Label: HARD CANDY CORRECTION CREME- octinoxate and octisalate cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated 08/13

If you are a consumer or patient please visit this version.

  • WARNINGS AND PRECAUTIONS

    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.

    Close
  • Folding Carton Artwork.jpg
  • INGREDIENTS AND APPEARANCE
    HARD CANDY CORRECTION CREME 
    octinoxate, octisalate cream
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:58875-101
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Octinoxate (OCTINOXATE) Octinoxate 2.55 g  in 42.5 g
    OCTISALATE (OCTISALATE) OCTISALATE 1.7 g  in 42.5 g
    Inactive Ingredients
    Ingredient Name Strength
    DIMETHICONE 5.15525 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 OXIDE 1.1333 g  in 42.5 g
    TITANIUM DIOXIDE 0.189 g  in 42.5 g
    FERRIC OXIDE RED 1.1333 g  in 42.5 g
    FERRIC OXIDE YELLOW 1.1333 g  in 42.5 g
    SILICA DIMETHYL SILYLATE 0.0425 g  in 42.5 g
    SILICON DIOXIDE 1.0115 g  in 42.5 g
    POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) 0.85 g  in 42.5 g
    TRIBEHENIN 2.89425 g  in 42.5 g
    CYCLOMETHICONE 5 2.171113 g  in 42.5 g
    DISTEARDIMONIUM HECTORITE 0.255425 g  in 42.5 g
    PROPYLENE CARBONATE 0.127713 g  in 42.5 g
    .ALPHA.-TOCOPHEROL ACETATE 0.0425 g  in 42.5 g
    PHENOXYETHANOL 0.17595 g  in 42.5 g
    SORBIC ACID 0.02125 g  in 42.5 g
    CAPRYLYL GLYCOL 0.1428 g  in 42.5 g
    ISODODECANE 1.70425 g  in 42.5 g
    WATER 13.68625 g  in 42.5 g
    GLYCERIN 1.27925 g  in 42.5 g
    SODIUM CHLORIDE 0.425 g  in 42.5 g
    MICA 0.195 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 LACTYLATE 0.425 g  in 42.5 g
    STEARETH-2 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)
    Close