Lycoris Rubus Whitening
FDA Label NDC 60778-030

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Lycoris Co., Ltd. for the product Lycoris Rubus Whitening (NDC 60778-030). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient, inactive ingredient, purpose, warnings, keep out of reach of children, indications and usage, dosage and administration, package label. principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Active Ingredient

Active Ingredient: Allantoin 0.5%

Inactive Ingredient

Inactive Ingredients: Water, Glycerin, Arbutin, Cyclopentasiloxane, Caprylic/Capric Triglyceride, Cetearyl Alcohol, Bis-PEG-18MethylEtherDimethylSilane, Butylene Glycol, Cyclohexasiloxane Rubus Hirsutus Fruit/Leaf Extract(2%), Sodium Hyaluronate, Betaine,Macadamia Ternifolia Seed Oil, Olea Europaea (Olive) Fruit Oil, PEG-40 Stearate, Stearic acid, GlycerylStearate, Phenoxyethanol, Cetearyl Glucoside, Hydrogenated Lecithin Methylparaben, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Camellia Japonica Ovary Powder, Potassium Hydroxide, Propylparaben, Tocopheryl Acetate Carbomer, Sodium Metabisulfite, Disodium EDTA, Xanthan Gum, Caramel, Eucalyptus Globulus Leaf Oil, Lavandula Angustifolia (Lavender) Oil, Rosmarinus Officinalis (Rosemary) Leaf Oil

Purpose

Purpose: Skin Protectant

Warnings

Warnings: 1. In case of having following symptoms after using this, you're advised to stop using it immediately. If you keep using it, the symptoms will get worse and need to consult a dermatologist. 1) In case of having problem such as red rash, swollenness, itching, stimulation during usage. 2) In case of having the same symptoms above on the part you put this product on by direct sunlight. 2. You are banned to use it on the part where you have a scar, eczema, or dermatitis. 3. In the case of getting it into your eyes, you have to wash it immediately.

Keep Out Of Reach Of Children

Keep out of reach of babies and children

Indications And Usage

Indications and usage: 1. Tighten the lid after using it. 2. Don't keep it in the place where the temperature is extremely hot or low and exposed to the direct sunlight. 3. Use it in the evening after washing face.

Dosage And Administration

Dosage and administration: Apply after washing face. Take a small amount of cream about 1.0-1.5g on to the fingertips and gently massage over the entire face.(cheeks, nostrils, corners, forehead, and the around of eyes, even your hands) Blot face lightly with tissue, and may sleep without washing it.

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