RED ORANGE SUN PACT SPF 50 PLUS PA PLUS PLUS PLUS

Dosage form: powder
Ingredients: OCTINOXATE 0.66g in 9.5g, TITANIUM DIOXIDE 0.29g in 9.5g, ZINC OXIDE 0.27g in 9.5g
Labeler: SKINFOOD CO., LTD.
NDC Code: 76214-037

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 3.104%, ZINC OXIDE 2.88%

Inactive ingredients:
Talc, Mica (CI 77019), Methyl Methacrylate Crosspolymer, Silica, Nylon-12, Ethylene/Acrylic Acid Copolymer, Methylene Bis-Benzotriazolyl Tetramethylbutylpheno, Trimethylolpropane Triethylhexanoate, Phenyl Trimethicone, Magnesium Myristate, Dimethicone, Aluminum Hydroxide, Methylparaben, MethiconeDimethicone/Methicone Copolymer, Iron Oxides (CI 77491), Iron Oxides (CI 77492), Fragrance(Parfum), Propylparaben, Iron Oxides (CI 77499), Citrus Aurantium Dulcis (Orange) Fruit Extract, Caprylic/Capric Triglyceride, Solanum Lycopersicum (Tomato) Fruit Oil, Water

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 PACT  SPF 50 PLUS PA PLUS PLUS PLUS
octinoxate powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76214-037
Route of AdministrationCUTANEOUSDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (OCTINOXATE) OCTINOXATE0.66 g  in 9.5 g
TITANIUM DIOXIDE (TITANIUM) TITANIUM DIOXIDE0.29 g  in 9.5 g
ZINC OXIDE (ZINC CATION) ZINC OXIDE0.27 g  in 9.5 g
Inactive Ingredients
Ingredient NameStrength
WATER 
TALC 
MICA 
SILICON DIOXIDE 
TRIMETHYLOLPROPANE TRIETHYLHEXANOATE 
PHENYL TRIMETHICONE 
MAGNESIUM MYRISTATE 
DIMETHICONE 
ALUMINUM HYDROXIDE 
METHYLPARABEN 
PROPYLPARABEN 
ORANGE 
MEDIUM-CHAIN TRIGLYCERIDES 
TOMATO 
Packaging
#Item CodePackage Description
1NDC:76214-037-019.5 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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