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 Type HUMAN OTC DRUG Item Code (Source) NDC:58875-101
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Octinoxate (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) Octinoxate 2.55 g  in 42.5 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 1.7 g  in 42.5 g
Inactive Ingredients
Ingredient Name Strength
DIMETHICONE (UNII: 92RU3N3Y1O) 5.15525 g  in 42.5 g
HYDROGENATED POLYDECENE (550 MW) (UNII: U333RI6EB7) 2.55425 g  in 42.5 g
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) (UNII: 035JKJ76MT) 1.27925 g  in 42.5 g
FERROSOFERRIC OXIDE (UNII: XM0M87F357) 1.1333 g  in 42.5 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) 0.189 g  in 42.5 g
FERRIC OXIDE RED (UNII: 1K09F3G675) 1.1333 g  in 42.5 g
FERRIC OXIDE YELLOW (UNII: EX438O2MRT) 1.1333 g  in 42.5 g
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W) 0.0425 g  in 42.5 g
SILICON DIOXIDE (UNII: ETJ7Z6XBU4) 1.0115 g  in 42.5 g
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) 0.85 g  in 42.5 g
TRIBEHENIN (UNII: 8OC9U7TQZ0) 2.89425 g  in 42.5 g
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) 2.171113 g  in 42.5 g
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) 0.255425 g  in 42.5 g
PROPYLENE CARBONATE (UNII: 8D08K3S51E) 0.127713 g  in 42.5 g
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) 0.0425 g  in 42.5 g
PHENOXYETHANOL (UNII: HIE492ZZ3T) 0.17595 g  in 42.5 g
SORBIC ACID (UNII: X045WJ989B) 0.02125 g  in 42.5 g
CAPRYLYL GLYCOL (UNII: 00YIU5438U) 0.1428 g  in 42.5 g
ISODODECANE (UNII: A8289P68Y2) 1.70425 g  in 42.5 g
WATER (UNII: 059QF0KO0R) 13.68625 g  in 42.5 g
GLYCERIN (UNII: PDC6A3C0OX) 1.27925 g  in 42.5 g
SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.425 g  in 42.5 g
MICA (UNII: V8A1AW0880) 0.195 g  in 42.5 g
CHROMIC OXIDE (UNII: X5Z09SU859) .006 g  in 42.5 g
FERRIC FERROCYANIDE (UNII: TLE294X33A) .001 g  in 42.5 g
CARMINIC ACID (UNII: CID8Z8N95N) .003 g  in 42.5 g
SODIUM STEAROYL LACTYLATE (UNII: IN99IT31LN) 0.425 g  in 42.5 g
STEARETH-2 (UNII: V56DFE46J5) 0.2125 g  in 42.5 g
Product Characteristics
Color brown Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:58875-101-01 42.5 g in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 06/12/2013
Labeler - Xtreme Color Inc. (628045858)
Establishment
Name Address ID/FEI Business Operations
NuWorld Corporation 628045858 manufacture(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.