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 221 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lip Balm SPF15 VanillaLIP BALM SPF15 VANILLALS Promotions Inc312d0dc5-3933-ecfe-e063-6294a90a9b662025-03-25WarningsExact identifier
application number: M020
Lip Balm SPF15 Blueberry CobblerLIP BALM SPF15 BLUEBERRY COBBLERLS Promotions Inc312fb7b0-86a9-ca88-e063-6294a90a76c82025-03-25WarningsExact identifier
application number: M020
Lip Balm SPF15 PeppermintLIP BALM SPF15 PEPPERMINTLS Promotions Inc3130be1c-0167-2389-e063-6394a90aa61d2025-03-25WarningsExact identifier
application number: M020
Drs. pharmacy sunscreen SPF 30SUNSCREEN SPF 30OL PHARMA TECH LLC. (Drs. Pharmacy)052dea5d-a775-8dc2-e063-6294a90a4f192025-03-25WarningsExact identifier
application number: M020
Drs. pharmacy sunscreen SPF 50SUNSCREEN SPF 50OL PHARMA TECH LLC. (Drs. Pharmacy)0def5c19-b088-2ffb-e063-6394a90aa1092025-03-25WarningsExact identifier
application number: M020
Drs. pharmacy sunscreen SPF 70SUNSCREEN SPF 70OL PHARMA TECH LLC. (Drs. Pharmacy)0def6fa1-b028-fad5-e063-6394a90a19132025-03-25WarningsExact identifier
application number: M020
Halo Glow Skin Tint SPF50 -84521ZINC OXIDEe.l.f. Cosmetics, Inc.31329426-d952-ee5d-e063-6294a90a55f42025-03-25WarningsExact identifier
application number: M020
Halo Glow Skin Tint SPF50 -84520ZINC OXIDEe.l.f. Cosmetics, Inc.31328845-9a67-d237-e063-6294a90a2a7f2025-03-25WarningsExact identifier
application number: M020
Halo Glow Skin Tint SPF50 -84519ZINC OXIDEe.l.f. Cosmetics, Inc.31327ea3-affd-ca13-e063-6294a90a72382025-03-25WarningsExact identifier
application number: M020
Halo Glow Skin Tint SPF50 -84517ZINC OXIDEe.l.f. Cosmetics, Inc.3132641a-e593-a9e8-e063-6294a90acc802025-03-25WarningsExact identifier
application number: M020
Halo Glow Skin Tint SPF50 -84518ZINC OXIDEe.l.f. Cosmetics, Inc.3132669c-e104-ae1e-e063-6294a90aee7f2025-03-25WarningsExact identifier
application number: M020
Halo Glow Skin Tint SPF 50 84514ZINC OXIDEe.l.f. Cosmetics, Inc.31324410-3142-89e1-e063-6294a90a22ee2025-03-25WarningsExact identifier
application number: M020
Halo Glow Skin Tint SPF 50 84515ZINC OXIDEe.l.f. Cosmetics, Inc.31324ff6-a091-a51b-e063-6294a90a1dbb2025-03-25WarningsExact identifier
application number: M020
Halo Glow Skin Tint SPF 50 84513ZINC OXIDEe.l.f. Cosmetics, Inc.3131d155-4c23-db51-e063-6294a90a00192025-03-25WarningsExact identifier
application number: M020
Halo Glow Skin Tint SPF50-84505ZINC OXIDEe.l.f. Cosmetics, Inc.312d171d-b057-96d1-e063-6394a90ac4292025-03-25WarningsExact identifier
application number: M020
Halo Glow Skin Tint SPF 50 84511ZINC OXIDEe.l.f. Cosmetics, Inc.313175f3-e42a-b2a7-e063-6294a90abcb72025-03-25WarningsExact identifier
application number: M020
Halo Glow Skin Tint SPF 50 84510ZINC OXIDEe.l.f. Cosmetics, Inc.3131696a-a37a-908b-e063-6294a90a5e952025-03-25WarningsExact identifier
application number: M020
Halo Glow Skin Tint SPF 50 84512ZINC OXIDEe.l.f. Cosmetics, Inc.31318380-79fe-c0e0-e063-6294a90af4fc2025-03-25WarningsExact identifier
application number: M020
Halo Glow Skin Tint SPF 50 84508ZINC OXIDEe.l.f. Cosmetics, Inc.3131512e-f97b-718e-e063-6294a90aa3c12025-03-25WarningsExact identifier
application number: M020
Halo Glow Skin Tint SPF 50 84509ZINC OXIDEe.l.f. Cosmetics, Inc.313147bc-0095-7cbd-e063-6294a90a7d282025-03-25WarningsExact 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