FDA.reportPublic FDA data

Journee Bio-restorative Day Balm Broad-spectrum Suncreen SPF 30

Product NDC
46783-002
Requested package NDC
46783-002-01
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

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

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 60 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
cle de peau BEAUTE THE FOUNDATION N M O20OCTINOXATE AND TITANIUM DIOXIDEShiseido Americas Corporation9507f6d1-c11c-428d-8d95-b436f27ba26a2026-02-24WarningsExact identifier
application number: M020
Perfect Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDESKIN PERFECT MEDICAL4b93538a-3b3e-90f7-e063-6294a90ab8982026-02-24WarningsExact identifier
application number: M020
ANTI-AGING TINTED SUNSCREENTITANIUM DIOXIDE, ZINC OXIDELASER GIRL SKINCARE, LLC4b93cd22-1289-29bc-e063-6294a90ab7812026-02-24WarningsExact identifier
application number: M020
ANTI-AGING TINTED SUNSCREENTITANIUM DIOXIDE, ZINC OXIDELASER GIRL SKINCARE, LLC4b943d72-dcde-e2e4-e063-6294a90ab7c42026-02-24WarningsExact identifier
application number: M020
ANTI-AGING NON-TINTED SUNSCREENTITANIUM DIOXIDE, ZINC OXIDELASER GIRL SKINCARE, LLC4b946c39-718b-d70e-e063-6394a90a0db82026-02-24WarningsExact identifier
application number: M020
Reunited Lipgloss SPF 30 - BTCH IS BACKHOMOSALATE, OCTOCRYLENE, OCTISALATEPrinceville Productions, LLC, DBA Reunited Beauty4b961531-fbca-d1cf-e063-6294a90ab9a12026-02-24WarningsExact identifier
application number: M020
sunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEMeijer, Inc.8f5e634c-765b-4ffe-bb12-753d64c90cf92026-02-24Warnings, Adverse reactionsExact identifier
application number: M020
Avobenzone, Homosalate, OctisalateAVOBENZONE, HOMOSALATE, OCTISALATEMeijer, Inc.e97bf30a-1465-4912-bd55-1e7dd993132b2026-02-24Warnings, Adverse reactionsExact identifier
application number: M020
Avobenzone, Homosalate, OctisalateAVOBENZONE, HOMOSALATE, OCTISALATEMeijer, Inc.67efcd94-00af-477b-bd14-d1c7b95d305a2026-02-24Warnings, Adverse reactionsExact identifier
application number: M020
Avobenzone, Homosalate, OctisalateAVOBENZONE, HOMOSALATE, OCTISALATEMeijer, Inc.3f3d2e1e-1e95-4719-8ca9-83b6b804ab9f2026-02-24Warnings, Adverse reactionsExact identifier
application number: M020
Sheer Touch Sunscreen Mist SPF 100AVOBENZONE, HOMOSALATE, OCTISALATEMeijer, Inc.f642788c-3643-459a-b736-0c06d0cd32a92026-02-24Warnings, Adverse reactionsExact identifier
application number: M020
Avobenzone, Homosalate, OctisalateAVOBENZONE, HOMOSALATE, OCTISALATEMeijer, Inc.95ba2b33-f593-4e95-bd6e-5910d6aa51582026-02-24Warnings, Adverse reactionsExact identifier
application number: M020
Avobenzone, Homosalate, OctisalateAVOBENZONE, HOMOSALATE, OCTISALATEMeijer, Inc.3b85004a-8832-4eac-bd70-1e607ae7af4b2026-02-24Warnings, Adverse reactionsExact identifier
application number: M020
Avobenzone, Homosalate, OctisalateAVOBENZONE, HOMOSALATE, OCTISALATEMeijer, Inc.7f0fc23b-2d70-4426-9d64-a6d2b643309f2026-02-24Warnings, Adverse reactionsExact identifier
application number: M020
Sport Sunscreen SPF 70AVOBENZONE, HOMOSALATE, OCTISALATEMeijer, Inc.0ae9edd8-bf76-4bb2-ab78-c43c017ba4a52026-02-24Warnings, Adverse reactionsExact identifier
application number: M020
Avbenzone, Homosalate, OctisalateAVBENZONE, HOMOSALATE, OCTISALATEMeijer, Inc.f8960995-66b6-4197-8976-b318fe01488f2026-02-24Warnings, Adverse reactionsExact identifier
application number: M020
Broad Spectrum Sunscreen SPF 30AVOBENZONE, HOMOSALATE, OCTISALATEMeijer, Inc.c76f5639-bd0f-4987-8c70-224ee33bbbad2026-02-24Warnings, Adverse reactionsExact identifier
application number: M020
Avobenzone, Homosalate, OctisalateAVOBENZONE, HOMOSALATE, OCTISALATEMeijer, Inc.8795b9a7-1938-4dd9-92ad-3c044feae1da2026-02-24Warnings, Adverse reactionsExact identifier
application number: M020
Avobenzone, Homosalate, OctisalateAVOBENZONE, HOMOSALATE, OCTISALATEMeijer, Inc.3f8bad95-8071-47b1-88a7-3a3f09f097b52026-02-24Warnings, Adverse reactionsExact identifier
application number: M020
UV RESTORE FACE SERUM SUNSCREEN SPF 50AVOBENZONE, HOMOSALATE, OCTISALATEBETTER INNOVATION LTD4b9a881a-835b-ef0c-e063-6394a90a94af2026-02-24WarningsExact 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