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 282 of 346 · 6,912 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join H.E.B Solutions Sunscreen SPORT SPF 70 CONTINUOUS SPRAY H.E.B f9b5b360-6b69-4006-934f-5bc8a9fdfcd0 2024-10-15 Warnings Exact identifier application number: M020 HEB GENERAL PROTECTION SPF 100 LOTION H-E-B 39d94e3a-98c8-44b0-bd2d-f318ac7bbf75 2024-10-15 Warnings Exact identifier application number: M020 H.E.B Solutions Sunscreen WET PROTECTION KIDS SPF 70 CONTINUOUS SPRAY H.E.B f823b236-5884-41d9-bff0-65b91664aaad 2024-10-15 Warnings Exact identifier application number: M020 H.E.B Solutions Sunscreen COOLING SPORT SPF 50 CONTINUOUS SPRAY H.E.B 67fdf3a0-08fe-4348-a4f9-a83f3cf46b72 2024-10-15 Warnings Exact identifier application number: M020 H.E.B Solutions Sunscreen ULTRA SPF 70 CONTINUOUS SPRAY H.E.B c16935ce-afdb-4571-b5a3-6dc5d01f721c 2024-10-15 Warnings Exact identifier application number: M020 H.E.B Solutions Sunscreen BABY SPF 50 LOTION SPRAY H.E.B 1082111f-bf04-4a98-b6a0-5da933652f1d 2024-10-15 Warnings Exact identifier application number: M020 H.E.B ULTRA SPF 50 SUNSCREEN H.E.B d6184ba2-0e47-459a-8777-1f27be2140a6 2024-10-15 Warnings Exact identifier application number: M020 H.E.B ULTRA SPF 30 SUNSCREEN H.E.B 90287874-cdfa-489c-936d-e487f6b3db96 2024-10-15 Warnings Exact identifier application number: M020 H.E.B SPF 50 SUNSCREEN H.E.B 2c9258ac-8cbe-4acf-9c02-bb993d69a3e5 2024-10-15 Warnings Exact identifier application number: M020 H.E.B SPF 50 SUNSCREEN H.E.B 39bf1379-3dee-4aa0-967a-36faccca4216 2024-10-15 Warnings Exact identifier application number: M020 H.E.B Solutions Sunscreen SPORT SPF 100 CONTINUOUS SPRAY H.E.B 301ae7e5-5a60-45d0-8cd5-553ba07db4c5 2024-10-15 Warnings Exact identifier application number: M020 Positive Light Tinted Moisturizer Broad Spectrum SPF 20 Sunscreen 28C HOMOSALATE, ZINC OXIDE Rare Beauty, LLC 2470d78c-724f-4181-e063-6294a90afeaa 2024-10-14 Warnings Exact identifier application number: M020 Positive Light Tinted Moisturizer Broad Spectrum SPF 20 Sunscreen 44N HOMOSALATE, ZINC OXIDE Rare Beauty, LLC 2471e0fa-ddc8-1c62-e063-6294a90a4408 2024-10-14 Warnings Exact identifier application number: M020 Walgreens 70 Hydrating Sport Broad Spectrum SPF 70 Sunscreen AVOBENZONE. HOMOSALATE, OCTISALATE, OCTOCRYLENE WALGREEN COMPANY fa2d08be-f67f-60dd-e053-6294a90adb3f 2024-10-14 Warnings Exact identifier application number: M020 Walgreens 90 Sport Continuous AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE WALGREEN COMPANY fa2e5b1b-f38f-11fe-e053-6394a90a4988 2024-10-14 Warnings Exact identifier application number: M020 Walgreens 70 Sheer Sunscreen AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE WALGREEN COMPANY fc635082-0a7a-f160-e053-6394a90abba3 2024-10-14 Warnings Exact identifier application number: M020 WALGREENS SPORT SPF 50 SUNSCREEN AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Walgreen Company a9ee1c60-6091-2229-e053-2995a90aa528 2024-10-14 Warnings Exact identifier application number: M020 WALGREENS BROAD SPECTRUM SPORT SPF 50 SUNSCREEN AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE WALGREEN COMPANY b10bdd6e-aa94-470f-8bbf-ff27a1d81938 2024-10-14 Warnings Exact identifier application number: M020 Walgreens Dry Touch Broad Spectrum SPF 55 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE WALGREEN COMPANY c628b15c-5fd2-fa5a-e053-2a95a90a43ac 2024-10-14 Warnings Exact identifier application number: M020 Walgreens SPF 30 Hydrating Continuous AVOBENZONE, HOMOSALATE, OCTOCRYLENE, WALGREEN COMPANY c8ae7f1a-d198-6609-e053-2a95a90ad462 2024-10-14 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