Label: ELF TINTED MOISTURIZER 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 17, 2010

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  • ACTIVE INGREDIENT

    Active Ingredient:

    Benzophenone-3: 5.0%

    Octyl Methoxycinnamate: 7.0%

  • PURPOSE

    Purpose:

    Sunscreen

  • INDICATIONS & USAGE

    Uses:

    • Hydrates, softens and smooths skin
    • Instant natural radiant glow
    • Helps protect against 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:

    Massage a pearl-sized amount into skin and neck daily.

  • STORAGE AND HANDLING

    Other Information:

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

  • INACTIVE INGREDIENT

    Inactive Ingredient:

    Water, Caprylic/Capric Triglyceride, Kaolin, Titanium Dioxide, Talc, Mica, Octyl Palmitate, Glyceryl Stearate, Synthetic Beeswax,  Stearic Acid, Stearyl Alcohol, DEA-Cetyl Phosphate, Propylene Glycol, Magnesium Aluminum Silicate, Phenoxyehtanol, Triethanolamine, Xanthan Gum, Fragrance, Methylparaben, Propylparaben, Ethylparaben, Disodium EDTA.

    May contain:

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

  • PRINCIPAL DISPLAY PANEL

    labelabel

  • INGREDIENTS AND APPEARANCE
    ELF TINTED MOISTURIZER SPF 15 
    oxybenzone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52664-003
    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
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    MICA (UNII: V8A1AW0880)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    KAOLIN (UNII: 24H4NWX5CO)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    TALC (UNII: 7SEV7J4R1U)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    WHITE WAX (UNII: 7G1J5DA97F)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    DIETHANOLAMINE CETYL PHOSPHATE (UNII: 4UG0316V9S)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    WATER (UNII: 059QF0KO0R) 42.35 g  in 100 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52664-003-0112 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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