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
TITANIUM DIOXIDE; ZINC OXIDE
Active strength
19.4; 9.7 mg/mL; mg/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
15FIX9V2JPTITANIUM DIOXIDE13463-67-7TITANIUM DIOXIDE
SOI2LOH54ZZINC OXIDE1314-13-2ZINC OXIDE

Packages

Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
83510-400-02835100400021 BOTTLE, PUMP in 1 CARTON (83510-400-02) / 30 mL in 1 BOTTLE, PUMP (83510-400-01) 2023-05-08NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Ware Sonny UniversalWare Cosmetics2025-11-14HUMAN OTC DRUG LABEL4