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 288 of 346 · 6,912 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Bali Body Watermelon Tanning Oil SPF 50 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Bali Body Pty Ltd 1fd37cec-807e-ddd3-e063-6294a90ae88e 2024-08-16 Warnings Exact identifier application number: M020 SunPlus SPF 30 Everyday Inspired Broad Spectrum Sunscreen AVOBENZONE, OCTISALATE, OCTOCRYLENE SUNPLUS SKIN CARE LLC fcae486a-5ea8-4f33-98bf-ec68a13d6b8a 2024-08-15 Warnings Exact identifier application number: M020 SunPlus SPF 50 Everyday Inspired Broad Spectrum Sunscreen AVOBENZONE, OCTISALATE, OCTOCRYLENE SUNPLUS SKIN CARE LLC a2a028a1-3f35-45f6-99a9-8a1c8b4c1f9b 2024-08-15 Warnings Exact identifier application number: M020 SKINRAYS Protective Bounce Butter Broad Spectrum SPF 30 Mineral Sunscreen by Glam up ZINC OXIDE Spigen Beauty Inc. 94c0d586-8de5-45d1-8a82-07555996e61d 2024-08-14 Warnings Exact identifier application number: M020 FUTURIST HYDRA RESCUE MOISTURIZING MAKEUP BROAD SPECTRUM SPF 45 ENSULIZOLE, OCTINOXATE, OCTISALATE, AND ZINC OXIDE ESTEE LAUDER INC 82db54ba-3ebd-4b70-b41c-b0d2faad7daa 2024-08-13 Warnings Exact identifier application number: M020 DERMA BRITE SPF 35 OCTINOXATE, OCTISALATE, OXYBENZONE PHARMAGEL INTERNATIONAL INC fe10912e-00e3-406c-a80c-d9c991dc9f8b 2024-08-13 Warnings Exact identifier application number: M020 SUN THERAPE FACE AND BODY SPF-35 AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE PHARMAGEL INTERNATIONAL INC 6a96623f-c37c-4e67-925e-f133461d726d 2024-08-13 Warnings Exact identifier application number: M020 SUN THERAPE SPORT SPF-35 HOMOSALATE, OCTINOXATE, OXYBENZONE, OCTOCRYLENE, OCTISALATE, AVOBENZONE PHARMAGEL INTERNATIONAL INC 0cc0de1e-c1c0-4a8a-ba5a-21e2470d61d9 2024-08-13 Warnings Exact identifier application number: M020 Biocorneum AVOBENZONE, HOMOSALATE, MERADIMATE, OCTISALATE, AND OCTOCRYLENE Biodermis LLC ef95f2b7-e438-4990-880d-81621edb2002 2024-08-13 Warnings Exact identifier application number: M020 TiZO ULTRA ZINC Non-Tinted SPF 40 MINERAL SUNSCREEN FOR BODY and FACE With Antioxidants C and E ZINC OXIDE Fallien Cosmeceuticals, Ltd 1f417082-5fd1-c95e-e063-6394a90a16ab 2024-08-09 Warnings Exact identifier application number: M020 Proceuticals Private Label by TiZO non-tinted foaming mineral sunscreen TITANIUM DIOXIDE, ZINC OXIDE Fallien Cosmeceuticals, Ltd 1f4491ab-95b0-cc14-e063-6394a90a73ca 2024-08-09 Warnings Exact identifier application number: M020 FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 7.5N OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior b737146d-fb50-4ed6-ab5e-6aff3393992a 2024-08-07 Warnings Exact identifier application number: M020 FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 6.5N OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 54b07420-6a30-4481-99f5-a7d6a4df898c 2024-08-07 Warnings Exact identifier application number: M020 FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 7W OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 65659277-cd30-453c-929e-3651c9f19da8 2024-08-07 Warnings Exact identifier application number: M020 FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 4.5N OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 28ae9c39-eb79-4a19-8149-af8d8e7901ae 2024-08-07 Warnings Exact identifier application number: M020 FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 6.5W OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 05f7119a-0c92-4393-a62d-8e84ec451d20 2024-08-07 Warnings Exact identifier application number: M020 FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 5N OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior b90ee1ba-17b5-4367-9df3-e9e27217960c 2024-08-07 Warnings Exact identifier application number: M020 FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 2.5N OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior ad5c5121-d75d-449d-a4db-a7b074787f68 2024-08-06 Warnings Exact identifier application number: M020 FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 00 OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 0018573d-922b-4642-9513-63481e9131d5 2024-08-06 Warnings Exact identifier application number: M020 FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 1.5N OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 83b20b0d-c2db-4720-8434-57b73847ebca 2024-08-06 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