Label: CANDY DOLL WHITE PURE POWDER SHINY- titanium dioxide, zinc oxide powder

  • Category: HUMAN OTC DRUG LABEL

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 February 15, 2017

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  • Active Ingredients

    Titanium Dioxide 6.72%

    Zinc Oxide 1.94%

  • 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

    talc, synthetic flourphlogopite, dimethicone/vinyl dimethicone crosspolymer, mica, silica, calcium carbonate, hdi/trimethylol hexyllactone crosspolymer, magnesium stearate, hydrogen dimethicone, iron oxides, aloe barbadensis leaf extract, cocos nucifera (coconut) oil, aluminum hydroxide, dimethicone, squalene, simmondsia chinensis (jojoba) seed oil, sodium hyaluronate, tocopherol

  • Questions

    Questions or Comments: Call Us 626-872-0164

  • PDP Image

    CandyDoll White Pure Powder Shiny.jpg

    CandyDoll White Pure Powder Shiny.jpg

  • INGREDIENTS AND APPEARANCE
    CANDY DOLL WHITE PURE POWDER SHINY 
    titanium dioxide, zinc oxide powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71245-106
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE0.194 g  in 10 g
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE0.672 g  in 10 g
    Inactive Ingredients
    Ingredient NameStrength
    SQUALANE (UNII: GW89575KF9)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    TALC (UNII: 7SEV7J4R1U)  
    BROWN IRON OXIDE (UNII: 1N032N7MFO)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71245-106-0110 g in 1 CASE; Type 0: Not a Combination Product02/13/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35202/13/2017
    Labeler - T-Garden Inc (697425635)
    Registrant - T-Garden Inc (697425635)
    Establishment
    NameAddressID/FEIBusiness Operations
    T-Garden Inc697425635manufacture(71245-106)
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