Label: NATURAL SUN AQ BODY AND FAMILY MILD SUN MILK- octinoxate, octisalate, titanium dioxide, avobenzone, enzacamene 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 29, 2010

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  • ACTIVE INGREDIENT

    OCTINOXATE (7.50%)
    OCTISALATE (3.00%)
    TITANIUM DIOXIDE (2.34%)
    AVOBENZONE (2.30%)
    ENZACAMENE (2.00%)

    WATER · CYCLOMETHICONE · GLYCERIN · DIPROPYLENE GLYCOL · DICAPRYLYL CARBONATE · OCTYLDODECYL NEOPENTANOATE · POTASSIUM CETYL PHOSPHATE · SORBITAN MONOSTEARATE · GLYCERYL MONOSTEARATE · POLYOXYL 100 STEARATE · DIMETHICONE · CETEARYL ALCOHOL · COPTIS · MINERAL OIL ·XANTHAN GUM ·  STEARIC ACID · ALOE FEROX LEAF · SILICON DIOXIDE  · EDETATE DISODIUM · IONONE  · BENZYL BENZOATE · BUTYLPHENYL METHYLPROPIONAL · .ALPHA.-HEXYLCINNAMALDEHYDE

  • PURPOSE

    Face and Body Sun Block.

  • WHEN USING

    Avoid contact with eyes.

  • STOP USE

     Discontinue use if sign of irritation or rash appear.

  • DOSAGE & ADMINISTRATION

    Dispense an adequate amount and apply evenly. (At the final stage of basic skincare, dispense an adequate amount and apply evenly to parts easily exposed to UV rays such as the face, neck, arms and legs)

  • PRINCIPAL DISPLAY PANEL


    NATURAL SUN AQ BODY AND FAMILY MILD SUN MILK

    SUN BLOCK

  • INGREDIENTS AND APPEARANCE
    NATURAL SUN AQ BODY AND FAMILY MILD SUN MILK 
    octinoxate, octisalate, titanium dioxide, avobenzone, enzacamene cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51523-101
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 mL  in 100 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE3 mL  in 100 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE2.34 mL  in 100 mL
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE2.3 mL  in 100 mL
    ENZACAMENE (UNII: 8I3XWY40L9) (ENZACAMENE - UNII:8I3XWY40L9) ENZACAMENE2 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CYCLOMETHICONE (UNII: NMQ347994Z)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
    OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)  
    POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
    SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    POLYOXYL 100 STEARATE (UNII: YD01N1999R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    BENZYL BENZOATE (UNII: N863NB338G)  
    BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51523-101-021 in 1 BOX
    1NDC:51523-101-01120 mL in 1 CONTAINER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35211/22/2010
    Labeler - THEFACESHOP CO., LTD (688329416)
    Registrant - THEFACESHOP CO., LTD (688329416)
    Establishment
    NameAddressID/FEIBusiness Operations
    THEFACESHOP CO., LTD688329416manufacture