RED ORANGE SUN SPF 45 PA PLUS PLUS PLUS- titanium dioxide powder 
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: TITANIUM DIOXIDE 13.937%, ZINC OXIDE 2.94%

Inactive ingredients:
Talc, Mica (CI 77019), Silica, Aluminum Starch Octenylsuccinate, Dimethicone, Ethylhexyl Methoxycinnamate, Methicone, Iron Oxides (CI 77492), Triethoxycaprylylsilane, Citrus Aurantium Dulcis (Orange) Peel Oil, Iron Oxides (CI 77491), Aluminum Hydroxide, Methylparaben, Iron Oxides (CI 77499), Propylparaben

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: Using the enclosed puff, apply evenly onto the entire face.

Dosage and administration:
Give a smooth tapping massage around your skin with the enclosed puff, and reapply to areas which produce sebum secretion as often as possible to give a fresh finish.

Image of carton

RED ORANGE SUN  SPF 45 PA PLUS PLUS PLUS
titanium dioxide powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76214-038
Route of AdministrationCUTANEOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM - UNII:D1JT611TNE) TITANIUM DIOXIDE2.79 g  in 20 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC OXIDE0.59 g  in 20 g
Inactive Ingredients
Ingredient NameStrength
TALC (UNII: 7SEV7J4R1U)  
MICA (UNII: V8A1AW0880)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
OCTINOXATE (UNII: 4Y5P7MUD51)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
ORANGE (UNII: 5EVU04N5QU)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76214-038-0120 g 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: 10/2011
Document Id: 3cb0defc-b395-41bd-ad8a-ec355965965b
Set id: 8f9b2c24-21ee-43fd-a0e0-0cb1d0391400
Version: 1
Effective Time: 20111009
 
SKINFOOD CO., LTD.