn Industries Inc
Effective date
2012-06-20
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-02 01:46:54

Label at a glance#

ProductSHISEIDO WHITE LUCENT BRIGHTENING SPOT-CONTROL BASE UV IVORY
Active ingredientOCTINOXATE, TITANIUM DIOXIDE
Label structure12 sections

Dosage and administration

For sunscreen use: apply liberally 15 minutes before sun exposure use a water resistant sunscreen if swimming or sweating reapply 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 su...

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 INGREDIENTS:Purpose
OCTINOXATE 2.9%Sunscreen
TITANIUM DIOXIDE 8.4%Sunscreen

Use

INDICATIONS & USAGE SECTION

  • helps prevent sunburn

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

OTC - STOP USE SECTION

Stop use and ask a doctor if 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.

Directions

DOSAGE & ADMINISTRATION SECTION

For sunscreen use:

  • apply liberally 15 minutes before sun exposure
  • use a water resistant sunscreen if swimming or sweating
  • reapply 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. – 2 p.m.
    • wear long-sleeve shirts, pants, hats, and sunglasses
  • children under 6 months: Ask a doctor

Inactive Ingredients

INACTIVE INGREDIENT SECTION

CYCLOMETHICONE, WATER, SD ALCOHOL 40-B, BUTYLENE GLYCOL, VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER, PEG-10 DIMETHICONE, CETYL ETHYLHEXANOATE, TRANEXAMIC ACID, ALUMINUM HYDROXIDE, GLYCERIN, SORBITAN SESQUIISOSTEARATE, DISTEARDIMONIUM HECTORITE, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, PEG/PPG-14/7 DIMETHYL ETHER, 2-O-ETHYL ASCORBIC ACID, SODIUM HYALURONATE, STEARIC ACID, ISOSTEARIC ACID, ALUMINUM DISTEARATE, TRISODIUM EDTA, POLYSILICONE-2, SODIUM METABISULFITE, BHT, TOCOPHEROL, PHENOXYETHANOL, FRAGRANCE, TITANIUM DIOXIDE, IRON OXIDES, CHROMIUM HYDROXIDE GREEN,

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

SPL UNCLASSIFIED SECTION

SHISEIDO AMERICA INC.
NEW YORK, N.Y. 10022
SHISEIDO DIST. NEW YORK • PARIS • MILANO

PRINCIPAL DISPLAY PANEL - 30mL Tube Carton - IVORY

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SHISEIDO

WHITE LUCENT

Brightening
Spot-Control
Base UV

BROAD SPECTRUM
SPF 37

SUNSCREEN

30mL NET WT. 1.1 OZ.

Principal Display Panel - 30mL Tube Carton - IVORY
Principal Display Panel - 30mL Tube Carton - IVORY

PRINCIPAL DISPLAY PANEL - 30mL Tube Carton - GREEN

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SHISEIDO

WHITE LUCENT

Brightening
Spot-Control
Base UV

BROAD SPECTRUM
SPF 37

SUNSCREEN

30mL NET WT. 1.1 OZ.

Principal Display Panel - 30mL Tube Carton - GREEN
Principal Display Panel - 30mL Tube Carton - GREEN

PRINCIPAL DISPLAY PANEL - 30mL Tube Carton - PINK

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SHISEIDO

WHITE LUCENT

Brightening
Spot-Control
Base UV

BROAD SPECTRUM
SPF 37

SUNSCREEN

30mL NET WT. 1.1 OZ.

Principal Display Panel - 30mL Tube Carton - PINK
Principal Display Panel - 30mL Tube Carton - PINK

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52686-249-602023-09-27C16284748780-19d75b9cf-e81c-f424-e053-dadaa90a57ceSHISEIDO WHITE LUCENT BRIGHTENING SPOT-CONTROL BASE UV
52686-250-602023-09-27C16284748780-19d75b9cf-e81c-f424-e053-dadaa90a57ceSHISEIDO WHITE LUCENT BRIGHTENING SPOT-CONTROL BASE UV
52686-251-602023-09-27C16284748780-19d75b9cf-e81c-f424-e053-dadaa90a57ceSHISEIDO WHITE LUCENT BRIGHTENING SPOT-CONTROL BASE UV
52686-249-602020-01-31C16284748780-19d75b9cf-e81c-f424-e053-dadaa90a57ceSHISEIDO WHITE LUCENT BRIGHTENING SPOT-CONTROL BASE UV
52686-250-602020-01-31C16284748780-19d75b9cf-e81c-f424-e053-dadaa90a57ceSHISEIDO WHITE LUCENT BRIGHTENING SPOT-CONTROL BASE UV
52686-251-602020-01-31C16284748780-19d75b9cf-e81c-f424-e053-dadaa90a57ceSHISEIDO WHITE LUCENT BRIGHTENING SPOT-CONTROL BASE UV

