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 118 of 357 · 7,139 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Non Tinted Mineral Sunscreen Stick TITANIUM DIOXIDE, ZINC OXIDE MILESTHETICS LLC 39959db9-5ee1-a27c-e063-6394a90a1e10 2025-12-15 Exact identifier application number: M020 Tinted Mineral Sunscreen Stick TITANIUM DIOXIDE, ZINC OXIDE MILESTHETICS LLC 3995f556-20fe-3e64-e063-6294a90a5efe 2025-12-15 Exact identifier application number: M020 Mineral Lip Sunscreen TITANIUM DIOXIDE, ZINC OXIDE MILESTHETICS LLC 3995385b-b10b-ca5c-e063-6294a90af43f 2025-12-15 Exact identifier application number: M020 Tinted Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE MILESTHETICS LLC 3994aa84-30b4-3dc4-e063-6394a90a23e7 2025-12-15 Exact identifier application number: M020 Non Tinted Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE MILESTHETICS LLC 39947913-f1cc-25d2-e063-6294a90a4229 2025-12-15 Exact identifier application number: M020 Non Tinted Mineral Sunscreen ZINC OXIDE Micro Fibro Blast 35425e24-3e2c-51db-e063-6394a90a5580 2025-12-15 Exact identifier application number: M020 Solar Shield Tinted ZINC OXIDE DENISE BELL SKIN CARE 396fe2ca-eb29-5952-e063-6294a90ab279 2025-12-15 Exact identifier application number: M020 Solar Shield Tinted ZINC OXIDE DENISE BELL SKIN CARE 396f91b3-3326-3239-e063-6294a90a5df9 2025-12-15 Exact identifier application number: M020 Tinted Mineral Sunscreen ZINC OXIDE Micro Fibro Blast 35422370-eb55-049c-e063-6294a90ad0a4 2025-12-15 Exact identifier application number: M020 Eclipse Face Tinted ZINC OXIDE DENISE BELL SKIN CARE 396f0151-2d0d-f4da-e063-6394a90a5f7f 2025-12-15 Exact identifier application number: M020 Eclipse Body Non Tinted ZINC OXIDE DENISE BELL SKIN CARE 396f56df-d0de-1344-e063-6294a90a46ea 2025-12-15 Exact identifier application number: M020 Solar Shield Tinted TITANIUM DIOXIDE, ZINC OXIDE DENISE BELL SKIN CARE 396eb781-5947-3665-e063-6294a90a38dd 2025-12-15 Exact identifier application number: M020 Sun Veil Illuminating Sunscreen SPF30 ZINC OXIDE Koco Life LLC 46001097-540e-65da-e063-6294a90af299 2025-12-15 Warnings Exact identifier application number: M020 Mineral Primer tinted SPF40 TITANIUM DIOXIDE, ZINC OXIDE Oracle Esthetics, LLC 3542d8d3-35a3-7d63-e063-6394a90a6fd1 2025-12-15 Exact identifier application number: M020 Mineral Primer non-tinted SPF40 TITANIUM DIOXIDE, ZINC OXIDE Oracle Esthetics, LLC 354357de-1a85-3bdb-e063-6294a90aa9a2 2025-12-15 Exact identifier application number: M020 Mineral Primer tinted SPF40 TITANIUM DIOXIDE, ZINC OXIDE Oracle Esthetics, LLC 35433254-1dc8-a8f3-e063-6394a90a29f0 2025-12-15 Exact identifier application number: M020 Sun Therapy Sunscreen ZINC OXIDE Skin Therapy Studio LLC 3544916b-3f63-3a7a-e063-6394a90ae507 2025-12-15 Exact identifier application number: M020 Ultra Zinc Mineral Non Tinted ZINC OXIDE Skin Therapy Studio LLC 3545d603-3d01-c51d-e063-6394a90a1599 2025-12-15 Exact identifier application number: M020 Sun Therapy Sunscreen ZINC OXIDE Skin Therapy Studio LLC 357efafb-aa1c-0d69-e063-6394a90a5135 2025-12-15 Exact identifier application number: M020 Ultra Zinc Mineral Non Tinted ZINC OXIDE Skin Therapy Studio LLC 35806102-6919-116f-e063-6294a90ad922 2025-12-15 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