QUINCE WHITENING SUN SPF 34 PA PLUS PLUS- octinoxate lotion 
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 7.0%, OCTISALATE 5.0%, TITANIUM DIOXIDE 0.93%

Inactive ingredients:
WATER, ISOAMYL p-METHOXYCINNAMATE, BUTYLENE GLYCOL, PROPYLENE GLYCOL, ARBUTIN, CETEARETH-6 OLIVATE, BIS-ETHYLHEXYLOXYPHENOL METHOXYPHENYL TRIAZINE, C14-22 ALCOHOLS, CYCLOPENTASILOXANE, POLYGLYCERYL-3 METHYLGLUCOSE DISTEARATE, SORBITAN STEARATE, C12-20 ALKYL GLUCOSIDE, SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER, BRASSICA OLERACEA ITALICA (BROCCOLI) EXTRACT, CHAENOMELES SINENSIS FRUIT EXTRACT, HONEY EXTRACT, ISOHEXADECANE, AMMONIUM ACRYLOYLDIMETHYLTAURATE/BEHENETH-25 METHACRYLATE CROSSPOLYMER, POLYSORBATE 80, POTASSIUM CETYL PHOSPHATE, DISODIUM EDTA, ALUMINUM HYDROXIDE, STEARIC ACID, BHT, TOCOPHERYL ACETATE, PROPYLPARABEN, PHENOXYETHANOL, METHYLPARABEN, FRAGRANCE, SILICA

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:
Use at the end of your daily skincare regimen.
Apply liberally onto face and body before sun exposure avoiding the eye area.

Dosage and administration:
For best results, apply at least 15 to 20 minutes before sun exposure.
Reapply frequently while out in the sun.

Image of bottle

QUINCE WHITENING SUN  SPF 34 PA PLUS PLUS
octinoxate lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76214-031
Route of AdministrationCUTANEOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE4.9 mL  in 70 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE3.5 mL  in 70 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM - UNII:D1JT611TNE) TITANIUM DIOXIDE0.65 mL  in 70 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
ARBUTIN (UNII: C5INA23HXF)  
C14-22 ALCOHOLS (UNII: B1K89384RJ)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
C12-20 ALKYL GLUCOSIDE (UNII: K67N5Z1RUA)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
BROCCOLI (UNII: UOI4FT57BZ)  
CHAENOMELES SPECIOSA FRUIT (UNII: 6S5Q1Q537Z)  
HONEY (UNII: Y9H1V576FH)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
ISOHEXADECANE (UNII: 918X1OUF1E)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76214-031-0170 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: 4c5fa4ee-7698-43ef-bc32-8f277e86ffbb
Set id: 457a843a-de7d-4657-a55d-263a62093ba2
Version: 1
Effective Time: 20110930
 
SKINFOOD CO., LTD.