# Laboratorios Farma Par Sas · 66-41 · COLOMBIA — FDA import alert red lists: firms subject to detention without physical examination

For Laboratorios Farma Par Sas · 66-41 · COLOMBIA, import alert is 66-41; import alert name is Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S; country is COLOMBIA; product is DermClarFace | Filler Bust | DD (Daily Defense) Cream | Tensioning Solution Sodium Piruvate 1% | Purifying Solution Artichoke Extract | Natural Reducing Extracts | HydraDerm LW 1% | HydraDerm LW 1% | Filler Bust | Tensioning Solution Sodium Piruvate 1% | DermClarFace | DD (Daily Defense) Cream | Natural Reducing Extracts | Purifying Solution Artichoke Extract | DermClarFace | Purifying Solution Artichoke Extract | DD (Daily Defense) Cream | HydraDerm LW 1% | Filler Bust | Natural Reducing Extracts | Tensioning Solution Sodium Piruvate 1% | Natural Reducing Extracts | DD (Daily Defense) Cream | HydraDerm LW 1% | Filler Bust | Purifying Solution Artichoke Extract | DermClarFace | Tensioning Solution Sodium Piruvate 1%; product code is 53 L - - 06 Moisturizing (Skin Care Preparations) | 53 L - - 06 Moisturizing (Skin Care Preparations) | 53 L - - 06 Moisturizing (Skin Care Preparations) | 53 L - - 06 Moisturizing (Skin Care Preparations) | 53 L - - 06 Moisturizing (Skin Care Preparations) | 53 L - - 06 Moisturizing (Skin Care Preparations) | 53 L - - 06 Moisturizing (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) | 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) | 53 L - - 99 Other Skin Care Preparations, N.E.C. | 53 L - - 99 Other Skin Care Preparations, N.E.C. | 53 L - - 99 Other Skin Care Preparations, N.E.C. | 53 L - - 99 Other Skin Care Preparations, N.E.C. | 53 L - - 99 Other Skin Care Preparations, N.E.C. | 53 L - - 99 Other Skin Care Preparations, N.E.C. | 53 L - - 99 Other Skin Care Preparations, N.E.C. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 V - - 99 Miscellaneous Patent Medicines, Etc; date published is 01/26/2018; address is CARRERA 20 70 A 54 BO , Bogota, COLOMBIA, verified against its source on 2026-09-16.

- **Firm:** Laboratorios Farma Par Sas _(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:** COLOMBIA _(verified: appears in the quote below)_
- **Address:** CARRERA 20 70 A 54 BO , Bogota, COLOMBIA _(verified: appears in the quote below)_
- **Date published:** 01/26/2018 _(verified: appears in the quote below)_
- **Product code:** 53 L - - 06 Moisturizing (Skin Care Preparations) | 53 L - - 06 Moisturizing (Skin Care Preparations) | 53 L - - 06 Moisturizing (Skin Care Preparations) | 53 L - - 06 Moisturizing (Skin Care Preparations) | 53 L - - 06 Moisturizing (Skin Care Preparations) | 53 L - - 06 Moisturizing (Skin Care Preparations) | 53 L - - 06 Moisturizing (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) | 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) | 53 L - - 99 Other Skin Care Preparations, N.E.C. | 53 L - - 99 Other Skin Care Preparations, N.E.C. | 53 L - - 99 Other Skin Care Preparations, N.E.C. | 53 L - - 99 Other Skin Care Preparations, N.E.C. | 53 L - - 99 Other Skin Care Preparations, N.E.C. | 53 L - - 99 Other Skin Care Preparations, N.E.C. | 53 L - - 99 Other Skin Care Preparations, N.E.C. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. _(verified: each item appears in the quote below)_
- **Product:** DermClarFace | Filler Bust | DD (Daily Defense) Cream | Tensioning Solution Sodium Piruvate 1% | Purifying Solution Artichoke Extract | Natural Reducing Extracts | HydraDerm LW 1% | HydraDerm LW 1% | Filler Bust | Tensioning Solution Sodium Piruvate 1% | DermClarFace | DD (Daily Defense) Cream | Natural Reducing Extracts | Purifying Solution Artichoke Extract | DermClarFace | Purifying Solution Artichoke Extract | DD (Daily Defense) Cream | HydraDerm LW 1% | Filler Bust | Natural Reducing Extracts | Tensioning Solution Sodium Piruvate 1% | Natural Reducing Extracts | DD (Daily Defense) Cream | HydraDerm LW 1% | Filler Bust | Purifying Solution Artichoke Extract | DermClarFace | Tensioning Solution Sodium Piruvate 1% _(verified: each item appears in the quote below)_
