LEADERS SUNBUDDY UV CUT SUN- octocrylene, octinoxate, octisalate stick

LEADERS SUNBUDDY UV CUT SUN by

Drug Labeling and Warnings

LEADERS SUNBUDDY UV CUT SUN by is a Otc medication manufactured, distributed, or labeled by LEADERS COSMETICS CO.,LTD., Hankook Cosmetics Manufacturing Co.,Ltd_Eumseong Factory. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients: Octocrylene 8%, Ethylhexyl Methoxycinnamate 7%, Ethylhexyl Salicylate 5%

INACTIVE INGREDIENT

Inactive Ingredients: Octyldodecanol, Diisostearyl Malate, Polymethylsilsesquioxane, Diethylamino Hydroxybenzoyl Hexyl Benzoate, Caprylic/Capric Triglyceride, Hydrogenated Polyisobutene, Silica, VinylDimethicone/Methicone Silsesquioxane Crosspolymer, Dibutyl Ethylhexanoyl Glutamide, Dibutyl Lauroyl Glutamide, Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine, Sorbitan Caprylate, Parfum, Eucalyptus Globulus Leaf Oil, Ectoin, Xylitylglucoside, Anhydroxylitol, Xylitol, Water, Glucose

PURPOSE

Purpose: Sunscreen

WARNINGS

Warning: For external use only. Not for human consumption. Discontinue use if irritation occurs. If irritation persists, consult a physician. The optimal temperature for storage is 10~30℃. When in use, maintain the content shorter than 1cm by adjusting the dial on the bottom of the product. Avoid direct contact with clothes or household items, since there is a possibility of stain/discoloration. Keep the product away from excessive heat and direct sunlight. Keep out of reach of children.

DESCRIPTION

Directions: At the last step of your skincare routine, twist the bottom of the product clockwise to pull up the content. Apply the content on the surface of the face from the inside to the outside. Re-apply regularly during longtime outdoor activities.

QUESTIONS

Questions or comments? -1-213-788-3597

Email us at 788-3597

Email us at support@leadersus.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

LEADERS SUNBUDDY UV CUT SUN 
octocrylene, octinoxate, octisalate stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69424-600
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octocrylene (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	Octocrylene	1.6 g  in 20 g
Octinoxate (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	Octinoxate	1.4 g  in 20 g
Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	Octisalate	1.0 g  in 20 g

Inactive Ingredients
Ingredient Name	Strength
Octyldodecanol (UNII: 461N1O614Y)
Diisostearyl Malate (UNII: QBS8A3XZGQ)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69424-600-02	1 in 1 CARTON	01/02/2018
1	NDC: 69424-600-01	20 g in 1 CONTAINER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	01/02/2018

Labeler - LEADERS COSMETICS CO.,LTD. (689524929)

Registrant - LEADERS COSMETICS CO.,LTD. (689524929)

Establishment
Name	Address	ID/FEI	Business Operations
Hankook Cosmetics Manufacturing Co.,Ltd_Eumseong Factory		688235645	manufacture(69424-600)