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
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 322 of 346 · 6,912 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join YOU-V SPF-30 Broad Spectrum Sunscreen TITANIUM DIOXIDE, ZINC OXIDE YouV, LLC 290cd617-aa90-4f10-8a1d-d8954b927004 2023-11-11 Warnings Exact identifier application number: M020 BEAST SPIT and POLISH FACE SPF-20 OCTOCRYLENE, OCTISALATE, AVOBENZONE Small Batch Beauty, LLC 27e5244b-4b69-4dec-9dd5-ba8b71b171b2 2023-11-11 Warnings Exact identifier application number: M020 SEVEN MINERALS Skin Friendly SPF 30 AVOBENZONE, OCTISALATE, OCTOCRYLENE Seven Minerals NA LLC bd60cf89-e0e9-48ad-b174-1ecf72557d9c 2023-11-11 Warnings Exact identifier application number: M020 OUTER REEF Reef Safe (WR) Broad Spectrum SPF 30 TITANIUM DIOXIDE Coral Reef Park Co., Inc. 743f3d23-0f5c-4724-9f69-411c109506e1 2023-11-11 Warnings Exact identifier application number: M020 SEVEN MINERALS Skin Friendly SPF 50 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Seven Minerals NA LLC 6d6b5b2a-210a-4606-9cdb-f6eec10f37e8 2023-11-11 Warnings Exact identifier application number: M020 KISS MY FACE SPF-50 Baby Mineral Sunscreen ZINC OXIDE WINDMILL HEALTH PRODUCTS LLC ac66ad82-a01f-4e44-92a7-b5ab5bd30922 2023-11-11 Warnings Exact identifier application number: M020 KISS MY FACE SPF-50 Daily Mineral Sunscreen ZINC OXIDE WINDMILL HEALTH PRODUCTS LLC 1745dc35-648e-4315-a285-c99ebeef4f6a 2023-11-11 Warnings Exact identifier application number: M020 KISS MY FACE SPF-50 Face Factor Mineral Sunscreen ZINC OXIDE WINDMILL HEALTH PRODUCTS LLC edc2c1e7-e1a8-4b49-96df-8a94eb6a242a 2023-11-11 Warnings Exact identifier application number: M020 ONCODERM Rx Mineral Sunscreen SPF-30 TITANIUM DIOXIDE, ZINC OXIDE Oncoderm, LLC 9f16e832-067c-4ae8-bd7d-6f0dc0ad6fae 2023-11-11 Warnings Exact identifier application number: M020 SEAWEED BATH CO. SPF 50 SPORT OCTOCRYLENE, ZINC OXIDE, OCTISALATE The Seaweed Bath Co. f01516bf-8aed-4402-a3f9-ef11c54d46b3 2023-11-11 Warnings Exact identifier application number: M020 SEAWEED BATH CO. SPF-30 OCTOCRYLENE, ZINC OXIDE, OCTISALATE The Seaweed Bath Co. 4df55434-fb9a-442d-82cf-16a4957f0a2a 2023-11-11 Warnings Exact identifier application number: M020 PROJECT REEF Mineral Sunscreen SPF-30 ZINC OXIDE Project Reef LLC b7de9ec2-6db1-4c89-b734-15c4bd5c3251 2023-11-11 Warnings Exact identifier application number: M020 SEAWEED BATH CO Cooling Mist SPF-60 Sport HOMOSALATE, OCTISALATE, ZINC OXIDE The Seaweed Bath Co. 98ccbb70-6e1a-4e92-a095-cbc4be12fcbf 2023-11-11 Warnings Exact identifier application number: M020 PROJECT REEF Mineral Sunscreen SPF-50 ZINC OXIDE, TITANIUM DIOXIDE Project Reef LLC 87b9170c-956e-4aa2-9416-da00cca81b58 2023-11-11 Warnings Exact identifier application number: M020 YOUTH CORRIDOR Soothe and Defend SPF-30 OCTOCRYLENE, OCTISALATE, ZINC OXIDE Youth Corridor 5c0873ff-8e76-48de-919d-f69794c4bd37 2023-11-11 Warnings Exact identifier application number: M020 ZITSTICKA MEGASHADE SUNSCREEN SERUM (SPF-50) HOMOSALATE, OCTINOXATE, OCTISALATE, ZINC OXIDE ZITSTICKA, Inc 32164318-7a7e-40b2-99da-8246c99fdbd3 2023-11-11 Warnings Exact identifier application number: M020 SUNNY Q Broad Spectrum SPF-30 ZINC OXIDE Sunny Q Sunscreen LLC 593870fa-425c-401c-ac26-f63f4ce0298f 2023-11-11 Warnings Exact identifier application number: M020 BRICKELL Daily Defense Face Moisturizer SPF-20 OCTISALATE, ZINC OXIDE BRICKELL BRANDS LLC 44806b83-9220-4d34-806d-20cf0a47186e 2023-11-11 Warnings Exact identifier application number: M020 BRICKELL Element Defense Moisturizer SPF-45 OCTOCRYLENE, OCTISALATE, ZINC OXIDE BRICKELL BRANDS LLC 94be278a-3773-469b-8e40-3242d1072a3d 2023-11-11 Warnings Exact identifier application number: M020 I KNOW Very Necessary Broad Spectrum SPF-40 Moisturizing Cream AVOBENZONE, OCTISALATE, OCTOCRYLENE Thirty7 LLC 6ff00b6e-1cc7-4cc4-842b-4e379f75e454 2023-11-11 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