- **FDA notes:** The product appears to be an unapproved new drug as the product website includes claims such as: '… [P]rotect it against the impact of free radicals, pollution, tobacco, exposure to the sun. It also helps to reduce the depth of wrinkles and lines of expression and to prevent their formation …'. In addition, the 'Antiaging,' 'Biostimulant' or 'Antiwrinkle' icons or vignettes, when reviewed in the full totality of the product labeling, imply that the product can be used to counteract, retard or control the aging process and would therefore also cause the product to be regarded as an unapproved new drug. | The product appears to be an unapproved new drug as the product label and website include claims such as: (label) '… Increases the bust area …'; (website) '… [E]nhances bust volume by increasing the adipose tissue in this area …'. In addition, the 'Antiaging,' 'Biostimulant' or 'Antiwrinkle' icons or vignettes, when reviewed in the full totality of the product labeling, imply that the product can be used to counteract, retard or control the aging process and would therefore also cause the product to be regarded as an unapproved new drug. | The product appears to be an unapproved new drug as the product label includes claims such as: '… Prevents premature skin aging caused by sun exposure …'; '… Protects the skin after surgery (post-peeling and dermabrasion), hyperchromias (sic) sun protection, and allergic recent scars …'. | The product appears to be an unapproved new drug as the product label includes claims such as: '… Helps reduce flaccidity …'. | The product appears to be an unapproved new drug as the product website includes claims such as: '… Purifying with lipodystrophic action …'. In addition, the 'lipolytic' icon or vignette implies or suggests that the product is intended for 'lipo therapy' which would also cause the product to be regarded as an unapproved new drug. | The product appears to be an unapproved new drug as the product website includes claims such as: '… Natural adjunctive treatment for obesity …'. In addition, the 'lipolytic' icon or vignette implies or suggests that the product is intended for 'lipo therapy' which would also cause the product to be regarded as an unapproved new drug. | The product appears to be an unapproved new drug as the 'Antiaging,' 'Biostimulant' or 'Antiwrinkle' icons or vignettes, when reviewed in the full totality of the product labeling, imply that the product can be used to counteract, retard or control the aging process and would therefore also cause the product to be regarded as an unapproved new drug. | The product appears to be an unapproved new drug as the 'Antiaging,' 'Biostimulant' or 'Antiwrinkle' icons or vignettes, when reviewed in the full totality of the product labeling, imply that the product can be used to counteract, retard or control the aging process and would therefore also cause the product to be regarded as an unapproved new drug. | The product appears to be an unapproved new drug as the product label and website include claims such as: (label) '… Increases the bust area …'; (website) '… [E]nhances bust volume by increasing the adipose tissue in this area …'. In addition, the 'Antiaging,' 'Biostimulant' or 'Antiwrinkle' icons or vignettes, when reviewed in the full totality of the product labeling, imply that the product can be used to counteract, retard or control the aging process and would therefore also cause the product to be regarded as an unapproved new drug. | The product appears to be an unapproved new drug as the product label includes claims such as: '… Helps reduce flaccidity …'. | The product appears to be an unapproved new drug as the product website includes claims such as: '… [P]rotect it against the impact of free radicals, pollution, tobacco, exposure to the sun. It also helps to reduce the depth of wrinkles and lines of expression and to prevent their formation …'. In addition, the 'Antiaging,' 'Biostimulant' or 'Antiwrinkle' icons or vignettes, when reviewed in the full totality of the product labeling, imply that the product can be used to counteract, retard or control the aging process and would therefore also cause the product to be regarded as an unapproved new drug. | The product appears to be an unapproved new drug as the product label includes claims such as: '… Prevents premature skin aging caused by sun exposure …'; '… Protects the skin after surgery (post-peeling and dermabrasion), hyperchromias (sic) sun protection, and allergic recent scars …'. | The product appears to be an unapproved new drug as the product website includes claims such as: '… Natural adjunctive treatment for obesity …'. In addition, the 'lipolytic' icon or vignette implies or suggests that the product is intended for 'lipo therapy' which would also cause the product to be regarded as an unapproved new drug. | The product appears to be an unapproved new drug as the product website includes claims such as: '… Purifying with lipodystrophic action …'. In addition, the 'lipolytic' icon or vignette implies or suggests that the product is intended for 'lipo therapy' which would also cause the product to be regarded as an unapproved new drug. | The product appears to be an unapproved new drug as the product website includes claims such as: '… [P]rotect it against the impact of free radicals, pollution, tobacco, exposure to the sun. It also helps to reduce the depth of wrinkles and lines of expression and to prevent their formation …'. In addition, the 'Antiaging,' 'Biostimulant' or 'Antiwrinkle' icons or vignettes, when reviewed in the full totality of the product labeling, imply that the product can be used to counteract, retard or control the aging process and would therefore also cause the product to be regarded as an unapproved new drug. | The product appears to be an unapproved new drug as the product website includes claims such as: '… Purifying with lipodystrophic action …'. In addition, the 'lipolytic' icon or vignette implies or suggests that the product is intended for 'lipo therapy' which would also cause the product to be regarded as an unapproved new drug. | The product appears to be an unapproved new drug as the product label includes claims such as: '… Prevents premature skin aging caused by sun exposure …'; '… Protects the skin after surgery (post-peeling and dermabrasion), hyperchromias (sic) sun protection, and allergic recent scars …'. | The product appears to be an unapproved new drug as the 'Antiaging,' 'Biostimulant' or 'Antiwrinkle' icons or vignettes, when reviewed in the full totality of the product labeling, imply that the product can be used to counteract, retard or control the aging process and would therefore also cause the product to be regarded as an unapproved new drug. | The product appears to be an unapproved new drug as the product label and website include claims such as: (label) '… Increases the bust area …'; (website) '… [E]nhances bust volume by increasing the adipose tissue in this area …'. In addition, the 'Antiaging,' 'Biostimulant' or 'Antiwrinkle' icons or vignettes, when reviewed in the full totality of the product labeling, imply that the product can be used to counteract, retard or control the aging process and would therefore also cause the product to be regarded as an unapproved new drug. | The product appears to be an unapproved new drug as the product website includes claims such as: '… Natural adjunctive treatment for obesity …'. In addition, the 'lipolytic' icon or vignette implies or suggests that the product is intended for 'lipo therapy' which would also cause the product to be regarded as an unapproved new drug. | The product appears to be an unapproved new drug as the product label includes claims such as: '… Helps reduce flaccidity …'. | The product appears to be an unapproved new drug as the product website includes claims such as: '… Natural adjunctive treatment for obesity …'. In addition, the 'lipolytic' icon or vignette implies or suggests that the product is intended for 'lipo therapy' which would also cause the product to be regarded as an unapproved new drug. | The product appears to be an unapproved new drug as the product label includes claims such as: '… Prevents premature skin aging caused by sun exposure …'; '… Protects the skin after surgery (post-peeling and dermabrasion), hyperchromias (sic) sun protection, and allergic recent scars …'. | The product appears to be an unapproved new drug as the 'Antiaging,' 'Biostimulant' or 'Antiwrinkle' icons or vignettes, when reviewed in the full totality of the product labeling, imply that the product can be used to counteract, retard or control the aging process and would therefore also cause the product to be regarded as an unapproved new drug. | The product appears to be an unapproved new drug as the product label and website include claims such as: (label) '… Increases the bust area …'; (website) '… [E]nhances bust volume by increasing the adipose tissue in this area …'. In addition, the 'Antiaging,' 'Biostimulant' or 'Antiwrinkle' icons or vignettes, when reviewed in the full totality of the product labeling, imply that the product can be used to counteract, retard or control the aging process and would therefore also cause the product to be regarded as an unapproved new drug. | The product appears to be an unapproved new drug as the product website includes claims such as: '… Purifying with lipodystrophic action …'. In addition, the 'lipolytic' icon or vignette implies or suggests that the product is intended for 'lipo therapy' which would also cause the product to be regarded as an unapproved new drug. | The product appears to be an unapproved new drug as the product website includes claims such as: '… [P]rotect it against the impact of free radicals, pollution, tobacco, exposure to the sun. It also helps to reduce the depth of wrinkles and lines of expression and to prevent their formation …'. In addition, the 'Antiaging,' 'Biostimulant' or 'Antiwrinkle' icons or vignettes, when reviewed in the full totality of the product labeling, imply that the product can be used to counteract, retard or control the aging process and would therefore also cause the product to be regarded as an unapproved new drug. | The product appears to be an unapproved new drug as the product label includes claims such as: '… Helps reduce flaccidity …'. _(verified: each item appears in the quote below)_

