Mineral Sunscreen SPF-30

Product NDC
83387-399
11-digit product format
833870399
Labeler code
83387
Product ID
83387-399_09769ae3-d1b1-e2dd-e063-6294a90a1f64
Type
HUMAN OTC DRUG
Nonproprietary name
TITANIUM DIOXIDE, ZINC OXIDE
Dosage form
LIQUID
Route
TOPICAL
Labeler
NEWCO LLC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-04-17
Substance
TITANIUM DIOXIDE; ZINC OXIDE
Active strength
60; 60 mg/mL; mg/mL
Pharmacologic classes
Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
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
83387-399-0083387039900177 mL in 1 BOTTLE, SPRAY (83387-399-00) 177 ml2023-04-17NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
ELIXIR Mineral Sunscreen Spray SPF-30NEWCO LLC2023-11-06HUMAN OTC DRUG LABEL2