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_7af0f836-c146-4bbf-b8e6-40e25f9a9723
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
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 4Y5P7MUD51 Internal UNII lookup SOI2LOH54Z Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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 6 of 357 · 7,139 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Stay Ageless Tinted Mineral Sunscreen BROAD SPECTRUM SPF30 CORBY, JR., TERRY L. 594443fd-8e27-4ec6-e063-6294a90a3ff0 2026-08-17 Warnings Exact identifier application number: M020 Meraki Protective Mist Sunscreen BROAD SPECTRUM SPF 30 MERAKI MEDICAL SPA LLC 59446224-0e97-ae2c-e063-6394a90a2a65 2026-08-17 Warnings Exact identifier application number: M020 Sun Zapper - Acne Pure Zinc Sunscreen SPF50 ZINC OXIDE Veganic SKN Limited 3ee435a5-70fb-0c8a-e063-6394a90a650a 2026-08-16 Warnings Exact identifier application number: M020 Sun Zapper - Anti-ageing pure zinc sunscreen SPF30 ZINC OXIDE SUNSCREEN VEGANIC SKN LIMITED 3f1dc3b2-c289-5996-e063-6394a90ac622 2026-08-16 Warnings Exact identifier application number: M020 ISNTREE HYALURONIC ACID SENSITIVE SUNSCREEN ZINC OXIDE ISNTREE Inc. 58e38665-0bca-fb02-e063-6394a90ad62a 2026-08-13 Warnings Exact identifier application number: M020 Neutrogena Ultra Sheer Daily Face Sunscreen Broad Spectrum SPF 70 AVOBENZONE, BEMOTRIZINOL, HOMOSALATE, OCTISALATE Kenvue Brands LLC 58d3d390-8b88-a6fe-e063-6394a90a9bf8 2026-08-12 Warnings Exact identifier application number: M020 Neutrogena Clear Face Sunscreen Acne Prone Skin Broad Spectrum SPF 60 AVOBENZONE, BEMOTRIZINOL, HOMOSALATE, OCTISALATE Kenvue Brands LLC 58d7a3e3-b7df-43ce-e063-6294a90a729c 2026-08-12 Warnings Exact identifier application number: M020 HEB 50 Marigold Scent Sunscreen AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE H.E.B. 58dafa24-24d5-aeb4-e063-6394a90a3c25 2026-08-12 Warnings Exact identifier application number: M020 TESALOVA Coconut SPF 30 Lip Balm SPF 30 AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE Tesalova Viktoriia PMU LLC 58dbb9f1-cfb3-62ac-e063-6394a90a6106 2026-08-12 Warnings Exact identifier application number: M020 Elta MD Skincare UV Stick Broad Spectrum SPF50 ZINC OXIDE CP Skin Health Group, Inc 58dd81db-46d4-d763-e063-6394a90abb0b 2026-08-12 Warnings Exact identifier application number: M020 Basin Coconut SPF 30 Lip Balm SPF 30 AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE Retail Concepts of Minnesota, Inc. 4a8e93a6-dcf9-3687-e063-6394a90a73ac 2026-08-12 Warnings Exact identifier application number: M020 UV Skin Recovery SPF 50 Red Correcting ZINC OXIDE CP Skin Health Group, Inc. 26e63890-d1af-d171-e063-6394a90af828 2026-08-12 Warnings Exact identifier application number: M020 UV Skin Recovery SPF 50 ZINC OXIDE CP Skin Health Group, Inc. 26d2683f-cfd5-50fd-e063-6394a90a7576 2026-08-12 Warnings Exact identifier application number: M020 doTERRA Sun Body MINERAL SUNSCREEN doTERRA International, LLC 58dcc56f-f093-469c-e063-6394a90a6088 2026-08-12 Warnings Exact identifier application number: M020 Sonage Protec Plus SPF 30 Mineral Sunscreen ZINC OXIDE ASA Universal Inc. dba: Sonage d92fc1df-bbeb-592a-e053-2a95a90a6951 2026-08-12 Warnings Exact identifier application number: M020 Colorescience Total Protection Body Shield Glow ZINC OXIDE Colorescience 52e1d987-a4f8-195e-e063-6294a90a5629 2026-08-11 Warnings Exact identifier application number: M020 Stay Ageless Tinted Mineral Sunscreen BROAD SPECTRUM SPF30 DR. SAMRAO'S OFFICE 58b2ca35-11ed-d848-e063-6294a90a5b37 2026-08-11 Warnings Exact identifier application number: M020 Ciele Tint and Protect ZINC OXIDE Ciele 0162d9c9-07fa-9210-e063-6294a90aa687 2026-08-11 Warnings Exact identifier application number: M020 NeoStrata Skin Active Matrix Support SPF 30 AVOBENZONE, OCTINOXATE, AND OCTISALATE NeoStrata Company Inc. 8e4b9c08-b906-4c5f-a243-55838ae28b90 2026-08-10 Warnings Exact identifier application number: M020 Sunscreen for Kids SPF 50 AVOBENZONE, HOMOSALATE, OCTISALATE The Kroger Co. 1c7cd904-ffff-48aa-91bd-cc978946b36a 2026-08-10 Warnings, Adverse reactions 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