Label: BRONZING DUO SPF 15 MINERAL COMPACT TINT 01 LIGHT- titanium dioxide powder

  • 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 April 24, 2012

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  • ACTIVE INGREDIENT

    TITANIUM DIOXIDE :   8.4%

  • INACTIVE INGREDIENTS

    TALC . ZINC STEARATE . ZEA MAYS (CORN) STARCH . OCTYLDODECYL STEAROYL STEARATE . DIMETHICONE . DIISOSTEARYL MALATE . PENTAERYTHRITYL TETRAISOSTEARATE . GLYCERIN . EMPETRUM NIGRUM FRUIT JUICE . SILICA . NYLON-12 . ASCORBYL PALMITATE . PARFUM/FRAGRANCE . TOCOPHEROL . HDI/TRIMETHYLOL HEXYLLACTONE  CROSSPOLYMER . AQUA/ WATER . BUTYLENE GLYCOL . RETINYL PALMITATE . BENZYL SALICYLATE . HYDROXYETHYL UREA . LIMONENE . CAMELLIA SINENSIS LEAF EXTRACT . BUTYLPHENYL METHYLPROPIONAL . PHENOXYETHANOL . POTASSIUM SORBATE . ALGIN . ACACIA SENEGAL GUM. ± /MAY CONTAIN/PEUT CONTENIR : [CI 77891/TITANIUM DIOXIDE . CI 77491/CI 77492/CI 77499/ IRON OXIDES . CI 77019/MICA . TIN OXIDE . ALUMINA . CI 19140/ YELLOW 5 LAKE]. [M2411A]

  • DIRECTIONS:

    apply liberally.  Reapply as needed.

  • WARNING:

    for external use only, not to be swallowed.  Avoid contact with eyes.

    Discontinue use

    if signs of irritation or rash appear.

  • Purpose

    Sunscreen

  • SPL UNCLASSIFIED SECTION

    This lightweight Bronzing Duo compact has two complementary shades that blend together for a natural-looking, sun-kissed complexion. Formulated with mineral and plant extracts that help protect and care for your skin. SPF 15.  Dermatologist tested.

  • PRINCIPAL DISPLAY PANEL

    01 light  Bronzing Duo   CLARINS PARIS SPF 15 Mineral Powder Compact 100%Mineral Screen  e 10g  0.35 Oz. Net Wt.   MFD FOR CLARINS PARIS 92200 Neuilly  95300 Pontoise - France   Made in Italy Distrib. Canada:  CLARINS CANADA Inc. 815 Desserte est Autoroute Chomedey  ALVAL (QUEBEC) H7W 5N4    www.clarins.com

  • Bronzing Duo SPF 15 Mineral Powder Compact Tint 01 Light 10g (58668-5351-1)


    Bottom Label

    Outer Package Light

  • INGREDIENTS AND APPEARANCE
    BRONZING DUO SPF 15 MINERAL COMPACT TINT 01 LIGHT 
    titanium dioxide powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58668-5351
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE8.4 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    TALC (UNII: 7SEV7J4R1U)  
    ZINC STEARATE (UNII: H92E6QA4FV)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    OCTYLDODECYL STEAROYL STEARATE (UNII: 3D47Q6D93C)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    PENTAERYTHRITYL TETRAISOSTEARATE (UNII: 9D7IK5483F)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    EMPETRUM NIGRUM FRUIT JUICE (UNII: 349W2L66Q1)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    NYLON-12 (UNII: 446U8J075B)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    WATER (UNII: 059QF0KO0R)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    BENZYL SALICYLATE (UNII: WAO5MNK9TU)  
    HYDROXYETHYL UREA (UNII: MBQ7DDQ7AR)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    ACACIA (UNII: 5C5403N26O)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    MICA (UNII: V8A1AW0880)  
    STANNIC OXIDE (UNII: KM7N50LOS6)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58668-5351-11 in 1 CARTON
    110 g in 1 BOX
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35204/24/2012
    Labeler - Laboratoires Clarins S.A. (503972197)
    Establishment
    NameAddressID/FEIBusiness Operations
    Laboratoires Clarins S.A.503972197manufacture
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