Home NDC 58411-680 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 Ingredient Strength OCTINOXATE 2010 mg/30mL OCTOCRYLENE 900 mg/30mL TITANIUM DIOXIDE 600 mg/30mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 5A68WGF6WM Internal UNII lookup 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 58411-680-20 SHISEIDO SYNCHRO SKIN SELF-REFRESHING TINT335 Medium Katsura 1 in 1 CONTAINER EMULSION 1 3 58411-680-20 SHISEIDO SYNCHRO SKIN SELF-REFRESHING TINT335 Medium Katsura 30 mL in 1 TUBE EMULSION 30 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 58411-680 SHISEIDO 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, 2 Current NDC, Legacy NDC, 2 package rows 20241228_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 196 of 353 · 7,041 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Earth Mama Tinted Mineral Sunscreen SPF 40 ZINC OXIDE Eleeo Brands LLC 3c455d29-df4e-f4d5-e063-6394a90a97ba 2025-08-13 Warnings Exact identifier application number: M020 Baby Bum Mineral 50 Sunscreen TITANIUM DIOXIDE, ZINC OXIDE Sun Bum, LLC 3c470ff8-37d6-a729-e063-6294a90aa525 2025-08-13 Warnings Exact identifier application number: M020 Sun Bum 50 Mineral Sunscreen 1 OZ ZINC OXIDE Sun Bum, LLC 3c483d04-8942-5269-e063-6294a90a3881 2025-08-13 Warnings Exact identifier application number: M020 BANANA BOAT AVOBENZONE/OCTOCRYLENE/OXYBENZONE Edgewell Personal Care Brands LLC 3c49c623-47c6-4dc9-e063-6294a90a0096 2025-08-13 Warnings Exact identifier application number: M020 100% MINERAL SUNSCREEN 100% MINERAL SUNSCREEN Guangzhou Pallas Cosmetics Co.,Ltd. 3c4a3b41-9183-3835-e063-6394a90aea61 2025-08-13 Warnings Exact identifier application number: M020 ERBORIAN CC CREME Color Correcting SPF 25 FAIR OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE LABORATOIRES M&L 4443d4e6-bdc9-4547-9189-e94e9e0bdd2d 2025-08-12 Warnings Exact identifier application number: M020 ERBORIAN CC Red Correct Color Correcting SPF 25 OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE LABORATOIRES M&L a6cd16cc-5fe3-41b5-b724-83e469cd4d5e 2025-08-12 Warnings Exact identifier application number: M020 ERBORIAN CC CREME Color Correcting SPF 25 BRONZE OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE LABORATOIRES M&L 4aa12cf0-0c48-4b40-9c9a-bd50523cce8a 2025-08-12 Warnings Exact identifier application number: M020 ERBORIAN CC CREME Color Correcting SPF 25 MEDIUM OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE LABORATOIRES M&L 5bdaa149-47aa-40ac-b17a-ea6d29099862 2025-08-12 Warnings Exact identifier application number: M020 NAKED SUNDAYS CABANA GLOW MINERAL GLOW SERUM DROPS Illuminating 40mL with Pink Algae SPF 50 ZINC OXIDE NAKED SUNDAYS PTY LTD 1dda967c-2d69-8948-e063-6294a90ad2a4 2025-08-12 Warnings Exact identifier application number: M020 NAKED SUNDAYS CABANA GLOW MINERAL GLOW SERUM DROPS BRONZE 15mL with wild Rosella SPF 50 ZINC OXIDE NAKED SUNDAYS PTY LTD 24e9a9b8-41ba-123a-e063-6394a90a73cb 2025-08-12 Warnings Exact identifier application number: M020 NAKED SUNDAYS CABANA GLOW MINERAL GLOW SERUM DROPS BRONZE 40mL with wild Rosella SPF 50 ZINC OXIDE NAKED SUNDAYS PTY LTD 1dd9fe59-9e40-fd06-e063-6394a90a4ca2 2025-08-12 Warnings Exact identifier application number: M020 Coola Anti-Aging Hand Cream Sunscreen AVOBENZONE, OCTOCRYLENE, OCTISALATE COOLA LLC 3c2fbf10-d68e-c601-e063-6294a90a09a3 2025-08-12 Warnings Exact identifier application number: M020 NAKED SUNDAYS CABANA GLOW MINERAL GLOW SERUM DROPS PEARL 15mL with Pink Algae SPF 50 ZINC OXIDE NAKED SUNDAYS PTY LTD 24ea340a-06cd-b085-e063-6394a90adff9 2025-08-12 Warnings Exact identifier application number: M020 AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 29C OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE Aekyung Industrial Co., Ltd. 15536331-fec5-4daa-824d-2e32d63e6452 2025-08-12 Warnings Exact identifier application number: M020 NAKED SUNDAYS CABANA GLOW MINERAL GLOW SERUM DROPS PEARL 40mL with Pink Algae SPF 50 ZINC OXIDE NAKED SUNDAYS PTY LTD 1ddad045-7703-ea7e-e063-6394a90a2a5a 2025-08-12 Warnings Exact identifier application number: M020 NAKED SUNDAYS CABANA GLOW MINERAL GLOW SERUM DROPS Sheer Tint 15mL SPF 50 ZINC OXIDE NAKED SUNDAYS PTY LTD 0cf45fbf-b257-f16a-e063-6294a90a8794 2025-08-12 Warnings Exact identifier application number: M020 NAKED SUNDAYS CABANA GLOW MINERAL GLOW SERUM DROPS Sheer Tint 40mL SPF 50 ZINC OXIDE NAKED SUNDAYS PTY LTD 1ddb1f53-69dd-643a-e063-6394a90ad600 2025-08-12 Warnings Exact identifier application number: M020 Earth Mama Lady Face Mineral Sunscreen - Medium/Dark Tint Broad Spectrum SPF 40 ZINC OXIDE Earth Mama Angel Baby LLC 908c41fd-0496-4237-813b-1135e10ae0c5 2025-08-12 Warnings Exact identifier application number: M020 Earth Mama Baby Mineral Sunscreen SPF 40 ZINC OXIDE Earth Mama Angel Baby, LLC 74475fba-4cdd-4b27-8ea4-646f4016580c 2025-08-12 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 58411-680-20 58411068020 1 TUBE in 1 CONTAINER (58411-680-20) / 30 mL in 1 TUBE 1 tube 2019-12-16 0000-00-00 No No Current