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 299 of 346 · 6,912 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join MELAN SPF-30 Antioxidant Body Mist Sunscreen AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE MELAN INC. 66b7c899-46fd-41a6-9a96-ebbf2b68ea25 2024-05-02 Warnings Exact identifier application number: M020 No7 Restore and Renew Face and Neck Multi Action Day Cream Sunscreen Broad Spectrum SPF 30 AVOBENZONE,OCTISALATE, OCTOCRYLENE. BCM Ltd 4ce3fe14-e33d-cbf6-e063-6294a90a42fe 2024-04-30 Warnings Exact identifier application number: M020 bareMinerals BAREPRO 24HR Wear Skin-Perfecting Matte Liquid Foundation Fair 10 Neutral ZINC OXIDE Orveon Global US LLC 1740393b-f8a3-475b-e063-6394a90a6fa8 2024-04-29 Warnings Exact identifier application number: M020 SUMMER GELEE SPF-30 HOMOSALATE, OCTISALATE, OCTOCRYLENE SUMMER GELEE LLC bc85db65-2acc-4b39-9189-f8916c487b61 2024-04-27 Warnings Exact identifier application number: M020 SUMMER GELEE SPF-4 HOMOSALATE, OCTISALATE SUMMER GELEE LLC c9ec81ad-0478-4026-bc6c-5582eb012b8d 2024-04-27 Warnings Exact identifier application number: M020 Natural Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE Sarati International, Inc. 16ef922d-78d1-1e70-e063-6394a90a3bbf 2024-04-25 Warnings Exact identifier application number: M020 PRISMA PROTECT SPF30 OCTOCRYLENE, HOMOSALATE, OCTISALATE, AND AVOBENZONE Dermalogica, LLC. e0e6d779-c491-43ed-acc9-274d1b60c1ff 2024-04-25 Warnings Exact identifier application number: M020 Degil Sun SPF 30 Sunscreen HOMOSALATE, OCTISALATE, OXYBENZONE,AVOBENZONE, OCTOCRYLENE Degil Safety Products (1989) Inc 16d8d1d0-e531-2a64-e063-6394a90a5b9c 2024-04-24 Warnings Exact identifier application number: M020 Chantecaille Just Skin Tinted Moisturizer Sunscreen Broad Spectrum SPF 15 Alabaster TITANIUM DIOXIDE Chantecaille Beaute Inc e1c562b8-76c0-4c6e-9276-900784c8639e 2024-04-24 Warnings Exact identifier application number: M020 Chantecaille Just Skin Tinted Moisturizer Sunscreen Broad Spectrum SPF 15 Wheat TITANIUM DIOXIDE Chantecaille Beaute Inc 89f19f7a-60e3-4080-a49a-a4eb3e6c27de 2024-04-24 Warnings Exact identifier application number: M020 Chantecaille Just Skin Tinted Moisturizer Sunscreen Broad Spectrum SPF 15 Aura TITANIUM DIOXIDE Chantecaille Beaute Inc de441a6c-55e3-4b11-afb3-d7db3c6971f0 2024-04-24 Warnings Exact identifier application number: M020 Chantecaille Just Skin Tinted Moisturizer Sunscreen Broad Spectrum SPF 15 Bliss TITANIUM DIOXIDE Chantecaille Beaute Inc 16d9e226-7694-922a-e063-6394a90aea85 2024-04-24 Warnings Exact identifier application number: M020 Chantecaille Just Skin Tinted Moisturizer Sunscreen Broad Spectrum SPF 15 Glow TITANIUM DIOXIDE Chantecaille Beaute Inc f868fe4f-4c10-4f0f-9f1d-008f06774408 2024-04-24 Warnings Exact identifier application number: M020 Chantecaille Just Skin Tinted Moisturizer Sunscreen Broad Spectrum SPF 15 Nude TITANIUM DIOXIDE Chantecaille Beaute Inc cb8feddc-ae98-42ea-ad1e-583dcacfa5d9 2024-04-24 Warnings Exact identifier application number: M020 Chantecaille Just Skin Tinted Moisturizer Sunscreen Broad Spectrum SPF 15 Opaline TITANIUM DIOXIDE Chantecaille Beaute Inc 1c918b4b-763b-48bf-9ae3-661eabafee16 2024-04-24 Warnings Exact identifier application number: M020 Chantecaille Just Skin Tinted Moisturizer Sunscreen Broad Spectrum SPF 15 Tan TITANIUM DIOXIDE Chantecaille Beaute Inc fdf05545-5a21-4238-b0d3-e3fcdfe866ff 2024-04-24 Warnings Exact identifier application number: M020 Chantecaille Just Skin Tinted Moisturizer Sunscreen Broad Spectrum SPF 15 Topaz TITANIUM DIOXIDE Chantecaille Beaute Inc 2012f671-7889-4e29-b70f-215cbc9dbdc7 2024-04-24 Warnings Exact identifier application number: M020 Chantecaille Just Skin Tinted Moisturizer Sunscreen Broad Spectrum SPF 15 Vanilla TITANIUM DIOXIDE Chantecaille Beaute Inc 7133c47d-ed1c-43e9-8cdf-42f7b2f215f5 2024-04-24 Warnings Exact identifier application number: M020 Eco Lips PlantPod Sunscreen Lip Balm Vanilla SPF 30 AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE Eco Lips. Inc. fd8edc49-762a-b718-e053-6394a90a65f5 2024-04-23 Warnings Exact identifier application number: M020 SKINPERFECT PRIMER SPF30 ZINC OXIDE Dermalogica, LLC. 692f9cda-eb6c-431f-a575-3778c6e12e3b 2024-04-23 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