FDA.reportPublic FDA data

ISNTREE ONION NEWPAIR SUNSCREEN

Manufacturer
ISNTREE Inc. | Kolmar Korea Co., Ltd
Effective date
2024-07-23
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:15:55

Label at a glance#

ProductISNTREE ONION NEWPAIR SUNSCREEN
Active ingredientHOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE, AVOBENZONE
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 %
Octinoxate 6.8 %
Octisalate 4.5 %
Octocrylene 4 %

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 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 ingredients

INACTIVE INGREDIENT SECTION

Water, Butyloctyl Salicylate, Butylene Glycol, Acrylates Copolymer, Niacinamide, Polymethylsilsesquioxane, C20-22 Alkyl Phosphate, C20-22 Alcohols, 1,2-Hexanediol, Glycerin, Pentylene Glycol, Caprylyl Methicone, Cetyl Alcohol, Dicaprylyl Carbonate, Glyceryl Stearate, Tromethamine, Poly C10-30 Alkyl Acrylate, Silica, Coco-Caprylate/Caprate, Dimethicone/Vinyl Dimethicone Crosspolymer, Dimethiconol, Trisiloxane, Polyacrylate Crosspolymer-6, Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Polyisobutene, Allium Cepa (Onion) Bulb Extract, Ethylhexylglycerin, Kaolin, Adenosine, Polyhydroxystearic Acid, Xanthan Gum, Triethoxycaprylylsilane, Alumina, Sorbitan Oleate, Caprylyl/Capryl Glucoside, Tocopherol, Allantoin, Panthenol, Houttuynia Cordata Extract, Caprylic/Capric Triglyceride, Hydrogenated Lecithin, Polyglyceryl-10 Diisostearate, Glycoproteins, Menadione, Ultramarines(CI 77007), Titanium Dioxide(CI 77891)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ISNTREE ONION NEWPAIR SUNSCREENISNTREE ONION NEWPAIR SUNSCREEN

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
81100-502-01ISNTREE ONION NEWPAIR SUNSCREEN50 mL in 1 TUBECREAM504
81100-502-02ISNTREE ONION NEWPAIR SUNSCREEN1 in 1 BOXCREAM14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81100-502ISNTREE ONION NEWPAIR SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE) CREAM [ISNTREE INC.]4Current NDC, 2 package rows20240725_0f072099-d57d-4dc4-e063-6394a90ab438.zip

Products#

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

DailyMed product names page 1 of 2 · 42 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
81100-50281100-502-01, 81100-502-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 40 matching rows.

Name, UNII, Kind table
NameUNIIKind
HOMOSALATEV06SV4M95SACTIB
OCTINOXATE4Y5P7MUD51ACTIB
OCTISALATE4X49Y0596WACTIB
OCTOCRYLENE5A68WGF6WMACTIB
NIACINAMIDE25X51I8RD4IACT
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS)59Z907ZB69IACT
C20-22 ALCOHOLSO4M0347C6AIACT
GLYCERINPDC6A3C0OXIACT
CETYL ALCOHOL936JST6JCNIACT
DICAPRYLYL CARBONATE609A3V1SUAIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
TITANIUM DIOXIDE15FIX9V2JPIACT
CAPRYLYL/CAPRYL OLIGOGLUCOSIDEE00JL9G9K0IACT
ALLANTOIN344S277G0ZIACT
PANTHENOLWV9CM0O67ZIACT
HOUTTUYNIA CORDATA FLOWERING TOPRH041UUZ22IACT
C20-22 ALKYL PHOSPHATEL4VKP0Y7RPIACT
WATER059QF0KO0RIACT
AVOBENZONEG63QQF2NOXACTIB
XANTHAN GUMTTV12P4NEEIACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
ALUMINUM OXIDELMI26O6933IACT
TOCOPHEROLR0ZB2556P8IACT
TROMETHAMINE023C2WHX2VIACT
PENTYLENE GLYCOL50C1307PZGIACT
CAPRYLYL TRISILOXANEQ95M2P1KJLIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
TRISILOXANE9G1ZW13R0GIACT
ONION492225Q21HIACT
SORBITAN MONOOLEATE06XEA2VD56IACT
ADENOSINEK72T3FS567IACT
COCOYL CAPRYLOCAPRATE8D9H4QU99HIACT
AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S)Q7UI015FF9IACT
KAOLIN24H4NWX5COIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
MENADIONE723JX6CXY5IACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
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 ONION NEWPAIR SUNSCREENAVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENEISNTREE Inc.0f072099-d57d-4dc4-e063-6394a90ab4382024-07-23WarningsExact identifier
ndc (package): 81100-502-01
ndc (package): 81100-502-02
ndc (product): 81100-502
ndc11 (package): 81100050202
ndc11 (package): 81100050201
spl id: 1de5929a-a02c-164d-e063-6294a90a7aaf
spl set id: 0f072099-d57d-4dc4-e063-6394a90ab438

Reported adverse events (FAERS/openFDA)#

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