Label: SOORYEHAN HYO FERMENTED SUN BLOCK- zinc oxide, titanium dioxide, ensulizole 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 September 28, 2011

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  • ACTIVE INGREDIENT

    OCTINOXATE 7ml
    TITANIUM DIOXIDE  2.52ml
    AMILOXATE  1.6ml
    BEMOTRIZINOL  1ml
    DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE  1ml
    ENSULIZOLE  3.9ml
    TROMETHAMINE  2.63ml

  • WARNINGS AND PRECAUTIONS

    For external use only.

  • KEEP OUT OF REACH OF CHILDREN

    If swallowed, get medical help or contact a Poison Control Center right away.

  • STOP USE

    Stop use if a rash or irritation develops and lasts.

  • WHEN USING

    Keep out of eyes. Rinse with water to remove.

  • PRINCIPAL DISPLAY PANEL

    SRH HYO FERMENTED SUN BLOCK CREAM



    HYO FERMENTED SUN BLOCK CREAM

  • INACTIVE INGREDIENT

    Enter section text here

  • INGREDIENTS AND APPEARANCE
    SOORYEHAN HYO FERMENTED SUN BLOCK 
    zinc oxide, titanium dioxide, ensulizole cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53208-549
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7 mL  in 100 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE2.52 mL  in 100 mL
    AMILOXATE (UNII: 376KTP06K8) (AMILOXATE - UNII:376KTP06K8) AMILOXATE1.6 mL  in 100 mL
    BEMOTRIZINOL (UNII: PWZ1720CBH) (BEMOTRIZINOL - UNII:PWZ1720CBH) BEMOTRIZINOL1 mL  in 100 mL
    DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE (UNII: ANQ870JD20) (DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE - UNII:ANQ870JD20) DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE1 mL  in 100 mL
    ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42) ENSULIZOLE3.9 mL  in 100 mL
    TROMETHAMINE (UNII: 023C2WHX2V) (TROMETHAMINE - UNII:023C2WHX2V) TROMETHAMINE2.63 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CYCLOMETHICONE (UNII: NMQ347994Z)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
    PEG-10 RAPESEED STEROL (UNII: 258O76T85M)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    C14-22 ALCOHOLS (UNII: B1K89384RJ)  
    SQUALANE (UNII: GW89575KF9)  
    MACADAMIA OIL (UNII: 515610SU8C)  
    TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)  
    ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    CERAMIDE 3 (UNII: 4370DF050B)  
    CHOLESTEROL (UNII: 97C5T2UQ7J)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    TROMETHAMINE (UNII: 023C2WHX2V)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    CETYL PHOSPHATE (UNII: VT07D6X67O)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    PONCIRUS TRIFOLIATA FRUIT (UNII: 44445L49J2)  
    DIOSPYROS KAKI LEAF (UNII: Q71GF9OBNO)  
    CHINESE CINNAMON (UNII: WS4CQ062KM)  
    ARTEMISIA PRINCEPS LEAF (UNII: SY077EW02G)  
    CHRYSANTHELLUM INDICUM TOP (UNII: STJ856D1Z0)  
    CHAENOMELES SPECIOSA FRUIT (UNII: 6S5Q1Q537Z)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    PUERARIA MONTANA VAR. LOBATA ROOT (UNII: PET93F4I3C)  
    BLACK COHOSH (UNII: K73E24S6X9)  
    POMEGRANATE (UNII: 56687D1Z4D)  
    SCHISANDRA CHINENSIS FRUIT (UNII: ABS794681C)  
    ANGELICA GIGAS ROOT (UNII: 32766B2FHX)  
    PATCHOULI OIL (UNII: F3IN55X5PO)  
    PRUNUS ARMENIACA SEED (UNII: 75356789IW)  
    LIGUSTICUM TENUISSIMUM ROOT (UNII: 2O0H84E074)  
    MUNG BEAN (UNII: 1LIB31N73G)  
    ASIAN GINSENG (UNII: CUQ3A77YXI)  
    CAROB (UNII: 5MG5Z946UO)  
    TRICHOSANTHES KIRILOWII ROOT (UNII: V409XGE0TS)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    EDETATE TRISODIUM (UNII: 420IP921MB)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53208-549-021 in 1 BOX
    1NDC:53208-549-0160 mL in 1 CONTAINER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35209/27/2011
    Labeler - LG Household and Healthcare, Inc. (688276187)
    Registrant - LG Household and Healthcare, Inc. (688276187)
    Establishment
    NameAddressID/FEIBusiness Operations
    LG Household and Healthcare, Inc.688276187manufacture
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