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 331 of 346 · 6,912 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join LA MER THE RADIANT SKINTINT BROAD SPECTRUM SPF 30 OCTINOXATE, OCTISALATE, AND TITANIUM DIOXIDE MAX HUBER RESEARCH LAB INC ecc942c7-5495-43b1-9ffa-d38be7891152 2023-10-30 Warnings Exact identifier application number: M020 Babo Botanicals Sheer Zinc Mineral Sunscreen SPF30 ZINC OXIDE Babo Botanicals, Inc. 08f0f32e-4b19-7a62-e063-6394a90af1b1 2023-10-30 Warnings Exact identifier application number: M020 BANANA BOAT PROTECTION PLUS VITAMINS SUNSCREEN UVA/UVB BROAD SPECTRUM SPF 50 AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE Edgewell Personal Care Brands LLC e5e5777c-2f67-14ed-e053-2a95a90a58a5 2023-10-30 Warnings Exact identifier application number: M020 CoreTex Sun X SPF 30 New AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE CoreTex Products Inc 08fb4748-d22d-35af-e063-6394a90a0827 2023-10-30 Warnings Exact identifier application number: M020 LIVE TINTED Hueguard 3-in-1 Mineral Sunscreen Moisturizer Primer Broad Spectrum SPF 30 ZINC OXIDE Live Tinted, Inc. d177b085-2bbd-49c1-b02b-a7b8d8ee0468 2023-10-28 Warnings Exact identifier application number: M020 Live Tinted Hueguard 3-in1 Mineral Sunscreen Moisturizer Primer Broad Spectrum SPF 30 ZINC OXIDE Live Tinted, Inc. cfceaf45-bab5-6858-e053-2a95a90a6be1 2023-10-28 Warnings Exact identifier application number: M020 LIVE TINTED Hueguard Invisible Sunscreen Stick Broad Spectrum SPF 50 Water Resistant 80 Mins HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE Live Tinted, Inc. 8e4d7c84-5acb-4857-860d-bf6837e4901e 2023-10-28 Warnings Exact identifier application number: M020 LIVE TINTED Hueguard 3-in-1 Mineral Sunscreen Moisturizer Primer Broad Spectrum SPF 30 ZINC OXIDE Live Tinted, Inc. 7bceeb0e-b557-438c-88ac-0148f6eb1b4d 2023-10-28 Warnings Exact identifier application number: M020 Green Defense daily mineral sunscreen Broad Spectrum SPF 30 ZINC OXIDE Farmacy Beauty LLC d1ae2696-fd1b-4422-a8e0-5209aeeb97eb 2023-10-28 Warnings Exact identifier application number: M020 LIVE TINTED Glow-up Hyperpigmentation Essentials ZINC OXIDE Live Tinted, Inc. ef06c1eb-6ce3-4b1b-8a7d-3e29ae172844 2023-10-28 Warnings Exact identifier application number: M020 SPF Elio Drops 30 Sheer ZINC OXIDE Allure Labs Inc 08c9fc56-7d4f-ebc5-e063-6294a90a5317 2023-10-28 Warnings Exact identifier application number: M020 SPF Elio Drops 30 Glow ZINC OXIDE Allure Labs Inc 08cbf8d6-8c27-1567-e063-6394a90a932e 2023-10-28 Warnings Exact identifier application number: M020 RESILIENCE MULTI-EFFECT TRI-PEPTIDE FACE AND NECK CREME BROAD SPECTRUM SPF 15 dry skin AVOBENZONE, OCTISALATE, AND OCTOCRYLENE ESTEE LAUDER INC d1ca8372-28a0-41e1-b92a-913fc09f7156 2023-10-27 Warnings Exact identifier application number: M020 Vivier Sheer SPF 30 Mineral TITANIUM DIOXIDE, ZINC OXIDE Vivier Pharma, Inc. 1be5ee36-3566-495c-aae2-4d0d7fc210ed 2023-10-27 Warnings Exact identifier application number: M020 Vivier Sheer SPF 45 ZINC OXIDE, OCTOCRYLENE, OCTINOXATE, OCTISALATE Vivier Pharma, Inc. c057138a-1111-4e7c-b94d-2ccd6bc3963c 2023-10-27 Warnings Exact identifier application number: M020 360 by QUR Spanish lime lip balm OCTINOXATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE Qur, Inc bedb3347-7498-3d7a-e053-2995a90a4b12 2023-10-26 Warnings Exact identifier application number: M020 360 by QUR Vanilla lace lip balm OCTINOXATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE Qur, Inc bedb4c53-adaa-3a8a-e053-2a95a90ae93a 2023-10-26 Warnings Exact identifier application number: M020 360 by QUR Watercress mint lip balm OCTINOXATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE Qur, Inc bedb7413-c074-a2d7-e053-2a95a90ac5cb 2023-10-26 Warnings Exact identifier application number: M020 PRIDEFUL SPF 15 LIP BALM-cherry vanilla HOMOSALATE, OCTISALATE, OCTOCRYLENE, AVOBENZONE PRIDEFUL LLC c827c6b4-c6d7-4585-b615-419db9520e7c 2023-10-26 Warnings Exact identifier application number: M020 PRIDEFUL SPF 15 LIP BALM-citrus HOMOSALATE, OCTISALATE, OCTOCRYLENE, AVOBENZONE PRIDEFUL LLC 2f20ee7e-3897-4263-b965-5155d89bfb5e 2023-10-26 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