Unilever Philippines, Inc. - Cavite Factory · 66-41 · PHILIPPINES
For Unilever Philippines, Inc. - Cavite Factory, import alert is 66-41; country is PHILIPPINES; import alert name is Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S; product is Roll on Deodorant Rexona Antiperspirant | Roll on Deodorant Rexona Antiperspirant | Cream Silk Dandruff Free Conditioner | New Vaseline Itch & Dandruff-Free (VASELINE ? PURPLE) | Roll on Deodorant Rexona Antiperspirant | Eskinol Spot-less White Facial Deep Cleanser | Eskinol Refreshing Facial Deep Cleanser with Pure Cucumber Extract | Eskinol Oil Control Facial Deep Cleanser with Pure Lemon Extract | Eskinol Papaya Smooth White Facial Deep Cleanser | Eskinol Spot-less White Facial Deep Cleanser | Eskinol Refreshing Facial Deep Cleanser with Pure Cucumber Extract | Eskinol Oil Control Facial Deep Cleanser with Pure Lemon Extract | Eskinol Papaya Smooth White Facial Deep Cleanser | Eskinol Spot-less White Facial Deep Cleanser | Eskinol Refreshing Facial Deep Cleanser with Pure Cucumber Extract | Eskinol Oil Control Facial Deep Cleanser with Pure Lemon Extract | Eskinol Papaya Smooth White Facial Deep Cleanser | Cream Silk Dandruff Free Conditioner | Roll on Deodorant Rexona Antiperspirant | Eskinol Spot-less White Facial Deep Cleanser | Eskinol Papaya Smooth White Facial Deep Cleanser | New Vaseline Itch & Dandruff-Free (VASELINE ? PURPLE) | Eskinol Oil Control Facial Deep Cleanser with Pure Lemon Extract | Eskinol Refreshing Facial Deep Cleanser with Pure Cucumber Extract; product code is 53 D - - 02 Perfumes (Fragrance Preparations) | 53 D - - 99 Other Fragrance Preparations, N.E.C. | 53 E - - 01 Hair Conditioners (Hair Preparations, Non-coloring) | 53 E - - 06 Shampoos (Hair Preparations, Non-coloring) | 53 J - - 02 Deodorants (underarm)(Not Antiperspirant) (Personal Cleanliness) | 53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations) | 53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations) | 53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations) | 53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations) | 53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations) | 53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations) | 53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations) | 53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (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. | 61 H - - 05 Zinc Pyrithione (Anti-Bacterial) | 62 W - - -- Astring/A-Perspirant | 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 10/10/2013; address is Gateway Business Park Barangay Javalera , Gen. Trias, Calabarzon, Cavite PHILIPPINES, verified against its source on 2026-10-01.
- Firm
- Unilever Philippines, Inc. - Cavite Factory verified
- Import alert
- 66-41
- Import alert name
- Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S.