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
OCTINOXATEACTIVE INGREDIENT4Y5P7MUD513
TITANIUM DIOXIDEACTIVE INGREDIENT15FIX9V2JP3
OCTINOXATEACTIVE MOIETY4Y5P7MUD513
TITANIUM DIOXIDEACTIVE MOIETY15FIX9V2JP3
.ALPHA.-TOCOPHEROLINACTIVE INGREDIENTH4N855PNZ13
2-O-ETHYL ASCORBIC ACIDINACTIVE INGREDIENT801M14RK9K3
ALUMINUM DISTEARATEINACTIVE INGREDIENT7P1HP1B9UI3
ALUMINUM HYDROXIDEINACTIVE INGREDIENT5QB0T2IUN03
BUTYLATED HYDROXYTOLUENEINACTIVE INGREDIENT1P9D0Z171K3
BUTYLENE GLYCOLINACTIVE INGREDIENT3XUS85K0RA3
CETYL ETHYLHEXANOATEINACTIVE INGREDIENT134647WMX43
CYCLOMETHICONEINACTIVE INGREDIENTNMQ347994Z3
EDETATE TRISODIUMINACTIVE INGREDIENT420IP921MB3
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G6753
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRT3
GLYCERININACTIVE INGREDIENTPDC6A3C0OX3
HYALURONATE SODIUMINACTIVE INGREDIENTYSE9PPT4TH3
ISOSTEARIC ACIDINACTIVE INGREDIENTX33R8U00623
PEG-10 DIMETHICONE (600 CST)INACTIVE INGREDIENT8PR7V1SVM03
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3T3
SODIUM METABISULFITEINACTIVE INGREDIENT4VON5FNS3C3
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65AP3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JP3
TRANEXAMIC ACIDINACTIVE INGREDIENT6T84R30KC13
WATERINACTIVE INGREDIENT059QF0KO0R3

Products#

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

DailyMed product names page 1 of 1 · 26 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
52686-24952686-249-60
52686-25052686-250-60
52686-25152686-251-60

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 69 matching rows.

