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 133 of 357 · 7,139 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Tinted Mineral Matte CE Sunscreen TITANIUM DIOXIDE, ZINC OXIDE The Maui Medical Group, Inc 34b72d14-b69b-e9dd-e063-6394a90a748e 2025-12-11 Exact identifier application number: M020 Tinted Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE SCIENCE CEUTICALS, LLC 369b20e2-2cad-e047-e063-6294a90a1bba 2025-12-11 Exact identifier application number: M020 Tinted Mineral Matte CE Sunscreen TITANIUM DIOXIDE, ZINC OXIDE The Maui Medical Group, Inc 34b60880-5fe1-b78f-e063-6294a90a748d 2025-12-11 Exact identifier application number: M020 Sheer Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE The Maui Medical Group, Inc 34b51190-6a6d-c5e0-e063-6394a90ae875 2025-12-11 Exact identifier application number: M020 Tinted Ultra Zinc Face and Body ZINC OXIDE LIV BODY AND BEAUTY LLC 374fae34-41b9-4cab-e063-6394a90a9b1d 2025-12-11 Exact identifier application number: M020 Z Bloc ZINC OXIDE The Maui Medical Group, Inc 34b64eb5-a91f-de43-e063-6294a90a8043 2025-12-11 Exact identifier application number: M020 Sheer Tinted Sunscreen Stick TITANIUM DIOXIDE, ZINC OXIDE The Maui Medical Group, Inc 34b6e8d0-6235-dac2-e063-6394a90afefd 2025-12-11 Exact identifier application number: M020 Tinted Sunscreen Face Primer TITANIUM DIOXIDE, ZINC OXIDE LIV BODY AND BEAUTY 374f6b79-2ac4-61cf-e063-6394a90a699b 2025-12-11 Exact identifier application number: M020 Non Tinted Ultra Zinc Face and Body ZINC OXIDE LIV BODY AND BEAUTY LLC 375008f2-8dd4-aa31-e063-6394a90a5be8 2025-12-11 Exact identifier application number: M020 Replenishing Daily Protection ZINC OXIDE The Maui Medical Group, Inc 34b96d82-7fcf-e452-e063-6394a90a781b 2025-12-11 Exact identifier application number: M020 Daily Sun Defense TITANIUM DIOXIDE, ZINC OXIDE LIV BODY AND BEAUTY LLC 3750c2fd-c5cc-fd00-e063-6394a90aeb89 2025-12-11 Exact identifier application number: M020 Non Tinted Ultra Zinc Face and Body ZINC OXIDE LIV BODY AND BEAUTY LLC 3750ffbf-a82d-b4b9-e063-6294a90a7d68 2025-12-11 Exact identifier application number: M020 The Block ZINC OXIDE ELITE ESTHETICS BY NICOLE CAROLINE LLC 34a6b17e-6e9e-3f2c-e063-6294a90a1c32 2025-12-11 Exact identifier application number: M020 SPF 40 Broad Spectrum Non-Tinted ZINC OXIDE Teton Dermatology Holdings, Inc. 35093797-008b-b265-e063-6294a90a9949 2025-12-11 Exact identifier application number: M020 Tinted Zinc Protection ZINC OXIDE Teton Dermatology Holdings, Inc. 3508d5a8-9d3c-51d1-e063-6394a90abc8e 2025-12-11 Exact identifier application number: M020 SPF 40 Broad Spectrum TITANIUM DIOXIDE, ZINC OXIDE Teton Dermatology Holdings, Inc. 35081ce0-2203-ab86-e063-6294a90aefd5 2025-12-11 Exact identifier application number: M020 Antioxidant SPF ZINC OXIDE Teton Dermatology Holdings, Inc. 3509a916-f3e1-9c53-e063-6394a90a5bff 2025-12-11 Exact identifier application number: M020 Ultimate Physical Sunscreen Tinted ZINC OXIDE HALEM DERMATOLOGY PLLC 35bb4953-ca8c-e927-e063-6394a90a1a31 2025-12-11 Exact identifier application number: M020 Lip Protection TITANIUM DIOXIDE, ZINC OXIDE Teton Dermatology Holdings, Inc. 3509eea7-f966-2080-e063-6294a90aeeb5 2025-12-11 Exact identifier application number: M020 Mineral Lip Sunscreen TITANIUM DIOXIDE, ZINC OXIDE HALEM DERMATOLOGY PLLC 35bce44e-d9f4-9279-e063-6394a90a6453 2025-12-11 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