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 294 of 346 · 6,912 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Silk Line Silk Day Cream SPF 15 OCTINOXATE, OCTOCRYLENE, OCTISALATE Biocosmetica Exel Argentina SRL b2965aba-fcde-16f6-e053-2995a90aa9d8 2024-06-30 Warnings Exact identifier application number: M020 Sun Shield On-the-Glow Sheer Stick SPF40 AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE Koco Life LLC 1c237d5a-1663-e9a1-e063-6294a90a6a24 2024-06-30 Warnings Exact identifier application number: M020 Exel Clarifying Line SPF 50 OCTINOXATE, OCTOCRYLENE, OXYBENZONE, TATANIUM DIOXIDE Exelencia importers 0d6d4098-4121-477e-b404-3ab18628ed68 2024-06-30 Warnings Exact identifier application number: M020 Silk Line Silk Day Cream SPF 15 OCTINOXATE, OCTOCRYLENE, OCTISALATE Exelencia Importers, Corp. b2d35086-748b-55d0-e053-2995a90a1898 2024-06-30 Warnings Exact identifier application number: M020 Maybelline New York Dream Fresh BB Beauty Balm Skin Perfector Broad Spectrum SPF 30 Sunscreen TITANIUM DIOXIDE L'Oreal USA Products Inc 28c51c59-dbfb-45e5-b536-6e5d5c5560d6 2024-06-28 Warnings Exact identifier application number: M020 Sun Shield Body Glow SPF50 HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE Koco Life LLC 180aa4d5-6dac-e658-e063-6394a90a3287 2024-06-28 Warnings Exact identifier application number: M020 Rose Gold Sun Shield Body Glow SPF45 AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE Koco Life LLC 1bf7d147-7051-2e76-e063-6294a90a1d13 2024-06-28 Warnings Exact identifier application number: M020 Golden Amber Sun Shield Body Glow SPF30 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Koco Life LLC 1bf97569-024a-9ef1-e063-6394a90a2822 2024-06-28 Warnings Exact identifier application number: M020 Jergens Natural Glow Face Daily Moisturizer for Fair/Medium Skin AVOBENZONE, OCTISALATE, OCTOCRYLENE Kao USA Inc. 365a98e0-737b-12b3-e054-00144ff8d46c 2024-06-28 Warnings Exact identifier application number: M020 Antioxidant Face Shield Mineral SPF30 ZINC OXIDE Koco Life LLC 1c31a971-0402-e12a-e063-6294a90ac91d 2024-06-28 Warnings Exact identifier application number: M020 Sun Essentials SPF Duo Kit AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE Koco Life LLC 1c329b86-664e-de1f-e063-6394a90a7c23 2024-06-28 Warnings Exact identifier application number: M020 IT COSMETICS YOUR SKIN BUT BETTER CC PLUS NUDE GLOW Color Correcting Medium Coverage Skin Tint plus Brightening Glow Serum plus Broad Spectrum SPF 40 Sunscreen HOMOSALATE, OCTISALATE AND OCTOCRYLENE L'Oreal USA Products Inc e879c055-9611-46a2-bcf6-8dd0a29a3129 2024-06-28 Warnings Exact identifier application number: M020 Lancome Paris Absolue Makeup Broad Spectrum SPF 20 Sunscreen Absolute Replenishing Makeup for Dry and Very Dry Skin OCTINOXATE L'Oreal USA Products Inc 90326e7e-8fdf-4221-afc0-208774d8ba6f 2024-06-28 Warnings Exact identifier application number: M020 LOreal Paris Collagen Moisture Filler Ultra Light Moisturizing Broad Spectrum SPF 30 Sunscreen AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE L'Oreal USA Products Inc c21fdc5e-236a-4a8e-ad59-1d9cd7507424 2024-06-28 Warnings Exact identifier application number: M020 Kiehls Ultra Facial Moisturizer Broad Spectrum SPF 30 Sunscreen AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE L'Oreal USA Products Inc 6925c546-056e-4be8-b4e9-55da0b6b62b3 2024-06-28 Warnings Exact identifier application number: M020 LOreal Paris Age Perfect Radiant Foundation Broad Spectrum SPF 50 Sunscreen with Antioxidants plus Concentrated Serum HOMOSALATE, OCTISALATE AND OCTOCRYLENE L'Oreal USA Products Inc 799c547c-a17a-43ee-92fc-061b5ec8a40c 2024-06-28 Warnings Exact identifier application number: M020 LOreal Paris Infallible UP TO 32H Fresh Wear Foundation Broad Spectrum SPF 25 Sunscreen OCTINOXATE AND TITANIUM DIOXIDE L'Oreal USA Products Inc f6457973-3718-44cd-a764-de0b089d4eee 2024-06-28 Warnings Exact identifier application number: M020 LOreal Paris Visible Lift Serum Absolute Advanced Makeup Broad Spectrum SPF 17 Sunscreen OCTINOXATE AND TITANIUM DIOXIDE L'Oreal USA Products Inc 8598d56b-adcd-48e8-b6fc-77bc934009c7 2024-06-27 Warnings Exact identifier application number: M020 MAYBELLINE NEW YORK INSTANT AGE REWIND ERASER TREATMENT MAKEUP OCTINOXATE BROAD SPECTRUM SPF 20 SUNSCREEN PLUS PROVITAMIN B5 OCTINOXATE L'Oreal USA Products Inc 12ec5a93-8c24-4ac9-94df-910dd8137e00 2024-06-27 Warnings Exact identifier application number: M020 Kiehls Since 1851 Dermatologist Solutions AutoTone Discoloration and UV Solution Broad Spectrum SPF 30 Sunscreen AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE L'Oreal USA Products Inc 6dbbc8ce-9457-4405-bb38-aa0c7550c62c 2024-06-27 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