Name, UNII, Kind table
NameUNIIKind
OCTINOXATE4Y5P7MUD51ACTIB
TITANIUM DIOXIDE15FIX9V2JPACTIB
CYCLOMETHICONENMQ347994ZIACT
WATER059QF0KO0RIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
PEG-10 DIMETHICONE (600 CST)8PR7V1SVM0IACT
CETYL ETHYLHEXANOATE134647WMX4IACT
TRANEXAMIC ACID6T84R30KC1IACT
ALUMINUM HYDROXIDE5QB0T2IUN0IACT
GLYCERINPDC6A3C0OXIACT
STEARIC ACID4ELV7Z65APIACT
FERRIC OXIDE RED1K09F3G675IACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
ISOSTEARIC ACIDX33R8U0062IACT
PHENOXYETHANOLHIE492ZZ3TIACT
ALUMINUM DISTEARATE7P1HP1B9UIIACT
EDETATE TRISODIUM420IP921MBIACT
2-O-ETHYL ASCORBIC ACID801M14RK9KIACT
SODIUM METABISULFITE4VON5FNS3CIACT
BUTYLATED HYDROXYTOLUENE1P9D0Z171KIACT
HYALURONATE SODIUMYSE9PPT4THIACT
.ALPHA.-TOCOPHEROLH4N855PNZ1IACT
OCTINOXATE4Y5P7MUD51ACTIB
TITANIUM DIOXIDE15FIX9V2JPACTIB
CYCLOMETHICONENMQ347994ZIACT
WATER059QF0KO0RIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
PEG-10 DIMETHICONE (600 CST)8PR7V1SVM0IACT
CETYL ETHYLHEXANOATE134647WMX4IACT
TRANEXAMIC ACID6T84R30KC1IACT
ALUMINUM HYDROXIDE5QB0T2IUN0IACT
GLYCERINPDC6A3C0OXIACT
STEARIC ACID4ELV7Z65APIACT
FERRIC OXIDE RED1K09F3G675IACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
ISOSTEARIC ACIDX33R8U0062IACT
PHENOXYETHANOLHIE492ZZ3TIACT
ALUMINUM DISTEARATE7P1HP1B9UIIACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 5 · 293 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TAEROSOL / TOPICAL1.05 %w/wExact identifier — unii candidate
6 equally ranked IID candidates
FERRIC OXIDE REDFERRIC OXIDE RED1K09F3G675DROPS / ORALNAExact identifier — unii candidate
21 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSPONGE / TOPICAL2 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KCAPSULE / ORAL3 mgExact identifier — unii candidate
32 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / AURICULAR (OTIC)63.64 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
SODIUM METABISULFITESODIUM METABISULFITE4VON5FNS3CINJECTION / INTRAPERITONEAL0.33 %w/vExact identifier — unii candidate
43 equally ranked IID candidates
ALUMINUM HYDROXIDEALUMINUM HYDROXIDE5QB0T2IUN0OINTMENT / TOPICALNAExact identifier — unii candidate
4 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPPOWDER, FOR SUSPENSION / ORAL297 mgExact identifier — unii candidate
40 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXPASTE / ORAL3822 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXEMULSION / INTRAVENOUS2.2 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
FERRIC OXIDE YELLOWFERRIC OXIDE YELLOWEX438O2MRTCAPSULE, EXTENDED RELEASE / ORAL7 mgExact identifier — unii candidate
20 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APPOWDER, FOR SUSPENSION / ORAL1203 mg/5mlExact identifier — unii candidate
26 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPLOTION / TOPICALNAExact identifier — unii candidate
40 equally ranked IID candidates
SODIUM METABISULFITESODIUM METABISULFITE4VON5FNS3CINJECTION, SOLUTION, CONCENTRATE / SUBCUTANEOUS0.15 %w/vExact identifier — unii candidate
43 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TCREAM / TOPICAL57 mgExact identifier — unii candidate
6 equally ranked IID candidates
FERRIC OXIDE REDFERRIC OXIDE RED1K09F3G675CAPSULE, COATED PELLETS / ORAL2 mgExact identifier — unii candidate
21 equally ranked IID candidates
HYALURONATE SODIUMHYALURONATE SODIUMYSE9PPT4THINJECTION, SUSPENSION / INTRAMUSCULAR23 mgExact identifier — unii candidate
5 equally ranked IID candidates
HYALURONATE SODIUMHYALURONATE SODIUMYSE9PPT4THGEL / TOPICAL463 mgExact identifier — unii candidate
5 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPGUM, CHEWING / BUCCAL182 mgExact identifier — unii candidate
40 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXAEROSOL, FOAM / TOPICAL21 mgExact identifier — unii candidate
75 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KCAPSULE, LIQUID FILLED / ORAL0.1 mgExact identifier — unii candidate
32 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KSOLUTION, CONCENTRATE / ORAL0.1 mg/1mlExact identifier — unii candidate
32 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPSUPPOSITORY, EXTENDED RELEASE / INTRAUTERINE1 mgExact identifier — unii candidate
40 equally ranked IID candidates
SODIUM METABISULFITESODIUM METABISULFITE4VON5FNS3CINJECTION / INFILTRATION0.5 %w/vExact identifier — unii candidate
43 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KSUPPOSITORY / RECTAL1 mgExact identifier — unii candidate
32 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KSUPPOSITORY / VAGINALNAExact identifier — unii candidate
