GOLDKIWI SUN SPF 36 PA PLUS PLUS- octinoxate cream

GOLDKIWI SUN by

Drug Labeling and Warnings

GOLDKIWI SUN by is a Otc medication manufactured, distributed, or labeled by SKINFOOD CO., LTD.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients: OCTINOXATE 7%, TITANIUM DIOXIDE 4.1%, ZINC OXIDE 2.85%

INACTIVE INGREDIENT

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

Purpose: Protects skin from UV rays.

WARNINGS

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:
Keep out of reach of children.

INDICATIONS & USAGE

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 & ADMINISTRATION

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

GOLDKIWI SUN  SPF 36 PA PLUS PLUS
octinoxate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76214-034
Route of Administration	CUTANEOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	3.5 g  in 50 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM - UNII:D1JT611TNE)	TITANIUM DIOXIDE	2.05 g  in 50 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC OXIDE	1.42 g  in 50 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76214-034-01	50 g in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	03/01/2011

Labeler - SKINFOOD CO., LTD. (690324173)

Registrant - SKINFOOD CO., LTD. (690324173)

Establishment
Name	Address	ID/FEI	Business Operations
SKINFOOD CO., LTD.		690324173	manufacture