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_7af0f836-c146-4bbf-b8e6-40e25f9a9723
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 51 of 357 · 7,139 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Mentholatum Natural Ice Original DIMETHICONE, OCTINOXATE, OCTISALATE The Mentholatum Company 29220eaa-87cb-4ebe-87db-d36288b3a9e4 2026-03-24 Warnings Exact identifier application number: M020 Sport Sunscreen SPF 50 AVOBENZONE, HOMOSALATE, OCTISALATE Amazon.com Services LLC f54c617f-794e-413b-b898-4a06622b4bee 2026-03-24 Warnings, Adverse reactions Exact identifier application number: M020 VITAL PERFECTION UPLIFTING AND FIRMING ADVANCED DAY AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTOCRYLENE Shiseido Americas Corporation 7b2d15c1-b9e1-4347-b138-9883f78822b3 2026-03-24 Warnings Exact identifier application number: M020 Sunscreen SPF 50 SUNSCREEN SPF 50 Guangzhou Ariel Biotech Co., Ltd. 4dd05620-30a3-9cea-e063-6294a90af18b 2026-03-24 Warnings Exact identifier application number: M020 Sunscreen SPF 50 SUNSCREEN SPF 50 Guangzhou Ariel Biotech Co., Ltd. 4dd1b722-4448-9675-e063-6294a90a5f4f 2026-03-24 Warnings Exact identifier application number: M020 Sky and Sol Face and Body Sunscreen SPF30 NON- NANO ZINC OXIDE Delta Ecommerce LLC 2dda185c-6ff8-953d-e063-6394a90acc53 2026-03-24 Warnings Exact identifier application number: M020 WHAMISA ORGANIC PEAR BLOSSOM SUNSCREEN ZINC OXIDE ENS KOREA Co., Ltd. 34f9688d-efa1-1d3f-e063-6294a90ab127 2026-03-23 Warnings Exact identifier application number: M020 HALORINNA SUN-SCREEN TRAVEL SPF50 SUN SCREEN Guangdong Bisutang Biotechnology Co., LTD 4dade579-ce77-eea5-e063-6394a90ad46a 2026-03-23 Warnings Exact identifier application number: M020 TIRTIR SUN BOUNCY GLOW LIP BALM SPF30 - 01 HAZY MAUVE ZINC OXIDE TIRTIR USA Inc. 4c92db00-59f1-ac02-e063-6394a90a7cf1 2026-03-23 Warnings Exact identifier application number: M020 Zinc Oxide 20% SUNSCREEN SPF 50 The Soleil Group, LLC 27d20573-0b6b-4d4b-94ca-69b476a883a7 2026-03-23 Warnings Exact identifier application number: M020 Babo Botanicals Hydrating Milk Mineral Sunscreen SPF 30 ZINC OXIDE Babo Botanicals, Inc. 4db37efb-2d37-7428-e063-6394a90a10e4 2026-03-23 Warnings Exact identifier application number: M020 All Good Mineral Sport Sunscreen Butter ZINC OXIDE Elemental Herbs, Inc. ff334e9c-dd12-92bc-e053-6394a90aa24b 2026-03-23 Warnings Exact identifier application number: M020 All Good Tinted Mineral Sunscreen Butter SPF 50 ZINC OXIDE Elemental Herbs, Inc. fe2bf779-e8b3-933f-e053-6394a90a369f 2026-03-23 Warnings Exact identifier application number: M020 ULTRA SOOTHER DRY-TOUCH SUNSCREEN HOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDE skinnplus 4dbc1035-c41c-308c-e063-6394a90a36c4 2026-03-23 Warnings Exact identifier application number: M020 Daily Defense Mineral Sunscreen Serum Broad Spectrum SPF 33 ZINC OXIDE Eva's Esthetics 0dd7cba3-bc74-4ec1-bd4a-a2f3ed533fc7 2026-03-23 Warnings Exact identifier application number: M020 MELAO Rice Probiotics Sunscreen ZINC OXIDE,ETHYLHEXYL SALICYLATE,ETHYLHEXYL METHOXYCINNAMATE Guangdong Aimu Biological Technology Co., Ltd 4ccaa734-83c1-611b-e063-6294a90ab3bf 2026-03-21 Warnings Exact identifier application number: M020 Vacation Lip Trips Desserts Pineapple Upside Down Cake AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE Vacation Inc. 69022828-8226-4977-a2ca-ad8e16793a59 2026-03-20 Warnings Exact identifier application number: M020 VACATION CLASSIC BROAD SPECTRUM SPF 30 SUNSCREEN AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE Vacation Inc. c7794831-52d1-4d80-936d-44af18ae0472 2026-03-20 Warnings Exact identifier application number: M020 YOUARE SUNSHINE Broad Spectrum SPF 50 Mineral Sunscreen ZINC OXIDE CA-Botana International 4d74a36c-ff68-afd9-e063-6394a90a08f8 2026-03-20 Warnings Exact identifier application number: M020 Lancome Paris UV Expert Aquagel Defense 50 Plus Sunscreen AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE SICOS ET CIE 468d4ed2-e616-aaaf-e063-6294a90af37a 2026-03-20 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