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 269 of 346 · 6,912 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Banana Boat ZINC OXIDE Edgewell Personal Care Brands LLC 1ce728be-966e-b662-e063-6394a90a0ba8 2024-10-30 Warnings Exact identifier application number: M020 RECIPE Infinite UV Shield Sunscreen Broad Spectrum SPF100 AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE COSMAX USA, INC. 2596a17e-4042-3544-e063-6294a90aa4c9 2024-10-29 Warnings Exact identifier application number: M020 Sunblocz ZINC OXIDE Olen Skin Care Corporation 36fec1f1-5e8b-5764-e054-00144ff8d46c 2024-10-29 Warnings Exact identifier application number: M020 Sunblocz Baby and Kids ZINC OXIDE Olen Skin Care Corporation 35cbb9d5-639c-207a-e054-00144ff88e88 2024-10-29 Warnings Exact identifier application number: M020 ZO Skin Health Daily Sheer Broad-Spectrum Sunscreen SPF 50 Water Resistant (40 Minutes) AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE ZO Skin Health, Inc. fd7d40fe-178a-e1b1-e053-6294a90a29a1 2024-10-29 Warnings Exact identifier application number: M020 ZO Skin Health Sunscreen Plus Primer Broad-Spectrum SPF 30 TITANIUM DIOXIDE AND ZINC OXIDE ZO Skin Health, Inc. 9a4f5be1-da04-48b9-897a-57f4a3d9d1ec 2024-10-29 Warnings Exact identifier application number: M020 TiZO Ultra Zinc SPF 40 (Non-Tinted) ZINC OXIDE Fallien Cosmeceuticals, LTD e4a06973-21bb-4eda-9b74-fc23bee141ab 2024-10-29 Warnings Exact identifier application number: M020 TiZO Ultra Zinc SPF 40 (Tinted) ZINC OXIDE Fallien Cosmeceuticals, LTD 36efd48b-910e-4b61-9519-a6d5c7e9a7c3 2024-10-29 Warnings Exact identifier application number: M020 ZO Skin Health Broad-Spectrum Sunscreen SPF 50 TITANIUM DIOXIDE, ZINC OXIDE ZO Skin Health, Inc. d817f80b-a998-b67e-e053-2995a90a1971 2024-10-29 Warnings Exact identifier application number: M020 SPF 15 Coconut Lip Balm ZINC OXIDE Naples Soap Company, Inc. 25a7510f-5ef3-9920-e063-6394a90a2079 2024-10-29 Warnings Exact identifier application number: M020 Defense Total High Protection SPF 50 No Color Daily Non-Greasy Face Protection HOMOSALATE, OCTOCRYLENE, AVOBENZONE Bel Star S.A. (Colombia) a7d69691-cecc-798e-e053-2a95a90a995f 2024-10-28 Warnings Exact identifier application number: M020 LBEL FOREVER ULTRA MATTE BASE CONTROL BRILLO DE LARGA DURACION FPS 15 SHINE CONTROL LONGWEAR FOUNDATION SPF 15 LATTE 180-F OCTINOXATE, ZINC OXIDE Bel Star S.A. eea17271-e8c8-ab21-e053-2995a90a2fcc 2024-10-28 Warnings Exact identifier application number: M020 LBEL SPECIALISTE DARK SPOT BRIGHTENING MOISTURIZING SPF 30 AVOBENZONE, OCTISALATE, OCTOCRYLENE BEL STAR SA fd90ffc6-a1e1-e02e-e053-6294a90a4e7c 2024-10-28 Warnings Exact identifier application number: M020 LBEL SOLUTIONS PRO-HIALURON BASE SERUM CON EFECTO RELLENO DE ARRUGAS FPS 15 WRINKLE FILLER EFFECT SERUM FOUNDATION SPF 15 CHAMPAGNE 170-N OCTINOXATE, ZINC OXIDE BEL STAR S.A. 0b782198-58e7-5343-e063-6294a90a3713 2024-10-28 Warnings Exact identifier application number: M020 FHF Elevated Shade 100% Mineral Sunscreen SUNSCREEN Owen Biosciences Inc dabd3b95-01d3-014c-e053-2a95a90a0fec 2024-10-28 Warnings Exact identifier application number: M020 RECIPE Infinite UV Shield Sunscreen Broad Spectrum SPF100 AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE BAY BELLE LABS 259653e7-dfe0-44a2-e063-6294a90a416d 2024-10-28 Warnings Exact identifier application number: M020 Banana Boat AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Edgewell Personal Care Brands LLC 8a21acbe-2f3d-cf78-e053-2a95a90a77f6 2024-10-27 Warnings Exact identifier application number: M020 Banana Boat AVOBENZONE, HOMOSALATE, OCTOCRYLENE Edgewell Personal Care Brands LLC 7961ff9f-75db-4977-e053-2a91aa0ae628 2024-10-27 Warnings Exact identifier application number: M020 Banana Boat Light as air face SUNSCREEN UVA UVB Broad Spectrum SPF 50 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Edgewell Personal Care Brands LLC 8a1c9a3c-394e-9122-e053-2995a90acb23 2024-10-27 Warnings Exact identifier application number: M020 Banana Boat AVOBENZONE, HOMOSALATE, OCTOCRYLENE Edgewell Personal Care Brands LLC 8b889b75-07ac-4276-e053-2a95a90a69c6 2024-10-27 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