TOMATO WRINKLE SUN SPF36 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 7%, TITANIUM DIOXIDE 4.1%, ZINC OXIDE 2.85%

Inactive ingredients:
WATER, CYCLOPENTASILOXANE, ISOAMYL p-METHOXYCINNAMATE, CETYL PEG/PPG-10/1 DIMETHICONE, PROPYLENE GLYCOL, SQUALANE, GLYCERIN, SORBITAN SESQUIOLEATE, STEARALKONIUM HECTORITE, BUTYLENE GLYCOL, LECITHIN, PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE, PEG-10 DIMETHICONE, OZOKERITE, LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE, TRIETHOXYCAPRYLYLSILANE, ALUMINUM HYDROXIDE, STEARIC ACID, DIMETHICONE/METHICONE COPOLYMER, POLYMETHYL METHACRYLATE, SOLANUM LYCOPERSICUM (TOMATO) FRUIT EXTRACT, ADENOSINE, TRIETHANOLAMINE, METHYLPARABEN, PROPYLPARABEN, PHENOXYETHANOL, 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 carton

TOMATO WRINKLE SUN  SPF36 PA PLUS PLUS
octinoxate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76214-029
Route of AdministrationCUTANEOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE3.5 mL  in 50 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM - UNII:D1JT611TNE) TITANIUM DIOXIDE2.05 mL  in 50 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC OXIDE1.43 mL  in 50 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SQUALANE (UNII: GW89575KF9)  
GLYCERIN (UNII: PDC6A3C0OX)  
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
TOMATO (UNII: Z4KHF2C175)  
TROLAMINE (UNII: 9O3K93S3TK)  
ADENOSINE (UNII: K72T3FS567)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76214-029-0150 mL in 1 CARTON
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: 11caa614-8cf5-4bba-818e-0c210f3f93f4
Set id: 940c6da8-1168-4488-96af-fdd9b8f36c46
Version: 1
Effective Time: 20110929
 
SKINFOOD CO., LTD.