- Country
- PHILIPPINES verified
- Address
- Gateway Business Park Barangay Javalera , Gen. Trias, Calabarzon, Cavite PHILIPPINES verified
- Date published
- 10/10/2013 verified
- Product code
- 53 D - - 02 Perfumes (Fragrance Preparations) | 53 D - - 99 Other Fragrance Preparations, N.E.C. | 53 E - - 01 Hair Conditioners (Hair Preparations, Non-coloring) | 53 E - - 06 Shampoos (Hair Preparations, Non-coloring) | 53 J - - 02 Deodorants (underarm)(Not Antiperspirant) (Personal Cleanliness) | 53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations) | 53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations) | 53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations) | 53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations) | 53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations) | 53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations) | 53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations) | 53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (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. | 61 H - - 05 Zinc Pyrithione (Anti-Bacterial) | 62 W - - -- Astring/A-Perspirant | 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. each item verified
- Product
- Roll on Deodorant Rexona Antiperspirant | Roll on Deodorant Rexona Antiperspirant | Cream Silk Dandruff Free Conditioner | New Vaseline Itch & Dandruff-Free (VASELINE ? PURPLE) | Roll on Deodorant Rexona Antiperspirant | Eskinol Spot-less White Facial Deep Cleanser | Eskinol Refreshing Facial Deep Cleanser with Pure Cucumber Extract | Eskinol Oil Control Facial Deep Cleanser with Pure Lemon Extract | Eskinol Papaya Smooth White Facial Deep Cleanser | Eskinol Spot-less White Facial Deep Cleanser | Eskinol Refreshing Facial Deep Cleanser with Pure Cucumber Extract | Eskinol Oil Control Facial Deep Cleanser with Pure Lemon Extract | Eskinol Papaya Smooth White Facial Deep Cleanser | Eskinol Spot-less White Facial Deep Cleanser | Eskinol Refreshing Facial Deep Cleanser with Pure Cucumber Extract | Eskinol Oil Control Facial Deep Cleanser with Pure Lemon Extract | Eskinol Papaya Smooth White Facial Deep Cleanser | Cream Silk Dandruff Free Conditioner | Roll on Deodorant Rexona Antiperspirant | Eskinol Spot-less White Facial Deep Cleanser | Eskinol Papaya Smooth White Facial Deep Cleanser | New Vaseline Itch & Dandruff-Free (VASELINE ? PURPLE) | Eskinol Oil Control Facial Deep Cleanser with Pure Lemon Extract | Eskinol Refreshing Facial Deep Cleanser with Pure Cucumber Extract each item verified
- FDA notes
- The aforementioned product appears to be an unapproved new drug as the product label implies the product is intended for use in the diagnosis; cure; mitigation; treatment; or prevention of disease. Examples of the products intended use from the product labeling include but are not limited to the following; anti-bacterial formula; Whitens; Lightens dark spots in as early as 1 week; Micro-cleanse Anti-bacterial Formula; With pure Calamansi Extract known to whiten skin; With Vitamin C derivative to help lighten dark spots in as early as 1 week | These products appear to be unapproved new drugs and they are promoted in labeling to meet the definition of a cosmetic under section 201(i), and a drug under section 201(g) of the Federal Food, Drug and Cosmetic Act (FD&C Act or the Act) in that they are intended for use in the cure, mitigation, treatment or prevention of disease and/or are intended to affect the structure of any function of the human body. Ingredients and products, when used as a cosmetic and a drug must meet the regulatory requirements of both a cosmetic and a drug. Statements of intended use meeting the definition of a drug that are identified in the labeling, but are not limited to: "micro cleanse anti-bacterial formula". These products also appear to be "new drugs" within the meaning of section 201(p) without an effective new drug application (NDA) [Unapproved New Drug, section 505(a)]. There are no approved applications in effect for these products. In addition, based on a preliminary search and review of the literature, there do not appear to be adequate and well controlled clinical studies sufficient to support a GRAS/E finding for the referenced products. | These products appear to be unapproved new drugs and they are promoted in labeling to meet the definition of a cosmetic under section 201(i), and a drug under section 201(g) of the Federal Food, Drug and Cosmetic Act (FD&C Act or the Act) in that they are intended for use in the cure, mitigation, treatment or prevention of disease and/or are intended to affect the structure of any function of the human body. Ingredients and products, when used as a cosmetic and a drug must meet the regulatory requirements of both a cosmetic and a drug. Statements of intended use meeting the definition of a drug that are identified in the labeling, but are not limited to: "micro cleanse anti-bacterial formula". These products also appear to be "new drugs" within the meaning of section 201(p) without an effective new drug application (NDA) [Unapproved New Drug, section 