# Maxigen Biotech, Inc. · 66-41 · TAIWAN — FDA import alert red lists: firms subject to detention without physical examination

For Maxigen Biotech, Inc. · 66-41 · TAIWAN, import alert is 66-41; import alert name is Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S; country is TAIWAN; product is Dp DERMACEUTICALS BRITE LITE 3D SCULPTURED MASK | Dp DERMACEUTICALS BRITE LITE 3D SCULPTURED MASK | Dp DERMACEUTICALS BRITE LITE 3D SCULPTURED MASK | Dp DERMACEUTICALS BRITE LITE 3D SCULPTURED MASK; product code is 53 J - - 01 Bath Soaps and Detergents (not Antiperspirant) (Personal Cleanliness) | 53 L - - -- Skin Care Prep | 53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C. | 66 V - - 99 Miscellaneous Patent Medicines, Etc; date published is 04/23/2021; address is Guishan District , No. 88 Keji 1st Rd.; Guishan Dist. , Taoyuan City, TAIWAN, verified against its source on 2026-09-16.

- **Firm:** Maxigen Biotech, Inc. _(verified: appears in the quote below)_
- **Import alert:** 66-41
- **Import alert name:** Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S.
- **Country:** TAIWAN _(verified: appears in the quote below)_
- **Address:** Guishan District , No. 88 Keji 1st Rd.; Guishan Dist. , Taoyuan City, TAIWAN _(verified: appears in the quote below)_
- **Date published:** 04/23/2021 _(verified: appears in the quote below)_
- **Product code:** 53 J - - 01 Bath Soaps and Detergents (not Antiperspirant) (Personal Cleanliness) | 53 L - - -- Skin Care Prep | 53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. _(verified: each item appears in the quote below)_
- **Product:** Dp DERMACEUTICALS BRITE LITE 3D SCULPTURED MASK | Dp DERMACEUTICALS BRITE LITE 3D SCULPTURED MASK | Dp DERMACEUTICALS BRITE LITE 3D SCULPTURED MASK | Dp DERMACEUTICALS BRITE LITE 3D SCULPTURED MASK _(verified: each item appears in the quote below)_
- **FDA notes:** The product appears to be an unapproved new drug as the product's label and associated website include claims such as (not an all-inclusive list): "Brightens, lightens the appearance of uneven skin tone discoloured skin..." (label); "[D]esigned to reduce the appearance of uneven skin tone, dark spots and blemishes, whilst helping the skin resist future darkening..." (label); "Brightens and lightens the appearance of uneven skin tone and discoloured skin..." (website); "[M]ay sedate pigment formation..." (both label and webpage); "Reduces the appearance of dark spots, age spots, freckles and sun damage..." (both label and website). | The product appears to be an unapproved new drug as the product's label and associated website include claims such as (not an all-inclusive list): "Brightens, lightens the appearance of uneven skin tone discoloured skin..." (label); "[D]esigned to reduce the appearance of uneven skin tone, dark spots and blemishes, whilst helping the skin resist future darkening..." (label); "Brightens and lightens the appearance of uneven skin tone and discoloured skin..." (website); "[M]ay sedate pigment formation..." (both label and webpage); "Reduces the appearance of dark spots, age spots, freckles and sun damage..." (both label and website). | The product appears to be an unapproved new drug as the product's label and associated website include claims such as (not an all-inclusive list): "Brightens, lightens the appearance of uneven skin tone discoloured skin..." (label); "[D]esigned to reduce the appearance of uneven skin tone, dark spots and blemishes, whilst helping the skin resist future darkening..." (label); "Brightens and lightens the appearance of uneven skin tone and discoloured skin..." (website); "[M]ay sedate pigment formation..." (both label and webpage); "Reduces the appearance of dark spots, age spots, freckles and sun damage..." (both label and website). | The product appears to be an unapproved new drug as the product's label and associated website include claims such as (not an all-inclusive list): "Brightens, lightens the appearance of uneven skin tone discoloured skin..." (label); "[D]esigned to reduce the appearance of uneven skin tone, dark spots and blemishes, whilst helping the skin resist future darkening..." (label); "Brightens and lightens the appearance of uneven skin tone and discoloured skin..." (website); "[M]ay sedate pigment formation..." (both label and webpage); "Reduces the appearance of dark spots, age spots, freckles and sun damage..." (both label and website). _(verified: each item appears in the quote below)_

