Label: HARMON REVITALIZING FACIAL SMOOTHER IMMEDIATE SKIN SMOOTHING FINISHING BROAD SPECTRUM SPF30 SUNSCREEN- avobenzone, homosalate, octisalate, octocrylene, oxybenzone cream

  • Category: HUMAN OTC DRUG LABEL

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 22, 2014

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  • Active ingredient

    Avobenzone 3%
    Homosalate 10%
    Octisalate 5%
    Octocrylene 5%
    Oxybenzone 6%

  • 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
  • Other Information

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

    dimethicone, dimethicone crosspolymer, C30-45 alkyldimethylsilyl polypropylsilsesquioxane, isododecane, cetyl methicone, butyrospermum parkii (shea butter), beeswax, silica, glycerin, C12-15 alkyl benzoate, BHT, water, tocopheryl acetate (vitamin E), talc.

  • Package/Label Principal Display Panel

    HARMON®
    FACEVALUES

    BROAD SEPECTRUM SPF 30 SUNSCREEN

    REVITALIZING
    FACIAL SMOOTHER

    IMMEDIATE SKIN SMOOTHING FINISHING CREAM

    WIPES AWAY THE LOOK OF WRINKLES, LINES & PORES

    1.18 FL OZ (35 mL)

    Compare Ours to L'Oreal® Revitalift® Miracle Blur Instant Skin Smoother Finishing Cream*

    What will Revitalizing Facial Smoother do for me?

    Our unique formula will visibly blur every small imperfection: wrinkles, lines and pores...instantly.

    INNOVATION:

    This instant skin smoother, with its light diffusing and soft-focus blurring effect, transforms your skin’s texture for a visibly smooth surface.

    IMMEDIATE RESULTS:

    Lines and wrinkles are visibly blurred and pores appear smaller. Along with broad spectrum SPF 30, Facial Smoother supports your fight against signs of aging when used with other sun protection measures. Read Directions on back.

    *This product is not manufactured or distributed by L'Oreal®, owner of the registered trademark Revitalift®

    Dermatologist tested
    Non-comedogenic (won’t clog pores)
    Sensitive skin tested
    Non-greasy
    Fragrance-free

    How to Use:

    For immediate skin smoothing effect, squeeze a dime-size amount in hands and smooth over face. For targeted areas, apply a smaller amount. Apply alone on clean skin, as part of your daily skincare routine.

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

    HARMON SATISFACTION GUARANTEED
    OR YOUR MONEY BACK

    Manufactured in Israel
    2D472 B1 C1

    Carton Label

    Carton Label

  • INGREDIENTS AND APPEARANCE
    HARMON REVITALIZING FACIAL SMOOTHER IMMEDIATE SKIN SMOOTHING FINISHING BROAD SPECTRUM SPF30 SUNSCREEN 
    avobenzone, homosalate, octisalate, octocrylene, oxybenzone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63940-472
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 100 mL
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE10 g  in 100 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE5 g  in 100 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE6 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    DIMETHICONE/DIENE DIMETHICONE CROSSPOLYMER (UNII: RSA9I561OK)  
    C30-45 ALKYL METHICONE (UNII: NFX970DSI2)  
    ISODODECANE (UNII: A8289P68Y2)  
    CETYL DIMETHICONE 45 (UNII: IK315POC44)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    WATER (UNII: 059QF0KO0R)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    TALC (UNII: 7SEV7J4R1U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63940-472-121 in 1 CARTON
    135 mL in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35204/01/2014
    Labeler - Harmon Stores Inc. (804085293)
    Registrant - Harmon Stores Inc. (804085293)