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 210 of 353 · 7,049 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Naturium Phyto-Glow Lip Balm SPF 45-Getaway AVOBENZONE, HOMOSALATE, OCTISALATE e.l.f. Cosmetics, Inc. 3808613f-88d6-6c1a-e063-6294a90a5bb2 2025-06-09 Warnings Exact identifier application number: M020 1000 Roses Daily Shade Facial SPF 18 OCTISALATE, OCTOCRYLENE, AND AVOBENZONE Andalou naturals 0923e090-6834-4373-80fe-21f00b8c1c17 2025-06-09 Warnings Exact identifier application number: M020 dAlba Vegan Fresh Sun Cushion ZINC OXIDE, HOMOSALATE, OCTOCRYLENE ADMTMAX LLC 20afcbab-a2f4-7965-e063-6294a90a83d1 2025-06-08 Warnings Exact identifier application number: M020 dAlba Vegan Mild Sunscreen ZINC OXIDE ADMTMAX LLC 20ab5698-cd9f-0821-e063-6394a90a60d7 2025-06-08 Warnings Exact identifier application number: M020 dAlba Vegan Fresh Sun Stick HOMOSALATE, ETHYLHEXYL METHOXYCINNAMATE, ETHYLHEXYL SALICYLATE ADMTMAX LLC 20ae82ae-bc8f-89d1-e063-6394a90afff2 2025-06-08 Warnings Exact identifier application number: M020 dAlba Vegan Essence Sunscreen HOMOSALATE, OCTOCRYLENE, ETHYLHEXYL METHOXYCINNAMATE, ETHYLHEXYL SALICYLATE ADMTMAX LLC 1ccfa213-2f83-ad50-e063-6294a90a38bf 2025-06-08 Warnings Exact identifier application number: M020 Pacifica Ultra CC Cream Radiant Foundation SPF 30 Warm/Medium ZINC OXIDE Pacifica Beauty, LLC 36ec6c9d-f7dc-0419-e063-6294a90a55e6 2025-06-06 Warnings Exact identifier application number: M020 Pacifica Ultra CC Cream Radiant Foundation SPF 30 Neutral/Fair ZINC OXIDE Pacifica Beauty, LLC 36ed9101-249a-922c-e063-6394a90a2608 2025-06-06 Warnings Exact identifier application number: M020 Rodan and Fields Reverse Brightening Defense Broad Spectrum SPF 50 Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE Rodan & Fields Beauty, LLC afa2d42e-b54d-4843-b313-0c44fe5c5d52 2025-06-06 Warnings Exact identifier application number: M020 1000 Roses CC Color Plus Correct Sheer Tan SPF 30 ZINC OXIDE Andalou naturals 9314e4fc-ba3e-480e-a005-b8928130ed70 2025-06-06 Warnings Exact identifier application number: M020 Neutrogena Sheer Zinc Face Mineral Sunscreen Broad Spectrum SPF 50 ZINC OXIDE Kenvue Brands LLC 3169bf3b-a5a8-4c3e-a182-9f24f8ade3ac 2025-06-05 Warnings Exact identifier application number: M020 Body Glove Sunscreen SPF 30 ZINC OXIDE, TITANIUM DIOXIDE SCUBASCREEN LLC 1d7a960c-4387-44dc-8d4e-881e21a8ae2e 2025-06-05 Warnings Exact identifier application number: M020 Vacation Classic Mini Whip SPF 30 Broad Spectrum SPF 30 HOMOSALATE, OCTISALATE, OCTOCRYLENE, AVOBENZONE Vacation Inc. 36d65cb2-c2e7-06d7-e063-6394a90a3822 2025-06-05 Warnings Exact identifier application number: M020 Vacation Classic Whip SPF 50 Broad Spectrum SPF 50 HOMOSALATE, OCTISALATE, OCTOCRYLENE, AVOBENZONE Vacation Inc. 36d747fb-b973-5611-e063-6394a90ac661 2025-06-05 Warnings Exact identifier application number: M020 Non Tinted Mineral Sunscreen Stick TITANIUM DIOXIDE, ZINC OXIDE BABYFACE LLC 36d7c8b3-554f-78d9-e063-6394a90a80f3 2025-06-05 Exact identifier application number: M020 Tinted Mineral Sunscreen Stick TITANIUM DIOXIDE, ZINC OXIDE BABYFACE LLC 36d80422-943f-3aba-e063-6294a90afb59 2025-06-05 Exact identifier application number: M020 Mineral Creme SPF 50 Mineral Creme SPF 50 Broad Spectrum UVA-UVB Sunscreen Water Resistant (80 min) TITANIUM DIOXIDE AND ZINC OXIDE MDSolarSciences f8e178d6-058c-462a-8e59-6721f28ad040 2025-06-05 Warnings Exact identifier application number: M020 Mineral Tinted SPF 30 Mineral Tinted SPF 30 Broad Spectrum Sunscreen Water Resistant (80 min) TITANIUM DIOXIDE AND ZINC OXIDE MDSolarSciences adcd6881-fa25-4312-95e5-5b47102aa6b9 2025-06-05 Warnings Exact identifier application number: M020 Mineral Moisture Defense SPF 50 TITANIUM DIOXIDE AND ZINC OXIDE MDSolarSciences 05ad73f3-a4e8-4f78-8212-3e8e3bda988c 2025-06-05 Warnings Exact identifier application number: M020 Solar SPF 40 Broad Spectrum SPF 40 Water Resistant (80 min) Mineral Suncreen TITANIUM DIOXIDE AND ZINC OXIDE MDSolarSciences 6ce602bb-c1f4-43c1-ae61-0f05d7952db3 2025-06-05 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