Label: PONDS CLARANT B3- avobenzone cream

  • 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 May 26, 2015

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  • ACTIVE INGREDIENT

    AVOBENZONE

  • INACTIVE INGREDIENT

    Water, myristic acid,stearic acid,niacinamide,ethylhexyl methoxycinnamate,glycerin, tapioca starch, triethanolamine, cyclopentasiloxane,PEG/PPG-18/18 dimethocone, cetyl alcohol, butyl methpxydibenzoylmethane, phnpxyethanol,fragance, carbomer, acrylates crosspolymer, methylparabene,propylparabene, disodium EDTA, sodium ascorbyl phosphate.

  • WARNINGS

    FOR EXTERNAL USE ONLY.

    AVOID CONTACT WITH EYES. If product gets into eyes, rinse thoroughly with water.

    Discontinue use and consult a physican:

    If you experience some irritation rash or other adverse reaction

  • DOSAGE & ADMINISTRATION

    Apply daily to face and ne ck. For best results, apply during the morning ( as a base for your make-up) and night.

  • PRINCIPAL DISPLAY PANEL

    Ponds Clarants B

  • INGREDIENTS AND APPEARANCE
    PONDS CLARANT B3 
    avobenzone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69772-615
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE100 g  in 3 g
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    GLUTAMIC ACID (UNII: 3KX376GY7L)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    GERANIOL (UNII: L837108USY)  
    BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)  
    ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
    WATER (UNII: 059QF0KO0R)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    OCTINOXATE (UNII: 4Y5P7MUD51)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69772-615-5050 g in 1 JAR; Type 0: Not a Combination Product05/26/2015
    2NDC:69772-615-12400 g in 1 JAR; Type 0: Not a Combination Product05/26/2015
    3NDC:69772-615-20200 g in 1 JAR; Type 0: Not a Combination Product05/26/2015
    4NDC:69772-615-30300 g in 1 JAR; Type 0: Not a Combination Product05/26/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35205/26/2015
    Labeler - Teresa Cecena DBA Genesis (078760958)
    Registrant - Teresa Cecena (078760958)
    Establishment
    NameAddressID/FEIBusiness Operations
    Teresa Cecena DBA078760958relabel(69772-615)
    Establishment
    NameAddressID/FEIBusiness Operations
    Unilever De Mexico, S. de R.L. De C.V.812625062manufacture(69772-615)
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