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 147 of 354 · 7,077 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Replenishing Daily Protection Sunscreen Invisible ZINC OXIDE KATHLEEN P. HUTTON, M.D., INC. A PROFESSIONAL CORPORATION 32462e88-0e74-a675-e063-6294a90ac564 2025-12-08 Exact identifier application number: M020 Mineral Based Foam Sunscreen Tinted TITANIUM DIOXIDE, ZINC OXIDE KATHLEEN P. HUTTON, M.D., INC. A PROFESSIONAL CORPORATION 32465271-abb9-d03f-e063-6294a90a990e 2025-12-08 Exact identifier application number: M020 Mineral Based Foam Sunscreen Non-Tinted TITANIUM DIOXIDE, ZINC OXIDE KATHLEEN P. HUTTON, M.D., INC. A PROFESSIONAL CORPORATION 32486bfb-0cc8-0283-e063-6394a90a9967 2025-12-08 Exact identifier application number: M020 Harrys Daily Facial SPF Broad Spectrum ZINC OXIDE Harry's, Inc. 39fdde34-45ec-bc22-e063-6394a90a7dce 2025-12-08 Warnings Exact identifier application number: M020 Healthy Mineral Sunscreen Brightening plus Tint ZINC OXIDE ZEN DERMATOLOGY, INC. 31e32e9c-9e0b-b678-e063-6294a90a66f5 2025-12-08 Exact identifier application number: M020 Healthy Mineral Sunscreen No Shine plus Tint ZINC OXIDE Zen Dermatology, Inc. 31576340-cb11-d944-e063-6294a90adef2 2025-12-08 Warnings Exact identifier application number: M020 Healthy Mineral Sunscreen No Shine - No Tint TITANIUM DIOXIDE, ZINC OXIDE Zen Dermatology, Inc. 31572a16-5f60-565f-e063-6394a90ab8c9 2025-12-08 Warnings Exact identifier application number: M020 Healthy Mineral Sunscreen Face and Body ZINC OXIDE Zen Dermatology, Inc. 31e376b4-098f-34d7-e063-6394a90a1772 2025-12-08 Exact identifier application number: M020 AcneFix Tinted Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE ACNEFIX INC. 315894b7-ac1b-0982-e063-6294a90ab879 2025-12-08 Exact identifier application number: M020 Shunly Natural Cover SPF50 TITANIUM DIOXIDE, ZINC OXIDE Shunly Skin Care a64e373b-b3f6-4024-b5f5-253783485cd6 2025-12-08 Warnings Exact identifier application number: M020 AcneFix Non-Tinted Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE ACNEFIX INC. 31583c7e-365a-d899-e063-6394a90aa63f 2025-12-08 Exact identifier application number: M020 Mineral Fusion Tinted TITANIUM DIOXIDE, ZINC OXIDE FOREFRONT DERMATOLOGY, S.C. 334ec844-5560-50f7-e063-6394a90a01be 2025-12-08 Exact identifier application number: M020 Mineral Fusion Tinted TITANIUM DIOXIDE, ZINC OXIDE FOREFRONT DERMATOLOGY, S.C. 334f90d6-68e5-db37-e063-6294a90a5fb1 2025-12-08 Exact identifier application number: M020 Skin Apeel Pure Protect SPF 40 Broad Spectrum ZINC OXIDE Skin Apeel, Inc. 18e78c7f-1523-a4f4-e063-6394a90aed97 2025-12-08 Warnings Exact identifier application number: M020 Silk Screen TITANIUM DIOXIDE, ZINC OXIDE Skin Apeel, Inc. 3c44baf4-9555-faad-e063-6294a90ab24f 2025-12-08 Warnings Exact identifier application number: M020 Glow Stick TITANIUM DIOXIDE, ZINC OXIDE Skin Apeel, Inc. 3c54b857-c017-a953-e063-6394a90a38df 2025-12-08 Warnings Exact identifier application number: M020 Lip Shield TITANIUM DIOXIDE, ZINC OXIDE Skin Apeel, Inc. 3c545e55-3f55-842b-e063-6394a90ae48e 2025-12-08 Warnings Exact identifier application number: M020 Bare Barrier Sport TITANIUM DIOXIDE, ZINC OXIDE Skin Apeel, Inc. 3c580794-eda3-de57-e063-6294a90a0303 2025-12-08 Warnings Exact identifier application number: M020 Flawless Brightening Sunscreen TITANIUM DIOXIDE, ZINC OXIDE Flawless Skin Care LLC 312e9ca0-a388-a546-e063-6294a90a15d6 2025-12-08 Warnings Exact identifier application number: M020 Mineral SPF 40, protect TITANIUM DIOXIDE, ZINC OXIDE Acne Specialists LLC 2f8859cf-8277-6ea9-e063-6294a90a1a75 2025-12-08 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