Biowhite Brightening
FDA Label NDC 44781-160

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Zion Synthetic Fiber Co., Ltd. for the product Biowhite Brightening (NDC 44781-160). 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 otc - active ingredient, inactive ingredient, otc - purpose, warnings, otc - keep out of reach of children, indications & usage, dosage & administration, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Otc - Active Ingredient

Active Ingredient: DIMETHICONE

Inactive Ingredient

Inactive Ingredients:
Water, Diglycerin, Caprylic Capric Triglyceride, Palmitoyl Pentapeptide-4, C12-15 Alkyl Benzoate, Butylene Glycol, Cetearyl Olivate, Sorbitan Olivate, Propylene Glycol Dicaprylate Dicaprate, Morus Alba Root Extract, Lactoferrin, Glycerin, Tocopheryl Acetate, Beeswax, Glyceryl Stearate, Cetyl Alcohol, Limnanthes Alba (Meadowfoam)Seed Oil, Cyclomethicone, Hydrogenated Lecithin, Alpha-Bisabolol, Sodium Hyaluronate, Lauryl Laurate, Ubiquinone, Polysorbate 20, Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Betula Alba Juice, Portulaca Oleracea extract, Calendula Officinalis Flower Extact, Punica Granatum Fruit Extract, Angelica Keiskei Leaf/Stem Extract, Solanum Lycopersicum (Tomato) Fruit Extract, Polygonum Multiflorum Root Extract, Solanum Tuberosum (Potato) Pulp Extract, Artemisia Vulgaris Extract, Vigna Radiata Seed Extract, Gingko Biloba Leaf Extract, Chamomilla Recutita (Matricaria) Flower Extract,
Hematite Extract, Aluminum Silicate, Topaz, Amethyst Powder, Zeolite, Isononyl Isononanoate, Triethanolamine, Allantoin, Carbomer, Dipotassium Glycyrrhizate, Disodium EDTA, Xanthan Gum, Methyl Paraben, Phenoxyethanol, Flavor

Otc - Purpose

Purpose:
It prevents skin's spots, blemishes, freckles, and thus, it effects to make skin whitening and brightening.

Warnings

Warnings:
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.
- In case of having problems such as red rash, swollenness, itching, stimulation during usage.
- In case of having the same symptoms above on the part you put this product on by direct sunlight.
You are banned to use it on the part where you have a scar, eczema, or dermatitis.
In case of getting it into your eyes, you have to wash it immediately.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children:
Keep out of the reach of babies and children.

Indications & Usage

Indication and usage:
Tighten the lid after using it.
Don't keep it in the place where the temperature is extremely hot or low and exposed to the direct sunlight.
Use it in the morning and evening, after using first Skin Softner and Essential Lotion.

Dosage & Administration

Dosage and administration:
Take up about 0.5g - 1.0g of it, and smooth over the entire face.

* Please review the disclaimer below.