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
15FIX9V2JPInternal UNII lookup
4Y5P7MUD51Internal 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 65 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tanning Club Mineral Sunscreen SPF 30ZINC OXIDETanning Club LLCd674ccbc-7bae-435c-a531-a79e569e69a92026-02-04WarningsExact identifier
application number: M020
Derma B Everyday Fit Sunscreen SPF 50AVOBEZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENENeoPharm Co., Ltd.ba38a43d-7a8a-4814-ba34-0e99124f5fca2026-02-04WarningsExact identifier
application number: M020
SHISEIDO URBAN ENVIRONMENT oil-free MINERAL SUNSCREEN SPF 42TITANIUM DIOXIDE AND ZINC OXIDESHISEIDO AMERICAS CORPORATION86630e82-f249-4866-82dd-3e21feb266c42026-02-04WarningsExact identifier
application number: M020
SHISEIDO URBAN ENVIRONMENT FRESH-MOISTURE SUNSCREEN SPF 42AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENESHISEIDO AMERICAS CORPORATION42adc51f-f500-485d-82a0-1266721412622026-02-04WarningsExact identifier
application number: M020
SHISEIDO URBAN ENVIRONMENT VITA-CLEAR SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENESHISEIDO AMERICAS CORPORATION60e55ebb-47b8-465e-819a-af195952e1ca2026-02-04WarningsExact identifier
application number: M020
SHISEIDO BENEFIANCE NUTRIPERFECT DAYAVOBENZONE, OCTINOXATE, AND OCTOCRYLENESHISEIDO AMERICAS CORPORATIONf644c67b-3a71-411b-b321-39a8b18af0c72026-02-04WarningsExact identifier
application number: M020
cle de peau BEAUTE UV PROTECTIVE NAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEShiseido Americas Corporation4b242b76-8aed-4939-9906-741828acd8152026-02-04WarningsExact identifier
application number: M020
cle de peau BEAUTE PORE-REFINING MATTIFYING VEILAVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENEShiseido Americas Corporationefcf240f-95cb-45e0-b58a-9c8f3609aa552026-02-04WarningsExact identifier
application number: M020
cle de peau BEAUTE PORE-REFINING MATTIFYING VEILAVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENEShiseido Americas Corporation270ecc83-4262-4102-a753-2acaf11360a02026-02-04WarningsExact identifier
application number: M020
Walgreens 50 Caramel and Pistachio Scented SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEWALGREEN COMPANY4a038017-9f15-b4b2-e063-6294a90a1b232026-02-04WarningsExact identifier
application number: M020
SHISEIDO ULTIMATE SUN PROTECTOROCTISALATE, OCTOCRYLENE, ZINC OXIDEShiseido Americas Corporationce6a28c1-56e6-4105-bc9d-9d1986ead4202026-02-04WarningsExact identifier
application number: M020
Sport Sunscreen SPF 30AVOBENZONE, HOMOSALATE, OCTISALATEHARRIS TEETERd52e2c61-edbc-4c26-b1a7-e8eb656db1882026-02-04Warnings, Adverse reactionsExact identifier
application number: M020
Sport Sunscreen SPF 50AVOBENZONE, HOMOSALATE, OCTISALATEHARRIS TEETERd365ed6d-a92f-473b-be19-b8b63d17f3b72026-02-04Warnings, Adverse reactionsExact identifier
application number: M020
Avobenzone, Homosalate, OctisalateAVOBENZONE, HOMOSALATE, OCTISALATEHARRIS TEETER0a3b4597-06fe-4689-9751-6577867d755e2026-02-04Warnings, Adverse reactionsExact identifier
application number: M020
Sport Sunscreen SPF 50AVOBENZONE, HOMOSALATE, OCTISALATEHARRIS TEETERb83ea476-fa32-4405-9ae3-f294836edb622026-02-04WarningsExact identifier
application number: M020
Sunplus SPF50 Face Body SunscreenSUNSCREENI.Shay Cosmetics26d55baf-66dc-b1b8-e063-6394a90a670d2026-02-04WarningsExact identifier
application number: M020
NUDESCREEN DEWY ILLUMINATING GLOW SPF 30 - Angel GlowZINC OXIDE SUNSCREENBentley Laboratories, LLC351217c4-8d71-41d9-ab08-c43857c0510c2026-02-04WarningsExact identifier
application number: M020
NIDA Invisible Fit Sun StickSUN STICKProso Corp49eca4f2-aae3-a0d5-e063-6394a90ab25f2026-02-03WarningsExact identifier
application number: M020
Shiny Hiny SPF 45 Mineral SunscreenZINC OXIDEShiny Hiny Products, LLC31adde36-5e1b-40ff-e063-6294a90a6f2e2026-02-03WarningsExact identifier
application number: M020
Walgreens 50 Passion Fruit Scented SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEWALGREEN COMPANY49f030d8-959c-a3cd-e063-6294a90ae1ba2026-02-03WarningsExact 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