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 316 of 346 · 6,912 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Boscia B.B. LIGHT Broad Spectrum SPF 27 PA Self-Adjusting Shade TITANIUM DIOXIDE, ZINC OXIDE Boscia LLC 5169b10e-5a8d-479a-a6a8-1e7a13cb70c4 2023-12-12 Warnings Exact identifier application number: M020 Boscia All In One B.B. Eye Brightener Broad Spectrum SPF 20 TITANIUM DIOXIDE Boscia LLC f76166f1-e987-4eaf-8192-14dc08c481f7 2023-12-12 Warnings Exact identifier application number: M020 Boscia Daily Defense Sunscreen Broad Spectrum SPF 50 PA OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE Boscia LLC 2a6b507f-0967-46e1-8360-0003772f1bdb 2023-12-12 Warnings Exact identifier application number: M020 Likewise Facial Moisturizer - Sun Protectant SPF 50 Normal to Oily Skin OCTINOXATE, OCTISALATE, ZINC OXIDE Likewise Incorporated 97bd2033-2cf0-4e5d-81e2-c453a1e3a65e 2023-12-12 Warnings Exact identifier application number: M020 3LAB Aqua BB SPF 40 BROAD SPECTRUM 01 TITANIUM DIOXIDE 3LAB, Inc. 703dc828-24b4-4f04-9f2c-4a2edfdf4632 2023-12-12 Warnings Exact identifier application number: M020 3LAB Aqua BB SPF 40 BROAD SPECTRUM 02 TITANIUM DIOXIDE 3LAB, Inc. 7c6c7062-91f7-4304-98c3-f77967a2d329 2023-12-12 Warnings Exact identifier application number: M020 Likewise Facial Moisturizer - Sun Protectant SPF 50 Normal to Dry Skin OCTINOXATE, OCTISALATE, ZINC OXIDE Likewise Incorporated 8a75dde9-8dcb-4f4a-b9df-88338bd2a440 2023-12-12 Warnings Exact identifier application number: M020 Everyday Facial Moisturizer And Sunscreen SPF 20 ZINC OXIDE 714 Essentials LTD 3a29018b-8103-4983-b0c5-5f340775a05d 2023-12-12 Warnings Exact identifier application number: M020 Likewise Hand Moisturizer - Sun Protectant SPF 50 OCTINOXATE, OCTISALATE, ZINC OXIDE Likewise Incorporated a54f0854-c55e-4a46-9084-16cb1be0f681 2023-12-12 Warnings Exact identifier application number: M020 3LAB PERFECT BB SPF 40 Broad Spectrum 01 TITANIUM DIOXIDE 3LAB, Inc bd39d2fb-8326-4e19-b634-7a7308313d8a 2023-12-12 Warnings Exact identifier application number: M020 3LAB PERFECT BB SPF 40 Broad Spectrum 03 TITANIUM DIOXIDE 3LAB, Inc 19884289-edb2-4d18-bd62-873533b94a10 2023-12-12 Warnings Exact identifier application number: M020 Bass Pro Shops Mineral Sun Stick Sunscreen Broad Spec SPF 40 TITANIUM DIOXIDE, ZINC OXIDE ENGLEWOOD LAB, INC. 92dc1a86-590e-4144-9d30-172645e63140 2023-12-12 Warnings Exact identifier application number: M020 3LAB PERFECT BB SPF 40 Broad Spectrum 02 TITANIUM DIOXIDE 3LAB, Inc bf4419b9-408d-469a-aa15-bbf419632f02 2023-12-12 Warnings Exact identifier application number: M020 3LAB PERFECT Sunscreen SPF 50 Plus Broad Spectrum HOMOSALATE, OCTISALATE, AVOBENZONE, OCTOCRYLENE 3LAB, Inc 2bee6b87-c889-4ea1-87ad-e28949bcb67a 2023-12-12 Warnings Exact identifier application number: M020 Likewise Facial Moisturizer - Sun Protectant SPF 50 Oily Skin TITANIUM DIOXIDE, ZINC OXIDE Likewise Incorporated 28b8c519-8417-427e-8d4f-94da44a69d9f 2023-12-12 Warnings Exact identifier application number: M020 BEET THE SUN LIGHTWEIGHT SUNSCREEN BROAD SPECTRUM SPF 40 PA AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE ENGLEWOOD LAB, INC. f5c795f0-63bc-3033-e053-2995a90a55ab 2023-12-12 Warnings Exact identifier application number: M020 Bass Pro Shops Bass P Sunscreen Broad Spectrum SPF 50 TITANIUM DIOXIDE, ZINC OXIDE ENGLEWOOD LAB, INC. c06ecc56-2044-4396-8acd-6d18af9b984c 2023-12-12 Warnings Exact identifier application number: M020 SUMMARY EVERYDAY MINERAL SUNSCREEN BROAD SPECTRUM SPF 30 TITANIUM DIOXIDE, ZINC OXIDE ENGLEWOOD LAB, INC. f5c7b7ce-b3ed-3e96-e053-2995a90a8ea9 2023-12-12 Warnings Exact identifier application number: M020 Milani SPF BFF 30 Primer AVOBENZONE, OCTINOXATE, OCTOCRYLENE, OXYBENZONE New Milani Group, LLC c7a1f2a7-d299-2116-e053-2995a90ad8c5 2023-12-12 Warnings Exact identifier application number: M020 MILANI MAKE IT LAST SUNSCREEN SETTING SPF 30 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE New Milani Group, LLC 8f52f614-1cfe-4ef0-8cb6-37afbfddf44c 2023-12-12 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