GOLDKIWI SUN SPF 50 PLUS PA PLUS PLUS PLUS- octinoxate stick 
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: OCTINOXATE 7%, ZINC OXIDE 4.9%, TITANIUM DIOXIDE 4.15%

Inactive ingredients:
Dimethicone, Triethylhexanoin, Silica, Talc, Phenyl Trimethicone, Isoamyl p-Methoxycinnamate, Polyethylene, Ceresin, Sorbitan Isostearate, Microcrystalline Wax, Vinyl Dimethicone/Methicone Silsesquiox ane Crosspolymer, Aluminum Hydroxide, Stearic Acid, Triethoxycaprylylsilane, Fragrance(Parfum), Polyglyceryl-2 Triisostearate, Iron Oxides (CI 77492), Glyceryl Caprylate, Caprylyl Glycol, Iron Oxides (CI 77491), Actinidia Chinensis (Kiwi) Fruit Extract, Argania Spinosa Kernel Oil, Hydroxyapatite, Helianthus Annuus (Sunflower) Seed Oil

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:
At the end of basic cosmetic care, apply in an adequate amount to body parts sensitive to UV radiation such as face, arms and legs, avoiding the eye area

Dosage and administration:
Apply about 15 to 20 minutes before going out.
Reapply as often as possible for a long-term outing or activities.

Image of bottle

GOLDKIWI SUN  SPF 50 PLUS PA PLUS PLUS PLUS
octinoxate stick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76214-039
Route of AdministrationCUTANEOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE1.47 g  in 21 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC OXIDE1.03 g  in 21 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM - UNII:D1JT611TNE) TITANIUM DIOXIDE0.87 g  in 21 g
Inactive Ingredients
Ingredient NameStrength
DIMETHICONE (UNII: 92RU3N3Y1O)  
TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
TALC (UNII: 7SEV7J4R1U)  
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
CERESIN (UNII: Q1LS2UJO3A)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
KIWI FRUIT (UNII: 71ES77LGJC)  
ARGAN OIL (UNII: 4V59G5UW9X)  
SUNFLOWER OIL (UNII: 3W1JG795YI)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76214-039-0121 g in 1 BOTTLE
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: 74f19ed5-a039-49c9-9b0d-d664fcb2e20d
Set id: ff32ffa8-f320-45b8-b514-6710f4972752
Version: 1
Effective Time: 20111009
 
SKINFOOD CO., LTD.