FDA.reportPublic FDA data

SHISEIDO SYNCHRO SKIN RADIANT LIFTING FOUNDATION

Product NDC
58411-577
11-digit product format
584110577
Labeler code
58411
Product ID
58411-577_47aba38c-f43c-3662-e063-6394a90ab08b
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
2020-09-20
Substance
OCTINOXATE; TITANIUM DIOXIDE
Active strength
2.484; .36 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 RADIANT LIFTING FOUNDATION
Brand name suffix
330
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OCTINOXATE2.484 g/30mL
TITANIUM DIOXIDE.36 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
8a0da327-a805-4ef9-b69a-14bf7278a81aAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5dbf91a8-ec29-4ffc-807c-e3bae7fb67b1Product name120201123
85bed648-23ca-4804-98e6-e36aee999cadProduct name120190717
80de93b4-8a94-428d-beb7-d644353ee70bProduct name120180424
eb4f7d5b-1286-40dc-b8bf-ad87ff51c688Product name120170522
db8eb201-78c7-4590-8a71-fac0a539bd8cProduct name120170404
141092be-5eb5-452e-9f69-2d350aa70a87Product name120161208

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58411-577-10SHISEIDO SYNCHRO SKIN RADIANT LIFTING FOUNDATION 3301 in 1 CARTONEMULSION14
58411-577-10SHISEIDO SYNCHRO SKIN RADIANT LIFTING FOUNDATION 33030 mL in 1 BOTTLEEMULSION304

