FDA.reportPublic FDA data

SPF 15

Product NDC
54473-174
11-digit product format
544730174
Labeler code
54473
Product ID
54473-174_22e7a4e4-595f-49e7-8380-ee3cce81200e
Type
HUMAN OTC DRUG
Nonproprietary name
TITANIUM DIOXIDE
Dosage form
POWDER
Route
TOPICAL
Labeler
Melaleuca, Inc.
Application
part352
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2010-09-15
Marketing end
0000-00-00
Substance
TITANIUM DIOXIDE
Active strength
1 g/10g
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
54473-174-012019-10-29C16284748780-1960f7f55-d157-8e05-e053-dbdaa90a074aLabel of Mineral Foundation Fair

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54473-174-01SPF 15Fair10 g in 1 CONTAINERPOWDER103

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TITANIUM DIOXIDEACTIVE INGREDIENT15FIX9V2JPSPF 15 FAIR (TITANIUM DIOXIDE) POWDER [MELALEUCA, INC.]3
TITANIUM DIOXIDEACTIVE MOIETY15FIX9V2JPSPF 15 FAIR (TITANIUM DIOXIDE) POWDER [MELALEUCA, INC.]3
ALPHA-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L0SPF 15 FAIR (TITANIUM DIOXIDE) POWDER [MELALEUCA, INC.]3
ASCORBYL PALMITATEINACTIVE INGREDIENTQN83US2B0NSPF 15 FAIR (TITANIUM DIOXIDE) POWDER [MELALEUCA, INC.]3
BISMUTH OXYCHLORIDEINACTIVE INGREDIENT4ZR792I587SPF 15 FAIR (TITANIUM DIOXIDE) POWDER [MELALEUCA, INC.]3
C12-15 ALKYL BENZOATEINACTIVE INGREDIENTA9EJ3J61HQSPF 15 FAIR (TITANIUM DIOXIDE) POWDER [MELALEUCA, INC.]3
CHLORPHENESININACTIVE INGREDIENTI670DAL4SZSPF 15 FAIR (TITANIUM DIOXIDE) POWDER [MELALEUCA, INC.]3
CHONDROITIN SULFATE (PORCINE)INACTIVE INGREDIENTV5E8ELO4W9SPF 15 FAIR (TITANIUM DIOXIDE) POWDER [MELALEUCA, INC.]3
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1OSPF 15 FAIR (TITANIUM DIOXIDE) POWDER [MELALEUCA, INC.]3
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675SPF 15 FAIR (TITANIUM DIOXIDE) POWDER [MELALEUCA, INC.]3
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTSPF 15 FAIR (TITANIUM DIOXIDE) POWDER [MELALEUCA, INC.]3
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357SPF 15 FAIR (TITANIUM DIOXIDE) POWDER [MELALEUCA, INC.]3
GLYCERININACTIVE INGREDIENTPDC6A3C0OXSPF 15 FAIR (TITANIUM DIOXIDE) POWDER [MELALEUCA, INC.]3
GLYCINEINACTIVE INGREDIENTTE7660XO1CSPF 15 FAIR (TITANIUM DIOXIDE) POWDER [MELALEUCA, INC.]3
HYALURONATE SODIUMINACTIVE INGREDIENTYSE9PPT4THSPF 15 FAIR (TITANIUM DIOXIDE) POWDER [MELALEUCA, INC.]3
HYALURONIC ACIDINACTIVE INGREDIENTS270N0TRQYSPF 15 FAIR (TITANIUM DIOXIDE) POWDER [MELALEUCA, INC.]3
KAOLININACTIVE INGREDIENT24H4NWX5COSPF 15 FAIR (TITANIUM DIOXIDE) POWDER [MELALEUCA, INC.]3
LECITHIN, SOYBEANINACTIVE INGREDIENT1DI56QDM62SPF 15 FAIR (TITANIUM DIOXIDE) POWDER [MELALEUCA, INC.]3
LYSINE HYDROCHLORIDEINACTIVE INGREDIENTJNJ23Q2COMSPF 15 FAIR (TITANIUM DIOXIDE) POWDER [MELALEUCA, INC.]3
MICAINACTIVE INGREDIENTV8A1AW0880SPF 15 FAIR (TITANIUM DIOXIDE) POWDER [MELALEUCA, INC.]3
ORNITHINE HYDROCHLORIDEINACTIVE INGREDIENTHBK84K66XHSPF 15 FAIR (TITANIUM DIOXIDE) POWDER [MELALEUCA, INC.]3
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TSPF 15 FAIR (TITANIUM DIOXIDE) POWDER [MELALEUCA, INC.]3
POTASSIUM SORBATEINACTIVE INGREDIENT1VPU26JZZ4SPF 15 FAIR (TITANIUM DIOXIDE) POWDER [MELALEUCA, INC.]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4SPF 15 FAIR (TITANIUM DIOXIDE) POWDER [MELALEUCA, INC.]3
SODIUM PYRROLIDONE CARBOXYLATEINACTIVE INGREDIENT469OTG57A2SPF 15 FAIR (TITANIUM DIOXIDE) POWDER [MELALEUCA, INC.]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPSPF 15 FAIR (TITANIUM DIOXIDE) POWDER [MELALEUCA, INC.]3
TREHALOSEINACTIVE INGREDIENTB8WCK70T7ISPF 15 FAIR (TITANIUM DIOXIDE) POWDER [MELALEUCA, INC.]3
TRIACETININACTIVE INGREDIENTXHX3C3X673SPF 15 FAIR (TITANIUM DIOXIDE) POWDER [MELALEUCA, INC.]3
UREAINACTIVE INGREDIENT8W8T17847WSPF 15 FAIR (TITANIUM DIOXIDE) POWDER [MELALEUCA, INC.]3
VITAMIN A PALMITATEINACTIVE INGREDIENT1D1K0N0VVCSPF 15 FAIR (TITANIUM DIOXIDE) POWDER [MELALEUCA, INC.]3
WATERINACTIVE INGREDIENT059QF0KO0RSPF 15 FAIR (TITANIUM DIOXIDE) POWDER [MELALEUCA, INC.]3
ZINC OXIDEINACTIVE INGREDIENTSOI2LOH54ZSPF 15 FAIR (TITANIUM DIOXIDE) POWDER [MELALEUCA, INC.]3
ZINC PIDOLATEINACTIVE INGREDIENTC32PQ86DH4SPF 15 FAIR (TITANIUM DIOXIDE) POWDER [MELALEUCA, INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54473-174SPF 15 FAIR (TITANIUM DIOXIDE) POWDER [MELALEUCA, INC.]3Legacy NDC, 1 package rows20101215_20c355ec-dbd0-4829-877d-64e83949e4ae.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
54473-174-015447301740110 g in 1 CONTAINER10 gHistorical