ISNTREE YAM ROOT MILK TONE UP SUNCREAM- zinc oxide cream

ISNTREE YAM ROOT MILK TONE UP SUNCREAM by

Drug Labeling and Warnings

ISNTREE YAM ROOT MILK TONE UP SUNCREAM 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 ingredient

Zinc Oxide 22.24 %

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 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

Water, Cyclohexasiloxane, Panthenol, Butyloctyl Salicylate, Propanediol, Isododecane, Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, Dicaprylyl Ether, Propylheptyl Caprylate, Niacinamide, Caprylyl Methicone, Disteardimonium Hectorite, Triethoxycaprylylsilane, Magnesium Sulfate, Lauryl Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, 1,2-Hexanediol, Polyglyceryl-2 Dipolyhydroxystearate, Polymethylsilsesquioxane, Glyceryl Caprylate, Caprylyl Glycol, Aluminum Hydroxide, Dioscorea Japonica Root Extract, Ethylhexylglycerin, Polymethyl Methacrylate, Adenosine, Sodium Hyaluronate, Tocopherol, Butylene Glycol, Hibiscus Esculentus Fruit Extract, Nelumbo Nucifera Root Extract, Corchorus Olitorius Leaf Extract, Angelica Keiskei Extract, Oryza Sativa (Rice) Extract, Avena Sativa (Oat) Meal Extract, Glycine Max (Soybean) Seed Extract, Titanium Dioxide(CI 77891), Iron Oxides(CI 77492, CI 77491, CI 77499)

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ISNTREE YAM ROOT MILK TONE UP SUNCREAM 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81100-503
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	11.12 g  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
PANTHENOL (UNII: WV9CM0O67Z)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
DIOSCOREA JAPONICA TUBER (UNII: I43FCF3356)
RICE GERM (UNII: 7N2B70SFEZ)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
CORCHORUS OLITORIUS LEAF (UNII: 1FG47O9LG5)
SOYBEAN (UNII: L7HT8F1ZOD)
NIACINAMIDE (UNII: 25X51I8RD4)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
OATMEAL (UNII: 8PI54V663Y)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
GLYCERYL MONOCAPRYLATE (UNII: TM2TZD4G4A)
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
ADENOSINE (UNII: K72T3FS567)
DICAPRYLYL ETHER (UNII: 77JZM5516Z)
PROPYLHEPTYL CAPRYLATE (UNII: 991Z19V2OD)
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)
TOCOPHEROL (UNII: R0ZB2556P8)
NELUMBO NUCIFERA ROOT (UNII: F60P1G6K6N)
PROPANEDIOL (UNII: 5965N8W85T)
ISODODECANE (UNII: A8289P68Y2)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81100-503-02	1 in 1 BOX	01/17/2024
1	NDC: 81100-503-01	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(81100-503)