GOLDKIWI SUN SPF50 PLUS 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 7.5%, ZINC OXIDE 4.90%, TITANIUM DIOXIDE 2.90%

INACTIVE INGREDIENT

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

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

GOLDKIWI SUN  SPF50 PLUS PA PLUS PLUS
octinoxate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76214-013
Route of Administration	CUTANEOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	3.75 g  in 50 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC OXIDE	2.45 g  in 50 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM - UNII:D1JT611TNE)	TITANIUM DIOXIDE	1.45 g  in 50 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76214-013-01	50 g in 1 CARTON

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