RED ORANGE SUN SPF 45 PA PLUS PLUS PLUS

Dosage form: powder
Ingredients: TITANIUM DIOXIDE 2.79g in 20g, ZINC OXIDE 0.59g in 20g
Labeler: SKINFOOD CO., LTD.
NDC Code: 76214-038

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: 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.

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 AdministrationCUTANEOUSDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (TITANIUM) TITANIUM DIOXIDE2.79 g  in 20 g
ZINC OXIDE (ZINC CATION) ZINC OXIDE0.59 g  in 20 g
Inactive Ingredients
Ingredient NameStrength
TALC 
MICA 
SILICON DIOXIDE 
ALUMINUM STARCH OCTENYLSUCCINATE 
DIMETHICONE 
OCTINOXATE 
TRIETHOXYCAPRYLYLSILANE 
ORANGE 
ALUMINUM HYDROXIDE 
METHYLPARABEN 
PROPYLPARABEN 
Packaging
#Item CodePackage Description
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/FEIOperations
SKINFOOD CO., LTD.690324173manufacture

Revised: 10/2011
 
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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