DR.ESLEE SUN MATTE- octinoxate liquid

Dr.eslee Sun Matte by

Drug Labeling and Warnings

Dr.eslee Sun Matte by is a Otc medication manufactured, distributed, or labeled by Ajou Medics Co., Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

active ingredient: ethylhexyl methoxycinnamate

INACTIVE INGREDIENT

inactive ingredient: Butylene Glycol, 4-Methylbenzylidene Camphor, Titanium Dioxide, Cetyl Alcohol, Octocrylene, Hydrogenated Polydecene, Polysorbate 80, Cyclomethicone, Stearic Acid, Glyceryl Stearate, PEG-100 Stearate, Sorbitan Stearate, Polyhydroxystearic Acid, Aluminum Hydroxide, Triethanolamine, Carbomer, Xanthan Gum, Poncirus Trifoliata Fruit Extract, Aloe Barbadensis Leaf Juice, Sodium Hyaluronate, Biosaccharide Gum-1, Tocopheryl Acetate, Disodium EDTA, Salicylic Acid, Farnesyl Acetate, Farnesol, Panthenyl, Triacetate, Hydrolyzed Algin, Zinc Sulfate, Phenoxyethanol, Methylparaben, Propylparaben, Butylparaben

PURPOSE

helps protect from UV-Rays

KEEP OUT OF REACH OF CHILDREN

keep out of reach of the children

INDICATIONS & USAGE

■ Apply Proper Amount of the cream on skin before sun exposure

WARNINGS

■ For external use only. Avoid contact with eyes.
■ Avoid contact with eyes.
■ Do not swallow. If swallowed, get medical help.
■ Keep out of reach of children.
■ Stop use and ask doctor if rash and irritation develops.

DOSAGE & ADMINISTRATION

Reapply Frequently, every 2 hours for best result

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DR.ESLEE SUN MATTE 
octinoxate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76340-3001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
ENZACAMENE (UNII: 8I3XWY40L9)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
C12-16 ALCOHOLS (UNII: S4827SZE3L)
OCTOCRYLENE (UNII: 5A68WGF6WM)
HYDROGENATED POLYDECENE (550 MW) (UNII: U333RI6EB7)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
CYCLOMETHICONE (UNII: NMQ347994Z)
STEARIC ACID (UNII: 4ELV7Z65AP)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PEG-100 STEARATE (UNII: YD01N1999R)
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
TROLAMINE (UNII: 9O3K93S3TK)
XANTHAN GUM (UNII: TTV12P4NEE)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
BIOSACCHARIDE GUM-1 (UNII: BB4PU4V09H)
EDETATE DISODIUM (UNII: 7FLD91C86K)
SALICYLIC ACID (UNII: O414PZ4LPZ)
FARNESOL (UNII: EB41QIU6JL)
ZINC SULFATE (UNII: 89DS0H96TB)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
BUTYLPARABEN (UNII: 3QPI1U3FV8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76340-3001-1	60 g in 1 TUBE; Type 0: Not a Combination Product	01/01/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		08/10/2011

Labeler - Ajou Medics Co., Ltd (688796473)

Registrant - Ajou Medics Co., Ltd (688796473)

Establishment
Name	Address	ID/FEI	Business Operations
Ajou Medics Co., Ltd		688796473	manufacture(76340-3001)