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
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 208 of 353 · 7,049 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join LBEL CONCENTRE BASE SERUM ANTIEDAD EFECTO LIFTING FPS 15 ANTI AGING LIFTING SERUM FOUNDATION SPF 15 CHAMPAGNE 170-N OCTINOXATE, ZINC OXIDE BEL STAR SA f9266687-73d2-dac9-e053-6394a90ac2a1 2025-06-20 Warnings Exact identifier application number: M020 LBEL DEFENSE TOTAL SUNSCREEN FOR FACE AND BODY SPF 50 AVOBENZONE, HOMOSALATE, OCTOCRYLENE BEL STAR SA fd0465aa-df1e-ce1c-e053-6294a90a2302 2025-06-20 Warnings Exact identifier application number: M020 FEIBTH TALLOW SUNSCREEN TALLOW SUNSCREEN Guangzhou Qiexiran Cosmetics Co., Ltd. 37ead2b1-12d4-af92-e063-6394a90af0d6 2025-06-19 Warnings Exact identifier application number: M020 LipBOMB TITANIUM DIOXIDE, ZINC OXIDE FLEUR DE VIE LLC 37ef4c1e-2183-a277-e063-6394a90ae2df 2025-06-19 Exact identifier application number: M020 Bioresist reinforcing effect face moisturizer SPF 30 AVOBENZONE, OCTISALATE, OCTOCRYLENE BEL STAR S A 99d7525d-b636-7f8e-e053-2a95a90a2080 2025-06-19 Warnings Exact identifier application number: M020 Ultra Balm Moisturizing Protective Balm for lips SPF 20 Nude Translucide OCTINOXATE, ZINC OXIDE BEL STAR S A c4d56723-3953-fb8e-e053-2a95a90a69d3 2025-06-19 Warnings Exact identifier application number: M020 SPF 50 Daily UV Defense Broad Spectrum Sunscreen OCTINOXATE, ZINC OXIDE Vi Medical Products, INC 2d814f8a-23b5-209f-e063-6394a90a5091 2025-06-19 Warnings Exact identifier application number: M020 Tinted Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE ESTHETICS BY RIKI LLC 37f2c5ed-c2f5-e569-e063-6294a90a15b1 2025-06-19 Exact identifier application number: M020 Ultra Balm Moisturizing Protective Balm for lips SPF 20 Nude Caramel OCTINOXATE, ZINC OXIDE BEL STAR S A c4f95c1b-acbe-4bb7-e053-2995a90a9120 2025-06-19 Warnings Exact identifier application number: M020 LBEL NUDE SKIN ULTRA LIGHT MATTE FOUNDATION WITH VITAMINS SPF 20 ALMENDRA 230-N OCTINOXATE, ZINC OXIDE Bel Star S.A. d22fde8a-ba14-2cc7-e053-2a95a90a0e53 2025-06-19 Warnings Exact identifier application number: M020 Correct and Protect Serum Broad Spectrum SPF 45 ZINC OXIDE Murad, LLC dba6e01b-a8ec-4812-bbe0-e418bb067032 2025-06-19 Warnings Exact identifier application number: M020 Truffoire Truffle Brightening OCTINOXATE, HOMOSALATE, OCTISALATE, OXYBENZONE AND AVOBENZONE Innovation Brands Inc. e3068ecf-0bee-4e8a-a439-4bb707a2845d 2025-06-18 Warnings Exact identifier application number: M020 Aveeno Kids Continuous Protection Sensitive Skin Mineral Sunscreen Broad Spectrum SPF 50 ZINC OXIDE Kenvue Brands LLC 383de98b-65b5-4398-a876-87367dc01d0b 2025-06-18 Warnings Exact identifier application number: M020 CB Multi-Active Moisturizer with SPF 30 OCTINOXATE, HOMOSALATE, OCTISALATE, OXYBENZONE AND AVOBENZONE Innovation Brands Inc. d9557a6c-78e9-4b01-8a4b-e0eceb511c4e 2025-06-18 Warnings Exact identifier application number: M020 1000 Roses CC Color plus Correct Sheer Beige SPF 30 ZINC OXIDE Andalou naturals 2e7f3570-f710-41dd-95a0-7c0613b317a2 2025-06-17 Warnings Exact identifier application number: M020 Skin by Scottie Beach Mode Mineral Sunscreen Roll-On SPF 30 TITANIUM DIOXIDE, ZINC OXIDE SKIN CARE BY SCOTTIE LLC a9afa58c-f438-48c6-bd30-eda41334df74 2025-06-16 Warnings Exact identifier application number: M020 Wellage Real Hyaluronic Watery Glow Sun Screen AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Hugel, Inc. 37aa2f7b-afa4-5cc9-e063-6294a90ae741 2025-06-16 Warnings Exact identifier application number: M020 Dermaka Sunscreen SPF 42, Tinted TITANIUM DIOXIDE, ZINC OXIDE DERMAKA SKIN PRODUCTS 9a967cd1-9eec-4255-b14b-ac2e33e4dbf0 2025-06-16 Warnings Exact identifier application number: M020 Elizabeth Arden Eight Hour Hydraplay SPF 40 OCTISALATE, HOMOSALATE, AVOBENZONE, OCTOCRYLENE Revlon Consumer Products Corp 2cc74177-0f62-106e-e063-6394a90a6e28 2025-06-16 Warnings Exact identifier application number: M020 BALI BODY SPF15 BRONZE SHIMMERING TANNING AVOBENZONE, OCTISALATE, OCTOCRYLENE Bali Body Pty Ltd 240d4d80-641c-ac57-e063-6394a90abe75 2025-06-16 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