## What the source says

> Laboratorios Farma Par Sas Date Published : 01/26/2018 CARRERA 20 70 A 54 BO , Bogota, COLOMBIA 53 L - - 06 Moisturizing (Skin Care Preparations) Date Published: 01/26/2018 Desc: DermClarFace Notes: The product appears to be an unapproved new drug as the product website includes claims such as: '… [P]rotect it against the impact of free radicals, pollution, tobacco, exposure to the sun. It also helps to reduce the depth of wrinkles and lines of expression and to prevent their formation …'. In addition, the 'Antiaging,' 'Biostimulant' or 'Antiwrinkle' icons or vignettes, when reviewed in the full totality of the product labeling, imply that the product can be used to counteract, retard or control the aging process and would therefore also cause the product to be regarded as an unapproved new drug. 53 L - - 06 Moisturizing (Skin Care Preparations) Date Published: 01/26/2018 Desc: Filler Bust Notes: The product appears to be an unapproved new drug as the product label and website include claims such as: (label) '… Increases the bust area …'; (website) '… [E]nhances bust volume by increasing the adipose tissue in this area …'. In addition, the 'Antiaging,' 'Biostimulant' or 'Antiwrinkle' icons or vignettes, when reviewed in the full totality of the product labeling, imply that the product can be used to counteract, retard or control the aging process and would therefore also cause the product to be regarded as an unapproved new drug. 53 L - - 06 Moisturizing (Skin Care Preparations) Date Published: 01/26/2018 Desc: DD (Daily Defense) Cream Notes: The product appears to be an unapproved new drug as the product label includes claims such as: '… Prevents premature skin aging caused by sun exposure …'; '… Protects the skin after surgery (post-peeling and dermabrasion), hyperchromias (sic) sun protection, and allergic recent scars …'. 53 L - - 06 Moisturizing (Skin Care Preparations) Date Published: 01/26/2018 Desc: Tensioning Solution Sodium Piruvate 1% Notes: The product appears to be an unapproved new drug as the product label includes claims such as: '… Helps reduce flaccidity …'. 53 L - - 06 Moisturizing (Skin Care Preparations) Date Published: 01/26/2018 Desc: Purifying Solution Artichoke Extract Notes: The product appears to be an unapproved new drug as the product website includes claims such as: '… Purifying with lipodystrophic action …'. In addition, the 'lipolytic' icon or vignette implies or suggests that the product is intended for 'lipo therapy' which would also cause the product to be regarded as an unapproved new drug. 53 L - - 06 Moisturizing (Skin Care Preparations) Date Published: 01/26/2018 Desc: Natural Reducing Extracts Notes: The product appears to be an unapproved new drug as the product website includes claims such as: '… Natural adjunctive treatment for obesity …'. In addition, the 'lipolytic' icon or vignette implies or suggests that the product is intended for 'lipo therapy' which would also cause the product to be regarded as an unapproved new drug. 53 L - - 06 Moisturizing (Skin Care Preparations) Date Published: 01/26/2018 Desc: HydraDerm LW 1% Notes: The product appears to be an unapproved new drug as the 'Antiaging,' 'Biostimulant' or 'Antiwrinkle' icons or vignettes, when reviewed in the full totality of the product labeling, imply that the product can be used to counteract, retard or control the aging process and would therefore also cause the product to be regarded as an unapproved new drug. 53 L - - 10 Wrinkle Smoothing (Skin Care Preparations) Date Published: 01/26/2018 Desc: HydraDerm LW 1% Notes: The product appears to be an unapproved new drug as the 'Antiaging,' 'Biostimulant' or 'Antiwrinkle' icons or vignettes, when reviewed in the full totality of the product labeling, imply that the product can be used to counteract, retard or control the aging process and would therefore also cause the product to be regarded as an unapproved new drug. 53 L - - 10 Wrinkle Smoothing (Skin Care Preparations) Date Published: 01/26/2018 Desc: Filler Bust Notes: The product appears to be an unapproved new drug as the product label and website include claims such as: (label) '… Increases the bust area …'; (website) '… [E]nhances bust volume by increasing the adipose tissue in this area …'. In addition, the 'Antiaging,' 'Biostimulant' or 'Antiwrinkle' icons or vignettes, when reviewed in the full totality of the product labeling, imply that the product can be used to counteract, retard or control the aging process and would therefore also cause the product to be regarded as an unapproved new drug. 53 L - - 10 Wrinkle Smoothing (Skin Care Preparations) Date Published: 01/26/2018 Desc: Tensioning Solution Sodium Piruvate 1% Notes: The product appears to be an unapproved new drug as the product label includes claims such as: '… Helps reduce flaccidity …'. 