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 201 of 353 · 7,049 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dolce and Gabbana Everlast Foundation SPF 20 12N Light MediumOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.L26062cd7-3817-46c7-b65f-92cd57eca5dd2025-08-05WarningsExact identifier
application number: M020
Dolce and Gabbana Everlast Foundation SPF 20 13C Light MediumOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.L448a24a3-91ef-4530-828c-e77d8aae7f0b2025-08-05WarningsExact identifier
application number: M020
JORDAN FAT KIDS Tallow Sunscreen SPF 30MENTHOL, METHYL SALICYLATEJORDAN FAT KIDS LLC72ac88cf-9f20-44ea-b3a2-12c922eec2b32025-08-04WarningsExact identifier
application number: M020
Dolce and Gabbana Everlast Foundation SPF 20 02C LightOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.L09f9e59b-6f71-4d42-9b5d-275f756d985b2025-08-04WarningsExact identifier
application number: M020
Dolce and Gabbana Everlast Foundation SPF 20 03W LightOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.L3b1e4480-8409-425e-b98d-eb4dcf2471e82025-08-04WarningsExact identifier
application number: M020
Dolce and Gabbana Everlast Foundation SPF 20 06W LightOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.L3090422e-fc18-45b8-88f2-6a9b282a72052025-08-04WarningsExact identifier
application number: M020
Dolce and Gabbana Everlast Foundation SPF 20 05N LightOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.Lf93aa5d2-90ab-4e11-874e-2ede4b25c4b62025-08-04WarningsExact identifier
application number: M020
Dolce and Gabbana Everlast Foundation SPF 20 04C LightOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.Lf055cd51-7b1d-43df-8990-8f60ba1eb91c2025-08-04WarningsExact identifier
application number: M020
Dolce and Gabbana Everlast Foundation SPF 20 07N LightOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.Ld4c76bc5-205b-45fd-8a02-4f4b174585032025-08-04WarningsExact identifier
application number: M020
AHAVA Extreme Daily Firmness And Protection Broad Spectrum SPF30HOMOSALATE, OCTISALATE, AVOBENZONE, ENSULIZOLE, AND OCTOCRYLENEAHAVA Dead Sea Laboratories Ltdb22af9ef-4b69-4e70-a65d-f421e1d178af2025-08-01WarningsExact identifier
application number: M020
Neutrogena Collagen Bank SPF Moisturizer Broad Spectrum SPF 30 and Neutrogena Collagen Bank MoisturizerAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEKenvue Brands LLC3b4dbc5a-0754-0e71-e063-6394a90aa63c2025-08-01WarningsExact identifier
application number: M020
Kids Tallow Sunscreen SPF50NON-NANO ZINC OXIDE 25%FOUNDATION COMMERCE INC3b4eca91-965f-66c6-e063-6394a90a78ca2025-08-01WarningsExact identifier
application number: M020
Vigority Tallow Sunscreen SPF30NON-NANO ZINC OXIDE 19%FOUNDATION COMMERCE INC3b4f5941-15ae-a760-e063-6394a90a2abe2025-08-01WarningsExact identifier
application number: M020
Pipette Mineral Sunscreen SPF 50ZINC OXIDEPipette LLC3a10657a-bc16-181d-e063-6294a90a485b2025-08-01WarningsExact identifier
application number: M020
No7 Restore and Renew Face and Neck Multi Action Day Cream Sunscreen Broad Spectrum SPF 30AVOBENZONE, OCTISALATE, OCTOCRYLENEBCM Cosmetique SAS3f0500cc-013b-7069-e063-6294a90a1a5f2025-08-01WarningsExact identifier
application number: M020
Daily Antioxidant Mineral SunscreenZINC OXIDEMONIKA G KIRIPOLSKY MD INC.3b3d7ff2-1463-8d8e-e063-6394a90a5ac82025-07-31WarningsExact identifier
application number: M020
Shaklee Shield Sheer Mineral Body Sunscreen SPF 30ZINC OXIDEShaklee Corpc9b8e04c-11ee-4c4f-8693-aa4dc6e66aca2025-07-31WarningsExact identifier
application number: M020
Equate SUNSCREEN spf 50 SPORT broadspectrumAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEWalmart4e5280b2-1437-4d97-bb4c-db1a1632fea72025-07-31WarningsExact identifier
application number: M020
Tallow Sunscreen SPF 30NON-NANO ZINC OXIDE 19%FOUNDATION COMMERCE INC3b410ed7-c629-e39c-e063-6294a90a12f62025-07-31WarningsExact identifier
application number: M020
Face Reality Brilliant Defense Sunscreen SPF 50OCTOCRYLENE, HOMOSALATE, OCTISALATE, AVOBENZONEFace Reality,LLC618f58b7-2f29-4dff-8c3a-4fdbe1eb8ce42025-07-29WarningsExact 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