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 44 of 357 · 7,139 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join TRUST MD SPF30 STEM CELL FACE OCTINOXATE OCTISALATE HOMOSALATE AVOBENZONE TITANIUM DIOXIDE Guangzhou Yapheon Health Industry Co., Ltd. 4f2ca12c-bc6f-61b8-e063-6294a90a0d7e 2026-04-11 Warnings Exact identifier application number: M020 MIDHA Rice Daily Moisture Sun Cream AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE MIDHA Cosmetic Co.,Ltd. 4b394107-7830-c2c6-e063-6294a90a07d9 2026-04-10 Warnings Exact identifier application number: M020 Abib Dewy tinted sunscreen Glow tube Deep OCTISALATE, OCTOCRYLENE, ZINC OXIDE FOURCOMPANY CO., LTD. 4f15d5ba-6396-56bf-e063-6394a90adb06 2026-04-10 Warnings Exact identifier application number: M020 Abib Dewy tinted sunscreen Glow tube Light OCTISALATE, OCTOCRYLENE, ZINC OXIDE FOURCOMPANY CO., LTD. 4f165895-aa84-e215-e063-6394a90a6256 2026-04-10 Warnings Exact identifier application number: M020 Abib Dewy tinted sunscreen Glow tube Medium OCTISALATE, OCTOCRYLENE, ZINC OXIDE FOURCOMPANY CO., LTD. 4f16b8a4-4279-5f79-e063-6294a90a353d 2026-04-10 Warnings Exact identifier application number: M020 Sheer Touch Sunscreen SPF 30 AVOBENZONE, HOMOSALATE, OCTISALATE Amazon.com Services LLC f5ca0416-548c-4be0-a69e-c7e1b52aba95 2026-04-10 Warnings, Adverse reactions Exact identifier application number: M020 LASPA TINTED MATTE SUNSCREEN SPF 20 LIGHT ZINC OXIDE The Green Cricket Inc c56fd135-f46a-51ce-e053-2a95a90ab7b3 2026-04-10 Warnings Exact identifier application number: M020 CorTex SunX 50 Thick AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE CoreTex Products Inc f67a6c6c-c314-1c9d-e053-2a95a90a7f1a 2026-04-10 Warnings Exact identifier application number: M020 Nu Skin 180 Degree UV Block Hydrator SPF 18 OCTINOXATE AND ZINC OXIDE NSE Products, Inc. b9635e59-bb08-4167-b7ba-54c3fc712589 2026-04-09 Warnings Exact identifier application number: M020 Sport Sunscreen SPF 50 AVOBENZONE, HOMOSALATE, OCTISALATE The Kroger Co. 79c6fe2a-34c2-44cc-81bc-796c4463d2a6 2026-04-09 Warnings, Adverse reactions Exact identifier application number: M020 Arizona Sun ProductsSurfblok Lip Balm SPF 15 LIP BALM Arizona Sun Products 11fdbae5-84ec-7b1d-e063-6294a90a2878 2026-04-09 Warnings Exact identifier application number: M020 Arizona Sun Prickly Pear Lip Balm SPF 15 SUNSCREEN LIP BALM Arizona Sun Products 11e9cb25-6ff8-a121-e063-6394a90a849e 2026-04-09 Warnings Exact identifier application number: M020 Arizona Sun Sunscreen SPF 8 SUNSCREEN Arizona Sun Products 11e8b612-29be-47ed-e063-6394a90ab9e7 2026-04-09 Warnings Exact identifier application number: M020 Arizona Sun ProductsSurfblok Lip Balm SPF 15 LIP BALM Arizona Sun Products 11fdcfd0-8b24-7efc-e063-6294a90af7fa 2026-04-09 Warnings Exact identifier application number: M020 Arizona Sun SPF 45 Cycleblok Sunscreen SUNSCREEN Arizona Sun Products 11e71a84-12d1-2d4f-e063-6294a90adcd6 2026-04-09 Warnings Exact identifier application number: M020 Arizona Sun SPF 45 Bikerblok Sunscreen SUNSCREEN Arizona Sun Products 11e6eafd-f967-b748-e063-6394a90aabfd 2026-04-09 Warnings Exact identifier application number: M020 YSE Beauty Skin Glow Primer SPF 30 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE MSS Beauty LLC 6a318e27-14e5-488e-ac19-010f69cb743d 2026-04-09 Warnings Exact identifier application number: M020 Arizona Sun Sunscreen Kids Water Resistant SPF 30 SUNSCREEN Arizona Sun Products 116ed17c-3b38-5e96-e063-6294a90a4246 2026-04-09 Warnings Exact identifier application number: M020 Arizona Sun SPF 45 Surfblok Sunscreen SUNSCREEN Arizona Sun Products 11e76815-9316-555d-e063-6294a90aeb81 2026-04-09 Warnings Exact identifier application number: M020 Arizona Sun Moisturizer SPF 3 MOISTURIZER Arizona Sun Products 1171af26-3040-552c-e063-6294a90ae220 2026-04-09 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