Label: OSCAR DE LA RENTA MOISTURIZING SUNSCREEN SPF 30- octinoxate, octisalate, oxybenzone 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 April 11, 2012

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  • Drug Facts


  • Active ingredients

    Octinoxate 7.5%
    Octisalate 5%
    Oxybenzone 6%

  • Use

    • helps prevent sunburn
  • Warnings

    Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging.  This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.

    For external use only

    Do not use

    on damaged or broken skin

    When using this product

    keep out of eyes.  Rinse with water to remove.

    Stop use and ask a doctor if

    rash occurs

    Keep out of reach of children

    If swallowed, get medical help or contact Poison Control Center right away.

  • Directions

    For sunscreen use

    • apply liberally 15 minutes before sun exposure
    • reapply at least every 2 hours
    • use a water resistant sunscreen if swimming or sweating
    • children 6 months of age: Ask a doctor
  • Other information

    • protect the product in this container from excessive heat and direct sun
  • Inactive ingredients

    WATER, ISODECYL NEOPENTANOATE, GLYCERIN, FRAGRANCE, CETEARYL GLUCOSIDE, CETEARYL ALCOHOL, GLYCERYL STEARATE, POTASSIUM CETYL PHOSPHATE, COCOGLYCERIDES, PHENOXYETHANOL, CYCLOPENTASILOXANE, SODIUM POLYACRYLATE, CAPRYLYL GLYCOL, HEXYL CINNAMAL, BENZYL SALICYLATE, OAT (AVENA SATIVA) KERNEL EXTRACT, LIMONENE, SORBIC ACID, BHT, HYDROXYCITRONELLOL, CYCLOHEXASILOXANE, LINALOOL, CITRONELLOL, GERANIOL, ETHYLHEXYLLAURATE, COCOYL HYDROLYZED WHEAT PROTEIN, HYDROLYZED SOY PROTEIN

  • Purpose

    Sunscreen

  • PRINCIPAL DISPLAY PANEL

    Oscar de La Renta MOISTURIZING SUNSCREEN CREAM SPF 30    e120 ML 5 FL OZ  
    DISTRIBUTED BY:   Oscar de La Renta 6 AVENUE DEL'EUROPE  77600 BUSSY SAINT GEORGES, FRANCE   
    II WEST 42ND STREET  NEW YORK, NY 10018   MADE IN USE   oscardelarenta.com

  • Oscar de la Renta Moisturizing Sunscreen Cream SPF 30 120ml/5 Fl OZ (45124-001-05)


    Oscar de la Renta 1

    Oscar de la Renta 2

  • INGREDIENTS AND APPEARANCE
    OSCAR DE LA RENTA MOISTURIZING SUNSCREEN SPF 30 
    octinoxate, octisalate, oxybenzone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:45124-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 mL  in 100 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 mL  in 100 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE6 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ISODECYL NEOPENTANOATE (UNII: W60VYE24XC)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
    COCO-GLYCERIDES (UNII: ISE9I7DNUG)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
    BENZYL SALICYLATE (UNII: WAO5MNK9TU)  
    OAT (UNII: Z6J799EAJK)  
    SORBIC ACID (UNII: X045WJ989B)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    HYDROXYCITRONELLOL (UNII: R0B4U2I48W)  
    CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    GERANIOL (UNII: L837108USY)  
    ETHYLHEXYL LAURATE (UNII: 8J6M396U72)  
    SOY PROTEIN (UNII: R44IWB3RN5)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:45124-001-051 in 1 CARTON
    1120 mL in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35204/11/2012
    Labeler - Oscar de la Renta LLC (071007918)
    Establishment
    NameAddressID/FEIBusiness Operations
    Suite K Value Added Services LLC036822144manufacture
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