Home NDC 46783-002 Journee Bio-restorative Day Balm Broad-spectrum Suncreen SPF 30
Product NDC 46783-002
11-digit product format 467830002
Labeler code 46783
Product ID 46783-002_d1d2fc30-392b-481c-b1ad-b6fe86b3f8a4
Type HUMAN OTC DRUG
Nonproprietary name OCTINOXATE and ZINC OXIDE
Dosage form LOTION
Route TOPICAL
Labeler Merz North America, Inc.
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2011-04-01
Substance OCTINOXATE; ZINC OXIDE
Active strength 75; 73 mg/mL; mg/mL
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
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 Journee Bio-restorative Day Balm Broad-spectrum Suncreen SPF 30
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength OCTINOXATE 75 mg/mL ZINC OXIDE 73 mg/mL
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 46783-002-01 Journee Bio-restorative Day Balm Broad-spectrum Suncreen SPF 30 1 in 1 CARTON LOTION 1 8 46783-002-01 Journee Bio-restorative Day Balm Broad-spectrum Suncreen SPF 30 15 mL in 1 BOTTLE LOTION 15 8 46783-002-02 Journee Bio-restorative Day Balm Broad-spectrum Suncreen SPF 30 1 in 1 CARTON LOTION 1 8 46783-002-02 Journee Bio-restorative Day Balm Broad-spectrum Suncreen SPF 30 30 mL in 1 BOTTLE LOTION 30 8 46783-002-03 Journee Bio-restorative Day Balm Broad-spectrum Suncreen SPF 30 200 mL in 1 BOTTLE LOTION 200 8 46783-002-05 Journee Bio-restorative Day Balm Broad-spectrum Suncreen SPF 30 4 mL in 1 TUBE LOTION 4 8 46783-002-50 Journee Bio-restorative Day Balm Broad-spectrum Suncreen SPF 30 1 in 1 CARTON LOTION 1 8 46783-002-50 Journee Bio-restorative Day Balm Broad-spectrum Suncreen SPF 30 50 mL in 1 BOTTLE LOTION 50 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 46783-002 JOURNEE BIO-RESTORATIVE DAY BALM BROAD-SPECTRUM SUNCREEN SPF 30 (OCTINOXATE AND ZINC OXIDE) LOTION [MERZ NORTH AMERICA, INC.] 6 Current NDC, Legacy NDC, 8 package rows 20241109_e120a659-0dfc-42ca-8158-58e8a0b457e5.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 179 of 354 · 7,077 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Curology The Lip Balm Broad Spectrum SPF 30 Sunscreen ZINC OXIDE Curology Inc. e441b13f-cb58-457f-e053-2a95a90adab9 2025-10-15 Warnings Exact identifier application number: M020 Curology Everyday Sunscreen Broad Spectrum SPF 30 No-clog UV defense ZINC OXIDE Curology 39a2a297-3af2-40d3-8b5d-f4eef2487fb2 2025-10-15 Warnings Exact identifier application number: M020 Colorescience Total Protection No Show Mineral Sunscreen ZINC OXIDE Colorescience 00d8bf32-aecd-22da-e063-6294a90a7567 2025-10-15 Warnings Exact identifier application number: M020 Impeccable Skin Sunscreen Foundation Broad Spectrum SPF 30 Sand ZINC OXIDE Cosmetic Enterprises Ltd 253c105b-215b-1e6e-e063-6294a90a11d7 2025-10-14 Warnings Exact identifier application number: M020 Impeccable Skin Sunscreen Foundation Broad Spectrum SPF 30 Tan ZINC OXIDE Cosmetic Enterprises Ltd 265bbb1a-ba96-6598-e063-6394a90a9415 2025-10-14 Warnings Exact identifier application number: M020 Resist Wrinkle Defense SPF 30 Paulas Choice ZINC OXIDE Cosmetic Enterprises Ltd d658fdc7-9dac-47bf-8e83-1433a29a6cf6 2025-10-14 Warnings Exact identifier application number: M020 SPF 50 Face Sunscreen Bioelements AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE Cosmetic Enterprises