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 312 of 346 · 6,912 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join SPF 30 Sunscreen AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE Tekweld Solutions, Inc. ea9f4d57-b00c-48ce-b833-9690be98bffd 2023-12-26 Warnings Exact identifier application number: M020 Best Skin Days BS SPF 30 ZINC OXIDE Allure Labs 0d7072f8-e808-5270-e063-6294a90a1ffa 2023-12-26 Warnings Exact identifier application number: M020 Lancome Paris Bienfait MultiVital Broad Spectrum SPF 30 Sunscreen AVOBENZONE, OCTISALATE AND OCTOCRYLENE L'Oreal USA Products Inc f0d6518b-d795-4740-a301-1804a932ec45 2023-12-23 Warnings Exact identifier application number: M020 Lancome Paris Skin Feels Good Broad Spectrum SPF 23 Sunscreen Hydrating Skin Tint Healthy Glow OCTINOXATE L'Oreal USA Products Inc 4f4a8c37-af08-4bf7-89bc-1e487417c146 2023-12-23 Warnings Exact identifier application number: M020 Lancome Paris Skin Feels Good Broad Spectrum SPF 23 Sunscreen Hydrating Skin Tint Healthy Glow OCTINOXATE SICOS ET CIE 7051f505-f874-4214-ad4f-55a956cc35a7 2023-12-23 Warnings Exact identifier application number: M020 Lancome Paris Absolue Premium Bx Replenishing and Rejuvenating Day AVOBENZONE, OCTISALATE AND OCTOCRYLENE L'Oreal USA Products Inc 08645f1d-7ba7-4410-8600-3d3f79d71385 2023-12-23 Warnings Exact identifier application number: M020 Lancome Paris Renergie Lift MultiAction Sunscreen Broad Spectrum SPF 15 Lift and Firming Face and Neck All Skin Types AVOBENZONE, OCTISALATE AND OCTOCRYLENE L'Oreal USA Products Inc fc847725-b7a9-41f1-a605-d1d892fed06f 2023-12-23 Warnings Exact identifier application number: M020 Lancome Paris Renergie Lift MultiAction Sunscreen Broad Spectrum SPF 15 Lift Firming Face Neck For All Skin Types AVOBENZONE, OCTISALATE AND OCTOCRYLENE SICOS ET CIE df67b49c-f8b6-4c0a-9e8d-c94dee3635ff 2023-12-23 Warnings Exact identifier application number: M020 Lancome Paris Absolue Premium Bx Replenishing Rejuvenating Broad Spectrum SPF 15 Day AVOBENZONE, OCTISALATE AND OCTOCRYLENE SICOS ET CIE a9b7e52c-8799-49ba-8b05-7559fe6668fe 2023-12-23 Warnings Exact identifier application number: M020 sugar rush skin treat poreless tinted moisturizer Broad Spectrum SPF 20 Sunscreen fair TITANIUM DIOXIDE AND ZINC OXIDE Tarte, Inc. 32569352-c51e-4f05-a8b0-749ef916a5af 2023-12-22 Warnings Exact identifier application number: M020 Circadia Circa-Shield Mineral Sunscreen SPF 30 ZINC OXIDE Circadia by Dr Pugliese, Inc. 2959aa56-be7f-4721-9701-e6d6e12cc850 2023-12-22 Warnings Exact identifier application number: M020 Amazonian Clay BB Tinted Moisturizer Broad Spectrum SPF 20 Sunscreen Ivory TITANIUM DIOXIDE AND ZINC OXIDE Tarte, Inc 0adb52f5-4e1f-4570-9b6f-584e4da61d9f 2023-12-22 Warnings Exact identifier application number: M020 ESTEE LAUDER DOUBLE WEAR SOFT GLOW MATTE CUSHION MAKEUP BROAD SPECTRUM SPF 36 OCTINOXATE, TITANIUM DIOXIDE AND ZINC OXIDE ESTEE LAUDER INC c670635a-63d8-4b0b-afd7-b26e969f93a1 2023-12-21 Warnings Exact identifier application number: M020 double duty beauty shape tape cloud coverage Broad Spectrum SPF 15 Sunscreen 16N fair-light neutral TITANIUM DIOXIDE Tarte, Inc. 62fffef6-29ae-4137-b0b9-fb93d6167933 2023-12-21 Warnings Exact identifier application number: M020 double duty beauty shape tape cloud coverage Broad Spectrum SPF 15 Sunscreen 12N fair neutral TITANIUM DIOXIDE Tarte, Inc. 889860fc-7fce-47e9-af28-a3b2aec04a0e 2023-12-21 Warnings Exact identifier application number: M020 JLo Beauty That Big Screen Broad Spectrum SPF 30 Moisturizer HOMOSALATE, OCTISALATE, AND ZINC OXIDE Ascendant Beauty LLC cba4e886-c4c6-4377-8f4c-250aef4b95fb 2023-12-21 Warnings Exact identifier application number: M020 COOLA Full Spectrum 360 Refreshing Water Cream SPF 50 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE COOLA LLC d12e30bd-88ee-4e34-ae63-c34766aed3a8 2023-12-20 Warnings Exact identifier application number: M020 COOLA Liplux Hydrating Oil SPF 30 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE COOLA LLC 2d2ad94c-ea13-43c0-ab7f-acecf4d2309f 2023-12-20 Warnings Exact identifier application number: M020 Coola Bare Republic Mineral Face-Lotion SPF 70 TITANIUM DIOXIDE 3.5% ZINC OXIDE 15.8% COOLA LLC a334a61d-5c5a-4f45-b202-6dd7bb3d250b 2023-12-20 Warnings Exact identifier application number: M020 Bare Republic Big Adventure Stick SPF 70 TITANIUM DIOXIDE 3.5% ZINC OXIDE 16.9% COOLA e800f72f-8c8b-4a12-843f-1ee404055cf0 2023-12-20 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