53 L - - 10 Wrinkle Smoothing (Skin Care Preparations) Date Published: 01/26/2018 Desc: DermClarFace Notes: The product appears to be an unapproved new drug as the product website includes claims such as: '… [P]rotect it against the impact of free radicals, pollution, tobacco, exposure to the sun. It also helps to reduce the depth of wrinkles and lines of expression and to prevent their formation …'. In addition, the 'Antiaging,' 'Biostimulant' or 'Antiwrinkle' icons or vignettes, when reviewed in the full totality of the product labeling, imply that the product can be used to counteract, retard or control the aging process and would therefore also cause the product to be regarded as an unapproved new drug. 53 L - - 10 Wrinkle Smoothing (Skin Care Preparations) Date Published: 01/26/2018 Desc: DD (Daily Defense) Cream Notes: The product appears to be an unapproved new drug as the product label includes claims such as: '… Prevents premature skin aging caused by sun exposure …'; '… Protects the skin after surgery (post-peeling and dermabrasion), hyperchromias (sic) sun protection, and allergic recent scars …'. 53 L - - 10 Wrinkle Smoothing (Skin Care Preparations) Date Published: 01/26/2018 Desc: Natural Reducing Extracts Notes: The product appears to be an unapproved new drug as the product website includes claims such as: '… Natural adjunctive treatment for obesity …'. In addition, the 'lipolytic' icon or vignette implies or suggests that the product is intended for 'lipo therapy' which would also cause the product to be regarded as an unapproved new drug. 53 L - - 10 Wrinkle Smoothing (Skin Care Preparations) Date Published: 01/26/2018 Desc: Purifying Solution Artichoke Extract Notes: The product appears to be an unapproved new drug as the product website includes claims such as: '… Purifying with lipodystrophic action …'. In addition, the 'lipolytic' icon or vignette implies or suggests that the product is intended for 'lipo therapy' which would also cause the product to be regarded as an unapproved new drug. 53 L - - 99 Other Skin Care Preparations, N.E.C. Date Published: 01/26/2018 Desc: DermClarFace Notes: The product appears to be an unapproved new drug as the product website includes claims such as: '… [P]rotect it against the impact of free radicals, pollution, tobacco, exposure to the sun. It also helps to reduce the depth of wrinkles and lines of expression and to prevent their formation …'. In addition, the 'Antiaging,' 'Biostimulant' or 'Antiwrinkle' icons or vignettes, when reviewed in the full totality of the product labeling, imply that the product can be used to counteract, retard or control the aging process and would therefore also cause the product to be regarded as an unapproved new drug. 53 L - - 99 Other Skin Care Preparations, N.E.C. Date Published: 01/26/2018 Desc: Purifying Solution Artichoke Extract Notes: The product appears to be an unapproved new drug as the product website includes claims such as: '… Purifying with lipodystrophic action …'. In addition, the 'lipolytic' icon or vignette implies or suggests that the product is intended for 'lipo therapy' which would also cause the product to be regarded as an unapproved new drug. 53 L - - 99 Other Skin Care Preparations, N.E.C. Date Published: 01/26/2018 Desc: DD (Daily Defense) Cream Notes: The product appears to be an unapproved new drug as the product label includes claims such as: '… Prevents premature skin aging caused by sun exposure …'; '… Protects the skin after surgery (post-peeling and dermabrasion), hyperchromias (sic) sun protection, and allergic recent scars …'. 