FDA.reportPublic FDA data

SHISEIDO WHITE LUCENT ONMAKEUP SPOT CORRECTING SERUM

Manufacturer
SHISEIDO AMERICAS CORPORATION | SHISEIDO AMERICA INC.
Effective date
2026-01-05
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:31:33

Label at a glance#

ProductSHISEIDO WHITE LUCENT ONMAKEUP SPOT CORRECTING SERUM NATURAL LIGHT
Active ingredientOCTINOXATE, TITANIUM DIOXIDE
Label structure11 sections

Indications and uses

helps prevent sunburn if used as directed with other sun protection measures (see Directions ), decreases the risk of skin cancer and early skin aging caused by the sun

Dosage and administration

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 ...

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 ingredientsPurpose
OCTINOXATE 2.9%Sunscreen
TITANIUM DIOXIDE 2.6%Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • helps prevent sunburn
  • if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

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.

Directions　

DOSAGE & ADMINISTRATION SECTION

  • 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

WATER•DIMETHICONE•GLYCERIN•SD ALCOHOL 40-B•METHYL METHACRYLATE CROSSPOLYMER•DIISOSTEARYL MALATE•BETAINE•PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE•PEG-10 DIMETHICONE•SORBITAN SESQUIISOSTEARATE•POTASSIUM METHOXYSALICYLATE•TRIMETHYLSILOXYSILICATE•DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER•TOCOPHERYL ACETATE•2-O-ETHYL ASCORBIC ACID•SODIUM HYALURONATE•PAEONIA SUFFRUTICOSA ROOT EXTRACT•PEG/PPG-14/7 DIMETHYL ETHER•REHMANNIA CHINENSIS ROOT EXTRACT•UNCARIA GAMBIR EXTRACT•CHLORELLA VULGARIS EXTRACT•ALUMINUM HYDROXIDE•DISTEARDIMONIUM HECTORITE•ALUMINUM DISTEARATE•POLYSILICONE-2•DISODIUM EDTA•SILICA•BUTYLENE GLYCOL•ALANINE•SODIUM CITRATE•ALCOHOL•BHT･TOCOPHEROL•CITRIC ACID•BARIUM SULFATE•SODIUM METABISULFITE•PRUNUS YEDOENSIS LEAF EXTRACT•HYDROGEN DIMETHICONE•ALUMINA•METHYLPARABEN•ETHYLPARABEN･FRAGRANCE•TITANIUM DIOXIDE•IRON OXIDES•MICA•

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 - 4 mL Bottle Carton - Natural Light

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SHI SEIDO

WHITE LUCENT

OnMakeup
Spot Correcting
Serum

BROAD SPECTRUM
SPF 25

SUNSCREEN

PROAPPROACH×2

4mL NET WT. .16 OZ.

PRINCIPAL DISPLAY PANEL - 4 mL Bottle Carton - Natural Light
PRINCIPAL DISPLAY PANEL - 4 mL Bottle Carton - Natural Light

PRINCIPAL DISPLAY PANEL - 4 mL Bottle Carton - Natural

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SHI SEIDO

WHITE LUCENT

OnMakeup
Spot Correcting
Serum

BROAD SPECTRUM
SPF 25

SUNSCREEN

PROAPPROACH×2

4mL NET WT. .16 OZ.

PRINCIPAL DISPLAY PANEL - 4 mL Bottle Carton - Natural
PRINCIPAL DISPLAY PANEL - 4 mL Bottle Carton - Natural

PRINCIPAL DISPLAY PANEL - 4 mL Bottle Carton - Medium

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SHI SEIDO

WHITE LUCENT

OnMakeup
Spot Correcting
Serum

BROAD SPECTRUM
SPF 25

SUNSCREEN

PROAPPROACH×2

4mL NET WT. .16 OZ.

PRINCIPAL DISPLAY PANEL - 4 mL Bottle Carton - Medium
PRINCIPAL DISPLAY PANEL - 4 mL Bottle Carton - Medium

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d1c9d1af-bddd-448d-86f7-69052b7d5b47Product name120220627
5dbf91a8-ec29-4ffc-807c-e3bae7fb67b1Product name120201123
85bed648-23ca-4804-98e6-e36aee999cadProduct name120190717
80de93b4-8a94-428d-beb7-d644353ee70bProduct name120180424
eb4f7d5b-1286-40dc-b8bf-ad87ff51c688Product name120170522
db8eb201-78c7-4590-8a71-fac0a539bd8cProduct name120170404
141092be-5eb5-452e-9f69-2d350aa70a87Product name120161208
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58411-296-102026-01-06C16284748780-19d75b9d0-6be3-f424-e053-dadaa90a57ceSHISEIDO WHITE LUCENT ONMAKEUP SPOT CORRECTING SERUM
58411-297-102026-01-06C16284748780-19d75b9d0-6be3-f424-e053-dadaa90a57ceSHISEIDO WHITE LUCENT ONMAKEUP SPOT CORRECTING SERUM
58411-296-102025-01-31C16284748780-19d75b9d0-6be3-f424-e053-dadaa90a57ceSHISEIDO WHITE LUCENT ONMAKEUP SPOT CORRECTING SERUM
58411-297-102025-01-31C16284748780-19d75b9d0-6be3-f424-e053-dadaa90a57ceSHISEIDO WHITE LUCENT ONMAKEUP SPOT CORRECTING SERUM
58411-298-102025-01-31C16284748780-19d75b9d0-6be3-f424-e053-dadaa90a57ceSHISEIDO WHITE LUCENT ONMAKEUP SPOT CORRECTING SERUM
58411-298-102023-12-21C16284748780-19d75b9d0-6be3-f424-e053-dadaa90a57ceSHISEIDO WHITE LUCENT ONMAKEUP SPOT CORRECTING SERUM
58411-298-102020-01-31C16284748780-19d75b9d0-6be3-f424-e053-dadaa90a57ceSHISEIDO WHITE LUCENT ONMAKEUP SPOT CORRECTING SERUM

