Label: BECCA MINERAL SPF PRIMER- zinc oxide cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 14, 2011

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  • ACTIVE INGREDIENT

    Active Ingredients                  Purpose

    Zinc Oxide 17%                     Sunscreen

    provides very high protection against sunburn

    Keep out of reach of children

    For external use only.

    Avoid contact with eyes.

    -Discontinue if signs of irritation or rash appear

    -Keep out of reach of children

    -Ask a doctor before use on children under six months

    -Contains hydroxybenzoates and phenoxyethanol

    -Apply generously 15 to 20 minutes before sun exposure and again after swimming or toweling

    Inactive Ingredients: Aqua (water-purified), Cyclomethicone, Caprylic/Capric Triglyceride, Glyceryl Distearate, Ceteareth-20 (Cetomacrogol 1000), PEG-30 Dipolyhydroxystearate, Phenoxyethanol, Methylparaben (Methyl Hydroxybenzoate), Tocopheryl acetate (D-Alpha-Tocopheryl Acetate), Parfum (Fragrance), Carbomer (Carbomer 940), Camellia Sinensis Extract (Camellia Sinensis Leaf Extract, Oenothera Biennis Oil (Evening Primrose Oil), Sodium Hyaluronate, Propylparaben (Propyl Hydroxybenzoate), Ubiquinone 10 (Ubidecarenone).



    image of secondary label

  • PRINCIPAL DISPLAY PANEL

    Becca

    Mineral SPF Primer

    SPF 30

    50 ml. / 1.7 fl.oz



    image of primary label

  • INGREDIENTS AND APPEARANCE
    BECCA  MINERAL SPF PRIMER
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51147-5010
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE17 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    CYCLOMETHICONE (UNII: NMQ347994Z)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    GLYCERYL DISTEARATE (UNII: 73071MW2KM)  
    POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    PEG-30 DIPOLYHYDROXYSTEARATE (UNII: 9713Q0S7FO)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
    CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    EVENING PRIMROSE OIL (UNII: 3Q9L08K71N)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    UBIDECARENONE (UNII: EJ27X76M46)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51147-5010-21 in 1 BOX
    1NDC:51147-5010-150 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35204/12/2011
    Labeler - Becca, Inc. (002000729)
    Registrant - Becca, Inc. (002000729)
    Establishment
    NameAddressID/FEIBusiness Operations
    Jalco Cosmetic Pty. Ltd.755470184manufacture
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