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 268 of 346 · 6,912 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join SPF30 EVERYDAY/YEAR-ROUND SUNSCREEN TITANIUM DIOXIDE ORGANIC & SUSTAINABLE BEAUTY d4f30d95-4a3f-49ad-817e-faa86fca5018 2024-11-07 Warnings Exact identifier application number: M020 Round Lab Birch Juice Moisturizing UVLOCK Sun Cushion ZINC OXIDE SEORIN COMPANY Co., Ltd. 26407b83-b417-6450-e063-6294a90ad2b1 2024-11-06 Warnings Exact identifier application number: M020 e.l.f. Holy Hydration Face Cream SPF 30 Sunscreen AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE e.l.f. Cosmetics, Inc b7898d65-df86-580a-e053-2a95a90a5b1b 2024-11-06 Warnings Exact identifier application number: M020 Bondi Sands Fragrance Free SPF 50 Sunscreen AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE BONDI SANDS (USA) INC. acda604c-27cf-d500-e053-2995a90a5d65 2024-11-06 Warnings Exact identifier application number: M020 Bondi Sands Fragrance Free SPF 50 Sunscreen AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE BONDI SANDS (USA) INC. acb92160-1749-d51b-e053-2995a90a9e87 2024-11-06 Warnings Exact identifier application number: M020 Bondi Sands Toasted Coconut Lip Balm with SPF 50 Sunscreen AVOBENZONE, HOMOSALATE, OCTOCRYLENE BONDI SANDS (USA) INC. acb8513e-723b-b7d6-e053-2995a90aed52 2024-11-06 Warnings Exact identifier application number: M020 Bondi Sands Fragrance Free Face SPF 50 Sunscreen AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE BONDI SANDS (USA) INC. acda9863-ad9f-e430-e053-2995a90a69a6 2024-11-06 Warnings Exact identifier application number: M020 Birch Juice Moisturizing UVLOCK Sunstick SPF 50 Broad Spectrum HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE SEORIN COMPANY Co., Ltd. 26442417-f238-1fc3-e063-6394a90a6f82 2024-11-06 Warnings Exact identifier application number: M020 Avene Mineral Sunscreen Face and Body ZINC OXIDE Pierre Fabre USA Inc. fb5b1e94-bed3-8486-e053-6294a90a3a84 2024-11-06 Warnings Exact identifier application number: M020 Avene Cleanance Mattifying SPF 30 ZINC OXIDE Pierre Fabre USA Inc. 2644f545-0625-7858-e063-6394a90a5963 2024-11-06 Warnings Exact identifier application number: M020 SPF30 CALENDULA SUNSCREEN TITANIUM DIOXIDE ORGANIC & SUSTAINABLE BEAUTY 64580be7-868c-40fb-b7b8-840b417b25d3 2024-11-06 Warnings Exact identifier application number: M020 KIDS SPF30 SUPER SENSITIVE PLUS C111 SUNSCREEN TITANIUM DIOXIDE ORGANIC & SUSTAINABLE BEAUTY 20ebe264-2f79-4eef-b83d-3f09a3ca2898 2024-11-06 Warnings Exact identifier application number: M020 Cream Oil Sunscreen ZINC OXIDE, TITANIUM DIOXIDE SUNSCREEN Owen Biosciences, Inc. b2ccdfea-1c27-42af-b9d8-752e9f91ae87 2024-11-05 Warnings Exact identifier application number: M020 Vivant Day Treatment SPF 15 OCTINOXATE 7.50% OCTISALATE 5.00% Vivant Pharmaceuticals, LLC 10a95d0a-366f-0611-e063-6294a90abb44 2024-11-05 Warnings Exact identifier application number: M020 ZO Skin Health Smart Tone Broad-Spectrum Sunscreen SPF 50 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE ZO Skin Health, Inc. 1560a6b6-8d4a-6942-e063-6294a90a4a44 2024-11-04 Warnings Exact identifier application number: M020 Bali Body Watermelon Tanning Oil SPF 15 AVOBENZONE, OCTISALATE, OCTOCRYLENE Bali Body Pty Ltd 07d96576-fd78-acf3-e063-6394a90af45b 2024-11-03 Warnings Exact identifier application number: M020 Neutrogena Mineral Ultra Sheer Dry-Touch Face and Body Sunscreen Broad Spectrum UVA-UVB SPF 50 ZINC OXIDE Kenvue Brands LLC 8f34c1f6-51fe-4719-ba1f-1e23c05e937b 2024-11-01 Warnings Exact identifier application number: M020 Byoma Moisturizing Sunscreen SPF 30 AVOBENZONE, HOMOSALATE, OCTISALATE BYOMA LIMITED 25de7939-3b18-7f9e-e063-6394a90a23a9 2024-11-01 Warnings Exact identifier application number: M020 Dr Edward Krulig New Melan Sunblock SPF 50 AVOBENZONE, OCTISALATE, OCTOCRYLENE KRULIG INTERNATIONAL, INC 21c301d2-b283-40e1-bf26-b4bdde278247 2024-10-31 Warnings Exact identifier application number: M020 ZO Skin Health Sheer Fluid Broad-Spectrum Sunscreen SPF 50 ZINC OXIDE ZO Skin Health, Inc. f218c158-19aa-ab90-e053-2a95a90aaef3 2024-10-31 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