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 23 of 357 · 7,139 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Ultra Violette Preen Screen Broad Spectrum SPF 50 AVONBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE Grace and Fire USA Inc. 26a0fc0d-a903-2ac1-e063-6394a90a13db 2026-06-01 Warnings Exact identifier application number: M020 Timesavvy Hybrid XL Cushion Sun Serum SPF 50 HOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDE ProBetter USA, Inc. 82a22071-f1bd-4fab-b929-8a00ef18f0d9 2026-05-31 Warnings Exact identifier application number: M020 Marine Screen Mineral Sunscreen Broad Spectrum SPF 50 ZINC OXIDE OSEA International, LLC 9aa20377-0ab9-4205-b9aa-24640a4641e7 2026-05-29 Warnings Exact identifier application number: M020 Ciele Blush and Protect Sugar ZINC OXIDE Ciele LLC 52f3a9f6-a226-6723-e063-6394a90a8706 2026-05-29 Warnings Exact identifier application number: M020 KIEHLS DERMATOLOGIST SOLUTIONS BETTER SCREEN MINER ALL UV SERUM BROAD SPECTRUM SPF 50 PLUS MINERAL SUNSCREEN TITANIUM DIOXIDE AND ZINC OXIDE LOreal USA Products Inc 294e6049-12b5-4b45-ae00-8ee1d9d2a1a4 2026-05-29 Warnings Exact identifier application number: M020 Daily Mineral Sunscreen 20% Zinc Oxide ZINC OXIDE INTEGRATIVE AESTHETICS BOSTON, LLC 52f818f4-8485-b228-e063-6294a90a9fe3 2026-05-29 Warnings Exact identifier application number: M020 Dr.G BRIGHT TONING UP TINTED SUNSCREEN ZINC OXIDE, OCTISALATE, HOMOSALATE GOWOONSESANG COSMETICS CO., LTD. 30d34459-b7fb-b0c6-e063-6294a90a08ac 2026-05-28 Warnings Exact identifier application number: M020 Dr.G GREEN MILD UP DEFENSE MINERAL SUNSCREEN ZINC OXIDE GOWOONSESANG COSMETICS CO., LTD. 30d49f24-3e13-385f-e063-6294a90ab5c8 2026-05-28 Warnings Exact identifier application number: M020 Dr.G R.E.D BLEMISH SOOTHING UP MOISTURE SUNSCREEN HOMOSALATE, OCTISALATE, AVOBENZONE GOWOONSESANG COSMETICS CO., LTD. 30d53b8a-7e35-0b2b-e063-6294a90aa8df 2026-05-28 Warnings Exact identifier application number: M020 Ciele Blush and Protect Berri ZINC OXIDE Ciele LLC 52e16cbc-b452-db18-e063-6394a90a4081 2026-05-28 Warnings Exact identifier application number: M020 Ciele Blush and Protect June ZINC OXIDE Ciele LLC 52e1c504-f0ee-2853-e063-6394a90a3139 2026-05-28 Warnings Exact identifier application number: M020 Ciele Blush and Protect January ZINC OXIDE Ciele LLC 52e186df-06aa-6528-e063-6294a90a3888 2026-05-28 Warnings Exact identifier application number: M020 Ciele Blush and Protect Berri ZINC OXIDE Ciele LLC 52e1398d-b170-ea89-e063-6294a90a7d24 2026-05-28 Warnings Exact identifier application number: M020 TIZO ULTRA NON TINTED MINERAL SUNSCREEN ZINC OXIDE 20% Fallien Cosmeceuticals, LTD 30d30610-2e6c-418c-bbcf-4ecd7f61be93 2026-05-28 Warnings Exact identifier application number: M020 Creme Foundation ZINC OXIDE Lauren Brooke Cosmetiques LLC 4d09907e-ddcd-9d62-e063-6394a90acf3f 2026-05-28 Warnings Exact identifier application number: M020 GOONGBE Moisture Sun Cushion Mild SPF 50 ZINC OXIDE Zero to Seven Inc. 1e8720b4-5e8b-dc8b-e063-6394a90aad34 2026-05-27 Warnings Exact identifier application number: M020 GOONGBE Fresh Sun Stick Mild SPF 50 ZINC OXIDE Zero to Seven Inc. 1e8727a4-0dc0-19dc-e063-6394a90a82b6 2026-05-27 Warnings Exact identifier application number: M020 Tallow and Sol SUNSCREEN SPF30 NON-NANO ZINC OXIDE 20% Guangzhou Shengyanghui Industrial Trading Co., Ltd 52c9dc0a-41f7-3e8a-e063-6394a90a8fca 2026-05-27 Warnings Exact identifier application number: M020 Tallow and SolSUNSCREEN SPF50 NON-NANO ZINC OXIDE 25% Guangzhou Shengyanghui Industrial Trading Co., Ltd 52cb56cf-f092-9f86-e063-6394a90ac2d3 2026-05-27 Warnings Exact identifier application number: M020 SPF 50 Mineral Sunscreen Face and Body ZINC OXIDE Toddle Born Wild, Inc. e97d82fe-cd45-43a5-9c1f-3900025240a1 2026-05-27 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