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 204 of 353 · 7,049 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Counter Beauty Dew Skin Tinted Moisturizer No. 4 ZINC OXIDE G2G Ventures, PBC 3a35f23b-3732-db3c-e063-6294a90ae00c 2025-07-18 Warnings Exact identifier application number: M020 Counter Beauty Dew Skin Tinted Moisturizer No. 5 ZINC OXIDE G2G Ventures, PBC 3a35fd79-f4d3-5ccf-e063-6294a90a9798 2025-07-18 Warnings Exact identifier application number: M020 Counter Beauty Dew Skin Tinted Moisturizer No. 6 ZINC OXIDE G2G Ventures, PBC 3a360053-5863-95fe-e063-6394a90a45c5 2025-07-18 Warnings Exact identifier application number: M020 Counter Beauty Dew Skin Tinted Moisturizer No. 8 ZINC OXIDE G2G Ventures, PBC 3a362e05-3a1e-8059-e063-6294a90ad525 2025-07-18 Warnings Exact identifier application number: M020 Counter Beauty Dew Skin Tinted Moisturizer No. 7 ZINC OXIDE G2G Ventures, PBC 3a3621c2-709a-82fd-e063-6294a90a7a7e 2025-07-18 Warnings Exact identifier application number: M020 Basin Pina Colada SPF 15 Broad Spectrum Sunscreen Lip Balm AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE Retail Concepts of Minnesota, Inc 3a39ac31-85c9-5e04-e063-6394a90aa537 2025-07-18 Warnings Exact identifier application number: M020 Basin American Pink Lemonade SPF 15 Broad Spectrum Sunscreen Lip Balm AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE Retail Concepts of Minnesota, Inc. 3a3afeda-f235-eac2-e063-6294a90a5a93 2025-07-18 Warnings Exact identifier application number: M020 Basin Chinese Mandarin SPF 15 Broad Spectrum Sunscreen Lip Balm AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE Retail Concepts of Minnesota, Inc. 3a3b5f56-aa36-01c7-e063-6294a90a6d62 2025-07-18 Warnings Exact identifier application number: M020 Counter Beauty Daily Sheer Defense SPF 25 ZINC OXIDE G2G Ventures, PBC 3a22d88b-cdb5-5656-e063-6294a90a5b77 2025-07-17 Warnings Exact identifier application number: M020 Counter Beauty Dew Skin Tinted Moisturizer No. 1 ZINC OXIDE G2G Ventures, PBC 3a2676ed-087d-f957-e063-6294a90ad457 2025-07-17 Warnings Exact identifier application number: M020 Sjolie Tanning SPF 30 Sunscreen ZINC OXIDE SJOLIE, INC. 3a283a09-2edb-f92c-e063-6294a90a82bd 2025-07-17 Warnings Exact identifier application number: M020 Neutrogena Clear Body Breakout Free Oil Free Sunscreen Broad Spectrum SPF 30 AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE Kenvue Brands LLC 32889c1e-d539-4b36-b012-9789c4a8d642 2025-07-16 Warnings Exact identifier application number: M020 GZE Tinted Sunscreen ZINC OXIDE 3% Guangzhou Yilong Cosmetics Co.,Ltd. 182612d8-76a4-44a1-e063-6394a90a8d5f 2025-07-15 Warnings Exact identifier application number: M020 Neutrogena Ultra Sheer Face Serum Sunscreen Broad Spectrum SPF 60 AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE Kenvue Brands LLC 089b798b-829f-aa86-e063-6294a90a8631 2025-07-15 Warnings Exact identifier application number: M020 MO HANDSOME Protection Sport Sunscreen SPF 30 AVOBENZONE, OCTISALATE, OCTOCRYLENE 8 PINE DESIGN LLC 982ada30-5f87-42c6-b9ea-fedd842aa09d 2025-07-15 Warnings Exact identifier application number: M020 Amarte ULTRA VEIL Daily SUNSCREEN Amarte USA LLC 39e9ca98-d0e8-6b8f-e063-6394a90aa366 2025-07-15 Warnings Exact identifier application number: M020 Amarte ULTRA VEIL BB Fair SUNSCREEN Amarte USA LLC 39e87950-4103-c2eb-e063-6394a90a0552 2025-07-15 Warnings Exact identifier application number: M020 LEBELAGE UV SUN ULTRA SHIELD SUNSTICK AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTYL SALICYLATE DONGDONGGURIMOO CO.,LTD. 39eea41c-8703-cf1f-e063-6394a90a5b1f 2025-07-14 Warnings Exact identifier application number: M020 Basin Vanilla SPF 30 Lip Balm SPF 30 AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE Retail Concepts of Minnesota, Inc. 4a8e7be0-97a6-ada5-e063-6294a90ae25a 2025-07-14 Warnings Exact identifier application number: M020 Kiehls Dermatologist Solutions Better Screen UV Serum Broad Spectrum SPF 50 Plus Sunscreen AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE L'Oreal USA Products Inc 48980ef3-ebda-450e-9f15-effad27dec9a 2025-07-11 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