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
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 76 of 357 · 7,139 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 3,5N Neutral OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 824c5f13-970e-4e9e-8f2a-2a01973d2e59 2026-01-16 Warnings Exact identifier application number: M020 Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 2W Warm OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior b7621ef5-47fc-4ccc-aedd-eac328ace7b9 2026-01-16 Warnings Exact identifier application number: M020 Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 3C Cool OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 64a29ff8-e24d-4818-9b54-734a0eb2a13f 2026-01-16 Warnings Exact identifier application number: M020 Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 2WP Warm Peach OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 17a0201b-b797-4e65-838f-1ce8d408a020 2026-01-16 Warnings Exact identifier application number: M020 Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 2WO Warm Olive OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 72e2c71a-da1d-497f-a8b7-491cff951c63 2026-01-16 Warnings Exact identifier application number: M020 Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 3CR Cool Fosy OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 19d1432a-96b0-4cef-b13e-895dd41b41d6 2026-01-16 Warnings Exact identifier application number: M020 Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 3N Neutral OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 5a06c820-ccd8-47ce-8bbf-7e90da92b1de 2026-01-16 Warnings Exact identifier application number: M020 Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 3W Warm OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 205e195a-fd30-44f7-9294-e701f0f766d6 2026-01-16 Warnings Exact identifier application number: M020 Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 3WP Warm Peach OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 5495ff75-0c83-4491-8af7-4aed7a779d7f 2026-01-16 Warnings Exact identifier application number: M020 Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 3WO Warm Olive OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 10bc345d-a5b1-4b70-bfa6-a2d7816904bf 2026-01-16 Warnings Exact identifier application number: M020 Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 4,5N Neutral OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 30268b6e-d42a-4314-b82f-24f9e81cca2a 2026-01-16 Warnings Exact identifier application number: M020 Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 4,5W Warm OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 545c962f-2a59-4d94-8fef-ebdba4127f42 2026-01-16 Warnings Exact identifier application number: M020 Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 4C Cool OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 17c9226b-459c-42fe-ac50-7e26db6b49af 2026-01-16 Warnings Exact identifier application number: M020 Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 4N Neutral OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 8cb27c4e-b2f4-4e60-a5ff-7cdda79a3af6 2026-01-16 Warnings Exact identifier application number: M020 Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 4W Warm OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior bf323e10-5479-44b3-b4b9-b8ca6b0f7688 2026-01-16 Warnings Exact identifier application number: M020 Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 4WO Warm Olive OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 2d6a5133-b847-4ecf-8c33-1cb05aca6b91 2026-01-16 Warnings Exact identifier application number: M020 Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 4WP Warm Peach OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 275be888-2c52-43ed-846a-55525002edcd 2026-01-16 Warnings Exact identifier application number: M020 Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 6,5W Warm OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior c73576a6-dbab-4205-add5-876a060b5022 2026-01-16 Warnings Exact identifier application number: M020 Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 wless Skin True Foundation SPF 20 7,5N Neutral OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 4ae761ac-df06-4913-a8bf-8ca1be32b5b7 2026-01-16 Warnings Exact identifier application number: M020 Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 5N Neutral OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 72c45120-6997-4250-b9b4-1cdb762efe1a 2026-01-16 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