Home NDC 83510-400 Ware Sonny Universal
Product NDC 83510-400
11-digit product format 835100400
Labeler code 83510
Product ID 83510-400_43906087-7f16-b1d1-e063-6294a90a7395
Type HUMAN OTC DRUG
Nonproprietary name Titanium dioxide, Zinc Oxide
Dosage form LOTION
Route TOPICAL
Labeler Ware Cosmetics
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-05-08
Substance ZINC OXIDE; TITANIUM DIOXIDE
Active strength 9.7; 19.4 mg/mL; mg/mL
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 Ware Sonny Universal
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ZINC OXIDE 9.7 mg/mL TITANIUM DIOXIDE 19.4 mg/mL
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 83510-400-01 Ware Sonny Universal 30 mL in 1 BOTTLE, PUMP LOTION 30 4 83510-400-02 Ware Sonny Universal 1 in 1 CARTON LOTION 1 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 83510-400 WARE SONNY UNIVERSAL (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [WARE COSMETICS] 2 Current NDC, 2 package rows 20241009_fe2b9d16-9215-e21e-e053-6394a90a5156.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 83510-400-01 83510040001 30 mL in 1 BOTTLE, PUMP 30 ml Historical 83510-400-02 83510040002 1 BOTTLE, PUMP in 1 CARTON (83510-400-02) / 30 mL in 1 BOTTLE, PUMP (83510-400-01) 2023-05-08 No No Current