FACE VALUES - AM FACIAL MOISTURIZING BROAD SPECTRUM SPF30 SUNSCREEN (HOMOSALATE, OCTINOXATE, OCTOCRYLENE, ZINC OXIDE) LOTION [HARMON STORES INC]

FACE VALUES - AM FACIAL MOISTURIZING BROAD SPECTRUM SPF30 SUNSCREEN (HOMOSALATE, OCTINOXATE, OCTOCRYLENE, ZINC OXIDE) LOTION [HARMON STORES INC]
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NDC 63940-121-11
Set ID 91280594-08bc-4d09-9346-3ea9d93bf1dc
Category HUMAN OTC DRUG LABEL
Packager Harmon Stores Inc
Generic Name
Product Class
Product Number
Application Number PART352
  • 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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