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 318 of 346 · 6,912 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join CCC Clean Corrective with Vitamin C Tinted Moisturizer Broad Spectrum SPF 30 ZINC OXIDE The Honest Company, Inc. c172d584-7cb6-a078-e053-2995a90ac78f 2023-12-05 Warnings Exact identifier application number: M020 EltaMD UV Sheer ZINC OXIDE AND OCTOCRYLENE SUNSCREEN CP Skin Health Group, Inc. 2564e811-70f5-4d00-be8e-686b55e31630 2023-12-05 Warnings Exact identifier application number: M020 CCC Clean Corrective with Vitamin C Tinted Moisturizer Broad Spectrum SPF 30 ZINC OXIDE, TITANIUM DIOXIDE The Honest Company, Inc. c1720cff-a897-68cb-e053-2995a90a30b6 2023-12-05 Warnings Exact identifier application number: M020 CCC Clean Corrective with Vitamin C Tinted Moisturizer Broad Spectrum SPF 30 ZINC OXIDE, TITANIUM DIOXIDE The Honest Company, Inc. c12272c3-d4ed-2212-e053-2995a90add37 2023-12-05 Warnings Exact identifier application number: M020 CCC Clean Corrective with Vitamin C Tinted Moisturizer Broad Spectrum SPF 30 ZINC OXIDE, TITANIUM DIOXIDE The Honest Company, Inc. c12272c3-d4f0-2212-e053-2995a90add37 2023-12-05 Warnings Exact identifier application number: M020 CCC Clean Corrective with Vitamin C Tinted Moisturizer Broad Spectrum SPF 30 ZINC OXIDE, TITANIUM DIOXIDE The Honest Company, Inc. c1228ca6-8fb4-5964-e053-2a95a90a30ca 2023-12-05 Warnings Exact identifier application number: M020 CCC Clean Corrective with Vitamin C Tinted Moisturizer Broad Spectrum SPF 30 ZINC OXIDE, TITANIUM DIOXIDE The Honest Company, Inc. c12292a8-c98f-eb27-e053-2a95a90a9bbc 2023-12-05 Warnings Exact identifier application number: M020 CCC Clean Corrective with Vitamin C Tinted Moisturizer Broad Spectrum SPF 30 ZINC OXIDE The Honest Company, Inc. c172d22a-0315-8e84-e053-2995a90a30b5 2023-12-05 Warnings Exact identifier application number: M020 CCC Clean Corrective with Vitamin C Tinted Moisturizer Broad Spectrum SPF 30 ZINC OXIDE The Honest Company, Inc. c172cabe-faab-6458-e053-2995a90aef66 2023-12-05 Warnings Exact identifier application number: M020 Sea Clearly Translucent Gel Sunscreen BS SPF 50 HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE Allure Labs 0bb4ec66-64ba-9583-e063-6394a90ac512 2023-12-04 Warnings Exact identifier application number: M020 Clearly Zinq Mineral Gel Sunscreen BS SPF 60 ZINC OXIDE Allure Labs 0bb7f0a4-13df-7734-e063-6294a90a242b 2023-12-04 Warnings Exact identifier application number: M020 RECHARGE Regimen for Balancing, Boosting and Defending Healthy-Looking skin TITANIUM DIOXIDE, ZINC OXIDE Rodan & Fields b7401ff8-ca47-4c74-813c-99c5f28c0b6d 2023-12-04 Warnings Exact identifier application number: M020 Eminence Bright Skin Moisturizer SPF 40 Sunscreen ZINC OXIDE Eminence Organic Skin Care 4f2ba93d-ec19-40c1-b4ca-53898841f55b 2023-12-02 Warnings Exact identifier application number: M020 Lilikoi Mineral Defense Sport Sunscreen SPF 30 ZINC OXIDE Eminence Organic Skin Care Ltd. 5375522a-17e3-48a1-8248-dd811c3823bf 2023-12-02 Warnings Exact identifier application number: M020 Eminence Lilikoi Daily Defense Moisturizer SPF 40 Sunscreen ZINC OXIDE Eminence Organic Skin Care edc9972a-affd-4099-aec1-3549a07fa83c 2023-12-02 Warnings Exact identifier application number: M020 Perbelle CC SPF43 UVA UVB Broad Spectrum TITANIUM DIOXIDE Perbelle Cosmetics Global Ltd. b5e2724e-9806-5bcc-e053-2a95a90a0508 2023-12-01 Warnings Exact identifier application number: M020 A PERFECT WORLD SPF 40 AGE DEFENSE BROAD SPECTRUM MOISTURIZER WITH WHITE TEA AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, AND OCTOCRYLENE ORIGINS NATURAL RESOURCES INC. abd8b302-a01c-478d-919a-22e686cb88da 2023-12-01 Warnings Exact identifier application number: M020 SHADE and ILLUMINATE SOFT RAD PRMR SPF OCTINOXATE,OCTISALATE,ZINC OXIDE TOM FORD BEAUTY DIST eac7d416-c243-4647-e053-2a95a90abcb7 2023-12-01 Warnings Exact identifier application number: M020 CCC Clean Corrective with Vitamin C Tinted Moisturizer Broad Spectrum SPF 30 ZINC OXIDE, TITANIUM DIOXIDE The Honest Company, Inc. c1228d15-a157-6989-e053-2995a90a44ea 2023-12-01 Warnings Exact identifier application number: M020 CAO Cosmetic Lip Sunscreen SPF 30 AVOBENZONE, OCTOCRYLENE S & J INTERNATIONAL ENTERPRISES PUBLIC COMPANY LIMITED d912b9e9-f351-e2b0-e053-2a95a90a9ca2 2023-11-30 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