FDA.reportPublic FDA data

ISNTREE HYALURONIC ACID DAILY SUN GEL 10 mL

Manufacturer
ISNTREE Inc. | Kolmar Korea Co.,LTD. Gwanjeong 2 factory
Effective date
2025-01-09
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:51:24

Label at a glance#

ProductISNTREE HYALURONIC ACID DAILY SUNGEL
Active ingredientHOMOSALATE, AVOBENZONE, OCTISALATE
Label structure12 sections

Indications and uses

• helps prevent sunburn • higher SPF gives more sunburn protection • 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

Dosage and administration

■ apply liberally 15 minutes before sun exposure. 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 ■ ch...

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 2.7 %
Homosalate 9 %
Octisalate 4.5 %

Purpose

OTC - PURPOSE SECTION

sunscreen

Uses

INDICATIONS & USAGE SECTION


• helps prevent sunburn • higher SPF gives more sunburn protection
• 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

WARNINGS SECTION

For external use only.

Do not use

OTC - DO NOT USE SECTION


• on damaged skin or broken skin.

When using this product

OTC - WHEN USING SECTION

• keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if

OTC - STOP USE SECTION

•rash or irritation develops and lasts.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION


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

Directions

DOSAGE & ADMINISTRATION SECTION


■ apply liberally 15 minutes before sun exposure.
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
■ children under 6 months of age: Ask a doctor
■ reapply at least every 2 hours.
■ use a water-resistant sunscreen if swimming or sweating.

Other information

OTHER SAFETY INFORMATION


■ protect the product from exessive 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 ingredients

INACTIVE INGREDIENT SECTION

Water, Butyloctyl Salicylate, Butylene Glycol, Diethylhexyl 2,6-Naphthalate, Niacinamide, C20-22 Alkyl Phosphate, C20-22 Alcohols, 1,2-Hexanediol, Pentylene Glycol, Acrylates Copolymer, Polymethylsilsesquioxane, Cetyl Alcohol, Poly C10-30 Alkyl Acrylate, VP/Eicosene Copolymer, Glyceryl Stearate, Silica, Tromethamine, Propanediol, Polyacrylate Crosspolymer-6, Xanthan Gum, Ethylhexylglycerin, Adenosine, Portulaca Oleracea Extract, Centella Asiatica Extract, Houttuynia Cordata Extract, Hydrolyzed Hyaluronic Acid, Hydrolyzed Sodium Hyaluronate, Dimethylsilanol Hyaluronate, Hyaluronic Acid, Sodium Hyaluronate, Potassium Hyaluronate, Sodium Hyaluronate Crosspolymer, Hydroxypropyltrimonium Hyaluronate, Sodium Hyaluronate Dimethylsilanol, Sodium Acetylated Hyaluronate, Tocopherol, Ectoin, Dipropylene Glycol, Sodium Palmitoyl Proline, Glycerin, Beta-Glucan, Nymphaea Alba Flower Extract

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ISNTREE HYALURONIC ACID DAILY SUN GELISNTREE HYALURONIC ACID DAILY SUN GEL

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
77dc03a4-fbfc-e6a3-fe95-285bbae40d75Product name220250814
d676a241-be05-4740-b3ee-1a5f2ed422d2Product name420180615
dd8bd48f-20d6-43c7-b471-3ae872868afaProduct name320180125
d41954ff-bc63-4b2c-aba0-9146707659d7Product name220151117

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81100-103-01ISNTREE HYALURONIC ACID DAILY SUNGEL10 mL in 1 TUBECREAM102
81100-103-02ISNTREE HYALURONIC ACID DAILY SUNGEL1 in 1 BOXCREAM12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81100-103ISNTREE HYALURONIC ACID DAILY SUNGEL (AVOBENZONE, HOMOSALATE, OCTISALATE) CREAM [ISNTREE INC.]2Current NDC, 2 package rows20250110_2b3bdbe1-ede9-cd60-e063-6394a90ab2f3.zip

Products#

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

DailyMed product names page 1 of 1 · 37 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
81100-10381100-103-01, 81100-103-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 35 matching rows.

Name, UNII, Kind table
NameUNIIKind
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS)59Z907ZB69IACT
XANTHAN GUMTTV12P4NEEIACT
ADENOSINEK72T3FS567IACT
DIETHYLHEXYL 2,6-NAPHTHALATEI0DQJ7YGXMIACT
NIACINAMIDE25X51I8RD4IACT
CETYL ALCOHOL936JST6JCNIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
PROPANEDIOL5965N8W85TIACT
HYALURONIC ACIDS270N0TRQYIACT
SODIUM PALMITOYL PROLINE64L053FRFOIACT
GLYCERINPDC6A3C0OXIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
HOMOSALATEV06SV4M95SACTIB
AVOBENZONEG63QQF2NOXACTIB
SODIUM ACETYLATED HYALURONATEWN66R7GL93IACT
BUTYLENE GLYCOL3XUS85K0RAIACT
DIMETHYLSILANOL HYALURONATEZ853O1D4TEIACT
HYALURONATE SODIUMYSE9PPT4THIACT
C20-22 ALCOHOLSO4M0347C6AIACT
TOCOPHEROLR0ZB2556P8IACT
DIPROPYLENE GLYCOLE107L85C40IACT
PENTYLENE GLYCOL50C1307PZGIACT
TROMETHAMINE023C2WHX2VIACT
CENTELLA ASIATICA TRITERPENOIDS4YS74Q4G4JIACT
HOUTTUYNIA CORDATA FLOWERING TOPRH041UUZ22IACT
OCTISALATE4X49Y0596WACTIB
PURSLANEM6S840WXG5IACT
ECTOINE7GXZ3858RYIACT
WATER059QF0KO0RIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S)Q7UI015FF9IACT
NYMPHAEA ALBA FLOWER40KQ7Q535OIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
C20-22 ALKYL PHOSPHATEL4VKP0Y7RPIACT
1,2-HEXANEDIOLTR046Y3K1GIACT

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
ISNTREE HYALURONIC ACID DAILY SUNGELAVOBENZONE, HOMOSALATE, OCTISALATEISNTREE Inc.2b3bdbe1-ede9-cd60-e063-6394a90ab2f32025-01-09WarningsExact identifier
ndc (package): 81100-103-01
ndc (package): 81100-103-02
ndc (product): 81100-103
ndc11 (package): 81100010302
ndc11 (package): 81100010301
spl id: 2b41b7d1-e8b9-ca5e-e063-6294a90a425d
spl set id: 2b3bdbe1-ede9-cd60-e063-6394a90ab2f3

Reported adverse events (FAERS/openFDA)#

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