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

Image of carton

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:69424-600-02	1 in 1 CARTON	01/02/2018	12/30/2019
1	NDC:69424-600-01	20 g in 1 CONTAINER; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	01/02/2018	12/30/2019

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

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

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

Revised: 7/2021

Document Id: 80bcdfd3-e5ba-4266-a0d2-d4b88cf9ff81

Set id: ffe21aff-faa4-4225-93bf-40377b9b7c08

Version: 2

Effective Time: 20210712

LEADERS COSMETICS CO.,LTD.