Label: CANDY DOLL BASIC BRIGHT PURE BASE MINT GREEN- titanium dioxide, zinc oxide lotion

  • 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 September 18, 2017

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  • Active Ingredients

    Titanium Dioxide 6.5%

    Zinc Oxide 4.81%

  • Purpose

    Sunscreen

  • Warnings

    For external use only

  • Do Not Use

    Do not use on broken or damaged skin

  • When Using

    When using this product keep out of eyes. Rinse with water to remove.

  • Stop use and ask a doctor

    Stop use and ask a doctor if rash or irritation occurs or lasts.

  • Keep Out of Reach of Children

    KEEP OUT OF REACH OF CHILDREN

  • Directions

    apply liberally before sun exposure and as needed

    children under 6 months of age: ask a doctor

  • Inactive Ingredients

    water, cyclopentasiloxane, glycerin, cetyl ethylhexanoate, butylene glycol, diphenylsiloxy phenyl tremethicone, methyl methacrylate crosspolymer, PEG-10 dimethicone, sorbitan sesquiisostearate, magnesium sulfate, sorbitan sesquioleate, cetyl PEG/PPG-10/1 dimethicone, disteardimonium hectorite, aluminum hydroxide, glyceryl behenate/eicosadioate, stearic acid, talc, ethylhexylglycerin, phenoxyethanol, dimethicone, propylene carbonate, hydrogen dimethicone, polyquaternium-51, sodium hyaluronate, aloe barbadensis leaf extract, cocos nucifera (coconut) oil, royal jelly extract, alumina, iron oxides, silica, aluminum hydroxide, chromium hydroxide green, stearic acid, talc, hydrogen dimethicone, mica, ultramarines, carmine, tin oxide,

  • Questions

    Questions or Comments: Call Us 626-872-0164

  • PDP Image

    CandyDoll Basic Bright Pure Base Mint Green.jpg

    CandyDoll Basic Bright Pure Base Mint Green.jpg

  • INGREDIENTS AND APPEARANCE
    CANDY DOLL BASIC BRIGHT PURE BASE MINT GREEN 
    titanium dioxide, zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71245-110
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE1.59 g  in 30 g
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE1.86 g  in 30 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    BROWN IRON OXIDE (UNII: 1N032N7MFO)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71245-110-0130 g in 1 TUBE; Type 0: Not a Combination Product09/18/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35209/18/2017
    Labeler - T-Garden Inc (697425635)
    Registrant - T-Garden Inc (697425635)
    Establishment
    NameAddressID/FEIBusiness Operations
    T-Garden Inc697425635manufacture(71245-110)
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