Label: CC CUSHION COMPACT SUNSCREEN - MEDIUM / DEEP- titanium dioxide, zinc oxide cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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, 2017

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  • DRUG FACTS

  • Active Ingredients: each 15 g contains

    Titanium Dioxide - 22.4%

    Zinc Oxide - 0.5%

  • PURPOSE

    Sunscreen

  • INDICATIONS & USAGE

    USES: Help to prevent sunburn. If used as directed with other sun protection measures (see directions) may decrease the risk of skin cancer and early skin ageing caused by the sun.

  • WARNINGS

    Warnings- For external use only. Do not use on damaged or broken skin.
    When using this product: Keep out of the eyes. Rinse with water to remove.
    Stop use and ask a doctor If rash occurs.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out the of reach of children. If product is swallowed, get medical help or contact a poison control center right away.

  • DOSAGE & ADMINISTRATION

    Directions: Apply liberally 15 minutes before sun exposure.

    Reapply

    • after 40 minutes of swimming or sweating
    • immediately after towel drying
    • atleast every 2 hours
    • children under 6 months: ask a doctor.
  • INACTIVE INGREDIENT

    Inactive Ingredients: Water(Aqua), Shea Butter, Jojoba Oil, Cucumber Extract, Grape Seed Oil, Yellow Beeswax, Chamomile Extract, Iron Oxide CI : 77492, Glycerin(and)Water(and) Dextran(and)Caprooyl Tetrapeptide-3, Mandelic Acid, Ascorbyl Glucoside, Aqua /Water (and) Tripleurospermum Maritimum Extract, Iron Oxide CI : 77491, Hyaluronic Acid, Iron Oxide CI : 77499, Phenoxyethanol, Vitamin-E.

  • SPL UNCLASSIFIED SECTION

    Color Control

    SunScreen Broad spectrum SPF50+

    Covers . Brightens . Protects . Soothes . Hydrates

  • Packaging

    image description

  • INGREDIENTS AND APPEARANCE
    CC CUSHION COMPACT SUNSCREEN - MEDIUM / DEEP 
    titanium dioxide, zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71190-9387
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE22.4 g  in 100 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION0.5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    JOJOBA OIL (UNII: 724GKU717M)  
    CUCUMBER (UNII: YY7C30VXJT)  
    GRAPE SEED OIL (UNII: 930MLC8XGG)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    CHAMOMILE (UNII: FGL3685T2X)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DEXTRAN 40 (UNII: K3R6ZDH4DU)  
    CAPROOYL TETRAPEPTIDE-3 (UNII: LZI0HJ3K2R)  
    MANDELIC ACID (UNII: NH496X0UJX)  
    ASCORBYL GLUCOSIDE (UNII: 2V52R0NHXW)  
    TRIPLEUROSPERMUM INODORUM WHOLE (UNII: 567N54UG4S)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    HYALURONIC ACID (UNII: S270N0TRQY)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71190-9387-41 in 1 CARTON01/18/2017
    115 g in 1 BOX; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35201/18/2017
    Labeler - Skin Pi LLC (080439471)
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