Prime Protection Sunscreen non tinted

Product NDC
85641-202
11-digit product format
856410202
Labeler code
85641
Product ID
85641-202_45c7395f-5c91-d388-e063-6294a90a1e29
Type
HUMAN OTC DRUG
Nonproprietary name
Titanium Dioxide, Zinc Oxide
Dosage form
CREAM
Route
TOPICAL
Labeler
KRISTI REDD ESTHETICS
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-04-21
Substance
TITANIUM DIOXIDE; ZINC OXIDE
Active strength
80; 38 mg/g; mg/g
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 formatDescriptionUnitsMarketing startSampleExclude flagStatus
85641-202-508564102025053 g in 1 BOTTLE, PUMP (85641-202-50) 53 g2021-04-21NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Prime Protection Sunscreen non tintedKRISTI REDD ESTHETICS | Custom Analytics LLC | Fragrance Manufacturing INC | Fallien Cosmeceuticals Ltd.2025-12-12HUMAN OTC DRUG LABEL2