Protectif Untinted

Product NDC
82038-007
11-digit product format
820380007
Labeler code
82038
Product ID
82038-007_1acd3232-7d83-8f27-e063-6294a90a0fb4
Type
HUMAN OTC DRUG
Nonproprietary name
Zinc Oxide and Titanium Dioxide
Dosage form
CREAM
Route
TOPICAL
Labeler
Derma Research Group Inc.
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-05-17
Substance
TITANIUM DIOXIDE; ZINC OXIDE
Active strength
6.5; 8.6 g/100g; g/100g
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
82038-007-02820380007021 BOTTLE, PUMP in 1 CARTON (82038-007-02) / 100 g in 1 BOTTLE, PUMP (82038-007-01) 2024-05-17NoNoHistorical
82038-007-04820380007041 BOTTLE, PUMP in 1 CARTON (82038-007-04) / 30 g in 1 BOTTLE, PUMP (82038-007-03) 2024-05-17NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Drug FactsDerma Research Group Inc.2024-06-13HUMAN OTC DRUG LABEL1