Maxigen Biotech, Inc. · 66-41 · TAIWAN
For Maxigen Biotech, Inc., import alert is 66-41; country is TAIWAN; import alert name is Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S; 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 2026-10-01.
- 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
What the source says
Maxigen Biotech, Inc. Date Published : 04/23/2021 Guishan District , No. 88 Keji 1st Rd.; Guishan Dist. , Taoyuan City, TAIWAN
— accessdata.fda.gov, retrieved 2026-09-15
Where each value comes from
The values above are stated away from the sentence quoted with the answer, so the passage that states them is shown here too.
Product code, Product and FDA notes
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).
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_190.html
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