FDA.reportPublic FDA data

SHISEIDO SYNCHRO SKIN SELF-REFRESHING TINT

Product NDC
58411-673
11-digit product format
584110673
Labeler code
58411
Product ID
58411-673_47b9c2a8-0ac1-cc8b-e063-6394a90a2359
Type
HUMAN OTC DRUG
Nonproprietary name
OCTINOXATE, OCTOCRYLENE, and TITANIUM DIOXIDE
Dosage form
EMULSION
Route
TOPICAL
Labeler
SHISEIDO AMERICAS CORPORATION
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-12-16
Substance
OCTINOXATE; OCTOCRYLENE; TITANIUM DIOXIDE
Active strength
2010; 900; 600 mg/30mL; mg/30mL; mg/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 TINT
Brand name suffix
115 Fair Shirakaba
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OCTINOXATE2010 mg/30mL
OCTOCRYLENE900 mg/30mL
TITANIUM DIOXIDE600 mg/30mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
15FIX9V2JPInternal UNII lookup
5A68WGF6WMInternal 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
26151cf4-0fee-4a42-92fd-4d7b9cef8381Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58411-673-20SHISEIDO SYNCHRO SKIN SELF-REFRESHING TINT115 Fair Shirakaba30 mL in 1 TUBEEMULSION303
58411-673-20SHISEIDO SYNCHRO SKIN SELF-REFRESHING TINT115 Fair Shirakaba1 in 1 CONTAINEREMULSION13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58411-673SHISEIDO SYNCHRO SKIN SELF-REFRESHING TINT 115 FAIR SHIRAKABA (OCTINOXATE, OCTOCRYLENE, AND TITANIUM DIOXIDE) EMULSION SHISEIDO SYNCHRO SKIN SELF-REFRESHING TINT 125 FAIR ASTERID (OCTINOXATE, OCTOCRYLENE, AND TITANIUM DIOXIDE) EMULSION SHISEIDO SYNCHRO SKIN SELF-REFRESHING TINT 215 LIGHT BUNA (OCTINOXATE, OCTOCRYLENE, AND TITANIUM DIOXIDE) EMULSION SHISEIDO SYNCHRO SKIN SELF-REFRESHING TINT 225 LIGHT MAGNOLIA (OCTINOXATE, OCTOCRYLENE, AND TITANIUM DIOXIDE) EMULSION SHISEIDO SYNCHRO SKIN SELF-REFRESHING TINT 235 LIGHT HIBA (OCTINOXATE, OCTOCRYLENE, AND TITANIUM DIOXIDE) EMULSION SHISEIDO SYNCHRO SKIN SELF-REFRESHING TINT 315 MEDIUM MATSU (OCTINOXATE, OCTOCRYLENE, AND TITANIUM DIOXIDE) EMULSION SHISEIDO SYNCHRO SKIN SELF-REFRESHING TINT 325 MEDIUM KEYAKI (OCTINOXATE, OCTOCRYLENE, AND TITANIUM DIOXIDE) EMULSION SHISEIDO SYNCHRO SKIN SELF-REFRESHING TINT 335 MEDIUM KATSURA (OCTINOXATE, OCTOCRYLENE, AND TITANIUM DIOXIDE) EMULSION SHISEIDO SYNCHRO SKIN SELF-REFRESHING TINT 415 TAN KWANZAN (OCTINOXATE, OCTOCRYLENE, 2Current NDC, Legacy NDC, 2 package rows20241228_26151cf4-0fee-4a42-92fd-4d7b9cef8381.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 117 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Stellar Tinted Mineral Sunscreen StickTITANIUM DIOXIDE, ZINC OXIDEThe Essential Brazilian Spa LLC3bb6488c-d216-8742-e063-6394a90a16e22025-12-15WarningsExact identifier
application number: M020
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEThe Essential Brazilian Spa LLC3bb8ee19-81b2-daed-e063-6394a90a0fb32025-12-15WarningsExact identifier
application number: M020
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEThe Essential Brazilian Spa LLC3bb6cfd4-fa4a-d1d9-e063-6394a90a8e432025-12-15WarningsExact identifier
application number: M020
Mineral Lip SunscreenTITANIUM DIOXIDE, ZINC OXIDEThe Essential Brazilian Spa LLC35442ac0-c361-e08f-e063-6294a90a5cb22025-12-15Exact identifier
application number: M020
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEThe Essential Brazilian Spa LLC3543e85d-9bc7-b8ed-e063-6294a90ae7d32025-12-15Exact identifier
application number: M020
Mineral Lip SunscreenTITANIUM DIOXIDE, ZINC OXIDEThe Essential Brazilian Spa LLC3bc8593d-fc6c-04aa-e063-6394a90a6d562025-12-15WarningsExact identifier
application number: M020
Mineral Sunscreen 20percent Zinc OxideZINC OXIDEMANTRA WELLNESS SPA338855fd-3008-44d9-e063-6294a90a5e072025-12-15Exact identifier
application number: M020
Tinted Replenishing Daily ProtectionZINC OXIDEMANTRA WELLNESS SPA33898415-4ee6-a384-e063-6394a90ae8e12025-12-15Exact identifier
application number: M020
Mineral Lip SunscreenTITANIUM DIOXIDE, ZINC OXIDEMantra Wellness Spa3389b0a3-40f9-b411-e063-6394a90a99592025-12-15Exact identifier
application number: M020
Mineral Sunscreen 20percent Zinc OxideZINC OXIDEMantra Wellness Spa338a11fb-24c6-8a0b-e063-6294a90a761e2025-12-15Exact identifier
application number: M020
Tinted Replenishing Daily ProtectionZINC OXIDEMantra Wellness Spa338aa5a2-29e3-fe0e-e063-6294a90a18fd2025-12-15Exact identifier
application number: M020
Non Tinted Mineral Sunscreen StickTITANIUM DIOXIDE, ZINC OXIDEMILESTHETICS LLC39959db9-5ee1-a27c-e063-6394a90a1e102025-12-15Exact identifier
application number: M020
Tinted Mineral Sunscreen StickTITANIUM DIOXIDE, ZINC OXIDEMILESTHETICS LLC3995f556-20fe-3e64-e063-6294a90a5efe2025-12-15Exact identifier
application number: M020
Mineral Lip SunscreenTITANIUM DIOXIDE, ZINC OXIDEMILESTHETICS LLC3995385b-b10b-ca5c-e063-6294a90af43f2025-12-15Exact identifier
application number: M020
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEMILESTHETICS LLC3994aa84-30b4-3dc4-e063-6394a90a23e72025-12-15Exact identifier
application number: M020
Non Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEMILESTHETICS LLC39947913-f1cc-25d2-e063-6294a90a42292025-12-15Exact identifier
application number: M020
Non Tinted Mineral SunscreenZINC OXIDEMicro Fibro Blast35425e24-3e2c-51db-e063-6394a90a55802025-12-15Exact identifier
application number: M020
Solar Shield TintedZINC OXIDEDENISE BELL SKIN CARE396fe2ca-eb29-5952-e063-6294a90ab2792025-12-15Exact identifier
application number: M020
Solar Shield TintedZINC OXIDEDENISE BELL SKIN CARE396f91b3-3326-3239-e063-6294a90a5df92025-12-15Exact identifier
application number: M020
Tinted Mineral SunscreenZINC OXIDEMicro Fibro Blast35422370-eb55-049c-e063-6294a90ad0a42025-12-15Exact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58411-673-20584110673201 TUBE in 1 CONTAINER (58411-673-20) / 30 mL in 1 TUBE1 tube2019-12-160000-00-00NoNoCurrent