# I-BEAUTY SRL · 66-41 · ITALY — FDA import alert red lists: firms subject to detention without physical examination

For I-BEAUTY SRL · 66-41 · ITALY, import alert is 66-41; import alert name is Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S; country is ITALY; product is Spot Corrector & Whitening Mask | Spot Corrector & Whitening Cream (Jar) | Spot Out & Whitening Kit | Spot Corrector & Whitening Cream (Sachet); product code is 53 L - - 10 Wrinkle Smoothing (Skin Care Preparations) | 53 L - - 10 Wrinkle Smoothing (Skin Care Preparations) | 53 L - - 10 Wrinkle Smoothing (Skin Care Preparations) | 53 L - - 10 Wrinkle Smoothing (Skin Care Preparations); date published is 12/05/2017; address is Via Quattro Novembre 11 , Alzano Lombardo, Bergamo ITALY, verified against its source on 2026-09-16.

- **Firm:** I-BEAUTY SRL _(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:** ITALY _(verified: appears in the quote below)_
- **Address:** Via Quattro Novembre 11 , Alzano Lombardo, Bergamo ITALY _(verified: appears in the quote below)_
- **Date published:** 12/05/2017 _(verified: appears in the quote below)_
- **Product code:** 53 L - - 10 Wrinkle Smoothing (Skin Care Preparations) | 53 L - - 10 Wrinkle Smoothing (Skin Care Preparations) | 53 L - - 10 Wrinkle Smoothing (Skin Care Preparations) | 53 L - - 10 Wrinkle Smoothing (Skin Care Preparations) _(verified: each item appears in the quote below)_
- **Product:** Spot Corrector & Whitening Mask | Spot Corrector & Whitening Cream (Jar) | Spot Out & Whitening Kit | Spot Corrector & Whitening Cream (Sachet) _(verified: each item appears in the quote below)_
- **FDA notes:** The product appears to be an unapproved new drug as the product label includes claims such as: "[R]educe and progressively eliminate cutaneous spots of melanin origin located at the epidermal level", "Ascorbil Glucoside [an ingredient in the product]: …stimulates skin immune system, suppress melanin production", and "Acetyl Glycyl Beta-Alanine [an ingredient in the product]: advanced whitening peptide able to regenerate damaged skin tissues." | The product appears to be an unapproved new drug as the product label includes claims such as: "Kojic Acid [an ingredient in the product]: whitening… skin lightening agent", "Phytic Acid [an ingredient in the product]: whitening…", "Arbutin [an ingredient in the product]: strong inhibitor of melanin (skin pigment) production", "Focus on: Spot on, whitening, lightening", and "Skin concern: hyperpigmentation." | The product appears to be an unapproved new drug as the product label and website include claims such as: "[R]educe and progressively eliminate cutaneous spots localized at the epidermal level and common hyperpigmentation problems", "Focus on: Spot on, whitening, lightening", and "Skin concern: hyperpigmentation…" | The product appears to be an unapproved new drug as the product label includes claims such as: "Kojic Acid [an ingredient in the product]: whitening… skin lightening agent", "Phytic Acid [an ingredient in the product]: whitening…", "Arbutin [an ingredient in the product]: strong inhibitor of melanin (skin pigment) production", "Focus on: Spot on, whitening, lightening", and "Skin concern: hyperpigmentation." _(verified: each item appears in the quote below)_

## What the source says

> I-BEAUTY SRL Date Published : 12/05/2017 Via Quattro Novembre 11 , Alzano Lombardo, Bergamo ITALY 53 L - - 10 Wrinkle Smoothing (Skin Care Preparations) Date Published: 12/05/2017 Desc: Spot Corrector & Whitening Mask Notes: The product appears to be an unapproved new drug as the product label includes claims such as: "[R]educe and progressively eliminate cutaneous spots of melanin origin located at the epidermal level", "Ascorbil Glucoside [an ingredient in the product]: …stimulates skin immune system, suppress melanin production", and "Acetyl Glycyl Beta-Alanine [an ingredient in the product]: advanced whitening peptide able to regenerate damaged skin tissues." 53 L - - 10 Wrinkle Smoothing (Skin Care Preparations) Date Published: 12/05/2017 Desc: Spot Corrector & Whitening Cream (Jar) Notes: The product appears to be an unapproved new drug as the product label includes claims such as: "Kojic Acid [an ingredient in the product]: whitening… skin lightening agent", "Phytic Acid [an ingredient in the product]: whitening…", "Arbutin [an ingredient in the product]: strong inhibitor of melanin (skin pigment) production", "Focus on: Spot on, whitening, lightening", and "Skin concern: hyperpigmentation." 53 L - - 10 Wrinkle Smoothing (Skin Care Preparations) Date Published: 12/05/2017 Desc: Spot Out & Whitening Kit Notes: The product appears to be an unapproved new drug as the product label and website include claims such as: "[R]educe and progressively eliminate cutaneous spots localized at the epidermal level and common hyperpigmentation problems", "Focus on: Spot on, whitening, lightening", and "Skin concern: hyperpigmentation…" 53 L - - 10 Wrinkle Smoothing (Skin Care Preparations) Date Published: 12/05/2017 Desc: Spot Corrector & Whitening Cream (Sachet) Notes: The product appears to be an unapproved new drug as the product label includes claims such as: "Kojic Acid [an ingredient in the product]: whitening… skin lightening agent", "Phytic Acid [an ingredient in the product]: whitening…", "Arbutin [an ingredient in the product]: strong inhibitor of melanin (skin pigment) production", "Focus on: Spot on, whitening, lightening", and "Skin concern: hyperpigmentation."

## 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/).