SOORYEHAN HYO FERMENTED SUN BLOCK - zinc oxide, titanium dioxide, ensulizole  cream 
LG Household and Healthcare, Inc.

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.

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SOORYEHAN HYO FERMENTED SUN BLOCK CREAM

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

For external use only.

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

Stop use if a rash or irritation develops and lasts.

Keep out of eyes. Rinse with water to remove.

SRH HYO FERMENTED SUN BLOCK CREAM



HYO FERMENTED SUN BLOCK CREAM

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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

Revised: 9/2011
Document Id: b6962d6b-f69c-4375-8bdc-4c1a1853552b
Set id: e6937dda-afe6-4f65-83e8-1a5a6ba15390
Version: 2
Effective Time: 20110928
 
LG Household and Healthcare, Inc.