Ltd 498b16c8-ba54-4a0a-8dbc-4b5cc368e214 2025-10-14 Warnings Exact identifier application number: M020 Skin Balancing Ultra Sheer Daily Defence SPF 30 Paulas Choice AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OXYBENZONE Cosmetic Enterprises Ltd 3bf31626-5580-457b-8a59-cc37f4ab0767 2025-10-14 Warnings Exact identifier application number: M020 Sunscreen Broad Spectrum SPF 30 Light Tropical Scent ZINC OXIDE Cosmetic Enterprises Ltd d8c7b82d-6151-2199-e053-2a95a90a6c20 2025-10-14 Warnings Exact identifier application number: M020 TOCOBO Cotton Airy Sun Stick AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE PICTON CO., Ltd. 412975d8-0b8b-23bf-e063-6294a90a5568 2025-10-14 Warnings Exact identifier application number: M020 TOCOBO Bio Watery Sun Screen AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE PICTON CO., Ltd. 4129e00b-951d-adbf-e063-6294a90a675e 2025-10-14 Warnings Exact identifier application number: M020 Sunny Sailor First Mate Face Stick SPF 30 ZINC OXIDE SUNNY SAILOR LLC c7908385-ff93-4c6c-9462-081c73023571 2025-10-13 Warnings Exact identifier application number: M020 Cloud Brush On Sunscreen SPF 50 ZINC OXIDE FUTURE 8 LLC 8b1eaf6c-9cd8-4c5e-beac-b8539c332ae3 2025-10-13 Warnings Exact identifier application number: M020 Sunplus Mist Sunscreen SPF 30 AVOBENZONE, OCTISALATE, OCTOCRYLENE SUNPLUS SKIN CARE LLC 951a7bdc-d5c5-4241-a482-c30a4b44f776 2025-10-13 Warnings Exact identifier application number: M020 Sunplus Mist Sunscreen SPF 50 AVOBENZONE, OCTISALATE, OCTOCRYLENE SUNPLUS SKIN CARE LLC da338ba7-7a92-4157-97f4-5ae9cc64853c 2025-10-13 Warnings Exact identifier application number: M020 Kinesys Broad Spectrum SPF 50 Alcohol Free Sunscreen OCTOCRYLENE, OCTINOXATE, HOMOSALATE, OCTISALATE, AND AVOBENZONE Wilc Healthcare Inc 998fe524-6469-4c9b-889b-3191882149ce 2025-10-13 Warnings Exact identifier application number: M020 Skinlycious Multi Protection Mineral Sunscreen Broad Spectrum SPF 30 TITANIUM DIOXIDE , ZINC OXIDE Skinlycious Pte Ltd e0ad02c3-f5ed-4b72-ba96-07d9c489a4ea 2025-10-13 Warnings Exact identifier application number: M020 Impeccable Skin Sunscreen Foundation Broad Spectrum SPF 30 Buff ZINC OXIDE Cosmetic Enterprises Ltd 265bc5e0-0a2a-842e-e063-6394a90aae0a 2025-10-13 Warnings Exact identifier application number: M020 Impeccable Skin Sunscreen Foundation Broad Spectrum SPF 30 Mocha ZINC OXIDE Cosmetic Enterprises Ltd 2748b6bc-e80b-ce66-e063-6394a90a400a 2025-10-13 Warnings Exact identifier application number: M020 Impeccable Skin Sunscreen Foundation Broad Spectrum SPF 30 Bronze ZINC OXIDE Cosmetic Enterprises Ltd 265bf123-c4c3-8414-e063-6394a90a4730 2025-10-13 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 46783-002-01 46783000201 1 BOTTLE in 1 CARTON (46783-002-01) / 15 mL in 1 BOTTLE 1 bottle 2011-04-01 0000-00-00 No No Current 46783-002-02 46783000202 1 BOTTLE in 1 CARTON (46783-002-02) > 30 mL in 1 BOTTLE 1 bottle 2011-04-01 0000-00-00 No No Current 46783-002-03 46783000203 200 mL in 1 BOTTLE (46783-002-03) 200 ml 2011-04-01 0000-00-00 No No Current 46783-002-05 46783000205 4 mL in 1 TUBE (46783-002-05) 4 ml 2011-04-01 0000-00-00 No No Current 46783-002-50 46783000250 1 BOTTLE in 1 CARTON (46783-002-50) > 50 mL in 1 BOTTLE 1 bottle 2019-06-18 0000-00-00 No No Current