Label: QUICK WRINKLE REPAIR MOISTURIZER BROAD SPECTRUM 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 November 12, 2013

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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.
    • Reapply at least every 2 hours
    • Use water resistant sunscreen if swimming or sweating
    • 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

    For Best Results:

    Apply daily to cleansed face and neck. Smooth a pearl-sized amount evenly in gentle massaging strokes until full absorbed. Works well under makeup.

  • Other Information

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

    water, decamethyltetrasiloxane, isononyl isononanoate, glycerin, cetyl alcohol, steareth-21, nylon-12, silica, stearyl alcohol, glyceryl stearate, PEG-100 stearate, phenoxyethanol, ethylhexylglycerin, dimethicone, dimethicone crosspolymer, fragrance, sodium styrene/acrylates divinylbenzene copolymer, ammonium nonoxynol-4-sulfate, propylene glycol, myrtus communis extract, xanthan gum, sodium hydroxide, retinyl palmitate, polysorbate 20, acrylates/C10-30 alkyl acrylate crosspolymer, disodium EDTA, ascorbic acid, BHT, hyaluronic acid

  • Package/Label Principal Display Panel

    Harmon® FaceValuesTM Quick Wrinkle Repair Moisturizer
    Broad Spectrum SPF30 Sunscreen
    Visible results     within a short time

    Compare Ours to the Active Ingredients in Neutrogena®
    Rapid Wrinkle Repair Moisturizer - SPF 30*

    1 Fl Oz (29 mL)

    Distributed by

    Harmon Stores, Inc.
    650 Liberty Ave.
    Union, NJ 07083 USA
    ©Harmon Stores, Inc.
    Visit us at:
    www.facevalues.com

    Manufactured in Israel

    3X310 B1 C1

    *This product is not manufactured or distributed by Neutrogena®, owner of the Rapid Wrinkle Repair Moisturizer.

    Label

    Label

  • INGREDIENTS AND APPEARANCE
    QUICK WRINKLE REPAIR MOISTURIZER BROAD SPECTRUM SPF30 
    avobenzone, homosalate, octisalate, octocrylene cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63940-310
    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)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    STEARETH-21 (UNII: 53J3F32P58)  
    NYLON-12 (UNII: 446U8J075B)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    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)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    HYALURONIC ACID (UNII: S270N0TRQY)  
    SODIUM POLYSTYRENE SULFONATE (UNII: 1699G8679Z)  
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63940-310-1129 mL in 1 BOTTLE, PUMP
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35211/15/2013
    Labeler - Harmon Stores Inc (804085293)
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