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 212 of 353 · 7,049 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Ola Botanicals Sunscreen SPF 30 ZINC OXIDE Natural Health Partners, LLC c7a7df0b-da8f-407d-a1ee-28f75070b23c 2025-06-02 Warnings Exact identifier application number: M020 MUSTELA MINERAL SUNSCREEN BROAD SPECTRUM SPF 50 ZINC OXIDE Expanscience Laboratories d/b/a Mustela 95ea5442-a7ca-0c7d-e053-2a95a90ad247 2025-06-02 Warnings Exact identifier application number: M020 Bluevado Sunfix ZINC OXIDE, TITANIUM DIOXIDE Magic Blue, LLC 31f1e961-3719-f70a-e063-6394a90a481e 2025-05-31 Warnings Exact identifier application number: M020 Sunny Sailor First Mate Face Stick SPF 30 ZINC OXIDE SUNNY SAILOR LLC 8ef7e0c8-e76b-4e84-ac9d-169f85e5e36e 2025-05-28 Warnings Exact identifier application number: M020 Dr Mercola Broad Spectrum SPF15 ZINC OXIDE Natural Health Partners, LLC 47f6b19e-ede8-0daf-e054-00144ff88e88 2025-05-28 Warnings Exact identifier application number: M020 Dr. Mercola Broad Spectrum ZINC OXIDE Natural Health Partners, LLC 47f6ec0a-1144-55dd-e054-00144ff8d46c 2025-05-28 Warnings Exact identifier application number: M020 Dr. Mercola Broad Spectrum TITANIUM DIOXIDE, ZINC OXIDE Natural Health Partners, LLC 47f6ab9e-fa73-496a-e054-00144ff8d46c 2025-05-28 Warnings Exact identifier application number: M020 Celavive Protective Day SPF 30 AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTOCRYLENE USANA Health Sciences, Inc. cf00763f-6b3e-4d50-b639-9a6d6f595961 2025-05-28 Warnings Exact identifier application number: M020 TALLOW SUNSCREEN NON-NANO ZINC OXIDE FOUNDATION COMMERCE INC 363e38bf-b4b4-dcc4-e063-6294a90a5d2f 2025-05-28 Warnings Exact identifier application number: M020 CoreTex SunX 50 Facestick AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE CoreTex Products Inc 364989ea-c93b-d404-e063-6294a90abd09 2025-05-28 Warnings Exact identifier application number: M020 Solvaderm Universal Tinted Moisturizer Sunscreen SPF 30 OCTINOXATE, ZINC OXIDE SOLVADERM LLC 86dbd8c3-e95a-49a8-afe6-ff9d985e28ba 2025-05-27 Warnings Exact identifier application number: M020 NATUREWELL HYDRASUN LIP BALM SPF30 CITRUS SPRITZ AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE LIP BALM Port Jervis Laboratories, Inc. 350b4cce-1627-5b8f-e063-6294a90aa6bf 2025-05-26 Warnings Exact identifier application number: M020 Protect Daily Ritual Mineral Sunscreen Tinted TITANIUM DIOXIDE, ZINC OXIDE Melinda Menezes, M.D., Inc. 35ce8307-387b-2b40-e063-6294a90a28bc 2025-05-23 Exact identifier application number: M020 OS-01 FACE SPF BD SPF 30 TINTED MEDIUM/DEEP ZINC OXIDE ONESKIN INC. 35d57d3f-376c-2307-e063-6294a90adf51 2025-05-23 Warnings Exact identifier application number: M020 Oathology Inzincable Lip Balm SPF 35 ZINC OXIDE SKINOATH LLC 289a5492-af57-42e5-82af-3f1e4b369d68 2025-05-22 Warnings Exact identifier application number: M020 NAELI Tinted Mineral Moisturizer Sunscreen SPF 50, Light ZINC OXIDE ALLI LLC 3cb4459b-1776-414a-b5c4-0ffb9f1df766 2025-05-22 Warnings Exact identifier application number: M020 NAELI Tinted Mineral Moisturizer Sunscreen SPF 50, Dark ZINC OXIDE ALLI LLC 81633684-f9ac-45cb-8a3e-f0c30b229a82 2025-05-22 Warnings Exact identifier application number: M020 Mineral Lip Sunscreen TITANIUM DIOXIDE, ZINC OXIDE Melinda Menezes, M.D., Inc. 35bea4f3-c19e-3e2e-e063-6394a90aeb69 2025-05-22 Exact identifier application number: M020 LBEL FOREVER HYDRA LONGWEAR AND HYDRATING FOUNDATION 90H SPF 15 ALMENDRA 230N OCTINOXATE, ZINC OXIDE BEL STAR S.A. 35c106b6-9a80-01e3-e063-6294a90abc35 2025-05-22 Warnings Exact identifier application number: M020 COSRX AIRY-LIGHT CLEAR SUNCREEN STICK COSRX inc. 313b1a73-8863-c458-e063-6394a90a01d6 2025-05-20 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