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

Additional Listing Data#

Finished product
Yes
Brand name base
Thu Brule Free Spirit Correct and Protect
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TITANIUM DIOXIDE19.4 mg/mL
ZINC OXIDE9.7 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii15FIX9V2JP, SOI2LOH54Z

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83859-0400-1Thu Brule Free Spirit Correct and Protect50 mL in 1 BOTTLELOTION503
83859-0400-2Thu Brule Free Spirit Correct and Protect1 in 1 CARTONLOTION13
83859-0400-3Thu Brule Free Spirit Correct and Protect10 mL in 1 BOTTLELOTION103
83859-0400-4Thu Brule Free Spirit Correct and Protect1 in 1 CARTONLOTION13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83859-0400THU BRULE FREE SPIRIT CORRECT AND PROTECT (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [LAUGHING BUDDHA LLC]1Current NDC, 4 package rows20241030_258a4f97-d811-0521-e063-6394a90aaf3b.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83859-0400-18385904000150 mL in 1 BOTTLE50 mlHistorical
83859-0400-2838590400021 BOTTLE in 1 CARTON (83859-0400-2) / 50 mL in 1 BOTTLE (83859-0400-1) 1 bottle2024-07-23NoNoCurrent
83859-0400-38385904000310 mL in 1 BOTTLE10 mlHistorical
83859-0400-4838590400041 BOTTLE in 1 CARTON (83859-0400-4) / 10 mL in 1 BOTTLE (83859-0400-3) 1 bottle2024-07-23NoNoCurrent