Label: IMAN SKIN TONE EVENER BB 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 August 15, 2012

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  • ACTIVE INGREDIENT

    Active Ingredient:

    Benzophenone-3: 3%

    Octyl methoxycinnamate: 7.5%

  • PURPOSE

    Purpose:

    Sunscreen

  • INDICATIONS & USAGE

    Uses:

    Help prevent sunburn

  • WARNINGS

    Warning:

    For external use only

    Skin Cancer/Skin Aging Alert:

    Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown to only help prevent sunburn, not skin cancer and skin aging.

    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 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 daily to clean skin, alone or under makeup. Apply over the entire face and neck.

    These with sensitive skin should wait 10 minutes after cleansing before application.

    Children under 6 months of age, ask a doctor.

  • STORAGE AND HANDLING


    Other Information

    Moderate protection against sunburn
  • INACTIVE INGREDIENT

    Inactive Ingredient:

    Water (Aqua), Butylene Glycol, Cyclopentasiloxane, Polyglyceryl-3 Diisostearate, Glycerin, Talc, Glyceryl Stearate, PEG-100 Stearate, Ammonium Acryloyldimethyltaurate/VP Copolymer, Garcinia Indica Seed Butter, Rumex Occidentalis Extract,Xanthan Gum, Alcohol Denat, Ascorbic Acid, Euterpe Oleracea Fruit Extract, Aloe Barbadenensis Leaf Juice, Vitis Vinifera (Grape) Seed Oil, Prunus Amygdalus Dulcis (Sweed Almond) Oil, Glycyrrhiza Blabra (Licorice) Root Extract, Tocopheryl Acetate, Retinyl Palmitate, Propyl Glycol, Sodium EDTA, Phenoxyethanol, Methylisothiazolinone.

    May Contain: Titanium Dioxide (CI 77891), Iron Oxides (CI 77491, CI 77492, CI 77499)

  • PRINCIPAL DISPLAY PANEL

    lablabel

  • INGREDIENTS AND APPEARANCE
    IMAN SKIN TONE EVENER BB SPF 15 
    oxybenzone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43438-003
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE3 g  in 100 mL
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    ALMOND OIL (UNII: 66YXD4DKO9)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R) 38.83 g  in 100 mL
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    1,2-BUTANEDIOL (UNII: RUN0H01QEU)  
    ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    ACAI (UNII: 46AM2VJ0AW)  
    GRAPE SEED OIL (UNII: 930MLC8XGG)  
    TALC (UNII: 7SEV7J4R1U)  
    ALCOHOL (UNII: 3K9958V90M)  
    AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)  
    GARCINIA INDICA SEED BUTTER (UNII: US2H3D7800)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43438-003-0130 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35208/16/2012
    Labeler - Impala, Inc. (068545164)
    Registrant - Impala, Inc. (068545164)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sheencolor Biotech Co., Ltd.545285306manufacture(43438-003)
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