Label: ANEW PLATINUM DAY- octinoxate, octisalate, oxybenzone, avobenzone 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 January 1, 2019

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  • ACTIVE INGREDIENT

    Active ingredients
    OCTINOXATE 7.5%, OCTISALATE 4.75%,
    OXYBENZONE 4.0%, AVOBENZONE 2.85%..................................

    Purpose
    ............................Sunscreen

  • INDICATIONS & USAGE

    Uses
    • helps prevent sunburn
    • if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

  • WARNINGS

    Warnings
    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 a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions
    • apply liberally 15 minutes before sun exposure
    • children under 6 months of age: ask a doctor
    • reapply at least every 2 hours
    • use a water resistant sunscreen if swimming or sweating
    • Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
    • limit time in the sun, especially from 10 a.m. – 2 p.m.
    • wear long-sleeved shirts, pants, hats, and sunglasses

  • STORAGE AND HANDLING

    Other Information
    protect the product in this container from excessive heat and direct sun

  • INACTIVE INGREDIENT

    Inactive ingredients: WATER, GLYCERIN, SILICA, DIMETHICONE, STEARIC ACID, STEARYL ALCOHOL, NONENOL, SAPINDUS RARAK FRUIT EXTRACT, POUZOLZIA PENTANDRA EXTRACT, METHOXYBENZOYL METHYLSULFONYL OXOPIPERIDINYL PIPERAZINECARBOXAMIDE, THIAZOLYLALANINE, SACCHAROMYCES/PLATINUM FERMENT, TRISILOXANE, DIMETHICONOL, MYRISTYL MYRISTATE, MALTODEXTRIN, PEG-100 STEARATE, CAPRYLYL GLYCOL,GLYCERYL STEARATE, SODIUM POLYACRYLATE, POLYURETHANE-40, POTASSIUM HYDROXIDE, ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER, DISODIUM EDTA, 1,2-HEXANEDIOL, PARFUM.

  • QUESTIONS

    Questions? 1-800-FOR-AVON

  • PRINCIPAL DISPLAY PANEL

    image of PDPimage of carton

  • INGREDIENTS AND APPEARANCE
    ANEW  PLATINUM DAY
    octinoxate, octisalate, oxybenzone, avobenzone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10096-0224
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE75 mg  in 1 g
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE47.5 mg  in 1 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE40 mg  in 1 g
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE28.5 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10096-0224-21 in 1 CARTON09/07/2019
    1NDC:10096-0224-150 g in 1 JAR; Type 0: Not a Combination Product
    2NDC:10096-0224-41 in 1 CARTON09/07/2010
    2NDC:10096-0224-315 g in 1 JAR; Type 0: Not a Combination Product
    3NDC:10096-0224-61 in 1 CARTON09/07/2010
    3NDC:10096-0224-57 g in 1 JAR; Type 0: Not a Combination Product
    4NDC:10096-0224-71.1 g in 1 PACKET; Type 0: Not a Combination Product09/07/2010
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35209/07/2010
    Labeler - New Avon LLC (080143520)
    Establishment
    NameAddressID/FEIBusiness Operations
    Fareva Morton Grove, Inc.116752326manufacture(10096-0224)
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