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 332 of 346 · 6,912 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join PRIDEFUL SPF 15 LIP BALM-passion fruit HOMOSALATE, OCTISALATE, OCTOCRYLENE, AVOBENZONE PRIDEFUL LLC d6b6389b-c8bd-4aca-8ccf-455dbc22070d 2023-10-26 Warnings Exact identifier application number: M020 PRIDEFUL SPF 15 LIP BALM-coconut HOMOSALATE, OCTISALATE, OCTOCRYLENE, AVOBENZONE PRIDEFUL LLC a6af5cdc-999d-45ba-a7a6-5e7330f8b9c0 2023-10-26 Warnings Exact identifier application number: M020 PRIDEFUL SPF 15 LIP BALM-melon HOMOSALATE, OCTISALATE, OCTOCRYLENE, AVOBENZONE PRIDEFUL LLC e201fec6-eb69-40fb-8459-02d64e34a3b7 2023-10-26 Warnings Exact identifier application number: M020 PRIDEFUL SPF 15 LIP BALM-orange mango HOMOSALATE, OCTISALATE, OCTOCRYLENE, AVOBENZONE PRIDEFUL LLC c50c9f00-6a0f-4307-b35d-7fc5fa3b7edf 2023-10-26 Warnings Exact identifier application number: M020 BANANA BOAT PROTECTION PLUS VITAMINS SUNSCREEN UVA/UVB BORAD SPECTRUM SPF 50 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Edgewell Personal Care Brands LLC e5fcb1fd-ad61-1ea5-e053-2a95a90a2472 2023-10-26 Warnings Exact identifier application number: M020 Grape Soda SPF 15 Broad Spectrum Lip Balm GRAPE SODA SPF 15 BROAD SPECTRUM LIP BALM Raining Rose, Inc a09a0b5f-93e4-d18a-e053-2a95a90a65f7 2023-10-26 Warnings Exact identifier application number: M020 Beeswax SPF 30 Broad Spectrum Lip Balm BEESWAX SPF 30 BROAD SPECTRUM LIP BALM Raining Rose, Inc a962bfca-03a3-8dde-e053-2a95a90abbb9 2023-10-26 Warnings Exact identifier application number: M020 Cream ZINC OXIDE Oxygen Development LLC 08a1e862-b55a-fb84-e063-6294a90a016a 2023-10-26 Warnings Exact identifier application number: M020 SIMPLE TRUTH MINERAL BASED SPF 50 SUNSCREEN TITANIUM DIOXIDE, ZINC OXIDE THE KROGER COMPANY a52872bf-cd0f-06da-e053-2995a90af28d 2023-10-26 Warnings Exact identifier application number: M020 Babo Botanicals Sensitive Baby Mineral Sunscreen SPF30 ZINC OXIDE Babo Botanicals, Inc. 08a36887-3997-8fff-e063-6394a90ae9d5 2023-10-26 Warnings Exact identifier application number: M020 PERFECTIONIST PRO MULTI-DEFENSE UV FLUID BROAD SPRECTRUM SPF 45 TITANIUM DIOXIDE AND ZINC OXIDE ESTEE LAUDER INC e87c4a76-5f21-4989-a1e0-0b7c6902f201 2023-10-26 Warnings Exact identifier application number: M020 Broad Spectrum SPF 15 Sunscreen Unflavored Lip Balm BROAD SPECTRUM SPF 15 SUNSCREEN UNFLAVORED LIP BALM Raining Rose efe20472-aa84-1cb4-e053-2a95a90abfd8 2023-10-26 Warnings Exact identifier application number: M020 Broad Spectrum SPF 15 Sunscreen Mint Lip Balm BROAD SPECTRUM SPF 15 SUNSCREEN MINT LIP BALM Raining Rose efe1113b-6101-0c15-e053-2a95a90a02a7 2023-10-26 Warnings Exact identifier application number: M020 Broad Spectrum SPF 15 Sunscreen Tropical Smoothie Lip Balm BROAD SPECTRUM SPF 15 SUNSCREEN TROPICAL SMOOTHIE LIP BALM Raining Rose efe176f7-9c11-106e-e053-2a95a90a9c88 2023-10-26 Warnings Exact identifier application number: M020 Broad Spectrum SPF 15 Sunscreen Citrus Lip Balm BROAD SPECTRUM SPF 15 SUNSCREEN CITRUS LIP BALM Raining Rose efdfc182-3ac0-1a3d-e053-2a95a90a894e 2023-10-26 Warnings Exact identifier application number: M020 Broad Spectrum SPF 15 Sunscreen Iced Pear Lip Balm BROAD SPECTRUM SPF 15 SUNSCREEN ICED PEAR LIP BALM Raining Rose efe01abd-0ee2-6bd6-e053-2a95a90a123d 2023-10-26 Warnings Exact identifier application number: M020 Diamond Luminous UV Defense Light Tinted Fluid Sunscreen Broad Spectrum SPF 40 TITANIUM DIOXIDE, ZINC OXIDE NATURA BISSE INTERNATIONAL SA bf8b71c7-257b-0eb6-e053-2a95a90a3a4c 2023-10-26 Warnings Exact identifier application number: M020 Carmex Weather Guard Moisturizing Lip Balm SPF 30 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, WHITE PETROLATUM Carma Laboratories, Inc. 843677f2-78fa-4f3d-9fe6-e45e35b728e3 2023-10-25 Warnings Exact identifier application number: M020 Carmex Daily Care Moisturizing Lip Balm Cupcake Batter SPF 15 OCTINOXATE, OXYBENZONE Carma Laboratories, Inc. baec9be7-5ae6-135c-e053-2995a90a2ed4 2023-10-25 Warnings Exact identifier application number: M020 Carmex Daily Care Moisturizing Lip Balm Fresh Cherry SPF 15 OCTINOXATE, OXYBENZONE Carma Laboratories, Inc. baea3596-6eb0-4d98-e053-2995a90a75cc 2023-10-25 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