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 73 of 357 · 7,139 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Slip Tint Broad Spectrum SPF 35 Sunscreen Tinted Moisturizer Shade Four ZINC OXIDE Clean Beauty For All, Inc (dba Saie) 1922e001-e699-7ac5-e063-6394a90a25d9 2026-01-20 Warnings Exact identifier application number: M020 Slip Tint Broad Spectrum SPF 35 Sunscreen Tinted Moisturizer Shade Six ZINC OXIDE Clean Beauty For All, Inc (dba Saie) a9350360-7932-459f-806c-399fa265e6c0 2026-01-20 Warnings Exact identifier application number: M020 Slip Tint Broad Spectrum SPF 35 Sunscreen Tinted Moisturizer Shade Three ZINC OXIDE Clean Beauty For All, Inc (dba Saie) 1923067f-1ab9-d168-e063-6394a90adbd0 2026-01-20 Warnings Exact identifier application number: M020 Slip Tint Broad Spectrum SPF 35 Sunscreen Tinted Moisturizer Shade Five and Half ZINC OXIDE Clean Beauty For All, Inc (dba Saie) 1922ee84-d7d0-80b1-e063-6394a90acf7b 2026-01-20 Warnings Exact identifier application number: M020 Slip Tint Broad Spectrum SPF 35 Sunscreen Tinted Moisturizer Shade Seven ZINC OXIDE Clean Beauty For All, Inc (dba Saie) 310a07bb-d32a-401f-955e-4c2860148a30 2026-01-20 Warnings Exact identifier application number: M020 Slip Tint Broad Spectrum SPF 35 Sunscreen Tinted Moisturizer Shade Five ZINC OXIDE Clean Beauty For All, Inc (dba Saie) 39ae4a97-7f96-4c95-a6de-0c779764fb02 2026-01-20 Warnings Exact identifier application number: M020 Slip Tint Broad Spectrum SPF 35 Sunscreen Tinted Moisturizer Shade Four and Half ZINC OXIDE Clean Beauty For All, Inc (dba Saie) 1922fc3e-055c-e51d-e063-6294a90a00f5 2026-01-20 Warnings Exact identifier application number: M020 Slip Tint Broad Spectrum SPF 35 Sunscreen Tinted Moisturizer Shade Nine ZINC OXIDE Clean Beauty For All, Inc (dba Saie) 9c7a31df-5bdd-403b-b807-1d1a801e1bb6 2026-01-20 Warnings Exact identifier application number: M020 Slip Tint Broad Spectrum SPF 35 Sunscreen Tinted Moisturizer Shade One ZINC OXIDE Clean Beauty For All, Inc (dba Saie) 1922fc51-ae53-acb8-e063-6394a90a14eb 2026-01-20 Warnings Exact identifier application number: M020 Wrinkle Repair Moisturizer SPF 30 EQB AVOBENZONE 2% HOMOSALATE 4% OCTISALATE 4% OCTOCRYLENE 2% Walmart a067e968-e598-40ef-95f2-c338b5e413dd 2026-01-20 Warnings Exact identifier application number: M020 Welmedix HomeCare PRO Fragile Skin Dual Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE Welmedix LLC 48da4589-0f5a-c25b-e063-6394a90ac18b 2026-01-20 Warnings Exact identifier application number: M020 SPF 50 Mineral Sunscreen Kids ZINC OXIDE 14.69% S&C Hampton Sun LLC 0bdb7d15-dc52-4e23-9417-fe73f17f6110 2026-01-20 Warnings Exact identifier application number: M020 DEWYTREE URBAN SHADE INVISIBLE SMOOTHING PORE SUNSTIC SUNSTICK OCTOCRYLENE, HOMOSALATE, ZINC OXIDE, OCTISALATE DEWYTREE CO. ,LTD 48406e68-eefd-d2c2-e063-6394a90a4ad9 2026-01-20 Warnings Exact identifier application number: M020 KONEUK SUNSCREEN SPF50 KONEUK SUNSCREEN SPF50 Guangzhou Meixi Biotechnology Co., Ltd. 48dd7f6e-2a4d-2c92-e063-6294a90a4255 2026-01-20 Warnings Exact identifier application number: M020 CHUDA AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE Premier Ocher LLC 1bc2a2df-a4cd-45e7-93c6-b35dbd8b280f 2026-01-20 Warnings Exact identifier application number: M020 Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 2CR Cool Fosy OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 12edec55-2414-4bbd-bc96-4599a96b96ac 2026-01-19 Warnings Exact identifier application number: M020 PROJECT REEF SPF-30 Mineral Sunscreen ZINC OXIDE Project Reef LLC a6077e6f-d987-4159-946f-3e2397247659 2026-01-19 Warnings Exact identifier application number: M020 OUTER REEF MINERAL SUNSCREEN SPF 30 TITANIUM DIOXIDE Coral Reef Park Co., Inc. 86ee2fdf-8a88-44e6-b12a-36a92360477a 2026-01-19 Warnings Exact identifier application number: M020 SABAL Mineral Sunscreen Broad Sprectrum SPF 30 ZINC OXIDE SABAL SUN LLC f917b446-4e10-4231-826e-fdac32e11186 2026-01-19 Warnings Exact identifier application number: M020 Plius Daily SPF Moisturizer SPF 30 AVOBENZONE, OCTISALATE, OCTOCRYLENE PLIUS, Inc 31866de9-afa0-4c11-be65-b61373551493 2026-01-19 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