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 226 of 353 · 7,041 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Sum 37 Micro Active Daily Moisture Sunscreen AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE LG HOUSEHOLD & HEALTH CARE LTD. 2eea94e1-2409-8ad6-e063-6294a90a5df8 2025-03-03 Warnings Exact identifier application number: M020 Sun Defense Minerals (Fair) ZINC OXIDE, TITANIUM DIOXIDE Eminence Organic Skin Care 2e21c9f9-acf8-997b-e063-6394a90ada3f 2025-03-01 Warnings Exact identifier application number: M020 Sun Defense Minerals (Medium) ZINC OXIDE, TITANIUM DIOXIDE Eminence Organic Skin Care 2e232e8d-4274-68bc-e063-6394a90a942b 2025-03-01 Warnings Exact identifier application number: M020 Sun Defense Minerals (Deep) ZINC OXIDE Eminence Organic Skin Care 2e23d463-fbc1-5718-e063-6294a90a7272 2025-03-01 Warnings Exact identifier application number: M020 Sun Defense Minerals (Deep) ZINC OXIDE Eminence Organic Skin Care 2e24391f-4982-efae-e063-6394a90accaa 2025-03-01 Warnings Exact identifier application number: M020 FRUDIA Blueberry Hydrating Air Fit Sunscreen OCTOCRYLENE, HOMOSALATE, OCTISALATE, AVOBENZONE WELCOS CO.,LTD. 8b2a1baa-e528-48d6-9cd8-c3cb55e0641b 2025-02-28 Warnings Exact identifier application number: M020 BRUSH ON BLOCK SPF 50 MINERAL ZINC OXIDE SPF Ventures, LLC 2f1b5454-8bf5-b447-e063-6394a90a743a 2025-02-27 Warnings Exact identifier application number: M020 Clear Defense SPF 45 ZINC OXIDE, OCTINOXATE Private Label Skin Care d681d92f-3501-4fca-b629-096341f20ab1 2025-02-27 Warnings Exact identifier application number: M020 HA Physical Tint SPF 44 ZINC OXIDE, TITANIUM DIOXIDE Private Label Skin Care a5e19d77-703e-41e0-9a02-19227dc6c819 2025-02-27 Warnings Exact identifier application number: M020 Physical Daily Defense Broad Spectrum Sunscreen SPF 40 ZINC OXIDE Private Label Skin Care 18444581-66a4-4eda-a8df-627fa3b4b98a 2025-02-26 Warnings Exact identifier application number: M020 BRUSH ON BLOCK SPF 50 MINERAL TRANSLUCENT ZINC ONLY REFILL ZINC OXIDE/TITANIUM DIOXIDE SPF Ventures, LLC 2f069114-9ca8-aed4-e063-6394a90a46d8 2025-02-26 Warnings Exact identifier application number: M020 Sei Bella Tinted BB Moisturizing Cream 230 N Melaleuca Inc. 2f133abb-cad2-2ac8-e063-6294a90aa480 2025-02-26 Warnings Exact identifier application number: M020 BRUSH ON BLOCK SPF 50 KIDS MINERAL ZINC OXIDE SPF Ventures, LLC 2f17b5fe-44da-964b-e063-6394a90ae699 2025-02-26 Warnings Exact identifier application number: M020 Sun Defense Minerals (Tan) ZINC OXIDE, TITANIUM DIOXIDE Eminence Organic Skin Care 2efb73a6-601d-61a4-e063-6294a90af825 2025-02-25 Warnings Exact identifier application number: M020 Rida Hair Research Institute AVOBENZONE,OCTISALATE,OCTOCRYLENE Rida LLC ece9dfd8-5f40-49b4-a97e-d4e6ffdb1dca 2025-02-25 Warnings Exact identifier application number: M020 COOLA Classic Body SPF 70 Peach Blossom AVOBENZONE, OCTISALATE, OCTOCRYLENE COOLA, LLC ed217698-f552-677e-e053-2995a90acb0a 2025-02-25 Warnings Exact identifier application number: M020 COOLA Classic Body SPF 30 Tropical Coconut AVOBENZONE, OCTISALATE, OCTOCRYLENE COOLA, LLC ed0f8249-aba8-b67c-e053-2a95a90af7eb 2025-02-25 Warnings Exact identifier application number: M020 Hydro Essence Broad Spectrum Sunscreen SPF 40 ZINC OXIDE, OCTINOXATE Private Label Skin Care f176c1b1-f539-417f-98b5-69d99365f2f2 2025-02-25 Warnings Exact identifier application number: M020 Sun Defense Minerals (Tan) ZINC OXIDE, TITANIUM DIOXIDE Eminence Organic Skin Care 2ee82379-6609-fd8e-e063-6294a90acf6c 2025-02-24 Warnings Exact identifier application number: M020 Vacation SPF 50 Classic AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Vacation Inc. f2780cb5-063c-10d3-e053-2995a90a8576 2025-02-24 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