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_7af0f836-c146-4bbf-b8e6-40e25f9a9723
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 42 of 357 · 7,139 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join EltaMD UV Restore Tinted TITANIUM DIOXIDE AND ZINC OXIDE SUNSCREEN CP Skin Health Group, Inc. 6a48ad0d-20e4-44b1-90d6-30bfbc68a152 2026-04-17 Warnings Exact identifier application number: M020 Pacto Refreshing Sunscreen Broad Spectrum SPF 50 AVOBENZONE, OCTISALATE, OCTOCRYLENE Mynd LLC 56ad7c97-3dae-4bac-a677-f5052dfdfea4 2026-04-16 Warnings Exact identifier application number: M020 ZO Skin Health Daily Mineral Sunshade Broad-Spectrum Sunscreen SPF 45 (Medium) TITANIUM DIOXIDE, ZINC OXIDE ZO Skin Health Inc. 4f95cd0a-f996-648b-e063-6294a90adc28 2026-04-16 Warnings Exact identifier application number: M020 ZO Skin Health Daily Mineral Sunshade Broad-Spectrum Sunscreen SPF 45 (Tan) TITANIUM DIOXIDE, ZINC OXIDE ZO Skin Health Inc. 4f968058-e851-86d0-e063-6294a90aa786 2026-04-16 Warnings Exact identifier application number: M020 Red Cherry SPF 15 Broad Spectrum Lip Balm RED CHERRY SPF 15 BROAD SPECTRUM LIP BALM Raining Rose, Inc 4f96d057-39b8-e4d5-e063-6394a90acb5c 2026-04-16 Warnings Exact identifier application number: M020 ZO Skin Health Daily Mineral Sunshade Broad-Spectrum Sunscreen SPF 45 (Deep) TITANIUM DIOXIDE, ZINC OXIDE ZO Skin Health Inc. 4f970778-97d6-40a9-e063-6394a90a6c89 2026-04-16 Warnings Exact identifier application number: M020 ZO Skin Health Sheer Fluid Tint Broad-Spectrum Sunscreen SPF 45 Fair-Light ZINC OXIDE ZO Skin Health, Inc. 4f9988a0-ae4a-9940-e063-6294a90ad91d 2026-04-16 Warnings Exact identifier application number: M020 MELAO Hydrating Mineral Sunscreen TITANIUM DIOXIDE,ZINC OXIDE Guangdong Aimu Biological Technology Co., Ltd 4f778eb0-55f7-38d0-e063-6394a90a69a0 2026-04-15 Warnings Exact identifier application number: M020 Tanning Club Everyday Sunscreen SPF 30 HOMOSALATE, OCTISALATE, OCTOCRYLENE, AVOBENZONE TANNING CLUB, LLC 75820400-a5e0-4cf5-8b4f-a52500ce62c3 2026-04-15 Warnings Exact identifier application number: M020 ZO Skin Health Daily Mineral Sunshade Broad-Spectrum Sunscreen SPF 45 TITANIUM DIOXIDE, ZINC OXIDE ZO Skin Health Inc. 4f81e482-8111-451c-e063-6294a90ad148 2026-04-15 Warnings Exact identifier application number: M020 Mineral Lip Sunscreen TITANIUM DIOXIDE, ZINC OXIDE UNDRBUDR, LLC 4f8353b3-4ac1-9703-e063-6294a90abdad 2026-04-15 Warnings Exact identifier application number: M020 Mineral Sunscreen Stick Non-Tinted TITANIUM DIOXIDE, ZINC OXIDE UNDRBUDR, LLC 4f83dd76-a8d8-916e-e063-6294a90ab6ed 2026-04-15 Warnings Exact identifier application number: M020 Mineral Sunscreen Stick - Tinted TITANIUM DIOXIDE, ZINC OXIDE UNDRBUDR, LLC 4f84619f-3415-7443-e063-6394a90a162a 2026-04-15 Warnings Exact identifier application number: M020 Amazonian Clay BB Tinted Moisturizer Broad Spectrum SPF 20 Sunscreen Ivory TITANIUM DIOXIDE AND ZINC OXIDE PML NYC, LLC 1be639a8-179a-7015-e063-6394a90ab64b 2026-04-15 Warnings Exact identifier application number: M020 PHELITYL DAY SPF 15 PHELITYL DAY SPF 15 PML NYC, LLC ea9d33d9-6f9f-0a66-e053-2a95a90abd42 2026-04-15 Warnings Exact identifier application number: M020 FIRMARINE MOISTURIZER SPF 30 FIRMARINE MOISTURIZER SPF 30 PML NYC, LLC ea9db179-1b69-01e0-e053-2a95a90a1628 2026-04-15 Warnings Exact identifier application number: M020 EVEN TRUE NUTRITIVE SKIN MOISTURIZER SPF 15 EVEN TRUE NUTRITIVE SKIN MOISTURIZER SPF 15 PML NYC, LLC eaa562b1-3fc6-1a85-e053-2995a90ad1ec 2026-04-15 Warnings Exact identifier application number: M020 DD Cream Dermatologically Defining BB Cream Broad Spectrum SPF 30 DD CREAM DERMATOLOGICALLY DEFINING BB CREAM BROAD SPECTRUM SPF 30 PML NYC, LLC ea90bb4d-6f4a-45c9-e053-2a95a90a53a7 2026-04-15 Warnings Exact identifier application number: M020 RICH GIRL HAND SPF 25 RICH GIRL HAND PML NYC, LLC ea8f4421-109f-41a5-e053-2a95a90a3832 2026-04-15 Warnings Exact identifier application number: M020 YOUR NAME MINERAL SHEERTINT BROAD SPECTRUM SPF 20- ALABASTER YOUR NAME MINERAL SHEER TINT PML NYC, LLC 0e24a63e-d76f-6581-e063-6394a90a6181 2026-04-15 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