FDA.reportPublic FDA data

SHISEIDO SYNCHRO SKIN SELF-REFRESHING FOUNDATION 140 PORCELAIN

Product NDC
58411-487
11-digit product format
584110487
Labeler code
58411
Product ID
58411-487_47a979e6-9974-9d6d-e063-6394a90ae0c8
Type
HUMAN OTC DRUG
Nonproprietary name
OCTINOXATE and TITANIUM DIOXIDE
Dosage form
EMULSION
Route
TOPICAL
Labeler
SHISEIDO AMERICAS CORPORATION
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-09-01
Substance
OCTINOXATE; TITANIUM DIOXIDE
Active strength
1.69; 2.001 g/30mL; g/30mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
SHISEIDO SYNCHRO SKIN SELF-REFRESHING FOUNDATION 140 PORCELAIN
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OCTINOXATE1.69 g/30mL
TITANIUM DIOXIDE2.001 g/30mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
15FIX9V2JPInternal UNII lookup
4Y5P7MUD51Internal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
0a214b6b-69a7-4cb9-9095-6fcf2b6945deAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58411-487-10SHISEIDO SYNCHRO SKIN SELF-REFRESHING FOUNDATION 140 PORCELAIN30 mL in 1 BOTTLEEMULSION305
58411-487-10SHISEIDO SYNCHRO SKIN SELF-REFRESHING FOUNDATION 140 PORCELAIN1 in 1 CARTONEMULSION15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58411-487SHISEIDO SYNCHRO SKIN SELF-REFRESHING FOUNDATION 110 ALABASTER (OCTINOXATE AND TITANIUM DIOXIDE) EMULSION SHISEIDO SYNCHRO SKIN SELF-REFRESHING FOUNDATION 120 IVORY (OCTINOXATE AND TITANIUM DIOXIDE) EMULSION SHISEIDO SYNCHRO SKIN SELF-REFRESHING FOUNDATION 130 OPAL (OCTINOXATE AND TITANIUM DIOXIDE) EMULSION SHISEIDO SYNCHRO SKIN SELF-REFRESHING FOUND .......TINOXATE AND TITANIUM DIOXIDE) EMULSION SHISEIDO SYNCHRO SKIN SELF-REFRESHING FOUNDATION 360 CITRINE (OCTINOXATE AND TITANIUM DIOXIDE) EMULSION SHISEIDO SYNCHRO SKIN SELF-REFRESHING FOUNDATION 410 SUNSTONE (OCTINOXATE AND TITANIUM DIOXIDE) EMULSION SHISEIDO SYNCHRO SKIN SELF-REFRESHING FOUNDATION 420 BRONZE (OCTINOXATE AND TITANIUM DIOXIDE) EMULSION [SHISEIDO AMERICAS CORPORATION]4Current NDC, Legacy NDC, 2 package rows20241228_0a214b6b-69a7-4cb9-9095-6fcf2b6945de.zip

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 119 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tinted Physical DefenseTITANIUM DIOXIDE, ZINC OXIDEATLANTA DERMOTOLOGY VEIN & RESEARCH CENTER35477ed2-0875-58d5-e063-6294a90a3d5d2025-12-15Exact identifier
application number: M020
Anti Aging Daily ProtectionZINC OXIDELEVERRIER, KAMILA35465f21-8bcd-6e44-e063-6294a90a8e5f2025-12-15Exact identifier
application number: M020
Anti Aging Daily ProtectionZINC OXIDELEVERRIER, KAMILA3546d369-3435-b56a-e063-6294a90a08432025-12-15Exact identifier
application number: M020
Tinted Facial SunscreenTITANIUM DIOXIDE, ZINC OXIDEHELTON SKIN & LASER INSTITUTE35a97770-2db9-99aa-e063-6294a90a459a2025-12-15Exact identifier
application number: M020
Tinted Replenishing Daily ProtectionZINC OXIDEHELTON SKIN & LASER INSTITUTE35a9d07d-70e5-5eed-e063-6394a90aebaf2025-12-15Exact identifier
application number: M020
Non-Tinted Sports StickTITANIUM DIOXIDE, ZINC OXIDEHELTON SKIN & LASER INSTITUTE35aa833a-19a1-99e9-e063-6394a90a840f2025-12-15Exact identifier
application number: M020
Tinted Facial PrimerTITANIUM DIOXIDE, ZINC OXIDEBEE NATURALS36c3352e-fa51-19ad-e063-6394a90a591b2025-12-15Exact identifier
application number: M020
Luminous Tinted MoisturizingZINC OXIDESKIN BOSS L.L.C.35a8ae26-82eb-e4ca-e063-6394a90a00222025-12-15Exact identifier
application number: M020
Restore Tinted MoisturizingZINC OXIDESKIN BOSS L.L.C.35a8e92e-ced2-fdcd-e063-6294a90acedc2025-12-15Exact identifier
application number: M020
Velvet Tinted Moisturizing Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDESKIN BOSS L.L.C.35a871dc-a707-9963-e063-6294a90a43962025-12-15Exact identifier
application number: M020
Velvet NT Moisturizing Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDESKIN BOSS L.L.C.35a8508d-7069-c2d6-e063-6394a90a62192025-12-15Exact identifier
application number: M020
Daily Skin Protection Sunscreen NTZINC OXIDESKINPLUSBYOROYO LLC35a94d6f-9b1c-1b26-e063-6394a90abe652025-12-15Exact identifier
application number: M020
Daily Skin Protection Sunscreen NTZINC OXIDESKINPLUSBYOROYO LLC35a9a6ed-c446-c90c-e063-6294a90aaa742025-12-15Exact identifier
application number: M020
Daily Skin Protection Sunscreen TintedZINC OXIDESKINPLUSBYOROYO LLC35a9ecd7-b416-0aab-e063-6294a90a323d2025-12-15Exact identifier
application number: M020
Proper Protection Plus Primer NTTITANIUM DIOXIDE, ZINC OXIDESkin & Proper LLC3596fe93-836b-4f8e-e063-6294a90a674a2025-12-15Exact identifier
application number: M020
Proper Protection Plus Primer TintedTITANIUM DIOXIDE, ZINC OXIDESkin & Proper LLC359723bb-6152-9566-e063-6294a90a59e02025-12-15Exact identifier
application number: M020
Daily Skin Protection Sunscreen TintedZINC OXIDESKINPLUSBYOROYO LLC35aa194a-9a2e-2b5f-e063-6294a90a98772025-12-15Exact identifier
application number: M020
Proper Protection Plus Primer NTTITANIUM DIOXIDE, ZINC OXIDESkin & Proper LLC3596cd73-0811-32bc-e063-6394a90ad1322025-12-15Exact identifier
application number: M020
Proper Protection Plus Primer TintedTITANIUM DIOXIDE, ZINC OXIDESkin & Proper LLC359782d7-6601-7d96-e063-6394a90af9dc2025-12-15Exact identifier
application number: M020
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEESTHETICS BY RIKI LLC37f1b692-0b80-0536-e063-6294a90ae8632025-12-15Exact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58411-487-10584110487101 BOTTLE in 1 CARTON (58411-487-10) / 30 mL in 1 BOTTLE1 bottle2019-09-010000-00-00NoNoCurrent