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 16 of 357 · 7,139 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Tinted Daily Wear Face Protection Mineral Based Sunscreen SPF 16 - Fair Light ZINC OXIDE REJUVA MINERALS INC 2abccc86-01d4-e45c-e063-6294a90a7f8b 2026-07-02 Warnings Exact identifier application number: M020 OHUI Ultimate Cover CC Cushion Compact 02 Natural Beige TITANIUM DIOXIDE LG H&H Co., Ltd. d307471c-6cc6-ce48-e053-2995a90a3e02 2026-07-02 Warnings Exact identifier application number: M020 Sunscreen SPF 50 AVOBENZONE 3% HOMOSALATE 10% OCTOCRYLENE 5% Worthy Promotional Products f5e2a412-e891-411d-85da-89f38cd61a9b 2026-07-02 Warnings Exact identifier application number: M020 Bath and Body Works SPF Bronze Kiss AVOBENZONE,HOMOSALATE,OCTISALATE Bath & Body Works, Inc. 5606c57b-7fdb-4317-e063-6294a90a996c 2026-07-02 Warnings Exact identifier application number: M020 Evereden Kids Mineral Sunscreen SPF 30 ZINC OXIDE Eden Brands Inc bba219a4-de83-76fd-e053-2995a90a2d69 2026-07-01 Warnings Exact identifier application number: M020 Kids Mineral Face Cream SPF20 ZINC OXIDE Eden Brands Inc fbfccb0c-e459-3282-e053-6394a90ad95d 2026-07-01 Warnings Exact identifier application number: M020 Evereden Fluid Silk Mineral Sunscreen PRO SPF50 TITANIUM DIOXIDE, ZINC OXIDE Eden Brands Inc. 2cb7773f-9a05-ad02-e063-6294a90af024 2026-07-01 Warnings Exact identifier application number: M020 Zinc Oxide 20% SUNSCREEN SPF 50 The Beach Rooster c2e57236-f184-4fa8-8fd5-c44cbf230058 2026-07-01 Warnings Exact identifier application number: M020 ISNTREE HYALURONIC ACID WATERY SUNSCREEN AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE ISNTREE Inc. 557477a2-def8-740b-e063-6294a90ad287 2026-06-30 Warnings Exact identifier application number: M020 HealthyDerm tallow mineral sunscreen SPF50 ZINC OXIDE 25% VIRENTIA LLC 557b0b1f-8cd9-735a-e063-6294a90ad60e 2026-06-30 Warnings Exact identifier application number: M020 OHUI Ultimate Cover CC Cushion Compact 01 Light Beige TITANIUM DIOXIDE LG H&H Co., Ltd. d2f9c54b-ac4e-5141-e053-2a95a90aa2b8 2026-06-30 Warnings Exact identifier application number: M020 Christian Dior Invisible UV Stick Broad Spectrum SPF 50 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Parfums Christian Dior 8e3840b2-b404-474f-aff7-dec3a64a70a4 2026-06-29 Warnings Exact identifier application number: M020 TOCOBO Blur Finish Sun Cushion Cotton Blue HOMOSALATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE PICTON Co., Ltd. 4d6ddee3-9a76-6c9c-e063-6394a90a1529 2026-06-29 Warnings Exact identifier application number: M020 Sun Bum Coconut Lip 30 Sunscreen Lip Balm AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Sun Bum, LLC 20d942fa-93de-45a8-e063-6294a90a2b49 2026-06-29 Warnings Exact identifier application number: M020 AVON ANEW SOLAIRE EVERYDAY MINERAL FACE PROTECTION BROAD SPECTRUM SPF 50 SUNSCREEN ZINC OXIDE THE AVON COMPANY 54f7c1d1-acdb-fd25-e063-6294a90a8173 2026-06-29 Warnings Exact identifier application number: M020 Earth Baby Broad Spectrum SPF 30 SUNSCREEN Earth Baby, Inc. 42556876-74ea-38e6-e054-00144ff8d46c 2026-06-28 Warnings Exact identifier application number: M020 TOCOBO Cotton Airy Sun Stick AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE PICTON CO., Ltd. 55364026-c55a-b370-e063-6294a90ae0d1 2026-06-27 Warnings Exact identifier application number: M020 Sun Does Matter Daily Face Sunscreen HOMOSALATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE Sundoesmatter Company Inc. 553687d8-d4e1-8361-e063-6294a90a24fe 2026-06-27 Warnings Exact identifier application number: M020 ORLASKIN HYDRATING SUNSCREEN SPF 50 OCTOCRYLENE ETHYLHEXYL METHOXYCINNAMATE ETHYLHEXYL SALICYLATE AVOBENZONE Guangzhou Yapheon Health Industry Co., Ltd. 552b4c87-4621-d5a7-e063-6294a90a042e 2026-06-26 Warnings Exact identifier application number: M020 Bath and Body Works SPF Waikiki Beach Coconut AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE Bath & Body Works, Inc. 1c30de8a-4d29-bbac-e063-6294a90a84d9 2026-06-26 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