Label: WRINKLE REPAIR MOISTURIZER SPF 30 EQB- avobenzone 2% homosalate 4% octisalate 4% octocrylene 2% lotion

  • 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 August 14, 2023

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  • Active ingredients                              Purpose

    Avonenzone 2%                                Sunscreen

    Homosalate 4%                                Sunscreen

    Octisalate 4%                                   Sunscreen

    Octocrylene  2%                               Sunscreen           

  • PURPOSE

  • Uses

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

  • Warnings For external use only

  • Do not use on

    • damaged or broken skin.

  • When using this product

    •keep out of eyes. Rinse with waterto remove.

  • Stop use and ask a doctor

    • if rash occurs.

  • Keep out of reach of children. If swallowed,get medical help orcontact a Poison Control Center right away

  • Directions:

    • apply liberal 15 minutes before sun exposure• reapply at least every 2 hours •use a water resistant sunscreen if swimmingor sweating•children under 6 months of age: ask a doctor• Sun Protection Measures:Spending time in the sun increase your risk of skin cancer and early skin aging. To decrease this risk. regularly usea sunscreen wrtha Broad Spectrum SPF value of15 or higher and other suncrin protection measures including:
    • limrt time in the sun, especial from 10a.m. -2 p.rn.•wear long-sleeve shorts , pants, hats and sunglasses

  • Inactive Ingredients

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    WRINKLE REPAIR MOISTURIZER SPF 30   EQB
    avobenzone 2% homosalate 4% octisalate 4% octocrylene 2% lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79903-205
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE2 g  in 100 mL
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE4 g  in 100 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE4 g  in 100 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE2 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    TRISILOXANE (UNII: 9G1ZW13R0G)  
    ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    STEARETH-21 (UNII: 53J3F32P58)  
    NYLON-12 (UNII: 446U8J075B)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)  
    STYRENE/ACRYLAMIDE COPOLYMER (500000 MW) (UNII: 5Z4DPO246A)  
    MYRTUS COMMUNIS TOP (UNII: 367E55FXGW)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    HYALURONIC ACID (UNII: S270N0TRQY)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79903-205-011 in 1 CARTON08/11/2023
    129 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM02008/11/2023
    Labeler - Walmart (051957769)
    Registrant - Bridgeview Investments LLC (035014854)
    Establishment
    NameAddressID/FEIBusiness Operations
    Dimensional Merchandising Inc076693183manufacture(79903-205)