Label: ELF SUPER GLOSSY LIP SHINE SPF 15- oxybenzone cream

  • 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 15, 2010

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  • ACTIVE INGREDIENT

    Active Ingredient:

    Benzophenone-3: 5.0%

    Octyl Methoxycinnamate: 7.0%

  • PURPOSE

    Purpose:

    Sunscreen

  • INDICATIONS & USAGE

    Uses:

    • Brilliant, never sticky long lasting shine
    • Moisturizes and soothes on contact
    • Protects sun and skin aging
  • WARNINGS

    Warning:

    For external use only

  • WHEN USING

    When using this product:

    Do not get into eyes

  • ASK DOCTOR

    Stop Use and Ask a Doctor if:

    Rash or irritation develops and lasts

  • 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:

    Apply liberally as often as needed before sun exposure.

  • STORAGE AND HANDLING

    Other Imformation:

    Store at room temperature 15-30C (59-86F)

  • INACTIVE INGREDIENT

    Inactive Ingredient:

    Paraffinium Liquidum (Mineral Oil), Polyisobutene, Silica, Mica, Fragrance, Methylparaben, Propylparaben.

    May contain:

    Iron Oxides (CI 77491, CI 77492, CI 77499), Manganese Violet (CI 77742), Mica (CI 77019), Red No. 7 Lake (CI 15850), Red No. 27 Lake (CI 45410), Red No. 6 Lake (CI 15851), Blue No. 1 Lake (CI 42090), Yellow No. 5 Lake (CI 19140), Yellow No. 6 Lake (CI 15985)

  • PRINCIPAL DISPLAY PANEL

    labellabel

  • INGREDIENTS AND APPEARANCE
    ELF SUPER GLOSSY LIP SHINE SPF 15 
    oxybenzone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52664-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE5 g  in 100 g
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    POLYISOBUTYLENE (1200000 MW) (UNII: FLT10CH37X)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    MICA (UNII: V8A1AW0880)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52664-001-0110 g in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35212/01/2010
    Labeler - Hangzhou Facecare Cosmetics Co., Ltd. (545341856)
    Registrant - Hangzhou Facecare Cosmetics Co., Ltd. (545341856)
    Establishment
    NameAddressID/FEIBusiness Operations
    Hangzhou Facecare Cosmetics Co., Ltd.545341856manufacture
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