TOMATO SUN SPF 36 PA PLUS PLUS- octinoxate cream

TOMATO SUN by

Drug Labeling and Warnings

TOMATO SUN by is a Otc medication manufactured, distributed, or labeled by SKINFOOD CO., LTD.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients: OCTINOXATE 6.5%, Titanium Dioxide 4.24%, Zinc Oxide 3.5%

INACTIVE INGREDIENT

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

Purpose: Protects skin from UV rays.

WARNINGS

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:
Keep out of reach of children.

INDICATIONS & USAGE

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 & ADMINISTRATION

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

TOMATO SUN  SPF 36 PA PLUS PLUS
octinoxate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76214-035
Route of Administration	CUTANEOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	3.25 mL  in 50 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM - UNII:D1JT611TNE)	TITANIUM DIOXIDE	2.12 mL  in 50 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC OXIDE	1.75 mL  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76214-035-01	50 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	03/01/2011

Labeler - SKINFOOD CO., LTD. (690324173)

Registrant - SKINFOOD CO., LTD. (690324173)

Establishment
Name	Address	ID/FEI	Business Operations
SKINFOOD CO., LTD.		690324173	manufacture