505(a)]. There are no approved applications in effect for these products. In addition, based on a preliminary search and review of the literature, there do not appear to be adequate and well controlled clinical studies sufficient to support a GRAS/E finding for the referenced products. | The aforementioned product appears to be an unapproved new drug as the product label implies the product is intended for use in the diagnosis; cure; mitigation; treatment; or prevention of disease. Examples of the products intended use from the product labeling include but are not limited to the following;anti-bacterial formula; Whitens; Micro-cleanse Anti-bacterial Formula; With pure Papaya Extract and Vitamin B3 to whiten skin in as early as 1 week. | The aforementioned product appears to be an unapproved new drug as the product label implies the product is intended for use in the diagnosis; cure; mitigation; treatment; or prevention of disease. Examples of the products intended use from the product labeling include but are not limited to the following;anti-bacterial formula; Whitens; Lightens dark spots in as early as 1 week; Micro-cleanse Anti-bacterial Formula; With pure Calamansi Extract known to whiten skin; With Vitamin C derivative to help lighten dark spots in as early as 1 week. | These products appear to be unapproved new drugs and they are promoted in labeling to meet the definition of a cosmetic under section 201(i), and a drug under section 201(g) of the Federal Food, Drug and Cosmetic Act (FD&C Act or the Act) in that they are intended for use in the cure, mitigation, treatment or prevention of disease and/or are intended to affect the structure of any function of the human body. Ingredients and products, when used as a cosmetic and a drug must meet the regulatory requirements of both a cosmetic and a drug. Statements of intended use meeting the definition of a drug that are identified in the labeling, but are not limited to: "micro cleanse anti-bacterial formula". These products also appear to be "new drugs" within the meaning of section 201(p) without an effective new drug application (NDA) [Unapproved New Drug, section 505(a)]. There are no approved applications in effect for these products. In addition, based on a preliminary search and review of the literature, there do not appear to be adequate and well controlled clinical studies sufficient to support a GRAS/E finding for the referenced products. | These products appear to be unapproved new drugs and they are promoted in labeling to meet the definition of a cosmetic under section 201(i), and a drug under section 201(g) of the Federal Food, Drug and Cosmetic Act (FD&C Act or the Act) in that they are intended for use in the cure, mitigation, treatment or prevention of disease and/or are intended to affect the structure of any function of the human body. Ingredients and products, when used as a cosmetic and a drug must meet the regulatory requirements of both a cosmetic and a drug. Statements of intended use meeting the definition of a drug that are identified in the labeling, but are not limited to: "micro cleanse anti-bacterial formula". These products also appear to be "new drugs" within the meaning of section 201(p) without an effective new drug application (NDA) [Unapproved New Drug, section 505(a)]. There are no approved applications in effect for these products. In addition, based on a preliminary search and review of the literature, there do not appear to be adequate and well controlled clinical studies sufficient to support a GRAS/E finding for the referenced products. | The aforementioned product appears to be an unapproved new drug as the product label implies the product is intended for use in the diagnosis; cure; mitigation; treatment; or prevention of disease. Examples of the products intended use from the product labeling include but are not limited to the following;anti-bacterial formula; Whitens; Micro-cleanse Anti-bacterial Formula; With pure Papaya Extract and Vitamin B3 to whiten skin in as early as 1 week. | The aforementioned product appears to be an unapproved new drug as the product label implies the product is intended for use in the diagnosis; cure; mitigation; treatment; or prevention of disease. Examples of the products intended use from the product labeling include but are not limited to the following;anti-bacterial formula; Whitens; Lightens dark spots in as early as 1 week; Micro-cleanse Anti-bacterial Formula; With pure Calamansi Extract known to whiten skin; ?With Vitamin C derivative to help lighten dark spots in as early as 1 week. | These products appear to be unapproved new drugs and they are promoted in labeling to meet the definition of a cosmetic under section 201(i), and a drug under section 201(g) of the Federal Food, Drug and Cosmetic Act (FD&C Act or the Act) in that they are intended for use in the cure, mitigation, treatment or prevention of disease and/or are intended to affect the structure of any function of the human body. Ingredients and products, when used as a cosmetic and a drug must meet the regulatory requirements of both a