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58411-577SHISEIDO SYNCHRO SKIN RADIANT LIFTING FOUNDATION 110 (OCTINOXATE AND TITANIUM DIOXIDE) EMULSION SHISEIDO SYNCHRO SKIN RADIANT LIFTING FOUNDATION 120 (OCTINOXATE AND TITANIUM DIOXIDE) EMULSION SHISEIDO SYNCHRO SKIN RADIANT LIFTING FOUNDATION 130 (OCTINOXATE AND TITANIUM DIOXIDE) EMULSION SHISEIDO SYNCHRO SKIN RADIANT LIFTING FOUNDATION 140 (OCTINOX .......NG FOUNDATION 530 (OCTINOXATE AND TITANIUM DIOXIDE) EMULSION SHISEIDO SYNCHRO SKIN RADIANT LIFTING FOUNDATION 540 (OCTINOXATE AND TITANIUM DIOXIDE) EMULSION SHISEIDO SYNCHRO SKIN RADIANT LIFTING FOUNDATION 550 (OCTINOXATE AND TITANIUM DIOXIDE) EMULSION SHISEIDO SYNCHRO SKIN RADIANT LIFTING FOUNDATION 560 (OCTINOXATE AND TITANIUM DIOXIDE) EMULSION [SHISEIDO AMERICAS CORPORATION]2Current NDC, Legacy NDC, 2 package rows20240112_8a0da327-a805-4ef9-b69a-14bf7278a81a.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 259 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mentholatum Medicated Lip Balm OriginalDIMETHICONE, OCTINOXATE, OCTISALATEThe Mentholatum Companyf84cc3a4-cc9f-4a38-8b7d-cf8d6cd39df12024-12-17WarningsExact identifier
application number: M020
Mentholatum Natural Ice Sport SPF 30AVOBENZONE, DIMETHICONE, OCTINOXATE, OCTISALATEThe Mentholatum Company57c35631-42d3-4c6c-bcbb-e2de92b45b132024-12-17WarningsExact identifier
application number: M020
Mary Kay TimeWise Repair Volu-Firm Day Cream Broad Spectrum SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONEMary Kay Inc.5f09503e-c455-4ac2-8d07-e8e66c2daa322024-12-17WarningsExact identifier
application number: M020
Mary Kay CC Cream Sunscreen Broad Spectrum SPF 15 Light to MediumHOMOSALATE, OCTINOXATE, OXYBENZONEMary Kay Inc.b5ca4bed-4f89-4020-a055-9d11f4cd50582024-12-17WarningsExact identifier
application number: M020
Mary Kay CC Cream Sunscreen Broad Spectrum SPF 15 DeepHOMOSALATE, OCTINOXATE, OXYBENZONEMary Kay Inc.e5fffd20-1d22-485a-9311-4cb4f9264f6f2024-12-17WarningsExact identifier
application number: M020
Mary Kay CC Cream Sunscreen Broad Spectrum SPF 15 Very DeepHOMOSALATE, OCTINOXATE, OXYBENZONEMary Kay Inc.404990e4-9499-4186-b39d-afc31834d3342024-12-17WarningsExact identifier
application number: M020
Mary Kay CC Cream Sunscreen Broad Spectrum SPF 15 Medium to DeepHOMOSALATE, OCTINOXATE, OXYBENZONEMary Kay Inc.6028e210-a8a3-4d84-a462-16a414c310522024-12-17WarningsExact identifier
application number: M020
Mary Kay CC Cream Sunscreen Broad Spectrum SPF 15 Very LightHOMOSALATE, OCTINOXATE, OXYBENZONEMary Kay Inc.af22b3a5-ac72-4c2a-aa7e-6b5ca07d89e82024-12-17WarningsExact identifier
application number: M020
Mary Kay TimeWise Daytime Defender Sunscreen Broad Spectrum SPF 30AVOBENZONE/OCTISALATE/OCTOCRYLENEMary Kay Inc.00f0f30d-236a-fd45-e063-6294a90a747d2024-12-17WarningsExact identifier
application number: M020
Softlips Cherry Cordial, Maple Butter, Frosted BerryDIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONEThe Mentholatum Companybab8447b-58b8-4160-a91e-05f9fd09ed1d2024-12-17WarningsExact identifier
application number: M020
STUDIO FIX FLUID BROAD SPECTRUM SPF 15OCTINOXATE, TITANIUM DIOXIDEMAKEUP ART COSMETICSfb59afc1-1dc9-f783-e053-6394a90a196b2024-12-17WarningsExact identifier
application number: M020
Mary Kay Mineral Facial Sunscreen Broad Spectrum SPF30ZINC OXIDEMary Kay Inc.0e9b15e4-e59c-f266-e063-6394a90ab81c2024-12-17WarningsExact identifier
application number: M020
MAC STUDIO WATERWEIGHT SPF 30 BROAD SPECTRUM FOUNDATION SUNSCREENOCTINOXATE, TITANIUM DIOXIDE, AND ZINC OXIDEMAKEUP ART COSMETICSe5fd3e40-de1d-4cdd-b725-4a517514ca352024-12-17WarningsExact identifier
application number: M020
STUDIO FINISH CONCEALER BROAD SPECTRUM SPF 35OCTINOXATE AND TITANIUM DIOXIDEMAKEUP ART COSMETICS2d034810-7210-4ad4-be23-ec2100f8c2f12024-12-17WarningsExact identifier
application number: M020
Aruba Aloe Hydrating Aloe Rich Sunscreen SPF 50AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATEAruba Aloe Balm NVacda1640-0d35-43dc-8734-d47b00cc85ed2024-12-17WarningsExact identifier
application number: M020
Mary Kay Foundation PrimerAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEMary Kay Inc.59d25b44-1adb-4790-8ce6-2d847a06b8b32024-12-17WarningsExact identifier
application number: M020
Mary Kay TimeWise Repair Volu-Firm The Go SetAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONEMary Kay Inc.cf7fb8f0-483d-443b-b381-086a255f07832024-12-17WarningsExact identifier
application number: M020
Mary Kay TimeWise Repair Volu-Firm Sampler SetAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONEMary Kay Inc.0a9ee359-19c1-4266-8a51-a68f655de1512024-12-17WarningsExact identifier
application number: M020
Mary Kay TimeWise Repair Volu-Firm SetAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONEMary Kay Inc.d459e2f7-dc78-4519-9733-01495fc447a22024-12-17WarningsExact identifier
application number: M020
Babo Botanicals Daily Sheer Tinted Mineral Sunscreen SPF 50ZINC OXIDEBabo Botanicals, Inc.2982ce67-f136-b93b-e063-6394a90a81ac2024-12-17WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58411-577-10584110577101 BOTTLE in 1 CARTON (58411-577-10) / 30 mL in 1 BOTTLE1 bottle2020-09-200000-00-00NoNoCurrent