FDA.reportPublic FDA data

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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage46783-00246783-002-02DDiscontinued by firm2026-11-13
excluded packagepackage46783-00246783-002-03DDiscontinued by firm2026-11-13
excluded packagepackage46783-00246783-002-05DDiscontinued by firm2026-11-13
excluded packagepackage46783-00246783-002-50DDiscontinued by firm2026-11-13

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 dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…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
IngredientStrength
OCTINOXATE75 mg/mL
ZINC OXIDE73 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4Y5P7MUD51Internal UNII lookup
SOI2LOH54ZInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
e120a659-0dfc-42ca-8158-58e8a0b457e5Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
46783-002-01Journee Bio-restorative Day Balm Broad-spectrum Suncreen SPF 301 in 1 CARTONLOTION18
46783-002-01Journee Bio-restorative Day Balm Broad-spectrum Suncreen SPF 3015 mL in 1 BOTTLELOTION158
46783-002-02Journee Bio-restorative Day Balm Broad-spectrum Suncreen SPF 301 in 1 CARTONLOTION18
46783-002-02Journee Bio-restorative Day Balm Broad-spectrum Suncreen SPF 3030 mL in 1 BOTTLELOTION308
46783-002-03Journee Bio-restorative Day Balm Broad-spectrum Suncreen SPF 30200 mL in 1 BOTTLELOTION2008
46783-002-05Journee Bio-restorative Day Balm Broad-spectrum Suncreen SPF 304 mL in 1 TUBELOTION48
46783-002-50Journee Bio-restorative Day Balm Broad-spectrum Suncreen SPF 301 in 1 CARTONLOTION18
46783-002-50Journee Bio-restorative Day Balm Broad-spectrum Suncreen SPF 3050 mL in 1 BOTTLELOTION508

