FDA.reportPublic FDA data

SHISEIDO SYNCHRO SKIN SELF-REFRESHING TINT

Product NDC
58411-680
11-digit product format
584110680
Labeler code
58411
Product ID
58411-680_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
335 Medium Katsura
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
4Y5P7MUD51Internal UNII lookup
15FIX9V2JPInternal UNII lookup
5A68WGF6WMInternal 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
58411-680-20SHISEIDO SYNCHRO SKIN SELF-REFRESHING TINT335 Medium Katsura1 in 1 CONTAINEREMULSION13
58411-680-20SHISEIDO SYNCHRO SKIN SELF-REFRESHING TINT335 Medium Katsura30 mL in 1 TUBEEMULSION303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58411-680SHISEIDO 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 110 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mattifying Mineral SPF40 TintedTITANIUM DIOXIDE, ZINC OXIDEELIZA ARAKELIAN36d4f6a7-1115-1efa-e063-6294a90a20c42025-12-17Exact identifier
application number: M020
Replenish SPF 40ZINC OXIDEELIZA ARAKELIAN36d69eb5-597d-14a0-e063-6394a90a0a492025-12-17Exact identifier
application number: M020
Mattifying Mineral SPF 40 TintedTITANIUM DIOXIDE, ZINC OXIDEELIZA ARAKELIAN36d45700-fc41-ef54-e063-6394a90abcc32025-12-17Exact identifier
application number: M020
Gentle Mineral SPF 40 TintedZINC OXIDEELIZA ARAKELIAN36d66cde-1f90-32b5-e063-6294a90acb342025-12-17Exact identifier
application number: M020
Replenish SPF 40ZINC OXIDEELIZA ARAKELIAN36d7148b-b1c4-a6a9-e063-6294a90af92f2025-12-17Exact identifier
application number: M020
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEHSC MIAMI, INC36d85902-fbd2-ba74-e063-6294a90acfc32025-12-17Exact identifier
application number: M020
DAY DEFENSETITANIUM DIOXIDE, ZINC OXIDETHE SKIN CARE SOURCE, INC.36ad1330-a8bf-e8f8-e063-6394a90acb022025-12-17Exact identifier
application number: M020
Non-Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEHSC MIAMI, INC36d9a8f3-7760-57f3-e063-6394a90a1a1e2025-12-17Exact identifier
application number: M020
Non-Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEHSC MIAMI, INC36d7a18b-5a12-84a9-e063-6394a90a7e382025-12-17Exact identifier
application number: M020
DAY DEFENSE TINTEDTITANIUM DIOXIDE, ZINC OXIDETHE SKIN CARE SOURCE, INC.36ad4442-e45f-90e2-e063-6294a90aeef52025-12-17Exact identifier
application number: M020
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEHSC MIAMI, INC36d8b849-cf73-e008-e063-6394a90a410a2025-12-17Exact identifier
application number: M020
TINTED RESTORATIVE MOISTURIZERZINC OXIDESKINERGIX LLC3636adf0-c3bd-7422-e063-6394a90aaccc2025-12-17Exact identifier
application number: M020
Premier ZincZINC OXIDEENSO SKINCARE & WELLNESS LLC3bb378c8-14b0-aa13-e063-6294a90a4db32025-12-17WarningsExact identifier
application number: M020
Protect and RenewZINC OXIDEENSO SKINCARE & WELLNESS LLC3bb479ed-1153-8e80-e063-6294a90a29372025-12-17WarningsExact identifier
application number: M020
Flawless FinishTITANIUM DIOXIDE, ZINC OXIDEENSO SKINCARE & WELLNESS LLC3b8df7ce-e5ce-aaf8-e063-6394a90afdae2025-12-17WarningsExact identifier
application number: M020
Shield Mineral Sunscreen TintedZINC OXIDESMOOTHE LLC369b9d76-f6c3-e25f-e063-6294a90adaf32025-12-17Exact identifier
application number: M020
Shield Mineral Sunscreen Non TintedZINC OXIDESMOOTHE LLC369bc20d-7192-7c0a-e063-6294a90a3dfe2025-12-17Exact identifier
application number: M020
Lip BalmTITANIUM DIOXIDE, ZINC OXIDEPATRICIA SOLIS MAKEUP ARTIST, LLC369d63a9-b9a9-9530-e063-6394a90ac8ef2025-12-17Exact identifier
application number: M020
Matte TintTITANIUM DIOXIDE, ZINC OXIDEPATRICIA SOLIS MAKEUP ARTIST, LLC369ced69-59b4-0f3c-e063-6294a90a582f2025-12-17Exact identifier
application number: M020
Hydra TintZINC OXIDEPATRICIA SOLIS MAKEUP ARTIST, LLC369d4e7a-8356-8f15-e063-6394a90acca82025-12-17Exact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58411-680-20584110680201 TUBE in 1 CONTAINER (58411-680-20) / 30 mL in 1 TUBE1 tube2019-12-160000-00-00NoNoCurrent