TOMATO SUN SPF 36 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 6.5%, Titanium Dioxide 4.24%, Zinc Oxide 3.5%

Inactive ingredients:
Water, Cyclomethicone, Dimethicone, Squalane, Dimethicone/Vinyl Dimethicone Crosspolymer, PEG-10 Dimethicone, Propylene Glycol, Triethanolamine, Dimethicone Copolyol, Hexyl Laurate, Cetyl Peg/Ppg-10/1 Dimethicone, Sorbitan Sesquioleate, Glycerin, Solanum Lycopersicum (Tomato) Extract, Silica, Stearalkonium Hectorite, Magnesium Aluminum Silicate, Alumina, Methylparaben, Fragrance, Propylparaben, Imidazolidinyl Urea

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

TOMATO SUN  SPF 36 PA PLUS PLUS
octinoxate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76214-035
Route of AdministrationCUTANEOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE3.25 mL  in 50 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM - UNII:D1JT611TNE) TITANIUM DIOXIDE2.12 mL  in 50 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC OXIDE1.75 mL  in 50 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CYCLOMETHICONE (UNII: NMQ347994Z)  
SQUALANE (UNII: GW89575KF9)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
TROLAMINE (UNII: 9O3K93S3TK)  
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
GLYCERIN (UNII: PDC6A3C0OX)  
TOMATO (UNII: Z4KHF2C175)  
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
IMIDUREA (UNII: M629807ATL)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76214-035-0150 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: 10/2011
Document Id: dda70e19-38b7-499a-8f60-f4dc0652e117
Set id: bf4bfedd-d601-4378-a90a-28375f9daf99
Version: 1
Effective Time: 20111007
 
SKINFOOD CO., LTD.