ISNTREE HYALURONIC ACID DAILY SUNGEL- avobenzone, homosalate, octisalate cream

ISNTREE HYALURONIC ACID DAILY SUNGEL by

Drug Labeling and Warnings

ISNTREE HYALURONIC ACID DAILY SUNGEL by is a Otc medication manufactured, distributed, or labeled by ISNTREE Inc., Kolmar Korea Co., Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Avobenzone 2.7 %
Homosalate 9 %
Octisalate 4.5 %

Purpose

sunscreen

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

Warnings

For external use only.

Do not use

on damaged skin or broken skin.

When using this product

keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if

rash or irritation develops and lasts.

Keep out of reach of children

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

Directions

■ 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

■ 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

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ISNTREE HYALURONIC ACID DAILY SUNGEL 
avobenzone, homosalate, octisalate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81100-501
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	4.5 g  in 50 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	1.35 g  in 50 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	2.25 g  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
XANTHAN GUM (UNII: TTV12P4NEE)
ADENOSINE (UNII: K72T3FS567)
DIETHYLHEXYL 2,6-NAPHTHALATE (UNII: I0DQJ7YGXM)
NIACINAMIDE (UNII: 25X51I8RD4)
CETYL ALCOHOL (UNII: 936JST6JCN)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
PROPANEDIOL (UNII: 5965N8W85T)
HYALURONIC ACID (UNII: S270N0TRQY)
SODIUM PALMITOYL PROLINE (UNII: 64L053FRFO)
GLYCERIN (UNII: PDC6A3C0OX)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
DIMETHYLSILANOL HYALURONATE (UNII: Z853O1D4TE)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
C20-22 ALCOHOLS (UNII: O4M0347C6A)
TOCOPHEROL (UNII: R0ZB2556P8)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
TROMETHAMINE (UNII: 023C2WHX2V)
CENTELLA ASIATICA TRITERPENOIDS (UNII: 4YS74Q4G4J)
HOUTTUYNIA CORDATA FLOWERING TOP (UNII: RH041UUZ22)
PURSLANE (UNII: M6S840WXG5)
ECTOINE (UNII: 7GXZ3858RY)
WATER (UNII: 059QF0KO0R)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9)
NYMPHAEA ALBA FLOWER (UNII: 40KQ7Q535O)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
C20-22 ALKYL PHOSPHATE (UNII: L4VKP0Y7RP)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81100-501-02	1 in 1 BOX	01/17/2024
1	NDC: 81100-501-01	50 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	01/17/2024

Labeler - ISNTREE Inc. (689043012)

Establishment
Name	Address	ID/FEI	Business Operations
Kolmar Korea Co., Ltd		963271745	manufacture(81100-501)