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 232 of 353 · 7,041 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join TiZO Ultra Zinc SPF 40 (Tinted) ZINC OXIDE Fallien Cosmeceuticals, LTD 2d0856cf-d3da-5a77-e063-6294a90ad5b4 2025-01-31 Warnings Exact identifier application number: M020 FRE PROTECT BODY Ultra-Light Gel Cream SPF 50 ZINC OXIDE Peer Pharm Ltd. 2cd83c55-851c-089e-e063-6294a90ad6bc 2025-01-30 Warnings Exact identifier application number: M020 FRE BRONZE ME Sun-Kissed Mineral Sunscreen SPF 50 ZINC OXIDE Peer Pharm Ltd. 2cd958a3-bad6-725e-e063-6294a90a8578 2025-01-30 Warnings Exact identifier application number: M020 FRE PLUMP ME PEPTIDE LIP TINT CASSIS SPF 30 ZINC OXIDE Peer Pharm Ltd. 2cd77d62-77df-f3a9-e063-6394a90ad57d 2025-01-30 Warnings Exact identifier application number: M020 FRE PLUMP ME PEPTIDE LIP TINT PAMPELONNE SPF 30 ZINC OXIDE Peer Pharm Ltd. 2caf3b6b-3a05-b24a-e063-6394a90a4799 2025-01-30 Warnings Exact identifier application number: M020 Jil Goorman Skincare Sun Guard SPF 30 AVOBENZONE, OCTISALATE, OCTOCRYLENE SAN DIEGO NATURAL SOAP COMPANY 9a088bed-3b85-4bf5-923b-4c99eb904a8d 2025-01-30 Warnings Exact identifier application number: M020 FRE PLUMP ME PEPTIDE LIP TINT MONACO SPF 30 ZINC OXIDE Peer Pharm Ltd. 2baf0278-7e13-4db0-e063-6294a90ae9de 2025-01-30 Warnings Exact identifier application number: M020 Babo Botanicals Sensitive Baby Mineral Sunscreen SPF50 ZINC OXIDE Babo Botanicals, Inc. 08a175ae-2307-ef8d-e063-6394a90ad234 2025-01-30 Warnings Exact identifier application number: M020 Babo Botanicals Super Shield Mineral Sunscreen SPF50 ZINC OXIDE Babo Botanicals, Inc 08b7bcfd-0c7c-a14f-e063-6294a90a7797 2025-01-30 Warnings Exact identifier application number: M020 Salt and Stone Sunscreen Lip Balm SPF 30 ZINC OXIDE Salt and Stone LLC b555aa10-1547-63cc-e053-2995a90ad20d 2025-01-30 Warnings Exact identifier application number: M020 COVER plus CORRECT/TINTED MOISTURIZER CC CRM FAIR OCTINOXATE, OCTISALATE, OXYBENZONE, AND TITANIUM DIOXIDE Bluemercury 5c590aed-d2f2-4478-8919-37c848752b42 2025-01-29 Warnings Exact identifier application number: M020 LiProtect SPF 35 ZINC OXIDE, TITANIUM DIOXIDE Science of Skincare 0d0a2657-4098-3c60-e063-6294a90acabb 2025-01-29 Warnings Exact identifier application number: M020 Perfect Sunscreen Tinted Mineral SPF50 ZINC OXIDE Bluemercury, Inc. 4c978154-679f-472a-95ab-56878c5c70cd 2025-01-29 Warnings Exact identifier application number: M020 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
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