DAILY FACIAL MOISTURIZER BROAD SPECTRUM SPF15 SUNSCREEN (AVOBENZONE, OCTOCRYLENE) CREAM [DOLGENCORP INC.]

DAILY FACIAL MOISTURIZER BROAD SPECTRUM SPF15 SUNSCREEN (AVOBENZONE, OCTOCRYLENE) CREAM [DOLGENCORP INC.]
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NDC 55910-326-11
Set ID 44ff5186-3c4e-400c-be42-2f89d78d7654
Category HUMAN OTC DRUG LABEL
Packager Dolgencorp Inc.
Generic Name
Product Class
Product Number
Application Number PART352
  • Active ingredient

    Avobenzone 3.0%

    Octocrylene 10.0%

  • 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.
    • Use a water resistant sunscreen if swimming or sweating
    • Reapply at least every 2 hours
    • 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 sunscree 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, disopropyl adipate, cyclopentasiloxane, glycerin, glyceryl stearate, PEG-100 stearate, titanium dioxide, alumina, simethicone, polymethyl methacrylate, phenoxyethanol, benzyl alcohol, triethanolamine, acrylates/C10-30 alkyl acrylate crosspolymer, tocopheryl acetate (vitamin E), carbomer, disodium EDTA

  • Package/Label Principal Display Panel

    DGbeauty Daily Facial Moisturizer Broad Spectrum SPF 15 Sunscreen

    • For all skin types
    • Non-greasy and lightweight
    • Protects from UVA and UVB rays

     

    Compare to Cetaphil®
    Daily Facial Moisturizer SPF 15 ingredients*

    4 FL OZ (118 mL)

    *This product is not manufactured or distributed by Galderma®, owner of the registered trademark Cetaphil.

    DISTRIBUTED BY:
    DOLGENCORP, LLC
    100 MISSION RIDGE
    GOODLETTSVILLE, TN 37072

    MANUFACTURED IN ISRAEL
    2T326 VT C1

    DG Daily Facial Moisturizer Carton Label

    Carton Label

  • INGREDIENTS AND APPEARANCE
    DAILY FACIAL MOISTURIZER BROAD SPECTRUM SPF15 SUNSCREEN 
    avobenzone, octocrylene cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55910-326
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 100 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE10 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:2) (UNII: 5KY68S2577)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55910-326-111 in 1 CARTON
    1118 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35207/20/2013
    Labeler - Dolgencorp Inc. (068331990)

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