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 169 of 354 · 7,077 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Indie Lee Daily Primer ZINC OXIDE America Exchange 38e5232b-7daf-7e61-e063-6394a90aa5b0 2025-11-06 Warnings Exact identifier application number: M020 Duette Untinted ZINC OXIDE Skin Theory Studios 3ce24b39-8bb1-1246-e063-6294a90a32d4 2025-11-06 Warnings Exact identifier application number: M020 Duette Tinted ZINC OXIDE Skin Theory Studios 3ce1d7cb-b37d-fb9f-e063-6394a90aaef3 2025-11-06 Warnings Exact identifier application number: M020 Truskin Broad Spectrum Mineral Sunscreen Facial Serum with Vitamin C and Aloe ZINC OXIDE Allure Labs 42f3999f-4163-fadc-e063-6294a90aacf3 2025-11-06 Warnings Exact identifier application number: M020 Melan RX ZINC OXIDE Melan RX f4bdf20c-b6bc-55f1-e053-2995a90ac308 2025-11-06 Warnings Exact identifier application number: M020 ESIKA HYDRACOLOR 2 IN 1 SPF 25 (FUCSIA CAUTIVANTE EXOTIC) - PINK OCTINOXATE AND OXYBENZONE Ventura Corporation LTD e1eb77f1-d65c-4af8-a7d9-90f10570960f 2025-11-06 Warnings Exact identifier application number: M020 Ultraceuticals Ultra UV Protective Daily Moisturising ZINC OXIDE Ultraceuticals fc8a5c02-23b4-b4d8-e053-6294a90a55ea 2025-11-06 Warnings Exact identifier application number: M020 Vaihea Protect Clean SPF Drops ZINC OXIDE Vaihea Skincare LLC fe7e3145-a8e2-d14f-e053-6394a90abb5e 2025-11-06 Warnings Exact identifier application number: M020 Refy Skin Trio ZINC OXIDE Refy 3029a690-dbb0-ff15-e063-6394a90abdbe 2025-11-06 Warnings Exact identifier application number: M020 Stream2Sea Broad Spectrum 20 TITANIUM DIOXIDE Stream2Sea, LLC 1775d07d-6914-6928-e054-00144ff88e88 2025-11-06 Warnings Exact identifier application number: M020 PHYSICAL TINTED MOISTURIZER SPF44 ZINC OXIDE, TITANIUM DIOXIDE Drmtlgy, LLC 483d0d28-56f3-4b37-af03-0331e1653d73 2025-11-06 Warnings Exact identifier application number: M020 Neutrogena Rapid Wrinkle Repair Retinol Moisturizer Sunscreen Broad Spectrum SPF 30 Day AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE Kenvue Brands LLC d3ebe2a9-434e-497c-8fed-b5c73c70a58b 2025-11-05 Warnings Exact identifier application number: M020 Clear Smart Shine Control Sunscreen Broad Spectrum SPF 25 AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE Distribuidora Comercial Jafra, S.A. de C.V. a57bcf44-580d-520e-e053-2a95a90a6923 2025-11-05 Warnings Exact identifier application number: M020 Spa Niacinamide And Vitamin E Hand Cream Broad Spectrum SPF 15 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Distribuidora Comercial Jafra, S.A. de C.V. 865057ce-f617-4232-a60e-e23c120b0a73 2025-11-05 Warnings Exact identifier application number: M020 Revitalize Solar Protection Fluid Broad Spectrum SPF 50 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Distribuidora Comercial Jafra, S.A. de C.V. 29b3ee35-e849-4427-a455-37d92c4b995c 2025-11-05 Warnings Exact identifier application number: M020 Sarah Creal Brilliant Repair Shield ZINC OXIDE Sarah Creal LLC 258ab6f2-f1a7-2d0d-e063-6294a90af34a 2025-11-05 Warnings Exact identifier application number: M020 Perricone MD Cold Plasma Plus Neck and Chest Broad Spectrum SPF 25 TITANIUM DIOXIDE THG Beauty USA LLC 23a55301-2277-6e4f-e063-6394a90af171 2025-11-05 Warnings Exact identifier application number: M020 Sun Bum Face and Body Stick 40 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Sun Bum, LLC 20d9d60d-e0ce-a177-e063-6394a90a162e 2025-11-05 Warnings Exact identifier application number: M020 Obagi Nu-Derm Fx System Normal-Dry Skin Transformation Complexion Brightening System TITANIUM DIOXIDE, ZINC OXIDE Obagi Cosmeceuticals LLC 4cbf1dc6-78b3-4e51-a53f-2018ac88136a 2025-11-04 Warnings Exact identifier application number: M020 SUNBEAT PROCARE FPS 50 KIDS HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE, ENSULIZOLE Tecnoglobal, PH7 S.A. DE C.V. 42c74ddf-70a3-f2b1-e063-6294a90a91a9 2025-11-04 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