Label: FACE VALUES - AM FACIAL MOISTURIZING BROAD SPECTRUM SPF30 SUNSCREEN- homosalate, octinoxate, octocrylene, zinc oxide lotion

  • 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

    Homosalate 12.0%
    Octinoxate 7.5%
    Octocrylene 2.0%
    Zinc Oxide 3.5%

  • 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

    water, niacinamide, behentrimonium methosulfate, cetyl alcohol, butylene glycol, cetearyl alcohol, glycerin, aluminum starch octenylsuccinate, boron nitride, propylene glycol, diazolidinyl urea, methylparaben, propylparaben, ceramide 3, ceramide 6- II, ceramide 1, phytosphingosine, cholesterol, sodium lauroyl lactylate, carbomer, xanthan gum, dimethicone, disodium EDTA, hyaluronic acid

  • Package/Label Principal Display Panel

    Harmon® FaceValuesTM AM Facial Moisturizing Lotion
    Broad Spectrum SPF30 Sunscreen
    moisturize
    restore
    maintain

    moisturizes to help repair & restore skin's protective barrier 

    with Ceramides & UVA/UVB Protection

    Non-comedogenic

    Compare Ours to the Active ingredients in CeraVe®
    AM Facial Moisturizing Lotion*

    3 Fl Oz (89 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

    8D121 B1 C1

    *This product is not manufactured or distributed by Coria Laboratories Ltd,
    owner of the registered trademark CeraVeTM.

    Label

    Label

  • INGREDIENTS AND APPEARANCE
    FACE VALUES - AM FACIAL MOISTURIZING BROAD SPECTRUM SPF30 SUNSCREEN 
    homosalate, octinoxate, octocrylene, zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63940-121
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE12 g  in 100 mL
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 g  in 100 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE2 g  in 100 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE3.5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    BEHENTRIMONIUM METHOSULFATE (UNII: 5SHP745C61)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
    BORON NITRIDE (UNII: 2U4T60A6YD)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    CERAMIDE 3 (UNII: 4370DF050B)  
    CERAMIDE 6 II (UNII: F1X8L2B00J)  
    CERAMIDE 1 (UNII: 5THT33P7X7)  
    PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)  
    CHOLESTEROL (UNII: 97C5T2UQ7J)  
    SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO)  
    CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    HYALURONIC ACID (UNII: S270N0TRQY)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63940-121-111 in 1 CARTON
    189 mL in 1 BOTTLE
    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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