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 125 of 357 · 7,139 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join 20Percent Zinc Oxide Sunscreen ZINC OXIDE Minder Day Spa, Inc. 35bee5f9-68d6-6302-e063-6394a90ada88 2025-12-15 Exact identifier application number: M020 20Percent Zinc Oxide Sunscreen ZINC OXIDE Minder Day Spa, Inc. 35bfd54a-d7b7-f1a7-e063-6294a90a039b 2025-12-15 Exact identifier application number: M020 AM RESTORE ZINC OXIDE Minder Day Spa, Inc. 35c03804-04e9-3d54-e063-6294a90a3407 2025-12-15 Exact identifier application number: M020 Deflectin Tinted Mineral Sunscreen ZINC OXIDE AEON AESTHETICS LLC 35d14660-8900-2cb0-e063-6394a90a317d 2025-12-15 Exact identifier application number: M020 Mineral Tinted Lip Sunscreen TITANIUM DIOXIDE, ZINC OXIDE JADEIA LIMITED INC 35cf36c1-50c9-e848-e063-6294a90a6658 2025-12-15 Exact identifier application number: M020 Flash Invisible Stick TITANIUM DIOXIDE, ZINC OXIDE AEON AESTHETICS LLC 35d2489e-4978-4fc3-e063-6294a90adfcc 2025-12-15 Exact identifier application number: M020 AM RESTORE ZINC OXIDE Minder Day Spa, Inc. 35c010ad-e25d-f197-e063-6294a90a0efb 2025-12-15 Exact identifier application number: M020 Flash Tinted Stick TITANIUM DIOXIDE, ZINC OXIDE AEON AESTHETICS LLC 35d28590-e746-7996-e063-6294a90ac7d8 2025-12-15 Exact identifier application number: M020 Mineral Tinted Sunscreen TITANIUM DIOXIDE, ZINC OXIDE JADEIA LIMITED INC 35cf03f4-200a-5643-e063-6394a90a9e02 2025-12-15 Exact identifier application number: M020 Daily Defense Tinted Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE JADEIA LIMITED INC 35cf708c-244e-63a8-e063-6394a90a3b96 2025-12-15 Exact identifier application number: M020 Daily Restore ZINC OXIDE TYRLIN ENTERPRISES, INC. 35cead50-86a7-2cf2-e063-6294a90a5f99 2025-12-15 Exact identifier application number: M020 Daily Defense Facial Sunscreen Plus Primer TITANIUM DIOXIDE, ZINC OXIDE LAURA CATHERINE, LLC 36e81e8e-0ba7-93e6-e063-6294a90a4e62 2025-12-15 Exact identifier application number: M020 Sacred Aura ZINC OXIDE IRIA SKIN OASIS LLC 36eaaa54-e288-6590-e063-6394a90a403d 2025-12-15 Exact identifier application number: M020 Daily Defense Facial Sunscreen Plus Primer TITANIUM DIOXIDE, ZINC OXIDE LAURA CATHERINE, LLC 36e84147-5dcd-517a-e063-6394a90a54ee 2025-12-15 Exact identifier application number: M020 Sacred Glow ZINC OXIDE IRIA SKIN OASIS LLC 36ead65c-a46c-7395-e063-6394a90a9e04 2025-12-15 Exact identifier application number: M020 Sheer Mineral Face And Body Sunscreen Non Tinted ZINC OXIDE LAURA CATHERINE, LLC 36e91877-c4c4-7fa3-e063-6294a90a1326 2025-12-15 Exact identifier application number: M020 Sheer Mineral Face And Body Sunscreen Tinted ZINC OXIDE LAURA CATHERINE, LLC 36e880af-debc-657f-e063-6394a90ab6ff 2025-12-15 Exact identifier application number: M020 Sheer Mineral Face And Body Sunscreen Tinted ZINC OXIDE LAURA CATHERINE, LLC 36e8b631-03e7-c1de-e063-6294a90aa530 2025-12-15 Exact identifier application number: M020 Sheer Mineral Face And Body Sunscreen Non Tinted ZINC OXIDE LAURA CATHERINE, LLC 36e957cf-cfa5-b122-e063-6294a90a78ce 2025-12-15 Exact identifier application number: M020 Skin Shield Plus ZINC OXIDE LAURA CATHERINE, LLC 36e9c2f3-ea89-0de3-e063-6394a90a9fb6 2025-12-15 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