PEACH SAKE SUN SPF32 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%, TITANIUM DIOXIDE 3.3%

Inactive ingredients:

WATER, ISOAMYL p-METHOXYCINNAMATE, PROPYLENE GLYCOL, BUTYLENE GLYCOL, POLYSORBATE 80, BIS-ETHYLHEXYLOXYPHENOL METHOXYPHENYL TRIAZINE, POLYGLYCERYL-3 METHYLGLUCOSE DISTEARATE, BIS-PEG-18 METHYL ETHER DIMETHYL SILANE, DIETHYLHEXYL CARBONATE, POLYGLYCERYL-6 POLYHYDROXYSTEARATE, RIMETHOXYCAPRYLYLSILANE, SORBITAN LAURATE, ALUMINUM HYDROXIDE, STEARIC ACID, POTASSIUM CETYL PHOSPHATE, SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER, ISOHEXADECANE, DIMETHICONE, PRUNUS PERSICA (PEACH) FRUIT EXTRACT, CHAMOMILLA RECUTITA (MATRICARIA) FLOWER EXTRACT, GLYCYRRHIZA GLABRA (LICORICE) ROOT EXTRACT, CENTELLA ASIATICA EXTRACT, GLYCINE SOJA (SOYBEAN) SEED EXTRACT, PYRUS MALUS (APPLE) FRUIT EXTRACT, CARBOMER, BHT, TOCOPHERYL ACETATE, CAMELLIA SINENSIS LEAF EXTRACT, TRIETHANOLAMINE, DISODIUM EDTA, RICE FERMENT FILTRATE (SAKE), PHENOXYETHANOL, METHYLPARABEN, PROPYLPARABEN, 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:
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

PEACH SAKE SUN  SPF32 PA PLUS PLUS
octinoxate lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76214-012
Route of AdministrationCUTANEOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE5.25 mL  in 75 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM - UNII:D1JT611TNE) TITANIUM DIOXIDE2.47 mL  in 75 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
DIETHYLHEXYL CARBONATE (UNII: YCD50O0Z6L)  
TRIMETHOXYCAPRYLYLSILANE (UNII: FZ07E4LW2M)  
SORBITAN MONOLAURATE (UNII: 6W9PS8B71J)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
ISOHEXADECANE (UNII: 918X1OUF1E)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PEACH (UNII: 3OKE88I3QG)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
CHAMOMILE (UNII: FGL3685T2X)  
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
CENTELLA ASIATICA (UNII: 7M867G6T1U)  
SOYBEAN (UNII: L7HT8F1ZOD)  
APPLE (UNII: B423VGH5S9)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
TROLAMINE (UNII: 9O3K93S3TK)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76214-012-0175 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: 6209c189-d628-4727-8aac-a565a7424afb
Set id: 6d5b07ab-c0a2-4494-8b07-a73573ef71c4
Version: 2
Effective Time: 20110907
 
SKINFOOD CO., LTD.