Medication Guide App

TOMATO WRINKLE SUN SPF36 PA PLUS PLUS

Dosage form: cream
Ingredients: OCTINOXATE 3.5mL in 50mL, TITANIUM DIOXIDE 2.05mL in 50mL, ZINC OXIDE 1.43mL in 50mL
Labeler: SKINFOOD CO., LTD.
NDC Code: 76214-029

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.

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.

TOMATO WRINKLE SUN  SPF36 PA PLUS PLUS
octinoxate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76214-029
Route of AdministrationCUTANEOUSDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (OCTINOXATE) OCTINOXATE3.5 mL  in 50 mL
TITANIUM DIOXIDE (TITANIUM) TITANIUM DIOXIDE2.05 mL  in 50 mL
ZINC OXIDE (ZINC CATION) ZINC OXIDE1.43 mL  in 50 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
CYCLOMETHICONE 5 
SILICON DIOXIDE 
PROPYLENE GLYCOL 
SQUALANE 
GLYCERIN 
SORBITAN SESQUIOLEATE 
BUTYLENE GLYCOL 
LECITHIN, SOYBEAN 
TRIETHOXYCAPRYLYLSILANE 
ALUMINUM HYDROXIDE 
STEARIC ACID 
METHYLPARABEN 
PHENOXYETHANOL 
PROPYLPARABEN 
TOMATO 
TROLAMINE 
ADENOSINE 
Packaging
#Item CodePackage Description
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/FEIOperations
SKINFOOD CO., LTD.690324173manufacture

Revised: 09/2011
 
SKINFOOD CO., LTD.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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