LEADERS SUNBUDDY DAILY MOISTURE SUNSCREEN- homosalate, octocrylene, octisalate, avobenzone cream

LEADERS SUNBUDDY DAILY MOISTURE SUNSCREEN by

Drug Labeling and Warnings

LEADERS SUNBUDDY DAILY MOISTURE SUNSCREEN by is a Otc medication manufactured, distributed, or labeled by LEADERS COSMETICS CO.,LTD.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient: Homosalate 9.5%, Octocrylene 5.0%, Ethylhexyl Salicylate 4.5%, Butyl Methoxydibenzoylmethane 3.0%

INACTIVE INGREDIENT

Inactive Ingredients: Water, Dipropylene Glycol, Glycerin, Niacinamide, Propanediol, Dimethicone/Vinyl Dimethicone Crosspolymer, Hydrolyzed Wheat Protein/PVP Crosspolymer, Argania SpinosaKernel Oil, Betula Alba Juice, Avena Sativa (Oat) Kernel Extract, Honey Extract, Vanilla Tahitensis Fruit Extract, Portu laca Oleracea Extract, Caprylyl Methicone, Perlite, Dicaprylyl Carbonate, Dimethicone, Glyceryl Stearate, PEG-100 Stearate, Ammonium Acryloyldimethyltaurate/VP Copolymer, Cetearyl Glucoside, Hydroxyacetophenone, Panthenol, Tocopheryl Acetate, Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Isohexadecane, Polysorbate 80, Dipotassium Glycyrrhizate, Adenosine, Sorbitan Oleate, Isoceteth-10, Isoceteth-25, Sodium Phytate, Ethylhexylglycerin, Butylene Glycol, 1,2-Hexanediol, Cetearyl Alcohol, Xanthan Gum, Disodium EDTA, Phenoxyethanol, Potassium Sorbate, Fragrance(Parfum), Iron Oxides (CI 77492), Iron Oxides (CI 77491), Iron Oxides (CI 77499)

PURPOSE

Purpose: Sunscreen

WARNINGS

Warning: For external use only. Do not use on damaged or broken skin. When using this product keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if rash occurs. Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

Directions: Take an appropriate amount and apply thinly to the face and neck which is likely to be exposed to UV rays at the final stage of skin care. Finish by tapping lightly. Apply liberally 15 min before sun exposure. Reapply after 40min of swimming or sweating.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

LEADERS SUNBUDDY DAILY MOISTURE SUNSCREEN 
homosalate, octocrylene, octisalate, avobenzone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69424-580
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Homosalate (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	Homosalate	6.65 g  in 70 mL
Octocrylene (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	Octocrylene	3.50 g  in 70 mL
Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	Octisalate	3.15 g  in 70 mL
Avobenzone (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	Avobenzone	2.10 g  in 70 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Dipropylene Glycol (UNII: E107L85C40)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69424-580-02	1 in 1 CARTON	02/10/2017
1	NDC: 69424-580-01	70 mL in 1 TUBE; 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	02/10/2017

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(69424-580)

Establishment
Name	Address	ID/FEI	Business Operations
LEADERS COSMETICS CO.,LTD.		689851373	manufacture(69424-580)