53 L - - 99 Other Skin Care Preparations, N.E.C. Date Published: 01/26/2018 Desc: HydraDerm LW 1% Notes: The product appears to be an unapproved new drug as the 'Antiaging,' 'Biostimulant' or 'Antiwrinkle' icons or vignettes, when reviewed in the full totality of the product labeling, imply that the product can be used to counteract, retard or control the aging process and would therefore also cause the product to be regarded as an unapproved new drug. 53 L - - 99 Other Skin Care Preparations, N.E.C. Date Published: 01/26/2018 Desc: Filler Bust Notes: The product appears to be an unapproved new drug as the product label and website include claims such as: (label) '… Increases the bust area …'; (website) '… [E]nhances bust volume by increasing the adipose tissue in this area …'. In addition, the 'Antiaging,' 'Biostimulant' or 'Antiwrinkle' icons or vignettes, when reviewed in the full totality of the product labeling, imply that the product can be used to counteract, retard or control the aging process and would therefore also cause the product to be regarded as an unapproved new drug. 53 L - - 99 Other Skin Care Preparations, N.E.C. Date Published: 01/26/2018 Desc: Natural Reducing Extracts Notes: The product appears to be an unapproved new drug as the product website includes claims such as: '… Natural adjunctive treatment for obesity …'. In addition, the 'lipolytic' icon or vignette implies or suggests that the product is intended for 'lipo therapy' which would also cause the product to be regarded as an unapproved new drug. 53 L - - 99 Other Skin Care Preparations, N.E.C. Date Published: 01/26/2018 Desc: Tensioning Solution Sodium Piruvate 1% Notes: The product appears to be an unapproved new drug as the product label includes claims such as: '… Helps reduce flaccidity …'. 66 V - - 99 Miscellaneous Patent Medicines, Etc. Date Published: 01/26/2018 Desc: Natural Reducing Extracts Notes: The product appears to be an unapproved new drug as the product website includes claims such as: '… Natural adjunctive treatment for obesity …'. In addition, the 'lipolytic' icon or vignette implies or suggests that the product is intended for 'lipo therapy' which would also cause the product to be regarded as an unapproved new drug. 66 V - - 99 Miscellaneous Patent Medicines, Etc. Date Published: 01/26/2018 Desc: DD (Daily Defense) Cream Notes: The product appears to be an unapproved new drug as the product label includes claims such as: '… Prevents premature skin aging caused by sun exposure …'; '… Protects the skin after surgery (post-peeling and dermabrasion), hyperchromias (sic) sun protection, and allergic recent scars …'. 66 V - - 99 Miscellaneous Patent Medicines, Etc. Date Published: 01/26/2018 Desc: HydraDerm LW 1% Notes: The product appears to be an unapproved new drug as the 'Antiaging,' 'Biostimulant' or 'Antiwrinkle' icons or vignettes, when reviewed in the full totality of the product labeling, imply that the product can be used to counteract, retard or control the aging process and would therefore also cause the product to be regarded as an unapproved new drug. 66 V - - 99 Miscellaneous Patent Medicines, Etc. Date Published: 01/26/2018 Desc: Filler Bust Notes: The product appears to be an unapproved new drug as the product label and website include claims such as: (label) '… Increases the bust area …'; (website) '… [E]nhances bust volume by increasing the adipose tissue in this area …'. In addition, the 'Antiaging,' 'Biostimulant' or 'Antiwrinkle' icons or vignettes, when reviewed in the full totality of the product labeling, imply that the product can be used to counteract, retard or control the aging process and would therefore also cause the product to be regarded as an unapproved new drug. 66 V - - 99 Miscellaneous Patent Medicines, Etc. Date Published: 01/26/2018 Desc: Purifying Solution Artichoke Extract Notes: The product appears to be an unapproved new drug as the product website includes claims such as: '… Purifying with lipodystrophic action …'. In addition, the 'lipolytic' icon or vignette implies or suggests that the product is intended for 'lipo therapy' which would also cause the product to be regarded as an unapproved new drug. 66 V - - 99 Miscellaneous Patent Medicines, Etc. Date Published: 01/26/2018 Desc: DermClarFace Notes: The product appears to be an unapproved new drug as the product website includes claims such as: '… [P]rotect it against the impact of free radicals, pollution, tobacco, exposure to the sun. It also helps to reduce the depth of wrinkles and lines of expression and to prevent their formation …'. In addition, the 'Antiaging,' 'Biostimulant' or 'Antiwrinkle' icons or vignettes, when reviewed in the full totality of the product labeling, imply that the product can be used to counteract, retard or control the aging process and would therefore also cause the product to be regarded as an unapproved new drug. 66 V - - 99 Miscellaneous Patent Medicines, Etc. Date Published: 01/26/2018 Desc: Tensioning Solution Sodium Piruvate 1% Notes: The product appears to be an unapproved new drug as the product label includes claims such as: '… Helps reduce flaccidity …'.

## 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/).