Home NDC 85339-203 SPF 40 Broad Spectrum
Product NDC 85339-203
11-digit product format 853390203
Labeler code 85339
Product ID 85339-203_45b3a342-878a-6db5-e063-6294a90aa648
Type HUMAN OTC DRUG
Nonproprietary name Titanium Dioxide, Zinc Oxide
Dosage form CREAM
Route TOPICAL
Labeler Teton Dermatology Holdings, Inc.
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-10-27
Substance ZINC OXIDE; TITANIUM DIOXIDE
Active strength 38; 80 mg/g; mg/g
NDC exclude flag No
Listing certified through 2026-12-31
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 SPF 40 Broad Spectrum
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ZINC OXIDE 38 mg/g TITANIUM DIOXIDE 80 mg/g
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 85339-203-50 SPF 40 Broad Spectrum 53 g in 1 BOTTLE, PUMP CREAM 53 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 85339-203 SPF 40 BROAD SPECTRUM (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [TETON DERMATOLOGY HOLDINGS, INC.] 1 Current NDC, 1 package rows 20250515_35081ce0-2203-ab86-e063-6294a90aefd5.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 26 of 357 · 7,139 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 85339-203-50 85339020350 53 g in 1 BOTTLE, PUMP (85339-203-50) 53 g 2023-10-27 No No Current