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58411-296-10SHISEIDO WHITE LUCENT ONMAKEUP SPOT CORRECTING SERUMNATURAL LIGHT4 mL in 1 BOTTLECREAM44
58411-296-10SHISEIDO WHITE LUCENT ONMAKEUP SPOT CORRECTING SERUMNATURAL LIGHT1 in 1 CARTONCREAM14
58411-297-10SHISEIDO WHITE LUCENT ONMAKEUP SPOT CORRECTING SERUMNATURAL1 in 1 CARTONCREAM14
58411-297-10SHISEIDO WHITE LUCENT ONMAKEUP SPOT CORRECTING SERUMNATURAL4 mL in 1 BOTTLECREAM44
58411-298-10SHISEIDO WHITE LUCENT ONMAKEUP SPOT CORRECTING SERUMMEDIUM1 in 1 CARTONCREAM14
58411-298-10SHISEIDO WHITE LUCENT ONMAKEUP SPOT CORRECTING SERUMMEDIUM4 mL in 1 BOTTLECREAM44

Products#

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

DailyMed product names page 1 of 2 · 46 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58411-29658411-296-10
58411-29758411-297-10
58411-29858411-298-10

Ingredients#

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

DailyMed ingredient rows page 1 of 4 · 126 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
DIMETHICONE92RU3N3Y1OIACT
GLYCERINPDC6A3C0OXIACT
DIISOSTEARYL MALATEQBS8A3XZGQIACT
BETAINE3SCV180C9WIACT
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONETYP81E471FIACT
PEG-10 DIMETHICONE (600 CST)8PR7V1SVM0IACT
POTASSIUM METHOXYSALICYLATE5G3H7U4Y7FIACT
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8)5041RX63GNIACT
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)9E4CO0W6C5IACT
.ALPHA.-TOCOPHEROL ACETATE, DL-WR1WPI7EW8IACT
2-O-ETHYL ASCORBIC ACID801M14RK9KIACT
HYALURONATE SODIUMYSE9PPT4THIACT
PAEONIA X SUFFRUTICOSA ROOT7M7E9A2C8JIACT
PEG/PPG-14/7 DIMETHYL ETHER6DNW9T7YT2IACT
REHMANNIA GLUTINOSA ROOT1BEM3U6LQQIACT
CHLORELLA VULGARISRYQ4R60M02IACT
ALUMINUM HYDROXIDE5QB0T2IUN0IACT
DISTEARDIMONIUM HECTORITEX687XDK09LIACT
ALUMINUM DISTEARATE7P1HP1B9UIIACT
EDETATE DISODIUM7FLD91C86KIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
BUTYLENE GLYCOL3XUS85K0RAIACT
ALANINEOF5P57N2ZXIACT
SODIUM CITRATE, UNSPECIFIED FORM1Q73Q2JULRIACT
ALCOHOL3K9958V90MIACT
BUTYLATED HYDROXYTOLUENE1P9D0Z171KIACT
.ALPHA.-TOCOPHEROLH4N855PNZ1IACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
BARIUM SULFATE25BB7EKE2EIACT
SODIUM METABISULFITE4VON5FNS3CIACT
PRUNUS X YEDOENSIS LEAF1Z125GA907IACT
HYDROGEN DIMETHICONE (13 CST)4QGR4P2YOIIACT
ALUMINUM OXIDELMI26O6933IACT
METHYLPARABENA2I8C7HI9TIACT
ETHYLPARABEN14255EXE39IACT
FERRIC OXIDE RED1K09F3G675IACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
FERROSOFERRIC OXIDEXM0M87F357IACT
MICAV8A1AW0880IACT

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 WHITE LUCENT ONMAKEUP SPOT CORRECTING SERUM NATURAL LIGHTOCTINOXATE AND TITANIUM DIOXIDESHISEIDO AMERICAS CORPORATIONbf736c5b-fc33-4cd5-8d18-03929f739d762026-01-05WarningsExact identifier
ndc (package): 58411-297-10
ndc (package): 58411-298-10
ndc (package): 58411-296-10
ndc (product): 58411-298
ndc (product): 58411-297
ndc (product): 58411-296
ndc11 (package): 58411029610
ndc11 (package): 58411029710
ndc11 (package): 58411029810
spl id: 47aab51b-96c9-d1c1-e063-6294a90a738e
spl set id: bf736c5b-fc33-4cd5-8d18-03929f739d76

Reported adverse events (FAERS/openFDA)#

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