ELF ACNE FIGHTING FOUNDATION CARAMEL (SALICYLIC ACID) CREAM [J. A. COSMETICS U.S. INC]

ELF ACNE FIGHTING FOUNDATION CARAMEL (SALICYLIC ACID) CREAM [J. A. COSMETICS U.S. INC]
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NDC 76354-705-01
Set ID 7019e43f-aa84-4334-85e5-8791df003dd3
Category HUMAN OTC DRUG LABEL
Packager J. A. Cosmetics U.S. INC
Generic Name
Product Class
Product Number
Application Number PART358H
  • ACTIVE INGREDIENT

    Active Ingredient:


    Salicylic Acid 0.5%

  • PURPOSE

    Purpose:

    Acne Treatment

  • INDICATIONS & USAGE

    Uses:

    For the treatment of acne

    Helps prevent new acne blemishes

  • WARNINGS

    Warning:

    For external use only

  • WHEN USING

    When Using This Product:

    Keep out of eyes, rinse with water to remove.

    Skin irrittion and dryness is more likely to occur if you use another topical acne medications at the same time.  If irritation occurs, only use one medication at a time.

  • ASK DOCTOR

    Stop use and ask a doctor If

    rash occurs

  • KEEP OUT OF REACH OF CHILDREN

    Keep Out of Reach of Children

  • DOSAGE & ADMINISTRATION

    Directions:

    Cleanse the skin thoroughly before applying medication. Cover the entire affected area with a thin layer one to three times daily. Because excessive drying of skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor. If bothersome dryness or peeling occurs, reduce application to once a day or every other day.

  • INACTIVE INGREDIENT

    Inactive Ingredient:

    Water,  Cyclopentasiloxane, Hydrogenated Polyisobutene, Ethoxydiglycol, Dimethicone, Cyclohexasiloxane, Dimethicone Crossploymer, PEG-10 Dimethicone, Dimethicone PEG 10/15 Crosspolymer, Magnesium Sulfate, Talc, Nylon-12, Phenoxyethanol, Propylene Glycol, Quaternium-18 Benonite, Triethoxycaprylysilane, Methylparaben, Ethylparaben, butylparaben, Propylparaben, Isobutylparaben, Cinnamomum Camphora (Camphor) Bark oil, Melaleuca Alternafolia (Tea Tree) Leaf Oil, Aloe Barbadensis Leaf Jiuce, Hexapeptide-9, Hamamelis Birginiana (Witch Hazel)

    May Contain:

    Iron Oxide (CI77491, CI77492, CI77499), Titanium Dioxide

  • PRINCIPAL DISPLAY PANEL

    box

    front

    back1

  • INGREDIENTS AND APPEARANCE
    ELF ACNE FIGHTING FOUNDATION CARAMEL 
    salicylic acid cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76354-705
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID0.5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)  
    WATER (UNII: 059QF0KO0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    CAMPHOR OIL (UNII: 75IZZ8Y727)  
    DIMETHICONE PEG-10 PHOSPHATE (UNII: O7Q5NJ7X88)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    NYLON-12 (UNII: 446U8J075B)  
    TALC (UNII: 7SEV7J4R1U)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    MAGNESIUM SULFATE ANHYDROUS (UNII: ML30MJ2U7I)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    BUTYLPARABEN (UNII: 3QPI1U3FV8)  
    ISOBUTYLPARABEN (UNII: 0QQJ25X58G)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WITCH HAZEL (UNII: 101I4J0U34)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76354-705-0136 mL in 1 BOTTLE; Type 0: Not a Combination Product08/09/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358H08/09/2015
    Labeler - J. A. Cosmetics U.S. INC (186705047)
    Registrant - Zhejiang Ayan Biotech Co., Ltd. (544377996)
    Establishment
    NameAddressID/FEIBusiness Operations
    Zhejiang Ayan Biotech Co., Ltd.544377996manufacture(76354-705)

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