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 15FIX9V2JP Internal UNII lookup 4Y5P7MUD51 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 162 of 354 · 7,077 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Pipette Diaper Rash ZINC OXIDE Pipette LLC 2a93998c-1855-9207-e063-6294a90ab0e9 2025-11-14 Warnings Exact identifier application number: M020 Ware Sonny Universal TITANIUM DIOXIDE, ZINC OXIDE Ware Cosmetics fe2b9d16-9215-e21e-e053-6394a90a5156 2025-11-14 Warnings Exact identifier application number: M020 YAY NOVELTY ALL-IN-ONE TITANIUM DIOXIDE, ZINC OXIDE YAY Novelty fb833158-d0d8-de7f-e053-6294a90adc5a 2025-11-14 Warnings Exact identifier application number: M020 Thu Brule Free Spirit Correct and Protect TITANIUM DIOXIDE, ZINC OXIDE Laughing Buddha LLC 258a4f97-d811-0521-e063-6394a90aaf3b 2025-11-14 Warnings Exact identifier application number: M020 Alpha-H Total Eclipse TITANIUM DIOXIDE, ZINC OXIDE Alpha-H fc8a4efe-7d5e-5f44-e053-6394a90a80aa 2025-11-14 Warnings Exact identifier application number: M020 Svens Everyday Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE Svens, Inc 912170ae-124c-5eb9-e053-2995a90a0ba3 2025-11-14 Warnings Exact identifier application number: M020 Wander Beauty Pack Up and Glow Priming TITANIUM DIOXIDE, ZINC OXIDE Wander Beauty 3d844efc-091c-9a9b-e063-6294a90aee7c 2025-11-14 Warnings Exact identifier application number: M020 Baby Bare Republic Mineral Sunscreen ZINC OXIDE COOLA, LLC b292d1a9-7ff8-0faf-e053-2995a90ae342 2025-11-14 Warnings Exact identifier application number: M020 Aspen Islanders Sheer Mineral Sport ZINC OXIDE Aspen Islanders LLC 0fcb2adf-71c9-3369-e063-6294a90aa806 2025-11-14 Warnings Exact identifier application number: M020 By the Beach Suncare SPF 30 SUNCARE MALON DAZE By the Beach Suncare LLC 4391728b-dfe7-3ffb-e063-6394a90a240e 2025-11-14 Warnings Exact identifier application number: M020 By the Beach Suncare SPF 30 SUNCARE CITRUS CRUSH By the Beach Suncare LLC 43918d25-e947-5e17-e063-6394a90ada7c 2025-11-14 Warnings Exact identifier application number: M020 By the Beach Suncare SPF 30 SUNCARE CANDY CLOUDS By the Beach Suncare LLC 4391728b-dfe8-3ffb-e063-6394a90a240e 2025-11-14 Warnings Exact identifier application number: M020 Sunsolve MD Balance and Clear ZINC OXIDE Sunsolve MD Inc 26f3595d-adef-a8a5-e063-6394a90adfd4 2025-11-14 Warnings Exact identifier application number: M020 Sunsolve MD Detox and Shield ZINC OXIDE Sunsolve MD Inc 26f3886b-a3a5-c9b7-e063-6394a90af6c3 2025-11-14 Warnings Exact identifier application number: M020 Sunsolve MD Mineral Shade Amber 002 ZINC OXIDE Sunsolve MD Inc 26e00001-9c68-0734-e063-6394a90a1787 2025-11-14 Warnings Exact identifier application number: M020 Sunsolve MD Mineral Shade Agate 003 ZINC OXIDE Sunsolve MD Inc 26e00001-9c6f-0734-e063-6394a90a1787 2025-11-14 Warnings Exact identifier application number: M020 Sunsolve MD Mineral Shade Bronzite 004 ZINC OXIDE Sunsolve MD Inc 26e13356-9ab5-246a-e063-6394a90a2a70 2025-11-14 Warnings Exact identifier application number: M020 Sunsolve MD Mineral Shade Onyx 006 ZINC OXIDE Sunsolve MD Inc 26e16b5e-dd2e-6fb8-e063-6394a90a6a7f 2025-11-14 Warnings Exact identifier application number: M020 Sunsolve MD Calm and Revitalize ZINC OXIDE Sunsolve MD Inc 26f3f534-a305-3530-e063-6394a90a75e1 2025-11-14 Warnings Exact identifier application number: M020 Sunsolve MD Mineral Shade Garnet 005 ZINC OXIDE Sunsolve MD Inc 26e1508f-d386-329b-e063-6394a90a0a98 2025-11-14 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