cosmetic and a drug. Statements of intended use meeting the definition of a drug that are identified in the labeling, but are not limited to: "micro cleanse anti-bacterial formula". These products also appear to be "new drugs" within the meaning of section 201(p) without an effective new drug application (NDA) [Unapproved New Drug, section 505(a)]. There are no approved applications in effect for these products. In addition, based on a preliminary search and review of the literature, there do not appear to be adequate and well controlled clinical studies sufficient to support a GRAS/E finding for the referenced products. | These products appear to be unapproved new drugs and they are promoted in labeling to meet the definition of a cosmetic under section 201(i), and a drug under section 201(g) of the Federal Food, Drug and Cosmetic Act (FD&C Act or the Act) in that they are intended for use in the cure, mitigation, treatment or prevention of disease and/or are intended to affect the structure of any function of the human body. Ingredients and products, when used as a cosmetic and a drug must meet the regulatory requirements of both a cosmetic and a drug. Statements of intended use meeting the definition of a drug that are identified in the labeling, but are not limited to: "micro cleanse anti-bacterial formula". These products also appear to be "new drugs" within the meaning of section 201(p) without an effective new drug application (NDA) [Unapproved New Drug, section 505(a)]. There are no approved applications in effect for these products. In addition, based on a preliminary search and review of the literature, there do not appear to be adequate and well controlled clinical studies sufficient to support a GRAS/E finding for the referenced products. | The aforementioned product appears to be an unapproved new drug as the product label implies the product is intended for use in the diagnosis; cure; mitigation; treatment; or prevention of disease. Examples of the products intended use from the product labeling include but are not limited to the following;anti-bacterial formula; Whitens; Micro-cleanse Anti-bacterial Formula; With pure Papaya Extract and Vitamin B3 to whiten skin in as early as 1 week. | The aforementioned product appears to be an unapproved new drug as the product label implies the product is intended for use in the diagnosis; cure; mitigation; treatment; or prevention of disease. Examples of the products intended use from the product labeling include but are not limited to the following;anti-bacterial formula; Whitens; Lightens dark spots in as early as 1 week; Micro-cleanse Anti-bacterial Formula; With pure Calamansi Extract known to whiten skin; With Vitamin C derivative to help lighten dark spots in as early as 1 week. | The aforementioned product appears to be an unapproved new drug as the product label implies the product is intended for use in the diagnosis; cure; mitigation; treatment; or prevention of disease. Examples of the products intended use from the product labeling include but are not limited to the following;anti-bacterial formula; Whitens; Micro-cleanse Anti-bacterial Formula; With pure Papaya Extract and Vitamin B3 to whiten skin in as early as 1 week. | These products appear to be unapproved new drugs and they are promoted in labeling to meet the definition of a cosmetic under section 201(i), and a drug under section 201(g) of the Federal Food, Drug and Cosmetic Act (FD&C Act or the Act) in that they are intended for use in the cure, mitigation, treatment or prevention of disease and/or are intended to affect the structure of any function of the human body. Ingredients and products, when used as a cosmetic and a drug must meet the regulatory requirements of both a cosmetic and a drug. Statements of intended use meeting the definition of a drug that are identified in the labeling, but are not limited to: "micro cleanse anti-bacterial formula". These products also appear to be "new drugs" within the meaning of section 201(p) without an effective new drug application (NDA) [Unapproved New Drug, section 505(a)]. There are no approved applications in effect for these products. In addition, based on a preliminary search and review of the literature, there do not appear to be adequate and well controlled clinical studies sufficient to support a GRAS/E finding for the referenced products. | These products appear to be unapproved new drugs and they are promoted in labeling to meet the definition of a cosmetic under section 201(i), and a drug under section 201(g) of the Federal Food, Drug and Cosmetic Act (FD&C Act or the Act) in that they are intended for use in the cure, mitigation, treatment or prevention of disease and/or are intended to affect the structure of any function of the human body. Ingredients and products, when used as a cosmetic and a drug must meet the regulatory requirements of both a cosmetic and a drug. Statements of intended use meeting the definition of a drug that are identified in the labeling, but are not limited to: "micro cleanse anti-bacterial formula". These products also appear to be "new drugs" within the meaning of section 201(p) without an effective new drug application (NDA) [Unapproved New Drug, section 505(a)]. There are no approved applications in effect for these products. In addition, based on a preliminary search and review of the literature, there do not appear to be adequate and well controlled clinical studies sufficient to support a GRAS/E finding for the referenced products. each item verified
