Label: CC DAILY CORRECT BROAD SPECTRUM SPF 35 SUNSCREEN MEDIUM TO DARK SUPERGOOP- titanium dioxide, zinc oxide cream

  • 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 November 12, 2020

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  • ACTIVE INGREDIENT

    Active Ingredients purpose

    Titanium Dioxide 1.42 % Sunscreen

    Zinc Oxide 20% Sunscreen

  • PURPOSE

    Uses

    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.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

  • INDICATIONS & USAGE

    Stop use and ask a doctor if rash occurs

  • WARNINGS

    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

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

  • DOSAGE & ADMINISTRATION

    Directions Apply liberally 15 minutes before sun exposure

    Use a water resistant sunscreen if swimming or sweating

    Reapply at least every 2 hours

    Children under 6 months: Ask a doctor

    Sun Protection Measures Spending time in the sun increases your skin of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:

    Limit time in the sun especially from 10 a.m.- 2 p.m.

    Wear long-sleeved shirts, pants, pants hats and sunglasses

  • INACTIVE INGREDIENT

    Inactive Ingredients Water, Cyclopentasiloxane, Propanediol, Dimethicone, Iron Oxides, Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone, Mica, Sodium Chloride, Pyrus Malus (apple) Fruit Extract, Phenoxyethanol, Glycerin, Dimethicone/PEG-10/15 Crosspolymer, Titanium Dioxide, Triethoxycaprylylsilane, Dimethicone/Vinyl Dimethicone Crosspolymer, Silica, Chondrus Crispus Extract, Tetrasodium EDTA, Hydrolyzed Chondrus Crispus Extract, Methylisothiazolinone, Tin Oxide, Sodium Hyaluronate.

  • PRINCIPAL DISPLAY PANEL

    CC cream Daily Correct Broad Spectrum SPF 35 Sunscreen

    Medium to Dark

    Self-Adjusting Shade

    PA +++

    Supergoop

    Paraben, Fragrance, and Oxybenzone Free

    1.6 fl. oz. / 47

    Tube

    box

  • INGREDIENTS AND APPEARANCE
    CC DAILY CORRECT BROAD SPECTRUM SPF 35 SUNSCREEN MEDIUM TO DARK   SUPERGOOP
    titanium dioxide, zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75936-122
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE1.42 g  in 100 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE20 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    MICA (UNII: V8A1AW0880)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    APPLE (UNII: B423VGH5S9)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CHONDRUS CRISPUS (UNII: OQS23HUA1X)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    STANNIC OXIDE (UNII: KM7N50LOS6)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75936-122-021 in 1 CARTON01/07/2013
    1NDC:75936-122-0147 mL in 1 TUBE; Type 0: Not a Combination Product
    2NDC:75936-122-043 mL in 1 TUBE; Type 0: Not a Combination Product01/07/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35201/07/2013
    Labeler - TAYLOR JAMES, LTD. (033381850)
    Registrant - TAYLOR JAMES, LTD. (033381850)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cosway Company, Inc.052400223manufacture(75936-122)