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 238 of 353 · 7,041 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join ECLIPSE SPF 50 ALL SHADES TITANIUM DIOXIDE, ZINC OXIDE SCIENCE OF SKINCARE LLC 49df51e6-be9a-41be-b3e1-bfc062aaceaa 2025-01-09 Warnings Exact identifier application number: M020 CoTZ Mineral Suns Stick - Tinted SPF 45 TITANIUM DIOXIDE, ZINC OXIDE Fallien Cosmeceuticals, LTD 44a6ff9b-8067-4f32-acb2-4ede54c79e6e 2025-01-09 Warnings Exact identifier application number: M020 NUDESCREEN BLUSH TINT SPF 30 - SUNKISSED ZINC OXIDE SUNSCREEN Bentley Laboratories, LLC c45b59d8-0196-4dce-bfaa-57c47f655fe8 2025-01-09 Warnings Exact identifier application number: M020 TiZO Tinted Lip Protection SPF 45 TITANIUM DIOXIDE, ZINC OXIDE Fallien Cosmeceuticals, LTD 81ee1b28-c7d7-4b34-b0f0-5a3cc7a139a2 2025-01-09 Warnings Exact identifier application number: M020 CoTZ Face Prime and Protect SPF 40 (Tinted) TITANIUM DIOXIDE, ZINC OXIDE Fallien Cosmeceuticals, LTD 1088fbf6-5790-490d-b272-ec281b4b76fa 2025-01-09 Warnings Exact identifier application number: M020 CoTZ Face Prime and Protect SPF 40 (Non-Tinted) TITANIUM DIOXIDE, ZINC OXIDE Fallien Cosmeceuticals, LTD f106f52b-2157-46c7-9f7c-50f43a649050 2025-01-09 Warnings Exact identifier application number: M020 NUDESCREEN BLUSH TINT SPF 30 - SUNNY SWEET CHEEKS ZINC OXIDE SUNSCREEN Bentley Laboratories, LLC 5c98bacb-8bbd-47b8-8987-50be1ed34fc0 2025-01-09 Warnings Exact identifier application number: M020 CoTZ Face Moisture ZINC OXIDE Fallien Cosmeceuticals, LTD db682516-6c8f-4009-a9ec-e21dfc64ce15 2025-01-09 Warnings Exact identifier application number: M020 L Bri CC DD Color Correcting Daily Defense Sunscreen SPF 30 Light Medium OCTOCRYLENE, ZINC OXIDE L'BRI Health & Beauty bcd22c9a-2db6-4653-9ab5-825f3f5cc420 2025-01-08 Warnings Exact identifier application number: M020 L Bri CC DD Color Correcting Daily Defense Sunscreen SPF 30 Light OCTOCRYLENE, ZINC OXIDE L'BRI Health & Beauty c66c2a54-97c8-4904-a44a-b3cf790837f5 2025-01-08 Warnings Exact identifier application number: M020 Sunscreen SPF 30 AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE Tempo Industries, Inc. af9aa56d-2f8a-55b9-e053-2a95a90a3258 2025-01-08 Warnings Exact identifier application number: M020 Baby Mineral Sunscreen Probiotics SPF55 ZINC OXIDE Hello Bello 0191b2e4-bcc5-541a-e063-6294a90a0e78 2025-01-08 Warnings Exact identifier application number: M020 Kids Face and Body Sunscreen SPF 50 ZINC OXIDE Hello Bello 01cc4ea0-e3de-32f1-e063-6394a90a1375 2025-01-08 Warnings Exact identifier application number: M020 Baby Mineral Sunscreen SPF55 ZINC OXIDE Hello Bello 0190eeaf-c5a0-3253-e063-6294a90a43c4 2025-01-08 Warnings Exact identifier application number: M020 Mineral Sunscreen SPF 50 ZINC OXIDE Hello Bello 01cc205b-a345-262a-e063-6394a90a955c 2025-01-08 Warnings Exact identifier application number: M020 Eco Lips Zinc SPF 30 Broad Spectrum Sunscreen Unscented ZINC OXIDE Eco Lips, Inc. febabad6-0bf2-a3f8-e053-6294a90a3aeb 2025-01-08 Warnings Exact identifier application number: M020 LESS EVERY TONE SPF 30 ZINC OXIDE Happy Farm Botanicals, Inc. e91ded4b-987d-17a8-e053-2995a90adc2e 2025-01-08 Warnings Exact identifier application number: M020 Stay AgelessTinted Mineral Sunscreen Broad Spectrum SPF 30 TITANIUM DIOXIDE AND ZINC OXIDE ETHEREAL AESTHETICS LLC 065d17cf-bea5-137f-e063-6394a90aeeb3 2025-01-08 Warnings Exact identifier application number: M020 Stay Ageless Tinted Mineral Sunscreen Broad Spectrum SPF 30 TITANIUM DIOXIDE AND ZINC OXIDE SERRAO, E JOHN MD FACOG fea61544-6684-ad34-e053-6294a90a48f3 2025-01-08 Warnings Exact identifier application number: M020 Tinted Mineral Sunscreen Broad Spectrum SPF 30 TITANIUM DIOXIDE AND ZINC OXIDE New Beginnings Tattoo Removal fea87de3-116f-4774-e053-6394a90a0aad 2025-01-08 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