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 263 of 346 · 6,912 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join MUSTELA MINERAL SUNSCREEN BROAD SPECTRUM SPF 50 ZINC OXIDE, TITANIUM DIOXIDE Expanscience Laboratories d/b/a Mustela beec926c-35a5-1901-e053-2a95a90ad043 2024-12-02 Warnings Exact identifier application number: M020 MUSTELA MINERAL SUNSCREEN SPF 50 ZINC OXIDE Expanscience Laboratories d/b/a Mustela b850f68e-4f52-6902-e053-2995a90aaa91 2024-12-02 Warnings Exact identifier application number: M020 Hero Force Shield Superbeam Sunscreen SPF 30 Apricot ZINC OXIDE Church & Dwight Co., Inc. 133dc4db-6598-4400-8aa4-022f66eb28fc 2024-12-02 Warnings Exact identifier application number: M020 AHAVA MultiVitamin Day SPF30 AVOBENZONE, ENSULIZOLE, OCTISALATE, AND OCTOCRYLENE AHAVA - Dead Sea Laboratories Ltd d9b8e9ae-ed05-4e9c-8d01-8fac183053a4 2024-12-02 Warnings Exact identifier application number: M020 ATTITUDE Sunly Mineral Sunscreen Face Stick Unscented SPF 30 ZINC OXIDE 9055-7588 Quebec Inc. DBA Attitude 0d8551c6-2efe-11a8-e063-6294a90aed01 2024-12-01 Warnings Exact identifier application number: M020 ATTITUDE Oatmeal Sensitive Natural Mineral Sunscreen Face Stick Unscented SPF 30 ZINC OXIDE 9055-7588 Quebec Inc. DBA Attitude 0d958343-31e3-0b7a-e063-6294a90a424a 2024-12-01 Warnings Exact identifier application number: M020 Attitude Kids mineral sunscreen unscented SPF 30 ZINC OXIDE 9055-7588 Qubec Inc. DBA Attitude c2461e22-1518-4f9e-ad8c-951784ef8b5f 2024-12-01 Warnings Exact identifier application number: M020 BIO SPECTRA ATTITUDE ZINC OXIDE 9055-7588 Quebec Inc. DBA Attitude 954713fe-c84c-41b4-913d-3507ed91e55d 2024-12-01 Warnings Exact identifier application number: M020 CAUDALIE Daily Mineral Sunscreen Broad Spectrum SPF 50 ZINC OXIDE Caudalie USA, Inc. 150e3bf3-7b05-e611-e063-6294a90a0932 2024-11-29 Warnings Exact identifier application number: M020 CLEARING DEFENSE SPF30 OCTOCRYLENE, HOMOSALATE, OCTISALATE, AND AVOBENZONE Dermalogica, LLC. 2cb559d3-dd79-4951-ad38-190fd4dd7c40 2024-11-27 Warnings Exact identifier application number: M020 Neutrogena Collagen Bank SPF Moisturizer Sunscreen Broad Spectrum SPF 30 and Neutrogena Collagen Bank Moisturizer AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Kenvue Brands LLC 1ccde0bc-08aa-8a25-e063-6394a90a2762 2024-11-25 Warnings Exact identifier application number: M020 Girlyish Skincare Mineral Sunscreen SPF 30 ZINC OXIDE Rise Skincare LLC 137ba0be-91ce-4bd0-9713-57b169359750 2024-11-25 Warnings Exact identifier application number: M020 FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 9N OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 95d657e5-cf89-48dd-a12e-f9664b131eb9 2024-11-25 Warnings Exact identifier application number: M020 FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 3N OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 33f42840-92f8-4fa1-86e9-ec0a06d637de 2024-11-25 Warnings Exact identifier application number: M020 FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 6W OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 20785934-e534-4ea5-8c15-f9669b042153 2024-11-25 Warnings Exact identifier application number: M020 FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 7N OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior e4464601-a9ec-413b-a883-9efe61f2f5b2 2024-11-25 Warnings Exact identifier application number: M020 FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 8N OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 5e7c879c-1e5c-4614-bec1-d363978c3b0d 2024-11-25 Warnings Exact identifier application number: M020 FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 4N OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 5c1f1f09-19fb-4ceb-bb6d-22d51b5733a8 2024-11-25 Warnings Exact identifier application number: M020 FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 5W OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior c8a48759-efac-47ac-972a-c994b6774e20 2024-11-25 Warnings Exact identifier application number: M020 FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 1N OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 793c18e5-4363-45b0-a184-0b6c69a91b2c 2024-11-25 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