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 227 of 353 · 7,041 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join BANANA BOAT AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE Edgewell Personal Care Brands LLC 2ee9b3dc-91cd-1af9-e063-6394a90a78e1 2025-02-24 Warnings Exact identifier application number: M020 BANANA BOAT AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE Edgewell Personal Care Brands LLC 2edc79f8-aac5-15eb-e063-6394a90a9736 2025-02-23 Warnings Exact identifier application number: M020 CYZONE STUDIO LOOK BASE DE ALTA COBERTURA Y LARGA DURACION FPS 20 AVELLANA 270-C OCTINOXATE, ZINC OXIDE BEL STAR S A dc25651b-0e30-c325-e053-2995a90a809e 2025-02-21 Warnings Exact identifier application number: M020 CYZONE STUDIO LOOK BASE DE ALTA COBERTURA Y LARGA DURACION FPS 20 AZUCAR BLANCA 110-C OCTINOXATE, ZINC OXIDE BEL STAR S A dc129cd6-a173-d2b3-e053-2a95a90aa04e 2025-02-21 Warnings Exact identifier application number: M020 COOLA Classic Liplux Lip Balm SPF 30 Tinted AVOBENZONE, OCTISALATE, OCTOCRYLENE COOLA, LLC eec6e7c8-17fe-f34b-e053-2995a90a78a0 2025-02-20 Warnings Exact identifier application number: M020 Drops AVOBENZONE OCTISALATE OCTOCRYLENE Vacation Inc. 1319d6ea-a580-79c5-e063-6394a90a4dca 2025-02-20 Warnings Exact identifier application number: M020 Vacation SPF 50 Super Spritz Face Mist AVOBENZONE, OCTISALATE, OCTOCRYLENE Vacation Inc. f67fbe98-93ce-2882-e053-2a95a90ab713 2025-02-20 Warnings Exact identifier application number: M020 REPAIRWEAR UPLIFTING FIRMING BROAD SPECTUM SPF 15 - NORMAL COMBO TO COMBINATION oily OCTINOXATE, OCTISALATE, AND TITANIUM DIOXIDE CLINIQUE LABORATORIES LLC 10edc0c1-9359-4c7a-a56e-bad06fea0056 2025-02-20 Warnings Exact identifier application number: M020 Mineral SPF 30 Brush-On Sun Defense ZINC OXIDE Mineral Fusion 29733dba-8824-461e-be44-335d6fe50d60 2025-02-19 Warnings Exact identifier application number: M020 Neutrogena Healthy Skin Invisibly Radiant UV Primer SPF 30 TITANIUM DIOXIDE, ZINC OXIDE Kenvue Brands LLC 20cd4d96-2046-3a50-e063-6394a90a1219 2025-02-18 Warnings Exact identifier application number: M020 COOLA Classic Body SPF 30 Pina Colada AVOBENZONE, OCTISALATE, OCTOCRYLENE COOLA, LLC edc59de7-c817-1a59-e053-2995a90a3408 2025-02-17 Warnings Exact identifier application number: M020 Liplux SPF 30 Lip Balm CLASSIC COOLA LLC b47b5f3a-43f3-ae7a-e053-2995a90ae16d 2025-02-17 Warnings Exact identifier application number: M020 COOLA Classic Body SPF 50 Fragrance Free AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE COOLA, LLC ed207afe-0b10-74c7-e053-2a95a90a9b87 2025-02-17 Warnings Exact identifier application number: M020 Avon Skin-So-Soft Bug Guard plus SPF 30 Sunscreen Gentle Breeze Insect Repellent Sunscreen OCTINOXATE, OXYBENZONE, OCTISALATE The Avon Company 2e5d6c93-f091-5388-e063-6394a90ad560 2025-02-17 Warnings Exact identifier application number: M020 KEYS SOULCARE DAILY MOISTURIZER BROAD SPECTRUM SPF30 SUNSCREEN AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE e.l.f. Cosmetics, Inc 31a98dc7-4b99-d845-e063-6394a90a2670 2025-02-17 Warnings Exact identifier application number: M020 Ultra sheer mineral sunscreen PRO SPF30 ZINC OXIDE Eden Brands Inc. 2ce06566-2eb0-9a00-e063-6394a90a9ba9 2025-02-14 Warnings Exact identifier application number: M020 Cell Fusion C Laser UV Defense Sunscreen Broad Spectrum SPF 50 HOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDE CMS LAB Inc. 2dff0386-e151-089a-e063-6394a90a0f53 2025-02-14 Warnings Exact identifier application number: M020 Cell Fusion C Airy Stick Sunscreen Broad Spectrum SPF 50 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE CMS LAB Inc. 2dffc699-3b56-2c70-e063-6294a90ae249 2025-02-14 Warnings Exact identifier application number: M020 Sun Defense Minerals (Sheer) ZINC OXIDE, TITANIUM DIOXIDE Eminence Organic Skin Care 2e2082aa-5ae3-2c04-e063-6294a90a140b 2025-02-14 Warnings Exact identifier application number: M020 Coola SPF 30 Mineral Sunscreen Fragrance Free ZINC OXIDE COOLA, LLC edc6048e-0ea0-41c5-e053-2a95a90a96d9 2025-02-14 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