Home NDC 58411-511 SHISEIDO SYNCHRO SKIN SELF-REFRESHING FOUNDATION 540 MAHOGANY
Product NDC 58411-511
11-digit product format 584110511
Labeler code 58411
Product ID 58411-511_47a97ed7-c0e2-aa2c-e063-6394a90a82e0
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 2019-09-01
Substance OCTINOXATE; TITANIUM DIOXIDE
Active strength 1.69; .345 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 SELF-REFRESHING FOUNDATION 540 MAHOGANY
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength OCTINOXATE 1.69 g/30mL TITANIUM DIOXIDE .345 g/30mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 4Y5P7MUD51 Internal UNII lookup 15FIX9V2JP Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 58411-511-10 SHISEIDO SYNCHRO SKIN SELF-REFRESHING FOUNDATION 540 MAHOGANY 1 in 1 CARTON EMULSION 1 3 58411-511-10 SHISEIDO SYNCHRO SKIN SELF-REFRESHING FOUNDATION 540 MAHOGANY 30 mL in 1 BOTTLE EMULSION 30 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 58411-511 SHISEIDO SYNCHRO SKIN SELF-REFRESHING FOUNDATION 430 CEDAR (OCTINOXATE AND TITANIUM DIOXIDE) EMULSION SHISEIDO SYNCHRO SKIN SELF-REFRESHING FOUNDATION 440 AMBER (OCTINOXATE AND TITANIUM DIOXIDE) EMULSION SHISEIDO SYNCHRO SKIN SELF-REFRESHING FOUNDATION 450 COPPER (OCTINOXATE AND TITANIUM DIOXIDE) EMULSION SHISEIDO SYNCHRO SKIN SELF-REFRESHING FOUNDATION 460 TOPAZ (OCTINOXATE AND TITANIUM DIOXIDE) EMULSION SHISEIDO SYNCHRO SKIN SELF-REFRESHING FOUNDATION 510 SUEDE (OCTINOXATE AND TITANIUM DIOXIDE) EMULSION SHISEIDO SYNCHRO SKIN SELF-REFRESHING FOUNDATION 520 ROSEWOOD (OCTINOXATE AND TITANIUM DIOXIDE) EMULSION SHISEIDO SYNCHRO SKIN SELF-REFRESHING FOUNDATION 530 HENNA (OCTINOXATE AND TITANIUM DIOXIDE) EMULSION SHISEIDO SYNCHRO SKIN SELF-REFRESHING FOUNDATION 540 MAHOGANY (OCTINOXATE AND TITANIUM DIOXIDE) EMULSION SHISEIDO SYNCHRO SKIN SELF-REFRESHING FOUNDATION 550 JASPER (OCTINOXATE AND TITANIUM DIOXIDE) EMULSION SHISEIDO SYNCHRO SKIN SELF-REFRESHING FOUNDATION 560 OBSIDIAN (OCTINOXATE AND TITANIUM DIOXIDE) EM 2 Current NDC, Legacy NDC, 2 package rows 20241228_fb6ac681-ff74-4420-a4f6-843d5f2b6d6b.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 346 of 346 · 6,912 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Antioxidant Sunscreen SPF 40 OCTINOXATE AND ZINC OXIDE Topiderm, Inc. 2686378c-8827-47fb-b3ed-07438bd4e9e2 2019-11-13 Warnings Exact identifier application number: M020 No7 Perfect and Perfect Intense Advanced All in One Foundation SPF 50 Cool Vanilla OCTINOXATE, TITANIUM DIOIXIDE, OCTISALATE BCM Cosmetique SAS d701c221-9f68-47ff-b766-2f4f1998649f 2019-10-08 Warnings Exact identifier application number: M020 No7 Perfect and Perfect Intense Advanced All in One Foundation SPF 50 Amber OCTINOXATE, TITANIUM DIOIXIDE, OCTISALATE BCM Cosmetique SAS 7f5e6872-4d26-410e-8afe-16a016f9a399 2019-10-08 Warnings Exact identifier application number: M020 No7 Perfect and Perfect Advanced All in One Foundation SPF 50 Warm Ivory OCTINOXATE, TITANIUM DIOIXIDE, OCTISALATE BCM Cosmetique SAS 1124ba7d-a328-409b-8c88-e74bb3e501f5 2019-10-08 Warnings Exact identifier application number: M020 No7 Perfect and Perfect Advanced All in One Foundation SPF 50 Honey OCTINOXATE, TITANIUM DIOIXIDE, OCTISALATE BCM Cosmetique SAS 9c407dc7-fcde-4660-9a06-57bd8a6b867d 2019-10-08 Warnings Exact identifier application number: M020 No7 Perfect and Perfect Intense Advanced All in One Foundation SPF 50 Chestnut OCTINOXATE, TITANIUM DIOIXIDE, OCTISALATE BCM Cosmetique SAS f07e8bb2-30ae-4337-ad60-84f55f2ff354 2019-10-08 Warnings Exact identifier application number: M020 Thinkbaby Sunscreen SPF 30 ZINC OXIDE thinkOperations,LLC 86249f33-e635-4455-a039-3a25aa3478df 2019-03-25 Warnings Exact identifier application number: M020 Sun Defense Mineral Sunscreen SPF 30 Face ZINC OXIDE derma e 635ae850-7ce4-4cb7-bdaf-bec00904ca02 2018-11-12 Warnings Exact identifier application number: M020 Thinksport Sunscreen SPF 30 ZINC OXIDE thinkOperations,LLC a8591509-65f7-4e62-8642-4b8e63f1fef3 2018-11-08 Warnings Exact identifier application number: M020 Essential Defense Everyday Clear Broad Spectrum SPF 47 Sunscreen ZINC OXIDE AND OCTINOXATE Allergan, Inc. bc872876-20e7-40cb-b79d-68998883681a 2016-03-01 Warnings Exact identifier application number: M020 TOTAL DEFENSE REPAIR BROAD SPECTRUM SPF 34 Sunscreen (Tinted) OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE AND ZINC OXIDE Allergan, Inc. 6a996e03-907f-4e6a-b232-0892b86956b0 2015-08-21 Warnings Exact identifier application number: M020 TiZO2 TITANIUM DIOXIDE, ZINC OXIDE Fallien Cosmeceuticals, LTD. 30468afc-9616-4765-b046-12e97a0a7827 2010-12-20 Warnings Exact identifier application number: M020
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 58411-511-10 58411051110 1 BOTTLE in 1 CARTON (58411-511-10) / 30 mL in 1 BOTTLE 1 bottle 2019-09-01 0000-00-00 No No Current