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 22 of 357 · 7,139 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Unseen Sunscreen SPF 50 OCTOCRYLENE, HOMOSALATE, OCTISALATE, AVOBENZONE Supergoop LLC 21b3491f-7b02-9bc5-e063-6294a90a0dc3 2026-06-04 Warnings Exact identifier application number: M020 Mineral Glowscreen Soft-Radiance Drops Golden Hour ZINC OXIDE Supergoop LLC 1f1be2a7-af96-d73d-e063-6394a90acc1a 2026-06-04 Warnings Exact identifier application number: M020 Play Antioxidant Body Mist WIth Vitamin C Broad Spectrum SPF 30 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Supergoop, LLC 975402e6-8c74-b18e-e053-2995a90a467e 2026-06-04 Warnings Exact identifier application number: M020 Derma E Sun Drops SPF 30 ZINC OXIDE derma e 76c29f24-e0d9-4235-b278-96e609bc58db 2026-06-04 Warnings Exact identifier application number: M020 ANESSA PERFECT UV SUNSCREEN SKINCARE MILK GB ZINC OXIDE OCTOCRYLENE ETHYLHEXYL SALICYLATE HOMOSALATE TITANIUM DIOXIDE HONGKONG JIAHE INTERNATIONAL HOLDING LIMITED 5354af18-50c4-5fba-e063-6394a90ace39 2026-06-03 Warnings Exact identifier application number: M020 ATOMY BB SUNSCREEN TITANIUM DIOXIDE, ZINC OXIDE ATOMY CO., LTD. b0cd27ee-4917-4800-bcdf-c6e14b28c1d1 2026-06-02 Warnings Exact identifier application number: M020 Atomy Sunscreen White Broad Spectrum SPF 50 PLUS HOMOSALATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE ATOMY CO., LTD. ad0b9091-a990-45bf-93f4-d886be1bbffe 2026-06-02 Warnings Exact identifier application number: M020 Atomy Sunscreen Beige Broad Spectrum SPF 50 PLUS HOMOSALATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE ATOMY CO., LTD. 994d5680-284e-4faf-a29b-4d28f8d46e8f 2026-06-02 Warnings Exact identifier application number: M020 BLDG Active Skin Repair Sun Stick Performance Sunscreen ZINC OXIDE Innovacyn, Inc. a751fc1d-5ee4-4ecc-8ade-2568d91890c4 2026-06-02 Warnings Exact identifier application number: M020 ANESSA PERFECT UV SUNSCREEN SKINCARE HOMOSALATE OCTOCRYLENE ETHYLHEXYL SALICYLATE HONGKONG JIAHE INTERNATIONAL HOLDING LIMITED 5347c9a1-2239-b617-e063-6294a90ac601 2026-06-02 Warnings Exact identifier application number: M020 Sungboon Editor Hydro Booster Moisture Sunscreen HOMOSALATE, OCTISALATE, OCTOCRYLENE, AVOBENZONE Olive International Co., Ltd. 4ea2292a-571c-475c-a64c-cbdd1f51f242 2026-06-02 Warnings Exact identifier application number: M020 Sungboon Editor Daily Invisible Blurring Sunscreen AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Olive International Inc. 42325963-0917-43c4-8fe0-130336c7fa81 2026-06-02 Warnings Exact identifier application number: M020 Matte Veil Tinted Broad Spectrum Sunscreen SPF 40 ZINC OXIDE, TITANIUM DIOXIDE Private Label Skin Care a8d60212-18a7-42af-8bb3-bfcff7690a49 2026-06-02 Warnings Exact identifier application number: M020 The Mineral Melt SPF30 ZINC OXIDE, TITANIUM DIOXIDE Dune Suncare Inc. 2114fc3b-c8ce-45d2-8a82-4dc54f0adaf3 2026-06-02 Warnings Exact identifier application number: M020 LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE ANTHELIOS UV AIR MINERAL SERUM SUNSCREEN BROAD SPECTRUM SPF 50 TITANIUM DIOXIDE AND ZINC OXIDE LOreal USA Products Inc a1acb789-5bf4-4447-b3c5-4a7d4d3013a7 2026-06-01 Warnings Exact identifier application number: M020 4ocean REEF SAFE SUNSCREEN SPF 40 ZINC OXIDE Stream2Sea, LLC 52d3d97c-a846-4721-acbe-52a525cb2011 2026-06-01 Warnings Exact identifier application number: M020 APRILSKIN MUGWORT CALMING SUNSCREEN OCTOCRYLENE, HOMOSALATE, OCTISALATE, AVOBENZONE APR US INC 50a7b64a-8b26-97ac-e063-6294a90ad77a 2026-06-01 Warnings Exact identifier application number: M020 Ultra Violette Future Screen Broad Spectrum SPF 50 ZINC OXIDE Grace and Fire USA Inc. 252fdc91-bbe2-58ec-e063-6294a90a5067 2026-06-01 Warnings Exact identifier application number: M020 Ultra Violette Vibrant Screen Broad Spectrum SPF 50 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Grace and Fire USA Inc. 2633a289-b3b2-b614-e063-6294a90ad214 2026-06-01 Warnings Exact identifier application number: M020 Ultra Violette Sequin Supreme SPF 50 OCTOCRYLENE, HOMOSALATE, OCTISALATE, AVOBENZONE Grace and Fire USA Inc. 41027faa-7d61-4970-e063-6294a90a7df4 2026-06-01 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