FDA.reportPublic FDA data

Journee Firm Riche Broad Spectrum Sunscreen SPF 30

Product NDC
46783-110
11-digit product format
467830110
Labeler code
46783
Product ID
46783-110_38c7117e-9d73-4b2b-9005-4287e4ec7fb0
Type
HUMAN OTC DRUG
Nonproprietary name
TITANIUM DIOXIDE and ZINC OXIDE
Dosage form
CREAM
Route
TOPICAL
Labeler
Merz North America, Inc.
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-03-15
Substance
TITANIUM DIOXIDE; ZINC OXIDE
Active strength
12.25; 10.2 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 Firm Riche Broad Spectrum Sunscreen SPF 30
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TITANIUM DIOXIDE12.25 mg/mL
ZINC OXIDE10.2 mg/mL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
46783-110-06Journee Firm Riche Broad Spectrum Sunscreen SPF 306 mL in 1 TUBECREAM63
46783-110-15Journee Firm Riche Broad Spectrum Sunscreen SPF 301 in 1 CARTONCREAM13
46783-110-15Journee Firm Riche Broad Spectrum Sunscreen SPF 3015 mL in 1 BOTTLE, PLASTICCREAM153
46783-110-50Journee Firm Riche Broad Spectrum Sunscreen SPF 3050 mL in 1 BOTTLE, PLASTICCREAM503
46783-110-50Journee Firm Riche Broad Spectrum Sunscreen SPF 301 in 1 CARTONCREAM13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46783-110JOURNEE FIRM RICHE BROAD SPECTRUM SUNSCREEN SPF 30 (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [MERZ NORTH AMERICA, INC.]2Current NDC, 5 package rows20231025_d4d4bfcf-3674-4847-8ad8-1716a8e821ae.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 249 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Buildable BlurHOMOSALATE, OCTISALATE, ZINC OXIDECOSMAX USA, CORPORATION06c62206-d838-8d9a-e063-6394a90a4c692024-12-26WarningsExact identifier
application number: M020
Ulta Beauty Tinted Moisturizer Cream Spf 24 LightAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECosmax Usa, Corporationfbbff4eb-a63e-b083-e053-6294a90a404a2024-12-26WarningsExact identifier
application number: M020
Buildable BlurHOMOSALATE, OCTISALATE, ZINC OXIDECOSMAX USA, CORPORATION06c6035e-c179-b3e6-e063-6394a90a86cd2024-12-26WarningsExact identifier
application number: M020
Buildable BlurHOMOSALATE, OCTISALATE, ZINC OXIDECOSMAX USA, CORPORATION06c618ae-3d4d-8c87-e063-6394a90a53962024-12-26WarningsExact identifier
application number: M020
KOPARI Sun Shield Soft Glow Daily Face SPF30OCTISALATE, OCTOCRYLENE, AVOBENZONE, HOMOSALATECOSMAX USA, CORPORATION0d436d06-3f81-b4a6-e063-6294a90aa6352024-12-26WarningsExact identifier
application number: M020
NEORA Invisibloc Sunscreen Gel Broad Spectrum SPF40AVOBENZONE, HOMOSALATE, OCTISALATECOSMAX USA, CORPORATION0d584736-3f55-2542-e063-6294a90af3cf2024-12-26WarningsExact identifier
application number: M020
NARS Radiance Primer Broad Spectrum SPF 35 SunscreenOCTISALATE, OCTOCRYLENE, AVOBENZONE, HOMOSALATECOSMAX USA, CORPORATION0d59d9cb-c891-1097-e063-6394a90a806e2024-12-26WarningsExact identifier
application number: M020
KOPARI Sun Shield Soft Glow Daily Face SPF30OCTISALATE, OCTOCRYLENE, AVOBENZONE, HOMOSALATECOSMAX USA, CORPORATION0d3673da-822b-09e2-e063-6394a90a348e2024-12-26WarningsExact identifier
application number: M020
Buildable BlurHOMOSALATE, OCTISALATE, ZINC OXIDECOSMAX USA, CORPORATION06c61c42-eddb-1ebd-e063-6294a90aee132024-12-26WarningsExact identifier
application number: M020
GLOSSIER INVISIBLE SHIELD DAILY SUNSCREEN BROAD SPECTRUM SPF 35AVOBENZONE, HOMOSALATE, OCTISALATECOSMAX USA, CORPORATION0d438692-cd83-ea42-e063-6394a90a862d2024-12-26WarningsExact identifier
application number: M020
KOPARI Antioxidant Face Shield Mineral SPF 30ZINC OXIDECOSMAX USA, CORPORATION0d43e22c-5e3d-df90-e063-6294a90aac2b2024-12-26WarningsExact identifier
application number: M020
NORWEX Protect Prevent Mineral Facial Sunscreen Broad Spectrum SPF30TITANIUM DIOXIDE, ZINC OXIDECOSMAX USA, CORPORATION0d489154-6168-977e-e063-6394a90aa6092024-12-26WarningsExact identifier
application number: M020
Ulta Beauty Tinted Moisturizer Cream Spf 24 FairAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECosmax Usa, Corporationfbbfa61a-cbb4-3104-e053-6394a90a832f2024-12-26WarningsExact identifier
application number: M020
Ulta Beauty Tinted Moisturizer Cream Spf 24 Tan to darkAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECosmax Usa, Corporatione6c4b8eb-5aa3-49c2-af9e-eaf5fafb029c2024-12-26WarningsExact identifier
application number: M020
Ulta Beauty Tinted Moisturizer Cream Spf 24 Light to MediumAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECosmax Usa, Corporationfbc05ceb-2e6b-3c37-e053-6394a90ac4f42024-12-26WarningsExact identifier
application number: M020
Ulta Beauty Tinted Moisturizer Cream Spf 24 MediumAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECosmax Usa, Corporationfbc0ff10-fb2f-e637-e053-6294a90a0c292024-12-26WarningsExact identifier
application number: M020
Ulta Beauty Tinted Moisturizer Cream Spf 24 DeepAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECosmax Usa, Corporation2984c64f-eaac-ecb6-e063-6394a90aeb122024-12-26WarningsExact identifier
application number: M020
Ulta Beauty Tinted Moisturizer Cream Spf 24 TanAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECosmax Usa, Corporation2984a014-a56f-753b-e063-6294a90a13f52024-12-26WarningsExact identifier
application number: M020
Julep No Excuses Gel for Face SPF40AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECosmax Usa, Corporation298404c4-d4be-7395-e063-6294a90a86bf2024-12-26WarningsExact identifier
application number: M020
Cover FX Invisible Primer SPF30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECosmax Usa, Corporation2983dd7c-7ca7-e952-e063-6394a90a30982024-12-26WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
46783-110-06467830110066 mL in 1 TUBE (46783-110-06) 6 ml2023-03-15NoNoCurrent
46783-110-15467830110151 BOTTLE, PLASTIC in 1 CARTON (46783-110-15) / 15 mL in 1 BOTTLE, PLASTIC2023-03-15NoNoCurrent
46783-110-50467830110501 BOTTLE, PLASTIC in 1 CARTON (46783-110-50) / 50 mL in 1 BOTTLE, PLASTIC2023-03-152027-04-01NoNoHistorical