NATURAL SUN AQ BODY AND FAMILY MILD SUN MILK - octinoxate, octisalate, titanium dioxide, avobenzone, enzacamene cream 
THEFACESHOP CO., LTD

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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Drug Facts

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

Face and Body Sun Block.

Avoid contact with eyes.

 Discontinue use if sign of irritation or rash appear.

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)


NATURAL SUN AQ BODY AND FAMILY MILD SUN MILK

SUN BLOCK

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

Revised: 11/2010
Document Id: b7e93fdb-4412-4271-b379-8d07992f0e82
Set id: 3a034956-a8a1-4117-a814-1ad35df4e9bb
Version: 2
Effective Time: 20101129
 
THEFACESHOP CO., LTD