Thu Brule Free Spirit Correct and Protect

Product NDC
83859-0400
11-digit product format
838590400
Labeler code
83859
Product ID
83859-0400_43908151-b168-fd7c-e063-6294a90a142f
Type
HUMAN OTC DRUG
Nonproprietary name
Titanium Dioxide, Zinc Oxide
Dosage form
LOTION
Route
TOPICAL
Labeler
Laughing Buddha LLC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-07-23
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 formatDescriptionUnitsMarketing startSampleExclude flagStatus
83859-0400-2838590400021 BOTTLE in 1 CARTON (83859-0400-2) / 50 mL in 1 BOTTLE (83859-0400-1) 1 bottle2024-07-23NoNoHistorical
83859-0400-4838590400041 BOTTLE in 1 CARTON (83859-0400-4) / 10 mL in 1 BOTTLE (83859-0400-3) 1 bottle2024-07-23NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Thu Brule Free Spirit Correct and ProtectLaughing Buddha LLC2025-11-14HUMAN OTC DRUG LABEL3