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 266 of 346 · 6,912 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Arbonne AgeWell Moisture Restoring Broad Spectrum SPF 15 Sunscreen ZINC OXIDE Arbonne International, LLC c172f793-3f7a-47b3-9db1-58487b8ad66c 2024-11-12 Warnings Exact identifier application number: M020 Hello Sunday The Everyday One Face Moisturiser SPF 50 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Kao USA Inc. 0c7e1aa2-7054-435d-e063-6394a90a2d08 2024-11-12 Warnings Exact identifier application number: M020 ZO Skin Health Sunscreen Plus Powder Broad-Spectrum SPF 45 ZINC OXIDE ZO Skin Health, Inc. be3c7ef2-dd08-0f1a-e053-2995a90ae14c 2024-11-12 Warnings Exact identifier application number: M020 TiZO Photoceutical AM Replenish - Tinted ZINC OXIDE Fallien Cosmeceuticals, LTD fbafa468-fce0-4597-bcb0-a816dc71ec7c 2024-11-12 Warnings Exact identifier application number: M020 Sunscreen Plus Powder Broad-Spectrum SPF 45 ZINC OXIDE ZO Skin Health, Inc. beb0b43b-a90d-05ae-e053-2995a90a1d8e 2024-11-12 Warnings Exact identifier application number: M020 Neutrogena Healthy Skin Anti-Aging Perfector Sunscreen Broad Spectrum SPF 20 Ivory to Fair 10 OCTINOXATE AND OCTISALATE Kenvue Brands LLC 0e489dec-9c7e-48c1-98cb-1aec91884a16 2024-11-11 Warnings Exact identifier application number: M020 Neutrogena Revitalizing Lip Balm SPF 20 - Sheeer Shimmer 10 OCTINOXATE AND OXYBENZONE Kenvue Brands LLC e77c07d4-4e64-4000-9e7a-963aa6c6448c 2024-11-11 Warnings Exact identifier application number: M020 Neutrogena Sheer Zinc DRY-TOUCH Sunscreen Broad Spectrum SPF50 ZINC OXIDE Kenvue Brands LLC 54a3b677-4510-4191-8386-ccdd10ccfcaa 2024-11-11 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 4.5W OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 504d8118-f84d-4f3f-abd1-463f3780a2cb 2024-11-11 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 2WO OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 0d4e667a-cf93-4f6d-8565-ecfa9a18cfbf 2024-11-11 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 2.5W OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior cb1d643e-34dc-48f2-aecd-ba2a35dc3403 2024-11-11 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 2W OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 097b3d7b-5dff-4206-99f1-6573902232e9 2024-11-11 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 4W OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior a621a610-7dd2-4ccd-bc48-8671e4f4a887 2024-11-11 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 3W OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 43296d42-7bc2-4073-8231-4a7921f9ebe3 2024-11-11 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 6N OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 5ee35643-bd86-4d55-914a-96f4670bfd07 2024-11-11 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 4WP OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior f519aa3f-11a1-4941-bf31-47ac11f5a703 2024-11-11 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 4WO OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 03f0ad8b-25b1-4b01-abad-d1b0851e15c5 2024-11-11 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 3CR OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior a6363bc5-6a99-4412-ba62-ec66054e2c71 2024-11-11 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 1.5W OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 9b2133dd-5dd0-476d-98c7-7f2e72024de7 2024-11-11 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 3WP OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 5b74e312-39b1-4b11-a678-b4fccea84581 2024-11-11 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