LEADERS SUNBUDDY ALL OVER SUN- avobenzone spray

LEADERS SUNBUDDY ALL OVER SUN by

Drug Labeling and Warnings

LEADERS SUNBUDDY ALL OVER SUN by is a Otc medication manufactured, distributed, or labeled by LEADERS COSMETICS CO.,LTD., Cosmax, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient: Butyl Methoxydibenzoylmethane 0.72%

INACTIVE INGREDIENT

Inactive Ingredients: Butane, Propane, Alcohol Denat, Water, Ethylhexyl benzoate, Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine, Propanediol, Polymethyl Methacrylate, Phenylbenzimidazole Sulfonic Acid, Caprylyl Methicone, Cetyl Dimethicone, C12-15 Alkyl Benzoate, Ethylhexyl Triazone, Aminomethyl Propanol, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Nelumbo Nucifera Flower Extract, Anthemis Nobilis Flower Extract, Vanilla Tahitensis Fruit Extract, Camellia Sinensis Leaf Extract, Aloe Barbadensis Leaf Extract, Nymphaea Alba Flower Extract, Prunus Mume Fruit Water, Glycerin, Cyclopentasiloxane, PEG-20 Glyceryl Triisostearate, Acrylates/Dimethicone Copolymer, Glycolipids, Sorbitan Laurate, Butylene Glycol, Ethylhexylglycerin, Phenoxyethanol, Fragrance(Parfum)

PURPOSE

Purpose: Sunscreen

WARNINGS

Warning: For external use only. Avoid contact with eyes. Not for human consumption. Discontinue use if irritation occurs. If irritation persists, consult a physician. Store in cool and dry space. Keep out of reach of children.

DESCRIPTION

Directions: After sufficiently shaking the spray bottle, spray on body parts that are easily exposed to UV rays such as the arms and legs keeping a distance of about 20cm. Gently pat to even out. It is more effective to frequently spray during long-hour outdoor activities. It is recommended to spray on hands first when applying to the face.

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

Email us at info@leadersus.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

LEADERS SUNBUDDY ALL OVER SUN 
avobenzone spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69424-590
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	0.64 g  in 90 mL

Inactive Ingredients
Ingredient Name	Strength
Butane (UNII: 6LV4FOR43R)
Propane (UNII: T75W9911L6)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69424-590-02	1 in 1 CARTON	07/01/2017
1	NDC: 69424-590-01	90 mL in 1 BOTTLE, SPRAY; 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	07/01/2017

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

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

Establishment
Name	Address	ID/FEI	Business Operations
LEADERS COSMETICS CO.,LTD.		689524929	relabel(69424-590)

Establishment
Name	Address	ID/FEI	Business Operations
Cosmax, Inc		689049693	manufacture(69424-590)