ELF BROAD SPECTRUM SPF 20 SUNSCREEN BUFF BB CREAM (OCTINOXATE) CREAM [J. A. COSMETICS U.S. INC]

ELF BROAD SPECTRUM SPF 20 SUNSCREEN BUFF BB CREAM (OCTINOXATE) CREAM [J. A. COSMETICS U.S. INC]
PDF | XML

NDC 76354-610-01
Set ID 3d816571-a9b4-491e-8650-3def890fb273
Category HUMAN OTC DRUG LABEL
Packager J. A. Cosmetics U.S. INC
Generic Name
Product Class
Product Number
Application Number PART352
  • ACTIVE INGREDIENT

    Active Ingredient:

    OCTINOXATE: 7.5%

    OCTISALATE: 5.0%

    OXYBENONE: 4.0%

  • PURPOSE

    Purpose:

    Sunscreen

  • INDICATIONS & USAGE

    Uses:

    Help prevent sunburn

    If used as directed with other sun protection measures, decreases the risk of skin cancer and early skin aging caused by the sun

  • WARNINGS

    Warning:

    For external use only

    Do not use on damaged or broken skin

  • WHEN USING

    When using this product:

    Keep out of eyes. Rinse with water to remove.

  • ASK DOCTOR

    Stop Use and Ask a Doctor if:

    Rash occurs

  • KEEP OUT OF REACH OF CHILDREN

    Keep Out of Reach of Children

    If swallowed, get medical help or contact a poison control center immediately

  • DOSAGE & ADMINISTRATION

    Directions:

    For sunscreen use:

    Apply generously 15 min before sun exposure. Reapply every two hours.

    Use a water resistant sunscreen if swimming or sweating

    Sun Protection Measures:

    Spending time in sun increases your risk of skin cancer or early skin aging. To decrease the risk, regularly use a sunscreen with broad spectrum SPF value of 15 or higher and other sun protection measures including

    • Limit time in the sun, especially from 10 am to 2 pm
    • Wear long sleeved shirts, pants, hats, and sunglasses.
    • Children under six months of age: ask a doctor
  • INACTIVE INGREDIENT

    Inactive Ingredient:

    Water, Glycerin, Propylene Glycol, C12-15 Akyl Benzoate, Titanium Dioxide, Cetyl PEG/PPG-10/1 Dimethicone, Cyclohexasiloxane, Cyclopentasiloxane, Sorbitan Olivate, Polymethyl Methacrylate, Sodium Chloride, Quaternium-18, Bentonite, Triethoxycaprylsilane, Dimethicone, Zinc Stereate, Talc, VP/Hexadecene Copolymer, Bisabolol, Tocopheryl Acetate, Simmondsia Chinensis (Jojoba) Seed Oil, Aloe Barbadensis Leaf Extract, Cucumis Sativus (Cucumber) Fruit Extract, Mica, Silica, Phenoxyethanol, Ethylhexylglycerin, Methylisothiazolinone, Fragrance

    May contain:

    Iron Oxides (CI 77491, CI 77492, CI 77499)

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    ELF BROAD SPECTRUM SPF 20 SUNSCREEN BUFF BB CREAM 
    octinoxate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76354-610
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 g  in 100 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE4 g  in 100 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    MICA (UNII: V8A1AW0880)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)  
    SORBITAN OLIVATE (UNII: MDL271E3GR)  
    SODIUM CHLORATE (UNII: T95DR77GMR)  
    QUATERNIUM-18 (UNII: O7757NO1VL)  
    BENTONITE (UNII: A3N5ZCN45C)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    ZINC STEARATE (UNII: H92E6QA4FV)  
    TALC (UNII: 7SEV7J4R1U)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ALOE ANDONGENSIS LEAF (UNII: N1P4NU25EJ)  
    JOJOBA OIL (UNII: 724GKU717M)  
    CUCUMBER FRUIT OIL (UNII: R81Y52NPCT)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76354-610-0128.5 mL in 1 BOTTLE; Type 0: Not a Combination Product10/10/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35210/10/2015
    Labeler - J. A. Cosmetics U.S. INC (186705047)
    Registrant - Hangzhou Facecare Cosmetics Co., Ltd. (545341856)
    Establishment
    NameAddressID/FEIBusiness Operations
    Columbia Cosmetics Manufacturing, Inc.068267863manufacture(76354-610)

Related Drugs