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 301 of 346 · 6,912 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Carmex Daily Care Moisturizing Lip Balm SPF 15 Assorted HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE Carma Laboratories, Inc. 22821e9d-eb3a-4e21-87ae-737b25125534 2024-04-03 Warnings Exact identifier application number: M020 Meadow and Bark SPF 45 Mineral Shimmer Sunscreen ZINC OXIDE Meadow and Bark 14bbd191-ef3b-628e-e063-6294a90a1e66 2024-04-03 Warnings Exact identifier application number: M020 Meadow and Bark SPF 45 Mineral Sport Sunscreen ZINC OXIDE Meadow and Bark 1494c0e1-97f5-411c-e063-6294a90ab2ca 2024-04-03 Warnings Exact identifier application number: M020 LBEL FOREVER HYDRA BASE HIDRATANTE DE LARGA DURACION FPS 15 HYDRATING LONGWEAR FOUNDATION SPF 15 LATTE 180-F OCTINOXATE, ZINC OXIDE BEL STAR S A ea3a0e07-a277-48c8-e053-2a95a90a172f 2024-04-02 Warnings Exact identifier application number: M020 Rio Radiance SPF 50 BodySpray OCTOCRYLENE, OCTISALATE, AVOBENZONE Sol de Janeiro USA, Inc 1520a151-70c4-8699-e063-6294a90adc6b 2024-04-02 Warnings Exact identifier application number: M020 Meijer SPF 30 Sunscreen AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Meijer 075efd92-1632-d8c8-e063-6294a90a8c1a 2024-04-02 Warnings Exact identifier application number: M020 Good Molecules Sheer Mineral Sunscreen SPF 30 ZINC OXIDE Good Molecules, LLC e9596344-a7ab-f582-e053-2a95a90a5525 2024-04-02 Warnings Exact identifier application number: M020 Carmex Daily Care Moisturizing Lip Balm SPF15 Broad Sprectrum Minis HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE Carma Laboratories, Inc. f5c4186e-f167-40fc-b308-0b4406d3ec55 2024-04-02 Warnings Exact identifier application number: M020 Carmex Daily Care Moisturizing Lip Balm SPF15 Broad Sprectrum Minis Holiday AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Carma Laboratories, Inc. 95d9a485-7418-437a-8e7d-ebcc09088356 2024-04-02 Warnings Exact identifier application number: M020 Rejuvenating Priming Moisturizer BS Sunscreen SPF30 ZINC OXIDE Allure Labs 14cff1a3-89b9-f4da-e063-6394a90a1a41 2024-03-29 Warnings Exact identifier application number: M020 Lemongrass Spa Products SPF 45 Tinted Mineral Sunscreen ZINC OXIDE Lemongrass Spa Products, LLC 14bcbaf9-76a5-f8ba-e063-6294a90a91f6 2024-03-28 Warnings Exact identifier application number: M020 Rubber Ducky SPF 50 Sunscreen AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Carefree Skincare Ventures, LLC 14bd5cf9-423e-53a8-e063-6394a90a29f1 2024-03-28 Warnings Exact identifier application number: M020 RV Illuminance Serum Tint Broad Spectrum 15 FACE FOUNDATION WITH SPF REVLON CONSUMER PR Consumer Products Corp 132aab60-da19-7079-e063-6394a90a1d76 2024-03-27 Warnings Exact identifier application number: M020 NAELI TINT Tinted Mineral Moisturizer SPF 50 ZINC OXIDE ALLI LLC 25a88843-078b-4589-b8b7-ea439ba6a15b 2024-03-27 Warnings Exact identifier application number: M020 Rio Radiance SPF 50 BodyLotion ZINC OXIDE SOL DE JANEIRO USA, INC. 14a85a88-c9a2-94ea-e063-6394a90a4e14 2024-03-27 Warnings Exact identifier application number: M020 Rio Radiance SPF 50 Body Oil OCTOCRYLENE, HOMOSALATE, OCTISALATE, AVOBENZONE SOL DE JANEIRO USA, INC. 14acf152-e72a-debb-e063-6294a90a243d 2024-03-27 Warnings Exact identifier application number: M020 RV Illuminance Serum Tint Broad Spectrum 15 Amber FACE FOUNDATION WITH SPF REVLON CONSUMER PR Consumer Products Corp 2a0ac71c-e53a-5ff9-e063-6394a90a4807 2024-03-27 Warnings Exact identifier application number: M020 EltaMD UV Pure SPF47 ZINC OXIDE AND TITANIUM DIOXIDE SUNSCREEN CP Skin Health Group, Inc. 9afe900b-4186-4189-a871-ad6f26fc26e4 2024-03-27 Warnings Exact identifier application number: M020 Eminence Daily Defense Tinted SPF ZINC OXIDE Eminence Organic Skin Care 14854bad-317e-154d-e063-6294a90a884f 2024-03-25 Warnings Exact identifier application number: M020 SPF 50 Mineral Based Facial Sunscreen TITANIUM DIOXIDE, ZINC OXIDE Hutton, Kathleen MD 5cf0d2e3-d496-424c-ac75-70ff5b87e9ca 2024-03-25 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