Label: WALGREENS WRINKLE REPAIR MOISTURIZER SPF30- avobenzone, homosalate, octisalate, octocrylene 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 10, 2014

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  • Active ingredient

    Avobenzone 2.0%
    Homosalate 4.0%
    Octisalate 4.0%
    Octocrylene 2.0%

  • Purpose

    Sunscreen

  • 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

    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.

  • Directions

    •
    Apply liberally 15 minutes before sun exposure.
    •
    Children under 6 months of age: ask a doctor
    •
    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
  • Other Information

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

    water, decamethyltetrasiloxane, isononyl isononanoate, cetyl alcohol, glycerin, steareth-21, stearyl alcohol, nylon-12, silica, glyceryl stearate, PEG-100 stearate, phenoxyethanol, ethylhexylglycerin, dimethicone, dimethicone/vinyldimethicone crosspolymer, sodium styrene/acrylates divinylbenzene copolymer, ammonium nonoxynol-4-sulfate, fragrance, propylene glycol, myrtus communis extract, xanthan gum, retinyl palmitate, polyacrylamide, C13-14 isoparaffin, laureth-7, sodium hydroxide, disodium EDTA, ascorbic acid, polysorbate 20, BHT, hyaluronic acid

  • Package/Label Principal Display Panel

    studio 35 beauty™ Wrinkle Repair Moisturizer
    Broad Spectrum SPF30 Sunscreen
    Fast, Visible Results

    Compare to Neutrogena®
    Rapid Wrinkle Repair, SPF 30

    1 Fl Oz (29 mL)

    Distributed by: Walgreen Co.
    200 Wilmot Rd., Deerfield, IL 60015
    100% Satisfaction Guaranteed

    walgreens.com ©2012 Walgreen Co.

    Manufactured in Israel

    Carton Label

    Carton Label

  • INGREDIENTS AND APPEARANCE
    WALGREENS WRINKLE REPAIR MOISTURIZER SPF30 
    avobenzone, homosalate, octisalate, octocrylene cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-9362
    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)  
    DECAMETHYLTETRASILOXANE (UNII: C23WAL597T)  
    ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    STEARETH-21 (UNII: 53J3F32P58)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    NYLON-12 (UNII: 446U8J075B)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    DIMETHICONE/DIENE DIMETHICONE CROSSPOLYMER (UNII: RSA9I561OK)  
    AMMONIUM NONOXYNOL-4 SULFATE (UNII: 9HIA70O4J0)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    MYRTUS COMMUNIS LEAF (UNII: U20N87188F)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I)  
    C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
    LAURETH-7 (UNII: Z95S6G8201)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    HYALURONIC ACID (UNII: S270N0TRQY)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-9362-1129 mL in 1 BOTTLE, PUMP
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35201/05/2013
    Labeler - Walgreens Company (008965063)
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