Home NDC 59958-202 SFL SUNSCREEN - SOL DEFENSE
Product NDC 59958-202
11-digit product format 599580202
Labeler code 59958
Product ID 59958-202_c7189101-10fc-167d-e053-2a95a90a7724
Type HUMAN OTC DRUG
Nonproprietary name Titanium Dioxide, Zinc Oxide
Dosage form CREAM
Route TOPICAL
Labeler Owen Biosciences Inc.
Application part352
Marketing category OTC MONOGRAPH FINAL
Marketing start 2012-09-11
Marketing end 0000-00-00
Substance TITANIUM DIOXIDE; ZINC OXIDE
Active strength 10 g/100g; g/100g
NDC exclude flag No
Listing certified through 2022-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 2 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 59958-202 U Excluded because listing certification expired excluded / ndc_excluded.zip 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 59958-202 59958-202-20 U Excluded because listing certification expired excluded / ndc_excluded.zip 0efc9e666f02…f202fb6c5f17…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 59958-202-20 SFL SUNSCREEN - SOL DEFENSESPF 30 60 g in 1 TUBE CREAM 60 7
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Titanium Dioxide ACTIVE INGREDIENT 15FIX9V2JP SFL SUNSCREEN - SOL DEFENSE SPF 30 (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [OWEN BIOSCIENCES, INC.] 1 Zinc Oxide ACTIVE INGREDIENT SOI2LOH54Z SFL SUNSCREEN - SOL DEFENSE SPF 30 (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [OWEN BIOSCIENCES, INC.] 1 Titanium Dioxide ACTIVE MOIETY 15FIX9V2JP SFL SUNSCREEN - SOL DEFENSE SPF 30 (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [OWEN BIOSCIENCES, INC.] 1 Zinc Oxide ACTIVE MOIETY SOI2LOH54Z SFL SUNSCREEN - SOL DEFENSE SPF 30 (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [OWEN BIOSCIENCES, INC.] 1 Cyclomethicone INACTIVE INGREDIENT NMQ347994Z SFL SUNSCREEN - SOL DEFENSE SPF 30 (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [OWEN BIOSCIENCES, INC.] 1 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 SFL SUNSCREEN - SOL DEFENSE SPF 30 (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [OWEN BIOSCIENCES, INC.] 1 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT SFL SUNSCREEN - SOL DEFENSE SPF 30 (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [OWEN BIOSCIENCES, INC.] 1 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 SFL SUNSCREEN - SOL DEFENSE SPF 30 (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [OWEN BIOSCIENCES, INC.] 1 Tribehenin INACTIVE INGREDIENT 8OC9U7TQZ0 SFL SUNSCREEN - SOL DEFENSE SPF 30 (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [OWEN BIOSCIENCES, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 59958-202 SFL SUNSCREEN - SOL DEFENSE SPF 30 (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [OWEN BIOSCIENCES INC.] 7 Legacy NDC, 1 package rows 20250112_4382d55d-1463-41e3-9805-4125055b2e42.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 59958-202-20 59958020220 60 g in 1 TUBE (59958-202-20) 60 g 2012-09-11 0000-00-00 No No Current