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 36 of 357 · 7,139 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join White Mint SPF 15 Broad Spectrum Lip Balm WHITE MINT SPF 15 BROAD SPECTRUM LIP BALM Raining Rose, Inc 50ff8c38-94f1-f589-e063-6294a90a5ba8 2026-05-04 Warnings Exact identifier application number: M020 Surface Sun SPF 50 Mineral ZINC OXIDE Surface Products Corp cabaf7e1-b940-4d6e-b21b-d99c3a4047a7 2026-05-04 Warnings Exact identifier application number: M020 SPF 50 Dry Touch Continuous No fragrance HOMOSALATE 10.00% OCTISALATE 5.00% AVOBENZONE 3.00% Surface Products Corp 503d6b48-3516-4264-9fe8-71a9939669fe 2026-05-04 Warnings Exact identifier application number: M020 Surface SPF 50 3oz Tinted mineral sunscreen with Water Resistance ZINC OXIDE Surface Products Corp 02b770cf-7351-444b-b2c8-ad112e9bea3e 2026-05-04 Warnings Exact identifier application number: M020 SPF 30 Dry Touch Continuous No fragrance HOMOSALATE 10.00% OCTISALATE 5.00% AVOBENZONE 3.00% Surface Products Corp d13c9e6e-a5da-4691-8792-9d6025e166d7 2026-05-04 Warnings Exact identifier application number: M020 LUMINOUS EYE CORRECTOR SPF 41 - MEDIUM TITANIUM DIOXIDE, ZINC OXIDE Drmtlgy, LLC 0206c676-c24d-470e-adb2-7cb3173f3727 2026-05-04 Warnings Exact identifier application number: M020 LUMINOUS EYE CORRECTOR SPF 41 - TAN TITANIUM DIOXIDE, ZINC OXIDE Drmtlgy, LLC 5c5aad09-9f93-4634-8db1-c67570b38b2b 2026-05-04 Warnings Exact identifier application number: M020 OBGE PORE-ZERO Oil CONTROL SUN Stick HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE Adapt Inc. 67209e46-1b7a-42df-b31f-fcb3cefbd7e1 2026-05-03 Warnings Exact identifier application number: M020 Equate OCTOCRYLENE, HOMOSALATE, OCTISALATE, AVOBENZONE WALMART INC 2617e5bc-27a2-f187-e063-6394a90a6980 2026-05-03 Warnings Exact identifier application number: M020 THANK YOU FARMER Sun Project Rice Tinted Mineral Sun Cream ZINC OXIDE THANK YOU FARMER CO., LTD 20a44597-3d44-f0ea-e063-6294a90a903d 2026-05-03 Warnings Exact identifier application number: M020 Ultra Violette Sheen Screen Hydrating Lip Balm Last Bite Broad Spectrum SPF 50 AVOBENZONE, OCTISALATE, OCTOCRYLENE Grace and Fire USA Inc. 4df3e90e-98a0-edbf-e063-6394a90ae3c9 2026-05-01 Warnings Exact identifier application number: M020 Ultra Violette Sheen Screen Hydrating Lip Balm Silk Pillow Broad Spectrum SPF 50 AVOBENZONE, OCTINOXATE, OCTOCRYLENE Grace and Fire USA Inc. 4df6d28b-64ce-59b3-e063-6394a90a6360 2026-05-01 Warnings Exact identifier application number: M020 EXTREME PROTECT SPF 30 OCTINOXATE, ZINC OXIDE SCIENCE OF SKINCARE LLC ecc4d304-e7e2-45b6-b9b2-2c64d3630860 2026-05-01 Warnings Exact identifier application number: M020 Blue Lizard Sport SPF 50 Sunscreen OCTISALATE AND TITANIUM DIOXIDE AND ZINC OXIDE Crown Laboratories 4955fa1c-789d-4f42-af75-70223310644a 2026-05-01 Warnings Exact identifier application number: M020 Blue Lizard Kids SPF 50 Sunscreen OCTISALATE AND TITANIUM DIOXIDE AND ZINC OXIDE Crown Laboratories ba4ae906-48c0-8384-e053-2995a90afb91 2026-05-01 Warnings Exact identifier application number: M020 Sun Shield Mineral UV Barrier Protect Broad Spectrum SPF 40 Sunscreen ZINC OXIDE Obagi Cosmeceuticals LLC 54a3f855-48de-4ae0-b1f0-e95739853065 2026-05-01 Warnings Exact identifier application number: M020 MEDICUBE PDRN HYDRATING UV SERUM HOMOSALATE, OCTOCRYLENE, OCTISALATE, ENSULIZOLE APR US INC 50a73981-985a-0a70-e063-6394a90a89cf 2026-04-30 Warnings Exact identifier application number: M020 Sky and Sol Body Sunscreen NON- NANO ZINC OXIDE Delta Ecommerce LLC 2ddaa628-0e81-c8a7-e063-6394a90a84f4 2026-04-30 Warnings Exact identifier application number: M020 Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 2CR Cool Rosy OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 6831832a-e52e-43ea-899f-f5d44bea5a94 2026-04-30 Warnings Exact identifier application number: M020 Carmex 10 count variety pack Lip Balm OCTINOXATE, OXYBENZONE, CAMPHOR (SYNTHETIC), WHITE PETROLATUM Carma Laboratories, Inc. 9c5168d5-31ed-4ce1-b16a-5f51f7e44ed2 2026-04-30 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