GOLDKIWI SUN SPF50 PLUS PA PLUS PLUS- octinoxate cream 
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 7.5%, ZINC OXIDE 4.90%, TITANIUM DIOXIDE 2.90%

Inactive ingredients:
Water, Cyclopentasiloxane, Ethylhexyl Salicylate, Glycerin, PEG-10 Dimethicone, Dimethicone, Dipropylene Glycol, Cetyl PEG/PPG-10/1 Dimethicone, Magnesium Sulfate, Disteardimonium Hectorite, Vinyl Dimethicone/Methicone Silsesquioxane Crosspolymer, Isoamyl p-Methoxycinnamate, Dimethicone/Vinyl Dimethicone Crosspolymer, Aluminum Hydroxide, Stearic Acid, Methyl Methacrylate Crosspolymer, Methylparaben, Phenoxyethanol, Fragrance(Parfum), Actinidia Chinensis (Kiwi) Fruit Extract, Propylparaben, Caffeine, Sea Water, Polydecene, Squalane, Viscum Album (Mistletoe) Extract, Palmitoyl Tripeptide-5

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 carton

GOLDKIWI SUN  SPF50 PLUS PA PLUS PLUS
octinoxate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76214-013
Route of AdministrationCUTANEOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE3.75 g  in 50 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC OXIDE2.45 g  in 50 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM - UNII:D1JT611TNE) TITANIUM DIOXIDE1.45 g  in 50 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
KIWI FRUIT (UNII: 71ES77LGJC)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
CAFFEINE (UNII: 3G6A5W338E)  
SQUALANE (UNII: GW89575KF9)  
PALMITOYL TRIPEPTIDE-5 (UNII: 2A3916MQHO)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76214-013-0150 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: 9/2011
Document Id: 0dff75e2-4230-4392-ac26-8b16abcaeaa9
Set id: acfa1308-d9e5-4cbf-bacc-3e9779e6f94c
Version: 2
Effective Time: 20110907
 
SKINFOOD CO., LTD.