DR.ESLEE SUN PROTECTION- octinoxate cream

Dr.eslee Sun Protection by

Drug Labeling and Warnings

Dr.eslee Sun Protection 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: Water, Propylene Glycol, Cyclopentasiloxane, Ethylhexyl Salicylate, Zinc Oxide,
Cyclohexasiloxane, Titanium Dioxide, Cetyl PEG/PPG-10/1 Dimethicone, Hydrogenated Poly(C6-14 Olefin), Betaine, Isoamyl p-Methoxycinnamate, Dimethicone, Disteardimonium Hectorite, Magnesium Sulfate, Methyl Methacrylate Crosspolymer, Silica, imethicone/Vinyl Dimethicone Crosspolymer, Aluminum Hydroxide, Stearic Acid, Triethoxycaprylylsilane, Tocopheryl Acetate, Houttuynia Cordata Extract, Allantoin, Hydrolyzed Collagen, Biosaccharide Gum-1, Portulaca Oleracea Extract, Phenoxyethanol, Methylparaben , Propylparaben, Butylparaben, Fragrance

PURPOSE

helps to 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 the skin before sun exposure

WARNINGS

■ For external use only.
■ 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

apply frequently every 2 hours for best result

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DR.ESLEE SUN PROTECTION 
octinoxate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76340-0004
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
ZINC OXIDE (UNII: SOI2LOH54Z)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
BETAINE (UNII: 3SCV180C9W)
DIMETHICONE (UNII: 92RU3N3Y1O)
MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB)
METHYL METHACRYLATE (UNII: 196OC77688)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
ALGELDRATE (UNII: 03J11K103C)
STEARIC ACID (UNII: 4ELV7Z65AP)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)
HOUTTUYNIA CORDATA FLOWERING TOP (UNII: RH041UUZ22)
ALLANTOIN (UNII: 344S277G0Z)
BIOSACCHARIDE GUM-1 (UNII: BB4PU4V09H)
PURSLANE (UNII: M6S840WXG5)
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: 76340-0004-1	60 g in 1 TUBE; Type 0: Not a Combination Product	03/11/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		03/11/2018

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(76340-0004)