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 4Y5P7MUD51 Internal UNII lookup 5A68WGF6WM 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 58411-680-20 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 229 of 346 · 6,912 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Stay Ageless Tinted Mineral Sunscreen Broad Spectrum SPF 30 TITANIUM DIOXIDE AND ZINC OXIDE BELLE MEDICAL LLC 2cdc69d3-2192-7a38-e063-6294a90a257f 2025-01-29 Warnings Exact identifier application number: M020 Stay Ageless Tinted Mineral Sunscreen Broad Spectrum SPF 30 TITANIUM DIOXIDE AND ZINC OXIDE Boxbar Beauty LLC 2d04c5e7-f3aa-873f-e063-6294a90a33d2 2025-01-29 Warnings Exact identifier application number: M020 SEAWEED BATH CO. Super Sheer Face Serum SPF-50 ZINC OXIDE The Seaweed Bath Co. a45b46f9-681f-4a8d-b561-165b995ccf80 2025-01-28 Warnings Exact identifier application number: M020 TiZO Photoceutical AM Replenish Non-Tinted ZINC OXIDE Fallien Cosmeceuticals, LTD 2cc62961-dcef-d7db-e063-6394a90a9ebd 2025-01-28 Warnings Exact identifier application number: M020 Every Sun Day Ultra-Sheer Priming Sunscreen Stick AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE Have & Be Co., Ltd. 2b53aa68-9c05-1682-e063-6294a90a968c 2025-01-28 Warnings Exact identifier application number: M020 TiZO Photoceutical AM Replenish - Tinted ZINC OXIDE Fallien Cosmeceuticals, LTD 2cc73c4f-30ea-0a51-e063-6394a90ac9a4 2025-01-28 Warnings Exact identifier application number: M020 TiZO Photoceutical AM Replenish - Tinted ZINC OXIDE Fallien Cosmeceuticals, LTD 2cc84aba-006b-a78e-e063-6294a90ae040 2025-01-28 Warnings Exact identifier application number: M020 TiZO Mineral Sun Defense SPF 50 TITANIUM DIOXIDE, ZINC OXIDE Fallien Cosmeceuticals Ltd. 2cc8f7ef-eda3-fe71-e063-6394a90a6a9a 2025-01-28 Warnings Exact identifier application number: M020 Baby Diaper Rash Cream ZINC OXIDE doTERRA International, LLC 641465a1-0daf-1bb9-e053-2a91aa0ab25d 2025-01-28 Warnings Exact identifier application number: M020 HydroPeptide S.P.F. Sun Protection Friends TITANIUM DIOXIDE, ZINC OXIDE HydroPeptide LLC f3669a1e-8b75-4e94-a3f0-71dcbc3fa914 2025-01-28 Warnings Exact identifier application number: M020 doTERRA sun Face Daily Moisturizer ZINC OXIDE doTERRA International, LLC f3836517-e3ec-5e9e-e053-2a95a90a7af1 2025-01-28 Warnings Exact identifier application number: M020 doTERRA sun ZINC OXIDE doTERRA International, LLC da5c48d6-1859-983d-e053-2a95a90a4c3e 2025-01-28 Warnings Exact identifier application number: M020 doTERRA sun ZINC OXIDE doTERRA International, LLC dd2fa6a2-2ba8-4333-e053-2a95a90a9790 2025-01-28 Warnings Exact identifier application number: M020 Tri-water sheer mineral sunscreen cushion SPF30 ZINC OXIDE Eden Brands Inc. 2cd22172-78cb-32f3-e063-6394a90a395d 2025-01-28 Warnings Exact identifier application number: M020 SOS Face Guard Broad Spectrum Sunscreen SPF 30 ZINC OXIDE Tower 28 6687006a-bd79-4e1c-a546-0f0b51b29948 2025-01-28 Warnings Exact identifier application number: M020 LBEL CONCENTRE GLOBAL ANTI AGING SERUM CONCEALER SPF 15 EYES FACE ALMENDRA 230 OCTINOXATE, ZINC OXIDE BEL STAR S.A. 2cb1a767-3228-71ea-e063-6294a90ac89e 2025-01-27 Warnings Exact identifier application number: M020 Meijer SPF 50 Sunscreen AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Meijer 26f7566e-5a89-21cf-e063-6294a90ac886 2025-01-27 Warnings Exact identifier application number: M020 TiZO Photoceutical AM Replenish Non-Tinted ZINC OXIDE Fallien Cosmeceuticals, LTD 2cb77125-ff77-2060-e063-6294a90ab69f 2025-01-27 Warnings Exact identifier application number: M020 GLOW RECIPE WATERMELON GLOW DEW SHIELD HYDRATING FLUID SPF 30 AVOBENZONE, HOMOSALATE, OCTISALATE Aramara Beauty LLC dba Glow Recipe 2cb90666-6517-a02c-e063-6294a90ab062 2025-01-27 Warnings Exact identifier application number: M020 Stay Ageless Tinted Mineral Sunscreen Broad Spectrum SPF 30 TITANIUM DIOXIDE AND ZINC OXIDE Z&Z Skin Essentials 2cdc48f3-474f-9c06-e063-6294a90afea1 2025-01-27 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