Hard Candy Correction Creme

Product NDC
58875-101
11-digit product format
588750101
Labeler code
58875
Product ID
58875-101_e0dd7b3f-fd21-4e0d-94a2-8603b38c9442
Type
HUMAN OTC DRUG
Nonproprietary name
Octinoxate, Octisalate
Dosage form
CREAM
Route
TOPICAL
Labeler
Xtreme Color Inc.
Application
part352
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2013-06-12
Marketing end
0000-00-00
Substance
OCTINOXATE; OCTISALATE
Active strength
3 g/42.5g; g/42.5g
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58875-101-012019-11-27C16284748780-19855d018-ee40-cd31-e053-dbdaa90ab51aHard Candy Correction Creme Broad Spectrum SPF-15

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58875-101-01Hard Candy Correction Creme42.5 g in 1 TUBECREAM42.51

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OctinoxateACTIVE INGREDIENT4Y5P7MUD51HARD CANDY CORRECTION CREME (OCTINOXATE, OCTISALATE) CREAM [XTREME COLOR INC.]1
OCTISALATEACTIVE INGREDIENT4X49Y0596WHARD CANDY CORRECTION CREME (OCTINOXATE, OCTISALATE) CREAM [XTREME COLOR INC.]1
OCTINOXATEACTIVE MOIETY4Y5P7MUD51HARD CANDY CORRECTION CREME (OCTINOXATE, OCTISALATE) CREAM [XTREME COLOR INC.]1
OCTISALATEACTIVE MOIETY4X49Y0596WHARD CANDY CORRECTION CREME (OCTINOXATE, OCTISALATE) CREAM [XTREME COLOR INC.]1
.ALPHA.-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L0HARD CANDY CORRECTION CREME (OCTINOXATE, OCTISALATE) CREAM [XTREME COLOR INC.]1
CAPRYLYL GLYCOLINACTIVE INGREDIENT00YIU5438UHARD CANDY CORRECTION CREME (OCTINOXATE, OCTISALATE) CREAM [XTREME COLOR INC.]1
CARMINIC ACIDINACTIVE INGREDIENTCID8Z8N95NHARD CANDY CORRECTION CREME (OCTINOXATE, OCTISALATE) CREAM [XTREME COLOR INC.]1
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5)INACTIVE INGREDIENT035JKJ76MTHARD CANDY CORRECTION CREME (OCTINOXATE, OCTISALATE) CREAM [XTREME COLOR INC.]1
CHROMIC OXIDEINACTIVE INGREDIENTX5Z09SU859HARD CANDY CORRECTION CREME (OCTINOXATE, OCTISALATE) CREAM [XTREME COLOR INC.]1
CYCLOMETHICONE 5INACTIVE INGREDIENT0THT5PCI0RHARD CANDY CORRECTION CREME (OCTINOXATE, OCTISALATE) CREAM [XTREME COLOR INC.]1
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1OHARD CANDY CORRECTION CREME (OCTINOXATE, OCTISALATE) CREAM [XTREME COLOR INC.]1
DISTEARDIMONIUM HECTORITEINACTIVE INGREDIENTX687XDK09LHARD CANDY CORRECTION CREME (OCTINOXATE, OCTISALATE) CREAM [XTREME COLOR INC.]1
FERRIC FERROCYANIDEINACTIVE INGREDIENTTLE294X33AHARD CANDY CORRECTION CREME (OCTINOXATE, OCTISALATE) CREAM [XTREME COLOR INC.]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675HARD CANDY CORRECTION CREME (OCTINOXATE, OCTISALATE) CREAM [XTREME COLOR INC.]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTHARD CANDY CORRECTION CREME (OCTINOXATE, OCTISALATE) CREAM [XTREME COLOR INC.]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357HARD CANDY CORRECTION CREME (OCTINOXATE, OCTISALATE) CREAM [XTREME COLOR INC.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXHARD CANDY CORRECTION CREME (OCTINOXATE, OCTISALATE) CREAM [XTREME COLOR INC.]1
HYDROGENATED POLYDECENE (550 MW)INACTIVE INGREDIENTU333RI6EB7HARD CANDY CORRECTION CREME (OCTINOXATE, OCTISALATE) CREAM [XTREME COLOR INC.]1
ISODODECANEINACTIVE INGREDIENTA8289P68Y2HARD CANDY CORRECTION CREME (OCTINOXATE, OCTISALATE) CREAM [XTREME COLOR INC.]1
MICAINACTIVE INGREDIENTV8A1AW0880HARD CANDY CORRECTION CREME (OCTINOXATE, OCTISALATE) CREAM [XTREME COLOR INC.]1
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3THARD CANDY CORRECTION CREME (OCTINOXATE, OCTISALATE) CREAM [XTREME COLOR INC.]1
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS)INACTIVE INGREDIENT59Z907ZB69HARD CANDY CORRECTION CREME (OCTINOXATE, OCTISALATE) CREAM [XTREME COLOR INC.]1
PROPYLENE CARBONATEINACTIVE INGREDIENT8D08K3S51EHARD CANDY CORRECTION CREME (OCTINOXATE, OCTISALATE) CREAM [XTREME COLOR INC.]1
SILICA DIMETHYL SILYLATEINACTIVE INGREDIENTEU2PSP0G0WHARD CANDY CORRECTION CREME (OCTINOXATE, OCTISALATE) CREAM [XTREME COLOR INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4HARD CANDY CORRECTION CREME (OCTINOXATE, OCTISALATE) CREAM [XTREME COLOR INC.]1
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XHARD CANDY CORRECTION CREME (OCTINOXATE, OCTISALATE) CREAM [XTREME COLOR INC.]1
SODIUM STEAROYL LACTYLATEINACTIVE INGREDIENTIN99IT31LNHARD CANDY CORRECTION CREME (OCTINOXATE, OCTISALATE) CREAM [XTREME COLOR INC.]1
SORBIC ACIDINACTIVE INGREDIENTX045WJ989BHARD CANDY CORRECTION CREME (OCTINOXATE, OCTISALATE) CREAM [XTREME COLOR INC.]1
STEARETH-2INACTIVE INGREDIENTV56DFE46J5HARD CANDY CORRECTION CREME (OCTINOXATE, OCTISALATE) CREAM [XTREME COLOR INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPHARD CANDY CORRECTION CREME (OCTINOXATE, OCTISALATE) CREAM [XTREME COLOR INC.]1
TRIBEHENININACTIVE INGREDIENT8OC9U7TQZ0HARD CANDY CORRECTION CREME (OCTINOXATE, OCTISALATE) CREAM [XTREME COLOR INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RHARD CANDY CORRECTION CREME (OCTINOXATE, OCTISALATE) CREAM [XTREME COLOR INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58875-101HARD CANDY CORRECTION CREME (OCTINOXATE, OCTISALATE) CREAM [XTREME COLOR INC.]1Legacy NDC, 1 package rows20130917_a3d06086-2c4c-44d4-a242-f452d163cb9f.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
58875-101-015887501010142.5 g in 1 TUBE42.5 gHistorical