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 290 of 346 · 6,912 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Clarity Rx Pucker Power lip plumper SPF 30 HOMOSALATE, OCTINOXATE, OCTISALATE, AVOBENZONE Topiderm, Inc. 92504982-fe0e-404d-b7cf-f6b340b89802 2024-07-31 Warnings Exact identifier application number: M020 Essential Sheer SPF 50 ZINC OXIDE TITANIUM DIOXIDE Topiderm, Inc. 2132dc18-85ee-4449-86d2-d9f698f286c6 2024-07-31 Warnings Exact identifier application number: M020 Proceuticals Private Label by TiZO tinted foaming mineral sunscreen TITANIUM DIOXIDE, ZINC OXIDE Fallien Cosmeceuticals, Ltd 1e78109f-4d2e-2705-e063-6294a90a5ad3 2024-07-30 Warnings Exact identifier application number: M020 Replenix Sheer SPF 50 ZINC OXIDE TITANIUM DIOXIDE Topiderm, Inc. 37d1f454-3bc9-4ce5-863c-0d4f6fa18fb4 2024-07-29 Warnings Exact identifier application number: M020 Dr Pawpaw MultiPurpose Lip Balm with natural PawPaw and SPF 30 AVOBENZONE, OCTINOXATE, OCTOCRYLENE, HOMOSALATE, OCTISALATE Dr Pawpaw Limited f2628e3e-9eb0-49cb-91a6-d15c48cb8a19 2024-07-25 Warnings Exact identifier application number: M020 Thinksport Daily Face SPF 50 ZINC OXIDE thinkOperations,LLC b2422785-bd35-4248-a68f-fb4b1492a4cd 2024-07-24 Warnings Exact identifier application number: M020 Thinkbaby Clear Zinc SPF 30 ZINC OXIDE thinkOperations,LLC 7cd9c971-5556-42dc-af7b-3a88221b8c94 2024-07-24 Warnings Exact identifier application number: M020 ISNTREE ONION NEWPAIR SUNSCREEN AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE ISNTREE Inc. 0f072099-d57d-4dc4-e063-6394a90ab438 2024-07-23 Warnings Exact identifier application number: M020 ISNTREE ONION NEWPAIR SUNSCREEN AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE ISNTREE Inc. 14b11b42-d1fe-572f-e063-6394a90a9eec 2024-07-23 Warnings Exact identifier application number: M020 Proceuticals Private Label by TiZO tinted mineral sunscreen 20% zinc oxide ZINC OXIDE Fallien Cosmeceuticals, Ltd 1dda8259-4121-3c76-e063-6394a90af189 2024-07-22 Warnings Exact identifier application number: M020 Eco Lips PlantPod Sunscreen Lip Balm Sport SPF 30 AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE Eco Lips. Inc. e64c8644-7af4-7b7f-e053-2995a90af711 2024-07-22 Warnings Exact identifier application number: M020 Thinksport SPF 30 ZINC OXIDE thinkOperations,LLC 2cecda56-4860-4d35-abc2-2bb9bdf35eae 2024-07-19 Warnings Exact identifier application number: M020 CVS Health SPORT SPF 30 AVOBENZONE HOMOSALATE OCTOCRYLENE CVS PHARMACY f0e8c724-b377-5dc0-e053-2995a90a0d54 2024-07-18 Warnings Exact identifier application number: M020 EQUATE Sunscreen SPORT Broad Spectrum SPF 30 AVOBENZONE HOMOSALATE OCTOCRYLENE WAL-MART STORES INC 4d819fd3-de12-4394-82f4-a48faf0b7092 2024-07-18 Warnings Exact identifier application number: M020 Big Lots Soundbody SPF 30 Ultra Sport Sunscreen AVOBENZONE HOMOSALATE OCTOCRYLENE BIG LOTS STORES, INC. f0e82a9f-17ac-b1c5-e053-2995a90ae07a 2024-07-18 Warnings Exact identifier application number: M020 Equaline SPORT Sunscreen SPF 30 AVOBENZONE HOMOSALATE OCTOCRYLENE United Natural Foods, Inc. dba UNFI f0e8dfd4-a77c-6384-e053-2a95a90a1e4a 2024-07-18 Warnings Exact identifier application number: M020 TopCare Everyday SPORT Sun Broad Spectrum SPF 30 AVOBENZONE HOMOSALATE OCTOCRYLENE TOPCO ASSOCIATES LLC f0e93aa8-1b09-1312-e053-2a95a90a7934 2024-07-18 Warnings Exact identifier application number: M020 Safeway Signature Sport Sunscreen SPF 30 AVOBENZONE HOMOSALATE OCTOCRYLENE Safeway, Inc. f557a3e2-e415-1b65-e053-2995a90a987a 2024-07-18 Warnings Exact identifier application number: M020 Target Up and Up Sunscreen Sport Broad Spectrum SPF 30 AVOBENZONE HOMOSALATE OCTOCRYLENE TARGET CORPORATION bad60bc1-cf78-7a33-e053-2995a90afdc3 2024-07-18 Warnings Exact identifier application number: M020 Scar Gel SPF 35 ZINC OXIDE derma e 8cd263aa-a54b-4c55-b3e2-6f6763987d4a 2024-07-17 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