## What the source says

> Maxigen Biotech, Inc. Date Published : 04/23/2021 Guishan District , No. 88 Keji 1st Rd.; Guishan Dist. , Taoyuan City, TAIWAN 53 J - - 01 Bath Soaps and Detergents (not Antiperspirant) (Personal Cleanliness) Date Published: 04/23/2021 Desc: Dp DERMACEUTICALS BRITE LITE 3D SCULPTURED MASK Notes: The product appears to be an unapproved new drug as the product's label and associated website include claims such as (not an all-inclusive list): "Brightens, lightens the appearance of uneven skin tone discoloured skin..." (label); "[D]esigned to reduce the appearance of uneven skin tone, dark spots and blemishes, whilst helping the skin resist future darkening..." (label); "Brightens and lightens the appearance of uneven skin tone and discoloured skin..." (website); "[M]ay sedate pigment formation..." (both label and webpage); "Reduces the appearance of dark spots, age spots, freckles and sun damage..." (both label and website). 53 L - - -- Skin Care Prep Date Published: 04/23/2021 Desc: Dp DERMACEUTICALS BRITE LITE 3D SCULPTURED MASK Notes: The product appears to be an unapproved new drug as the product's label and associated website include claims such as (not an all-inclusive list): "Brightens, lightens the appearance of uneven skin tone discoloured skin..." (label); "[D]esigned to reduce the appearance of uneven skin tone, dark spots and blemishes, whilst helping the skin resist future darkening..." (label); "Brightens and lightens the appearance of uneven skin tone and discoloured skin..." (website); "[M]ay sedate pigment formation..." (both label and webpage); "Reduces the appearance of dark spots, age spots, freckles and sun damage..." (both label and website). 53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C. Date Published: 04/23/2021 Desc: Dp DERMACEUTICALS BRITE LITE 3D SCULPTURED MASK Notes: The product appears to be an unapproved new drug as the product's label and associated website include claims such as (not an all-inclusive list): "Brightens, lightens the appearance of uneven skin tone discoloured skin..." (label); "[D]esigned to reduce the appearance of uneven skin tone, dark spots and blemishes, whilst helping the skin resist future darkening..." (label); "Brightens and lightens the appearance of uneven skin tone and discoloured skin..." (website); "[M]ay sedate pigment formation..." (both label and webpage); "Reduces the appearance of dark spots, age spots, freckles and sun damage..." (both label and website). 66 V - - 99 Miscellaneous Patent Medicines, Etc. Date Published: 04/23/2021 Desc: Dp DERMACEUTICALS BRITE LITE 3D SCULPTURED MASK Notes: The product appears to be an unapproved new drug as the product's label and associated website include claims such as (not an all-inclusive list): "Brightens, lightens the appearance of uneven skin tone discoloured skin..." (label); "[D]esigned to reduce the appearance of uneven skin tone, dark spots and blemishes, whilst helping the skin resist future darkening..." (label); "Brightens and lightens the appearance of uneven skin tone and discoloured skin..." (website); "[M]ay sedate pigment formation..." (both label and webpage); "Reduces the appearance of dark spots, age spots, freckles and sun damage..." (both label and website).

## Source

- https://www.accessdata.fda.gov/cms_ia/importalert_190.html

Last verified: 2026-09-16. Review by: 2026-11-15.
Part of [FDA import alert red lists: firms subject to detention without physical examination](https://referencesource.org/fda-import-alert-red-list/).