Home NDC 59958-408 Cream Oil Sunscreen
Product NDC 59958-408
11-digit product format 599580408
Labeler code 59958
Product ID 59958-408_2630ac67-a827-30c9-e063-6394a90a3561
Type HUMAN OTC DRUG
Nonproprietary name Zinc Oxide, Titanium Dioxide Sunscreen
Dosage form CREAM
Route TOPICAL
Labeler Owen Biosciences, Inc.
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2020-04-04
Substance ZINC OXIDE; TITANIUM DIOXIDE
Active strength 21; 1.25 g/100g; g/100g
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 Cream Oil Sunscreen
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ZINC OXIDE 21 g/100g TITANIUM DIOXIDE 1.25 g/100g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination SOI2LOH54Z Internal UNII lookup 15FIX9V2JP Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 59958-408-01 Cream Oil Sunscreen 50 g in 1 TUBE CREAM 50 4 59958-408-02 Cream Oil Sunscreen 1 in 1 CARTON CREAM 1 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 59958-408 CREAM OIL SUNSCREEN (ZINC OXIDE, TITANIUM DIOXIDE SUNSCREEN) CREAM [OWEN BIOSCIENCES, INC.] 4 Current NDC, Legacy NDC, 2 package rows 20241107_b2ccdfea-1c27-42af-b9d8-752e9f91ae87.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 27 of 354 · 7,077 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 59958-408-01 59958040801 50 g in 1 TUBE 50 g Historical 59958-408-02 59958040802 1 TUBE in 1 CARTON (59958-408-02) / 50 g in 1 TUBE (59958-408-01) 1 tube 2020-04-04 0000-00-00 No No Current