Label: SUPER CC COLOR CORRECTION CARE PRIMER STICK SPF 30- octinoxate, octocrylene, oxybenzone,titanium dioxide, zinc oxide stick

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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.

Drug Label Information

Updated January 20, 2016

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  • Active ingredients

    Octinoxate 5.6%, Titanium Dioxide 5.2%

    Octocrylene 4.2% Zinc Oxide 4.0%

    Oxybenzone 5.1%

  • Purpose

    Sunscreen

  • Use

    Helps prevent Sunburn. If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

  • Warnings

    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

  • Keep out of reach of children

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    ▪ Apply liberally 15 minutes before sun exposure

    ▪ Use a water resistant sunscreen if swimming or sweating ▪ Reapply:

    ▪ Immediately after towel drying • At least every 2 hours • Sun Protection

    Measures. Spending time in the sun increases your risk of skin cancer

    and early skin aging. To decrease this risk, regularly use a sunscreen with

    a broad spectrum SPF of 15 or higher and other sun protection measures

    including: ▪ Limit time in sun, especially from 10 a.m.- 2 p.m.

    ▪ Wear long-sleeve shirts, pants, hats, and sunglasses ▪ Children under

    6 months: Ask a doctor

  • Inactive Ingredients

    Ethylhexyl Palmitate, Silica, Caprylic/Capric, Triglyceride, Triisotridecyl Trimellitate, C12-15 Alkyl Benzoate, Hydrogenated Microcrystalline Wax, HDI/Trimethylol Hexyllactone Crosspolymer, Aluminum Starch Octenylsuccinate, Polyethylene,Ozokerite, Synthetic Wax, Hydroxycapric Acid, Hydroxycaprylic Acid, Hydroxycinnamic Acid, Teprenone, Butylene Glycol, Dimethicone, Hydrogen Dimethicone, Kaolin, Mica, PEG-4, Synthetic Fluorphlogopite, Tin Oxide, Phenxoyethanol. May Contain: Blue 1 Lake, Iron Oxides, Red 40 Lake, Titanium Dioxide, Yellow 5 Lake

  • Other information

    ▪ Protect this product from excessive heat and direct sun

  • Questions or Comments?

    ▪ Call 1-800-227-0333 (USA only) or www.PhysiciansFormula.com

  • Package Label

    Package Label

  • INGREDIENTS AND APPEARANCE
    SUPER CC COLOR CORRECTION CARE PRIMER STICK  SPF 30
    octinoxate, octocrylene, oxybenzone,titanium dioxide, zinc oxide stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:31645-189
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE5.1 g  in 100 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE4 g  in 100 g
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE4.2 g  in 100 g
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE5.6 g  in 100 g
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE5.2 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    STANNIC OXIDE (UNII: KM7N50LOS6)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    TRIISODECYL TRIMELLITATE (UNII: 6IFP38QKFS)  
    C12-15 ALKYL BENZOATE (UNII: A9EJ3J61HQ)  
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
    HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)  
    ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
    LOW DENSITY POLYETHYLENE (UNII: J245LN42AI)  
    SYNTHETIC WAX (1200 MW) (UNII: Q3Z4BCH099)  
    HYDROXYCAPRIC ACID (UNII: B41993WR8W)  
    HYDROXYCAPRYLIC ACID (UNII: 0R6X0G0S8A)  
    P-COUMARIC ACID (UNII: IBS9D1EU3J)  
    TEPRENONE (UNII: S8S8451A4O)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    DIMETHICONE 20 (UNII: H8YMB5QY0D)  
    KAOLIN (UNII: 24H4NWX5CO)  
    MICA (UNII: V8A1AW0880)  
    POLYETHYLENE GLYCOL 200 (UNII: R95B8J264J)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:31645-189-011 in 1 BOX01/15/2016
    1NDC:31645-189-4713.5 g in 1 CONTAINER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35201/15/2016
    Labeler - Physicians Formula Inc (021261805)