Reference Source

Maxigen Biotech, Inc. · 66-41 · TAIWAN

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
Import alert
66-41
Import alert name
Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S.
Country
TAIWAN verified
Address
Guishan District , No. 88 Keji 1st Rd.; Guishan Dist. , Taoyuan City, TAIWAN verified
Date published
04/23/2021 verified
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. each item verified
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 each item verified
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). each item verified
Sourceaccessdata.fda.gov
Verified
Review by
DatasetFDA import alert red lists: firms subject to detention without physical examination

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).

accessdata.fda.gov, retrieved 2026-09-15

Source

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