GOLDKIWI SUN SPF 36 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%, TITANIUM DIOXIDE 4.1%, ZINC OXIDE 2.85%

Inactive ingredients:
WATER, CYCLOPENTASILOXANE, ISOAMYL p-METHOXYCINNAMATE, CETYL PEG/PPG-10/1 DIMETHICONE, ACTINIDIA CHINENSIS (KIWI) FRUIT EXTRACT, SQUALANE, PROPYLENE GLYCOL, SODIUM CHLORIDE, SORBITAN SESQUIOLEATE, STEARALKONIUM HECTORITE, GLYCERIN, PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE, PEG-10 DIMETHICONE, OZOKERITE, LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE, TRIETHOXYCAPRYLYLSILANE, ALUMINUM HYDROXIDE, STEARIC ACID, DIMETHICONE/METHICONE COPOLYMER, POLYMETHYL METHACRYLATE, TRIETHANOLAMINE, CITRULLUS VULGARIS (WATERMELON) FRUIT EXTRACT, PRUNUS MUME FRUIT EXTRACT, SODIUM PALMITOYL PROLINE, NYMPHAEA ALBA FLOWER EXTRACT, PANTHENOL, DISODIUM COCOAMPHODIACETATE, TRITICUM VULGARE (WHEAT) GERM EXTRACT, SACCHAROMYCES CEREVISIAE EXTRACT, SODIUM HYALURONATE, PROPYLPARABEN, METHYLPARABEN, PHENOXYETHANOL, FRAGRANCE, SILICA

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:
For best results, apply at least 15 to 20 minutes before sun exposure.
Reapply frequently while out in the sun.

Image of carton

GOLDKIWI SUN  SPF 36 PA PLUS PLUS
octinoxate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76214-034
Route of AdministrationCUTANEOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE3.5 g  in 50 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM - UNII:D1JT611TNE) TITANIUM DIOXIDE2.05 g  in 50 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC OXIDE1.42 g  in 50 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
KIWI FRUIT (UNII: 71ES77LGJC)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SQUALANE (UNII: GW89575KF9)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
GLYCERIN (UNII: PDC6A3C0OX)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
TROLAMINE (UNII: 9O3K93S3TK)  
WATERMELON (UNII: 231473QB6R)  
PRUNUS MUME FRUIT (UNII: 639190I8CU)  
SODIUM PALMITOYL PROLINE (UNII: 64L053FRFO)  
NYMPHAEA ALBA FLOWER (UNII: 40KQ7Q535O)  
PANTHENOL (UNII: WV9CM0O67Z)  
DISODIUM COCOAMPHODIACETATE (UNII: 18L9G3U51M)  
WHEAT GERM (UNII: YR3G369F5A)  
SACCHAROMYCES CEREVISIAE (UNII: 978D8U419H)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76214-034-0150 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: dfb9c43e-537a-4ea3-ada2-5ac2d7cc7b23
Set id: 3fb42cbd-8198-4163-a03d-146993f88aad
Version: 1
Effective Time: 20111006
 
SKINFOOD CO., LTD.