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
5A68WGF6WMInternal UNII lookup
4Y5P7MUD51Internal UNII lookup
15FIX9V2JPInternal 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 38 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
RE SCREEN BROAD SPECTRUM SPF 30 SUNSCREENZINC OXIDEZouck LLC507560fe-c7ad-329a-e063-6394a90a039a2026-04-27WarningsExact identifier
application number: M020
SoloVeganHOMOSALATE, OCTISALATE, OCTOCRYLENE, AVOBENZONEYES SALES INC.435748e6-c39a-efee-e063-6294a90ad0e52026-04-27WarningsExact identifier
application number: M020
SCREEN SCREEN BROAD SPECTRUM SPF 30 SUNSCREENZINC OXIDEZouck LLC50764f40-7881-81a3-e063-6294a90ad1cf2026-04-27WarningsExact identifier
application number: M020
Obagi Skintrinsiq Antioxidant ProtocolAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONEObagi Cosmeceuticals LLC495bc176-b292-448f-a5a6-00de2e475e542026-04-27WarningsExact identifier
application number: M020
TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30BRIGHTENING SKIN TINTPML NYC, LLCf45bd7bd-a802-33e4-e053-2a95a90a61a72026-04-23WarningsExact identifier
application number: M020
TRACELESS MINERAL BROAD SPECTRUM SPF SUNSCREEN AND PRIMERTRACELESS MINERAL BROAD SPECTRUM SPF SUNSCREEN AND PRIMERPML NYC, LLC1c2e9b0d-ba0e-1767-e063-6394a90a756c2026-04-23WarningsExact identifier
application number: M020
Skincare LdeL Retinol Day Broad Spectrum SPF 20AVOBENZONE, HOMOSALATE, OXYBENZONE, AND OCTINOXATEBeauty Solutions, Ltd.76e2ed34-c643-402b-9c9d-04eac789d3c22026-04-22WarningsExact identifier
application number: M020
Johnsons Baby Mineral Sunscreen SPF 30TITANIUM DIOXIDE, ZINC OXIDEKenvue Brands LLC4fe04c4b-2751-0561-e063-6394a90af7682026-04-22WarningsExact identifier
application number: M020
Johnsons Baby Mineral Sunscreen Stick SPF 50ZINC OXIDEKenvue Brands LLC4fe1d3c6-7748-d966-e063-6394a90a97ff2026-04-22WarningsExact identifier
application number: M020
OVERLAPS ECTOIN MOIST SUNAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEOverlaps Corp.4c3ed60b-e515-8ff0-e063-6294a90a86df2026-04-22WarningsExact identifier
application number: M020
Lazy Face SPF 30 FacescreenTITANIUM DIOXIDE, ZINC OXIDESunny Day Creations500ee303-7302-68d5-e063-6394a90ac6d42026-04-22WarningsExact identifier
application number: M020
Lazy Face SPF 30 FacestickZINC OXIDESunny Day Creations50101b55-793e-dbe4-e063-6394a90a61992026-04-22WarningsExact identifier
application number: M020
Broad Spectrum Sunscreen SPF 30OCTOCRYLENE 10% HOMOSALATE 10% OCTISALATE 5 % AVOBENZONE 3%S&C Hampton Sun LLCe6103de6-1d80-46fd-b9d4-893f60941def2026-04-22WarningsExact identifier
application number: M020
PhotoAge GuardAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDEMACROMOTION, INC.50164bd8-469d-9ec1-e063-6294a90a543d2026-04-22WarningsExact identifier
application number: M020
THANK YOU FARMER Sun Project Silky Calming Sun StickAVOBENZONE, OCTISALATE, HOMOSALATE, OCTOCRYLENETHANK YOU FARMER CO., LTD49947114-5137-dc45-e063-6394a90ad9d02026-04-22WarningsExact identifier
application number: M020
Sky and Sol Intense Healing Lip JellyNON-NANO ZINC OXIDEDelta Ecommerce LLC2ddaa215-7433-c8fa-e063-6394a90a43162026-04-22WarningsExact identifier
application number: M020
Broad Spectrum SPF45ZINC OXIDE, OCTINOXATEDrmtlgy, LLC0445ee5f-45a8-4fd5-ae4d-62f66e6f0be82026-04-21WarningsExact identifier
application number: M020
BLDG Active Skin Repair Face and Body Performance SunscreenZINC OXIDEInnovacyn, Inc.70cb98cf-739b-4d46-b45a-535ff0a4531c2026-04-21WarningsExact identifier
application number: M020
Freaks of Nature Mineral SunscreenZINC OXIDE MINERAL SUNSCREENEmpack Spraytech Inc.4ffdb1c6-b2c6-628f-e063-6394a90a27692026-04-21WarningsExact identifier
application number: M020
THANK YOU FARMER Sun Project Water Sun CreamAVOBENZONE, ETHYLHEXYL SALICYLATE, HOMOSALATE, OCTOCRYLENETHANK YOU FARMER CO., LTD5004126b-0a9c-21fb-e063-6294a90a52372026-04-21WarningsExact 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