FDA.reportPublic FDA data

Dr.eslee Sun Protection

Manufacturer
Ajou Medics Co., Ltd
Effective date
2022-04-17
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 22:03:27

Label at a glance#

ProductDr.eslee Sun Protection
Active ingredientOCTINOXATE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

active ingredient: ethylhexyl methoxycinnamate

INACTIVE INGREDIENT SECTION

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

OTC - PURPOSE SECTION

helps to protect from UV-Rays

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

keep out of reach of the children

INDICATIONS & USAGE SECTION

apply proper amount of the cream on the skin before sun exposure

WARNINGS SECTION

■ 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 SECTION

apply frequently every 2 hours for best result

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

package label
package label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76340-0004-12022-04-17C16284748780-1d6a99b39-3428-a426-e053-dadaa90af4c2Drug Facts
76340-0004-12022-01-28C16284748780-1d6a99b39-3428-a426-e053-dadaa90af4c2Drug Facts

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 25 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76340-000476340-0004-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 24 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
CYCLOMETHICONE 50THT5PCI0RIACT
ZINC OXIDESOI2LOH54ZIACT
CYCLOMETHICONE 6XHK3U310BAIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
BETAINE3SCV180C9WIACT
DIMETHICONE92RU3N3Y1OIACT
MAGNESIUM SULFATE, UNSPECIFIEDDE08037SABIACT
METHYL METHACRYLATE196OC77688IACT
SILICON DIOXIDEETJ7Z6XBU4IACT
ALGELDRATE03J11K103CIACT
STEARIC ACID4ELV7Z65APIACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
.ALPHA.-TOCOPHEROL ACETATE, D-A7E6112E4NIACT
HOUTTUYNIA CORDATA FLOWERING TOPRH041UUZ22IACT
ALLANTOIN344S277G0ZIACT
BIOSACCHARIDE GUM-1BB4PU4V09HIACT
PURSLANEM6S840WXG5IACT
PHENOXYETHANOLHIE492ZZ3TIACT
METHYLPARABENA2I8C7HI9TIACT
PROPYLPARABENZ8IX2SC1OHIACT
BUTYLPARABEN3QPI1U3FV8IACT
OCTINOXATE4Y5P7MUD51ACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
dce5788e-f595-50dc-e053-2995a90aa20f672012ea-87f2-6da5-e053-2991aa0ac3222022-04-17WarningsExact identifier
spl id: dce5788e-f595-50dc-e053-2995a90aa20f
spl set id: 672012ea-87f2-6da5-e053-2991aa0ac322

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.