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Isntree yam root milk tone up suncream - Medication Information

Product NDC Code 81100-503
Drug Name

Isntree yam root milk tone up suncream

Type Brand
Active Ingredients
Zinc oxide 11.12 g/50ml
Route TOPICAL
Dosage Form CREAM
Application Number M020
Labeler Name ISNTREE Inc.
Packages
Package NDC Code Description
81100-503-02 1 tube in 1 box (81100-503-02) / 50 ml in 1 tube (81100-503-01)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active ingredient Zinc Oxide 22.24 %

Dosage and administration

Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.
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.

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
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)

Indications and usage

A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.
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

Purpose

Information about the drug product’s indications for use.
Purpose sunscreen

Spl product data elements

Usually a list of ingredients in a drug product.
ISNTREE YAM ROOT MILK TONE UP SUNCREAM Zinc Oxide PANTHENOL TRIETHOXYCAPRYLYLSILANE CAPRYLYL GLYCOL DIOSCOREA JAPONICA TUBER RICE GERM CAPRYLYL TRISILOXANE POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE ETHYLHEXYLGLYCERIN CORCHORUS OLITORIUS LEAF SOYBEAN NIACINAMIDE DISTEARDIMONIUM HECTORITE HYALURONATE SODIUM ALUMINUM HYDROXIDE BUTYLENE GLYCOL OATMEAL 1,2-HEXANEDIOL GLYCERYL MONOCAPRYLATE WATER CYCLOMETHICONE 6 POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) ADENOSINE DICAPRYLYL ETHER PROPYLHEPTYL CAPRYLATE MAGNESIUM SULFATE, UNSPECIFIED FORM TOCOPHEROL NELUMBO NUCIFERA ROOT ZINC OXIDE ZINC OXIDE PROPANEDIOL ISODODECANE TITANIUM DIOXIDE BUTYLOCTYL SALICYLATE

Package label principal display panel

The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.
ISNTREE YAM ROOT MILK TONE UP SUN CREAM

Do not use

Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.
Do not use • on damaged skin or broken skin.

Keep out of reach of children

Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.
Keep out of reach of children If swallowed, get medical help or contact a Poison Control Center right away.

Other safety information

Information about safe use and handling of the product that may not have been specified in another field.
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.

Stop use

Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.
Stop use and ask a doctor if •rash or irritation develops and lasts.

When using

Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.
When using this product • keep out of eyes. Rinse with water to remove.

Warnings

Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.
Warnings For external use only.

Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API