HARD CANDY CORRECTION CREME- octinoxate and octisalate cream 
Xtreme Color Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Hard Candy Correction Creme
Broad Spectrum SPF-15

For external use only.

Do not use on damaged or broken skin.

When using this product keep out of eyes.

Rinse with water to remove.

Stop use and ask a doctor if rash occurs.

Folding Carton Artwork.jpg

Folding Carton Artwork.jpg

HARD CANDY CORRECTION CREME 
octinoxate, octisalate cream
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:58875-101
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (OCTINOXATE) Octinoxate2.55 g  in 42.5 g
OCTISALATE (OCTISALATE) OCTISALATE1.7 g  in 42.5 g
Inactive Ingredients
Ingredient NameStrength
DIMETHICONE5.15525 g  in 42.5 g
HYDROGENATED POLYDECENE (550 MW)2.55425 g  in 42.5 g
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5)1.27925 g  in 42.5 g
FERROSOFERRIC OXIDE1.1333 g  in 42.5 g
TITANIUM DIOXIDE0.189 g  in 42.5 g
FERRIC OXIDE RED1.1333 g  in 42.5 g
FERRIC OXIDE YELLOW1.1333 g  in 42.5 g
SILICA DIMETHYL SILYLATE0.0425 g  in 42.5 g
SILICON DIOXIDE1.0115 g  in 42.5 g
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS)0.85 g  in 42.5 g
TRIBEHENIN2.89425 g  in 42.5 g
CYCLOMETHICONE 52.171113 g  in 42.5 g
DISTEARDIMONIUM HECTORITE0.255425 g  in 42.5 g
PROPYLENE CARBONATE0.127713 g  in 42.5 g
.ALPHA.-TOCOPHEROL ACETATE0.0425 g  in 42.5 g
PHENOXYETHANOL0.17595 g  in 42.5 g
SORBIC ACID0.02125 g  in 42.5 g
CAPRYLYL GLYCOL0.1428 g  in 42.5 g
ISODODECANE1.70425 g  in 42.5 g
WATER13.68625 g  in 42.5 g
GLYCERIN1.27925 g  in 42.5 g
SODIUM CHLORIDE0.425 g  in 42.5 g
MICA0.195 g  in 42.5 g
CHROMIC OXIDE.006 g  in 42.5 g
FERRIC FERROCYANIDE.001 g  in 42.5 g
CARMINIC ACID.003 g  in 42.5 g
SODIUM STEAROYL LACTYLATE0.425 g  in 42.5 g
STEARETH-20.2125 g  in 42.5 g
Product Characteristics
ColorbrownScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58875-101-0142.5 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35206/12/2013
Labeler - Xtreme Color Inc. (628045858)
Establishment
NameAddressID/FEIBusiness Operations
NuWorld Corporation628045858manufacture(58875-101), pack(58875-101), label(58875-101)

Revised: 8/2013
Document Id: e0dd7b3f-fd21-4e0d-94a2-8603b38c9442
Set id: a3d06086-2c4c-44d4-a242-f452d163cb9f
Version: 1
Effective Time: 20130827
 
Xtreme Color Inc.