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 321 of 346 · 6,912 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Gin Amber Beauty Mineral Sunscreen Broad Spectrum SPF 25 BB Cream ZINC OXIDE Gin Amber Beauty LLC 32f48fe4-5788-449e-9ed8-9cd8b2ecc1c0 2023-11-14 Warnings Exact identifier application number: M020 Private Label SPF 50 80 min Water Resistant HOMOSALATE, OCTISALATE, ZINC OXIDE SUNSCREEN Swiss-American CDMO, LLC 8849fa88-24c8-410d-b16e-60da38288f98 2023-11-14 Warnings Exact identifier application number: M020 Cetaphil Sheer Mineral Face Liquid Sunscreen SPF 50 ZINC OXIDE Galderma Laboratories, L.P. 0d09b812-b3ca-4214-bed7-7e21ee3288b7 2023-11-14 Warnings Exact identifier application number: M020 DAYWEAR ADVANCED MULTI-PROTECTION ANTI-OXIDANT 24H-MOISTURE CREME BROAD SPECTRUM SPF15 AVOBENZONE, HOMOSALATE, OCTISALATE ESTEE LAUDER INC 0a0bfe4a-53b6-5b7c-e063-6394a90a23ec 2023-11-13 Warnings Exact identifier application number: M020 Bull Frog SPF 50 Mosquito Coast Sunscreen Plus Inspect Repellent AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE BULLFROG BRANDS, LLC. f70b39c6-9f40-f5c1-e053-6394a90a1d43 2023-11-13 Warnings Exact identifier application number: M020 Bull Frog SPF 50 AVOBENZONE 3.00% HOMOSALATE 15.00% OCTISALATE 5.00% OCTOCRYLENE 10.00% Bullfrog Brands, LLC c90fc29e-d9fe-a6c9-e053-2995a90a69b3 2023-11-13 Warnings Exact identifier application number: M020 Tropical Sands, SPF-50 Broad Spectrum Sunscreen TITANIUM DIOXIDE, ZINC OXIDE Elements Brands, Inc. 493551d0-10a0-3d78-e054-00144ff8d46c 2023-11-11 Warnings Exact identifier application number: M020 Tropical Sands SPF-30 Broad Spectrum Sunscreen TITANIUM DIOXIDE, ZINC OXIDE Elements Brands, Inc. 494a7886-d677-1648-e054-00144ff8d46c 2023-11-11 Warnings Exact identifier application number: M020 Tropical Sands SPF-30 Broad Spectrum Sunscreen TITANIUM DIOXIDE, ZINC OXIDE Elements Brands, Inc. ab691543-e37a-487a-912e-56d2e0e4d30a 2023-11-11 Warnings Exact identifier application number: M020 LBri Pure nNatural Oil Free Moisturizer OCTINOXATE, AVOBENZONE, OCTISALATE L'Bri Health & Beauty 47f6ab9e-fa47-496a-e054-00144ff8d46c 2023-11-11 Warnings Exact identifier application number: M020 PURE HAVEN BODY SPF 30 TITANIUM DIOXIDE, ZINC OXIDE Pure haven, LLC 6f298fcd-8a97-8f66-e053-2991aa0adb10 2023-11-11 Warnings Exact identifier application number: M020 Sunstation All-Natural SPF 30 Sunscreen TITANIUM DIOXIDE, ZINC OXIDE Sunstation USA, LLC 499d366a-a7f1-6070-e054-00144ff88e88 2023-11-11 Warnings Exact identifier application number: M020 PURE HAVEN Face Sunscreen SPF-30 ZINC OXIDE Pure Haven, LLC 1fff88a0-4d23-4cd7-872e-1a0b8c680342 2023-11-11 Warnings Exact identifier application number: M020 Pure Haven Essentials TITANIUM DIOXIDE, ZINC OXIDE Pure Haven LLC 4bccc017-266d-11ce-e054-00144ff8d46c 2023-11-11 Warnings Exact identifier application number: M020 No BS SPF20 Moisturizer OCTINOXATE, AVOBENZONE, OCTOCRYLENE Product Management LLC 690f68fa-d110-4a75-9a14-04aac1be4584 2023-11-11 Warnings Exact identifier application number: M020 koa protect our ocean life OXYBENZONE FREE Broad Spectrum SPF 30 UVA UVB Protection Sunscreen TITANIUM DIOXIDE, ZINC OXIDE Kapa'ihi, Inc 66e5eb1b-4ef0-459d-8428-b3e2f221bc85 2023-11-11 Warnings Exact identifier application number: M020 Sea Star Sparkle SPF-50 PARTY CAKE OCTINOXATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDE MJ Products Association, LLC 8cfaf1b6-0f25-4770-9760-2440b2c153b7 2023-11-11 Warnings Exact identifier application number: M020 Sea Star Sparkle SPF-50 VERY BERRY OCTINOXATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDE MJ Products Association, LLC 88c403ea-7c78-423e-b05e-1e17c21c5a53 2023-11-11 Warnings Exact identifier application number: M020 FITGLOW Vita Shield Hyaluronic Primer SPF-30 ZINC OXIDE FITGLOW BEAUTY LLC b9ba7783-74ca-4736-8a60-169215859047 2023-11-11 Warnings Exact identifier application number: M020 BLUE MONARCH Tinted SPF-50 (Rose Gold) ZINC OXIDE Blue Monarch, LLC 9ba00a03-1015-4946-8c9b-5ef377a32e4b 2023-11-11 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