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 34 of 357 · 7,139 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 3CR Cool Rosy OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior d12905b6-97aa-429a-8800-23856fe31f06 2026-05-06 Warnings Exact identifier application number: M020 Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 0N Neutral OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 43599d17-81f4-4c6e-b6bd-d1e700b668ee 2026-05-06 Warnings Exact identifier application number: M020 Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 0.5N Neutral OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 116f09db-f859-40c5-8857-33503903ee76 2026-05-06 Warnings Exact identifier application number: M020 Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 2N Neutral OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 480e5bf9-8e24-4335-a434-93255ceb640e 2026-05-06 Warnings Exact identifier application number: M020 Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 1.5N Neutral OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 7057feab-20fe-4547-8223-0816904bcfd6 2026-05-06 Warnings Exact identifier application number: M020 Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 1CR Cool Rosy OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 672a804d-ba8e-4c03-91fc-3edc0b12c627 2026-05-06 Warnings Exact identifier application number: M020 Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 3.5N Neutral OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior b656394d-a410-4f8c-a632-815a349fb17e 2026-05-06 Warnings Exact identifier application number: M020 Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 6.5N Neutral OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 4d47292f-35f2-4e9f-a9d8-2df57cbe92cf 2026-05-06 Warnings Exact identifier application number: M020 Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 7N Neutral OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 96258152-5255-4f04-9a35-c5a76b9c0520 2026-05-06 Warnings Exact identifier application number: M020 Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 3W Warm OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 5df158da-3280-4ce6-a04c-370999343400 2026-05-06 Warnings Exact identifier application number: M020 Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 2.5N Neutral OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior be60feb0-8c16-4ef6-a36f-423ed18e098c 2026-05-06 Warnings Exact identifier application number: M020 Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 3N Neutral OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 2d7678b4-b082-4911-80a2-c019eb529414 2026-05-06 Warnings Exact identifier application number: M020 Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 9N Neutral OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 00c9da7c-d4c7-49da-afa9-1fde93a81540 2026-05-06 Warnings Exact identifier application number: M020 Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 2W Warm OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 201acd8e-23c6-43fd-81dc-a814c3d8160b 2026-05-06 Warnings Exact identifier application number: M020 Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 8N Neutral OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior b24806b1-d9da-4373-b072-6d9a262ea365 2026-05-06 Warnings Exact identifier application number: M020 Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 5N Neutral OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior c981ae5e-e7e8-484b-b682-fb96d501e03b 2026-05-06 Warnings Exact identifier application number: M020 Poth Clear Gel Sunscreen SPF 50 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Poth LLC 1b0b6716-f4e1-4a3b-9f06-1c95f1f8a17a 2026-05-06 Warnings Exact identifier application number: M020 FORGE SKIN MINERAL TALLOW SUNSCREEN 30 SPF FORGE SKIN MINERAL TALLOW SUNSCREEN 30 SPF Horizons Ventures LLC 5127ac89-3dff-5966-e063-6394a90a11db 2026-05-06 Warnings Exact identifier application number: M020 PREMIUM BEAUTY BALM BROAD SPECTRUM SPF 30 OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, AND ZINC OXIDE Have & Be Co., Ltd. 4a7e868d-6310-6ee4-e063-6394a90aebce 2026-05-06 Warnings Exact identifier application number: M020 Vivaiodays Sunscreen with Turmeric ZINC OXIDE 5SENCO INC DBA VIVAIODAYS 5129e680-f485-9c66-e063-6394a90a0e7e 2026-05-06 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