FDA.reportPublic FDA data

COSRX

Manufacturer
COSRX inc.
Effective date
2025-12-01
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 01:18:59

Label at a glance#

ProductCOSRX
Active ingredientAVOBENZONE, OCTOCRYLENE, HOMOSALATE, OCTISALATE
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 2.5%

Homosalate 9.0%

Octisalate 4.5%

Octocrylene 9.0%

OTC - PURPOSE SECTION

Sunscreen

OTC - WHEN USING SECTION

Helps prevent sunburn.
If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

WARNINGS SECTION

For external use only

Do not use on damanged 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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

DESCRIPTION SECTION

Apply liberally 15 minutes before sun exposure
Children under 6 months of age : Ask a doctor.
Reapply at least every 2 hours.
Use a water-resistant sunscreen if swimming or sweating.
Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including :

Limit time in the sun, especially from 10 a.m. - 2 p.m.

Wear long-sleeved shirts, pants, hats, and sunglasses.

INDICATIONS & USAGE SECTION

OTHER SAFETY INFORMATION

Protect the product in this container from excessive heat and direct sun.
Sun alert : Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risks of skin aging, skin cancer, and other harmful effects of the sun.

INACTIVE INGREDIENT SECTION

Water / Aqua / Eau, Propanediol, Butyloctyl salicylate, Diphenylsiloxy phenyl trimethicone, Dimethicone, VP/Eicosene copolymer, Silica, Trisiloxane, Cyclopentasiloxane, Trimethylsiloxysilicate, 1,2-Hexanediol, Behenyl alcohol, Glyceryl stearate, PEG-100 stearate, C14-22 alcohols, Cetyl alcohol, Potassium cetyl phosphate, Polyacrylate-13, Polyisobutene, Fragrance / Parfum, C12-20 Alkyl glucoside, Butylene glycol, Disodium EDTA, Ethylhexylglycerin, Polysorbate 20, Sorbitan isostearate, Dextrin, Theobroma cacao (cocoa) extract, Gossypium herbaceum (cotton) extract, Glucose, Tocopherol

OTC - QUESTIONS SECTION

global@cosrx.co.kr

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Vitamin E

Vitalizing Sunscreen

Tocopherol

SPF 50+ sunscreen contains Vitamin E

to protect your skin from light (UV rays)

and heat (Aging signs) leaving your

skin healthy and moisturized.

SPF50+ BROAD SPECTRUM

50mL /1.69 fl. oz.

COSRXVITALIZING SUNSCREEMVITALIZING SUNSCREEM

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
cb89b86a-369e-4204-8910-ae797c503af3Product name120230706
d4880ace-a516-8c47-8dfd-73a4ba5887d7Product name220180830
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70319-220-012025-01-30C16284748780-12cef2736-9f9c-d83d-e063-dadaa90ab31fdaf0291e-770c-eaf2-e053-2a95a90a0b67

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70319-220-01COSRX1 in 1 CARTONLOTION16
70319-220-01COSRX50 mL in 1 TUBELOTION506

Products#

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

DailyMed product names page 1 of 1 · 34 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70319-22070319-220-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 32 matching rows.

Name, UNII, Kind table
NameUNIIKind
1,3-PROPANEDIOL BIS(4-AMINOBENZOATE)8860R9ORQRIACT
VINYLPYRROLIDONE/EICOSENE COPOLYMER035MV9S1C3IACT
AVOBENZONEG63QQF2NOXACTIB
OCTOCRYLENE5A68WGF6WMACTIB
1,2-HEXANEDIOLTR046Y3K1GIACT
DOCOSANOL9G1OE216XYIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
C14-22 ALCOHOLSB1K89384RJIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
TRISILOXANE9G1ZW13R0GIACT
CYCLOMETHICONE 50THT5PCI0RIACT
TRIMETHYLSILOXYSILICATE (M/Q 1.0-1.2)78GX033D7IIACT
PEG-100 STEARATEYD01N1999RIACT
CETYL ALCOHOL936JST6JCNIACT
CETETH-189E0067TYQHIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
DIPHENYLSILOXY PHENYL TRIMETHICONEI445L28B12IACT
DIMETHICONE92RU3N3Y1OIACT
ECHINACEA PURPUREA FLOWERING TOP WATERG72P70SL42IACT
ANHYDROUS DEXTROSE5SL0G7R0OKIACT
HOMOSALATEV06SV4M95SACTIB
POLYISOBUTYLENE (45000 MW)YR8AQ94O31IACT
EDETATE DISODIUM7FLD91C86KIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
POLYSORBATE 207T1F30V5YHIACT
SORBITAN ISOSTEARATE01S2G2C1E4IACT
COCOAD9108TZ9KGIACT
LEVANT COTTON SEED550E4N439VIACT
.ALPHA.-TOCOPHEROL, DL-7QWA1RIO01IACT
POTASSIUM CETYL PHOSPHATE03KCY6P7UTIACT
C12-20 ALKYL GLUCOSIDEK67N5Z1RUAIACT
OCTISALATE4X49Y0596WACTIB

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
COSRXVITAMIN E VITALIZING SUNSCREENCOSRX inc.daf0291e-770c-eaf2-e053-2a95a90a0b672025-12-01WarningsExact identifier
ndc (package): 70319-220-01
ndc (product): 70319-220
ndc11 (package): 70319022001
spl id: 4415daaf-9353-7695-e063-6394a90ad88c
spl set id: daf0291e-770c-eaf2-e053-2a95a90a0b67

Reported adverse events (FAERS/openFDA)#

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