FDA.reportPublic FDA data

Thu Brule Free Spirit Correct and Protect

Manufacturer
Laughing Buddha LLC
Effective date
2025-11-14
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:16:00

Label at a glance#

ProductThu Brule Free Spirit Correct and Protect
Active ingredientZINC OXIDE, TITANIUM DIOXIDE
Label structure8 sections

Label contents#

Full prescribing information#

Thu Brule Free Spirit Correct and Protect

DOSAGE & ADMINISTRATION SECTION

Dosage and AdministrationDosage and Administration

Thu Brule Free Spirit Correct and Protect

INACTIVE INGREDIENT SECTION

Inactive ingredientsInactive ingredients

Thu Brule Free Spirit Correct and Protect

INDICATIONS & USAGE SECTION

Indications & usageIndications & usage

Thu Brule Free Spirit Correct and Protect

OTC - ACTIVE INGREDIENT SECTION

Active IngredientsActive Ingredients

Thu Brule Free Spirit Correct and Protect

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

keep out of reach of childrenkeep out of reach of children

Thu Brule Free Spirit Correct and Protect

OTC - PURPOSE SECTION

purposepurpose

Thu Brule Free Spirit Correct and Protect

WARNINGS SECTION

Warning LabelWarning Label

Thu Brule Free Spirit Correct and Protect

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PDPPDP

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

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 38 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83859-040083859-0400-1, 83859-0400-2, 83859-0400-3, 83859-0400-4

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 36 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCERINPDC6A3C0OXIACT
CETETH-20I835H2IHHXIACT
RUTTNERA LAMELLOSA OIL5XZ38R4SUTIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
POLYESTER-70841698D2FIACT
LECITHIN, SOYBEAN1DI56QDM62IACT
SODIUM ASCORBATES033EH8359IACT
TOCOPHEROLR0ZB2556P8IACT
PULLULAN8ZQ0AYU1TTIACT
CAPRYLYL GLYCOL00YIU5438UIACT
XANTHAN GUMTTV12P4NEEIACT
NEOPENTYL GLYCOL DIHEPTANOATE5LKW3C543XIACT
PHENOXYETHANOLHIE492ZZ3TIACT
.ALPHA.-BISABOLOL, (+)-105S6I733ZIACT
ALLANTOIN344S277G0ZIACT
TRICETEARETH-4 PHOSPHATE69534Y66NOIACT
STEARETH-20L0Q8IK9E08IACT
HEXYLENE GLYCOLKEH0A3F75JIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
SODIUM CITRATE1Q73Q2JULRIACT
ZINC OXIDESOI2LOH54ZACTIB
DIMETHICONOL/PROPYLSILSESQUIOXANE/SILICATE CROSSPOLYMER (450000000 MW)9KB5R958PBIACT
TITANIUM DIOXIDE15FIX9V2JPACTIB
ETHYLHEXYL ISONONANOATEI6KB4GE3K4IACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
DICRATERIA ROTUNDA OILZ0DWU9R4GMIACT
FERRIC OXIDE RED1K09F3G675IACT
OCTYLDODECYL NEOPENTANOATEX8725R883TIACT
SQUALANEGW89575KF9IACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
PEG-75 STEARATEOT38R0N74HIACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
TRILAURETH-4 PHOSPHATEM96W2OLL2VIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
WATER059QF0KO0RIACT
CETYL ALCOHOL936JST6JCNIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Thu Brule Free Spirit Correct and ProtectTITANIUM DIOXIDE, ZINC OXIDELaughing Buddha LLC258a4f97-d811-0521-e063-6394a90aaf3b2025-11-14WarningsExact identifier
ndc (package): 83859-0400-1
ndc (package): 83859-0400-4
ndc (package): 83859-0400-2
ndc (package): 83859-0400-3
ndc (product): 83859-0400
ndc11 (package): 83859040001
ndc11 (package): 83859040004
ndc11 (package): 83859040002
ndc11 (package): 83859040003
spl id: 43908151-b168-fd7c-e063-6294a90a142f
spl set id: 258a4f97-d811-0521-e063-6394a90aaf3b

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.