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

  • 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 14, 2017

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

View All Sections
  • Active Ingredients

    Titanium Dioxide 6.21%

    Zinc Oxide 5.30%

  • 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, alumina, aluminum hydroxide, glyceryl behenate/eicosadioate, stearic acid, talc, ethylhexylglycerin, phenoxyethanol, dimethicone, propylene carbonate, mica, hydrogen dimethicone, ultramarines, iron oxides, polyquaternium-51, carmine, tin oxide, sodium hyaluronate, aloe barbadensis leaf extract, cocos nucifera (coconut) oil, royal jelly extract

  • Questions

    Questions or Comments: Call Us 626-872-0164

  • PDP Image

    CandyDoll Bright Pure Base.jpg CandyDoll Bright Pure Base

  • INGREDIENTS AND APPEARANCE
    CANDY DOLL BRIGHT PURE BASE 
    titanium dioxide, zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71245-102
    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:71245-102-0130 g in 1 TUBE; 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(71245-102)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials

More Info on this Drug

Get Label RSS Feed, View NDC Code(s)NEW!