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46783-002JOURNEE BIO-RESTORATIVE DAY BALM BROAD-SPECTRUM SUNCREEN SPF 30 (OCTINOXATE AND ZINC OXIDE) LOTION [MERZ NORTH AMERICA, INC.]6Current NDC, Legacy NDC, 8 package rows20241109_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 327 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
RADIANCE Silky Mineral Primer Sunscreen SPF-42 HONEYTITANIUM DIOXIDE, ZINC OXIDESANTO REMEDIO LLC867a88df-9a18-447f-8301-2ec91566302e2023-11-06WarningsExact identifier
application number: M020
CALIFORNIA MANGO SPF-30 SUNSCREENAVOBENZONE, OCTISALATE, OCTOCRYLENECALMANGO, INCe0de0504-763d-4518-8a9c-67724077701d2023-11-06WarningsExact identifier
application number: M020
KOVR All-Natural SPF-30 Moisturizing Sunscreen for MenTITANIUM DIOXIDE, ZINC OXIDEACTIVE LIFE INCbf766aab-a52d-41e8-a06a-f2e536d2219b2023-11-06WarningsExact identifier
application number: M020
PROJECT REEF SPF-50ZINC OXIDE, TITANIUM DIOXIDEProject Reef LLC6bcd470c-6994-4d28-8370-4cc9d68e1e782023-11-06WarningsExact identifier
application number: M020
BB OSKIN Broad Spectrum SPF-30TITANIUM DIOXIDE, OCTOCRYLENE, ZINC OXIDEO'Skin Studio NYd84cca38-b673-484e-aa25-df58d904d4d32023-11-06WarningsExact identifier
application number: M020
MIAMI MD SUN SHIELD Broad Spectrum SPF 40AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEBRAND BOLT LLC3a53d53a-129a-41c3-a8e7-c1b1bb98d8bd2023-11-06WarningsExact identifier
application number: M020
JOY SPRING Kids Mineral Sunscreen SPF-30ZINC OXIDEJOYSPRING HOLDINGS LLC76613a3d-f4a8-4961-b36a-d84b4e10dea02023-11-06WarningsExact identifier
application number: M020
Aruba Aloe Sport Line Lip Balm Broad Spectrum SPF 30TITANIUM DIOXIDE, ZINC OXIDEAruba Aloe Balm NV80461b6d-b1b7-4220-894d-8bd4259094742023-11-06WarningsExact identifier
application number: M020
Sport Broad Spectrum SPF50 Water Resistant 80 minutes Mineral Sunscreen UVA UVB Protection StickZINC OXIDEAruba Aloe Balm NV3201cc8b-5fee-4f3b-a826-e349786d1b322023-11-06WarningsExact identifier
application number: M020
Broad Spectrum SPF50 Water Resistant (80 minutes) Mineral Sunscreen UVA UVB Protection Stick for KidsZINC OXIDEAruba Aloe Balm NV25f060eb-628c-4a11-b1d7-06922ee86b242023-11-06WarningsExact identifier
application number: M020
SPF30 SunscreenAVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCITSALATEZhejiang Ayan Biotech Co., Ltd.44321dff-1a61-452f-8324-6de2a196db512023-11-06WarningsExact identifier
application number: M020
SPF30 SunscreenAVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCITSALATEZhejiang Ayan Biotech Co., Ltd.cac6f5e5-91c2-4978-bffd-5ca2a75906372023-11-06WarningsExact identifier
application number: M020
SPF15 SunscreenAVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATEZhejiang Ayan Biotech Co.,Ltd.68035415-47c3-4eed-93f4-bb6b26c9149a2023-11-06WarningsExact identifier
application number: M020
SPF30 Sunscreen and Antibacterial Hand SanitizerALCOHOL, AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATEZhejiang Ayan Biotech Co., Ltd.b5e2458f-8e84-4e57-b6f7-e428a94c97a42023-11-06WarningsExact identifier
application number: M020
SPF30 Sunscreen and SPF15AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATEZhejiang Ayan Biotech Co.,Ltd.6c40259b-565a-46d0-90d0-ccc1867645522023-11-06WarningsExact identifier
application number: M020
Image Skincare Prevention Plus Daily Ultimate ProtectionHOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDE SUNSCREENSwiss-American CDMO, LLC3473f94c-5faf-4415-9605-f58ec93cd2682023-11-06WarningsExact identifier
application number: M020
Image MD Restoring Lip Enhancer SPF15SUNSCREENSwiss-American CDMO, LLCe296579e-ba30-4a29-afe0-bb51f863369c2023-11-06WarningsExact identifier
application number: M020
Image Prevention Refiner Primer SPF50ZINC OXIDE, TITANIUM DIOXIDE SUNSCREENSwiss-American CDMO, LLC0e490f11-666c-420c-8c12-b45cd238ce472023-11-06WarningsExact identifier
application number: M020
Image Prevention Plus Professional Ultimate Protection Moisturizer SPF50HOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDE SUNSCREENSwiss-American CDMO, LLCd807f94a-f933-47d9-938f-b91f663af0782023-11-06WarningsExact identifier
application number: M020
Farmasi BB Beauty Balm Cream SPF 15- 01 LightTITANIUM DIOXIDEFarmasi US LLC97c1da03-b79c-46a3-a9f0-7aeb94ed66da2023-11-05WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
46783-002-01467830002011 BOTTLE in 1 CARTON (46783-002-01) / 15 mL in 1 BOTTLE1 bottle2011-04-010000-00-00NoNoCurrent
46783-002-02467830002021 BOTTLE in 1 CARTON (46783-002-02) > 30 mL in 1 BOTTLE1 bottle2011-04-010000-00-00NoNoCurrent
46783-002-0346783000203200 mL in 1 BOTTLE (46783-002-03) 200 ml2011-04-010000-00-00NoNoCurrent
46783-002-05467830002054 mL in 1 TUBE (46783-002-05) 4 ml2011-04-010000-00-00NoNoCurrent
46783-002-50467830002501 BOTTLE in 1 CARTON (46783-002-50) > 50 mL in 1 BOTTLE1 bottle2019-06-180000-00-00NoNoCurrent