YAM DOUBLE CARE FLUID SPF17 PA PLUS PLUS- octinoxate cream 
SKINFOOD 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

Active ingredients: OCTINOXATE 4.0%, AVOBENZONE 1.5%, ENSULIZOLE 1.0%

Inactive ingredients:
WATER, DIISOPROPYL SEBACATE, ALCOHOL DENAT., POLYGLYCERYL-3 METHYLGLUCOSE DISTEARATE, PHENETHYL BENZOATE, ARBUTIN, 4-METHYLBENZYLIDENE CAMPHOR, DIMETHICONE, 1,2-HEXANEDIOL, SODIUM HYDROXIDE, GLYCERYL STEARATE, PEG-100 STEARATE, CARBOMER, DISODIUM EDTA, DIOSCOREA JAPONICA ROOT EXTRACT, XANTHAN GUM,
TOCOPHERYL ACETATE, ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER, PHENOXYETHANOL, METHYLPARABEN, BUTYLPARABEN, FRAGRANCE

Purpose: Protects skin from UV rays.

Warnings:
For external use only. Avoid contact with eyes.
Discontinue use if signs of irritation appear.

Keep out of reach of children:
Keep out of reach of children.

Indication and usage: Apply on skin liberally.

Dosage and administration: Dispense an ample amount and apply a thin layer onto the skin.

Image of bottle

YAM DOUBLE CARE FLUID  SPF17 PA PLUS PLUS
octinoxate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76214-015
Route of AdministrationCUTANEOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE5.6 mL  in 140 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE2.1 mL  in 140 mL
ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42) ENSULIZOLE1.4 mL  in 140 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
DIISOPROPYL SEBACATE (UNII: J8T3X564IH)  
PHENETHYL BENZOATE (UNII: 0C143929GK)  
ARBUTIN (UNII: C5INA23HXF)  
ENZACAMENE (UNII: 8I3XWY40L9)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
PEG-100 STEARATE (UNII: YD01N1999R)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
BUTYLPARABEN (UNII: 3QPI1U3FV8)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
DIOSCOREA JAPONICA ROOT (UNII: I43FCF3356)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76214-015-01140 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35203/01/2011
Labeler - SKINFOOD CO., LTD. (690324173)
Registrant - SKINFOOD CO., LTD. (690324173)
Establishment
NameAddressID/FEIBusiness Operations
SKINFOOD CO., LTD.690324173manufacture

Revised: 9/2011
Document Id: 783fcb21-2ce4-4843-bff3-52a4b600a6ed
Set id: 740314fd-ab41-45ee-89e6-11317a562338
Version: 1
Effective Time: 20110907
 
SKINFOOD CO., LTD.