32 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KSHAMPOO / TOPICAL0.1 %w/wExact identifier — unii candidate
32 equally ranked IID candidates
FERRIC OXIDE REDFERRIC OXIDE RED1K09F3G675TABLET / ORAL8 mgExact identifier — unii candidate
21 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXELIXIR / ORAL5621 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXFILM, EXTENDED RELEASE / TRANSDERMAL306.2 mgExact identifier — unii candidate
75 equally ranked IID candidates
FERRIC OXIDE YELLOWFERRIC OXIDE YELLOWEX438O2MRTTABLET, FILM COATED / ORAL6 mgExact identifier — unii candidate
20 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPSUSPENSION / ORAL113 mgExact identifier — unii candidate
40 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APAEROSOL, FOAM / VAGINAL4 %w/wExact identifier — unii candidate
26 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCLOTH / TOPICAL0.05 mg/mgExact identifier — unii candidate
75 equally ranked IID candidates
.ALPHA.-TOCOPHEROL.ALPHA.-TOCOPHEROLH4N855PNZ1TABLET, FILM COATED / ORAL246 mgExact identifier — unii candidate
10 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUSPENSION / OPHTHALMIC58 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION / INTRAVENOUS33750 mgExact identifier — unii candidate
75 equally ranked IID candidates
SODIUM METABISULFITESODIUM METABISULFITE4VON5FNS3CTABLET / SUBLINGUAL2 mgExact identifier — unii candidate
43 equally ranked IID candidates
FERRIC OXIDE YELLOWFERRIC OXIDE YELLOWEX438O2MRTTABLET, COATED / ORAL1 mgExact identifier — unii candidate
20 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXOINTMENT / TOPICALNAExact identifier — unii candidate
75 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APSOAP / TOPICAL6 %w/wExact identifier — unii candidate
26 equally ranked IID candidates
FERRIC OXIDE REDFERRIC OXIDE RED1K09F3G675TABLET, CHEWABLE / ORAL2 mgExact identifier — unii candidate
21 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCONCENTRATE / ORAL1800 mgExact identifier — unii candidate
75 equally ranked IID candidates
FERRIC OXIDE REDFERRIC OXIDE RED1K09F3G675CAPSULE, EXTENDED RELEASE / ORAL5 mgExact identifier — unii candidate
21 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXLIQUID / ORAL2400 mgExact identifier — unii candidate
75 equally ranked IID candidates
SODIUM METABISULFITESODIUM METABISULFITE4VON5FNS3CINJECTION, EMULSION / INTRAVENOUS0.03 %w/vExact identifier — unii candidate
43 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPCAPSULE, DELAYED RELEASE / ORAL55 mgExact identifier — unii candidate
40 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPPASTE, DENTIFRICE / DENTAL0.4 %w/wExact identifier — unii candidate
40 equally ranked IID candidates
SODIUM METABISULFITESODIUM METABISULFITE4VON5FNS3CSOLUTION / IONTOPHORESIS0.05 %w/vExact identifier — unii candidate
43 equally ranked IID candidates
BUTYLENE GLYCOLBUTYLENE GLYCOL3XUS85K0RASYSTEM / TRANSDERMAL8.12 mgExact identifier — unii candidate
2 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSYSTEM / IONTOPHORESIS168.1 mgExact identifier — unii candidate
75 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPINSERT, EXTENDED RELEASE / OPHTHALMIC0.4 mgExact identifier — unii candidate
40 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUSPENSION/ DROPS / OPHTHALMIC2.5 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KFILM, SOLUBLE / ORAL0.06 mgExact identifier — unii candidate
32 equally ranked IID candidates
BUTYLENE GLYCOLBUTYLENE GLYCOL3XUS85K0RASYSTEM / TOPICAL1400 mgExact identifier — unii candidate
2 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KOINTMENT / TOPICAL57 mgExact identifier — unii candidate
32 equally ranked IID candidates
CYCLOMETHICONECYCLOMETHICONENMQ347994ZSOLUTION / TOPICAL11.57 %w/vExact identifier — unii candidate
5 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TGEL / TOPICAL14 mgExact identifier — unii candidate
6 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPFILM / BUCCAL3 mgExact identifier — unii candidate
40 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KINJECTION / INTRAVENOUSNAExact identifier — unii candidate
32 equally ranked IID candidates

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
774f1f45-7222-4127-8d2f-a0fdea01c393f63f494d-a449-495d-bb89-79f53fa521a52023-09-27WarningsExact identifier
spl set id: f63f494d-a449-495d-bb89-79f53fa521a5

Reported adverse events (FAERS/openFDA)#

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