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 239 of 353 · 7,041 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Stay AgelessTinted Mineral Sunscreen Broad Spectrum SPF 30 TITANIUM DIOXIDE AND ZINC OXIDE PURA VIDA BODY & MIND SPA, INC. 04b38e97-c4b3-df23-e063-6394a90ae6b7 2025-01-08 Warnings Exact identifier application number: M020 EVEN DEFENSE Mineral Sunscreen Broad Spectrum SPF 30 TITANIUM DIOXIDE AND ZINC OXIDE Premier Plastic Surgery bc9221fe-89b4-4ad8-e053-2995a90aa041 2025-01-08 Warnings Exact identifier application number: M020 Stay Ageless Tinted Mineral Sunscreen Broad Spectrum SPF 30 TITANIUM DIOXIDE AND ZINC OXIDE Emerald Aesthetics LLC f80f439d-f4f0-fbf3-e053-6294a90ae0ef 2025-01-08 Warnings Exact identifier application number: M020 Stay Ageless Tinted Mineral Sunscreen Broad Spectrum SPF 30 TITANIUM DIOXIDE AND ZINC OXIDE Suzanne's Skin2soul LLC fea667a1-6bec-9819-e053-6394a90a9b96 2025-01-08 Warnings Exact identifier application number: M020 Stay Ageless Tinted Mineral Sunscreen Broad Spectrum SPF 30 TITANIUM DIOXIDE AND ZINC OXIDE BEAUTY SENSE MEDSPA INC fe93a337-8d2f-35d3-e053-6294a90acb3c 2025-01-08 Warnings Exact identifier application number: M020 Sunscreen Emulsion SPF50plus OCTOCRYLENE,ETHYLHEXYL METHOXYCIRNNAMATE,TITANIUM DIOXIDE,ETHYLHEXYL SALICYLATE Guangzhou Senmai Biotechnology Co. 1d560670-026b-bd34-e063-6394a90a9af4 2025-01-08 Warnings Exact identifier application number: M020 Allies of Skin Sunless Tan SPF 50 Daily Self Tanner AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE ALLIES GROUP PTE. LTD. 4d58de8e-875b-4b77-b0ef-b9d760aaced8 2025-01-07 Warnings Exact identifier application number: M020 Pop Zinc Sunscreen ZINC OXIDE Guangzhou Haishi Biological Technology Co., Ltd 2b29ddb2-5730-8a67-e063-6394a90ae416 2025-01-07 Warnings Exact identifier application number: M020 COOLA Anti-Aging Sun Silk Drops Sunscreen SPF 30 AVOBENZONE, OCTISALATE, OCTOCRYLENE SUNSCREEN SERUM COOLA LLC bbb29d0c-ae1f-409e-8fd6-ff3ea34dc9c2 2025-01-07 Warnings Exact identifier application number: M020 Advanced Day Ultimate Protect Sunscreen SPF 50 BUTYL METHOXYDIBENZOYLMETHANE, ETHYLHEXYL SALICYLATE Medik8 Limited 29071920-ba90-871a-e063-6294a90aee27 2025-01-06 Warnings Exact identifier application number: M020 Dimples Bath Co - Sunstick New Kid On The Block ZINC OXIDE Dimples Bath Co. LLC 26f682f4-2440-f111-e063-6294a90ab4b7 2025-01-06 Warnings Exact identifier application number: M020 Diaper Rash Cream Happy Cheeks DIAPER RASH HAPPY CHEEKS Dimples Bath Co. LLC 26cef2eb-a133-11ec-e063-6394a90a0f08 2025-01-06 Warnings Exact identifier application number: M020 New Kid on the Block ZINC OXIDE Dimples Bath Co. LLC 26fec959-c234-6692-e063-6394a90a6600 2025-01-06 Warnings Exact identifier application number: M020 New Kid on the Block ZINC OXIDE Dimples Bath Co. LLC 26f85758-820f-3f73-e063-6294a90a289d 2025-01-06 Warnings Exact identifier application number: M020 Bondi Sands SPF 60 Sunny Spritz Face Mist HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE BONDI SANDS (USA) INC. 2b0f0b56-233f-4c6a-e063-6394a90aea6f 2025-01-06 Warnings Exact identifier application number: M020 Bondi Sands SPF 60 Sunny Spritz Body Mist HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE BONDI SANDS (USA) INC. 2b0fe721-b92a-4181-e063-6394a90a846a 2025-01-06 Warnings Exact identifier application number: M020 sunbetter Broad Spectrum SPF 56 Sunscreen Stick Sheer ZINC OXIDE, TITANIUM DIOXIDE SKINBETTER SCIENCE LLC 92c4e4cb-aadc-26f4-e053-2995a90a03d5 2025-01-06 Warnings Exact identifier application number: M020 sunbetter Broad Spectrum SPF 56 Sunscreen Compact Sheer ZINC OXIDE, TITANIUM DIOXIDE SKINBETTER SCIENCE LLC b8a4986d-c28f-c4f4-e053-2a95a90a7167 2025-01-06 Warnings Exact identifier application number: M020 sunbetter Broad Spectrum SPF 68 Sunscreen Compact Tone Smart ZINC OXIDE, TITANIUM DIOXIDE SKINBETTER SCIENCE LLC 8f119447-045b-43f3-e053-2995a90aea77 2025-01-06 Warnings Exact identifier application number: M020 sunbetter Broad Spectrum SPF 75 Sunscreen Tone Smart ZINC OXIDE, TITANIUM DIOXIDE SKINBETTER SCIENCE LLC b878ee3b-6897-3c4a-e053-2995a90afed7 2025-01-06 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