What the source says
Unilever Philippines, Inc. - Cavite Factory Date Published : 10/10/2013 Gateway Business Park Barangay Javalera , Gen. Trias, Calabarzon, Cavite PHILIPPINES
— accessdata.fda.gov, retrieved 2026-09-24
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 D - - 02 Perfumes (Fragrance Preparations) Date Published: 10/10/2013 Desc: Roll on Deodorant Rexona Antiperspirant 53 D - - 99 Other Fragrance Preparations, N.E.C. Date Published: 10/10/2013 Desc: Roll on Deodorant Rexona Antiperspirant 53 E - - 01 Hair Conditioners (Hair Preparations, Non-coloring) Date Published: 03/02/2018 Desc: Cream Silk Dandruff Free Conditioner 53 E - - 06 Shampoos (Hair Preparations, Non-coloring) Date Published: 12/19/2017 Desc: New Vaseline Itch & Dandruff-Free (VASELINE ? PURPLE) 53 J - - 02 Deodorants (underarm)(Not Antiperspirant) (Personal Cleanliness) Date Published: 10/10/2013 Desc: Roll on Deodorant Rexona Antiperspirant 53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations) Date Published: 04/17/2015 Desc: Eskinol Spot-less White Facial Deep Cleanser Notes: The aforementioned product appears to be an unapproved new drug as the product label implies the product is intended for use in the diagnosis; cure; mitigation; treatment; or prevention of disease. Examples of the products intended use from the product labeling include but are not limited to the following; anti-bacterial formula; Whitens; Lightens dark spots in as early as 1 week; Micro-cleanse Anti-bacterial Formula; With pure Calamansi Extract known to whiten skin; With Vitamin C derivative to help lighten dark spots in as early as 1 week 53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations) Date Published: 12/10/2019 Desc: Eskinol Refreshing Facial Deep Cleanser with Pure Cucumber Extract Notes: These products appear to be unapproved new drugs and they are promoted in labeling to meet the definition of a cosmetic under section 201(i), and a drug under section 201(g) of the Federal Food, Drug and Cosmetic Act (FD&C Act or the Act) in that they are intended for use in the cure, mitigation, treatment or prevention of disease and/or are intended to affect the structure of any function of the human body. Ingredients and products, when used as a cosmetic and a drug must meet the regulatory requirements of both a cosmetic and a drug. Statements of intended use meeting the definition of a drug that are identified in the labeling, but are not limited to: "micro cleanse anti-bacterial formula". These products also appear to be "new drugs" within the meaning of section 201(p) without an effective new drug application (NDA) [Unapproved New Drug, section 505(a)]. There are no approved applications in effect for these products. In addition, based on a preliminary search and review of the literature, there do not appear to be adequate and well controlled clinical studies sufficient to support a GRAS/E finding for the referenced products. 53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations) Date Published: 12/10/2019 Desc: Eskinol Oil Control Facial Deep Cleanser with Pure Lemon Extract Notes: These products appear to be unapproved new drugs and they are promoted in labeling to meet the definition of a cosmetic under section 201(i), and a drug under section 201(g) of the Federal Food, Drug and Cosmetic Act (FD&C Act or the Act) in that they are intended for use in the cure, mitigation, treatment or prevention of disease and/or are intended to affect the structure of any function of the human body. Ingredients and products, when used as a cosmetic and a drug must meet the regulatory requirements of both a cosmetic and a drug. Statements of intended use meeting the definition of a drug that are identified in the labeling, but are not limited to: "micro cleanse anti-bacterial formula". These products also appear to be "new drugs" within the meaning of section 201(p) without an effective new drug application (NDA) [Unapproved New Drug, section 505(a)]. There are no approved applications in effect for these products. In addition, based on a preliminary search and review of the literature, there do not appear to be adequate and well controlled clinical studies sufficient to support a GRAS/E finding for the referenced products. 53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations) Date Published: 04/17/2015 Desc: Eskinol Papaya Smooth White Facial Deep Cleanser Notes: The aforementioned product appears to be an unapproved new drug as the product label implies the product is intended for use in the diagnosis; cure; mitigation; treatment; or prevention of disease. Examples of the products intended use from the product labeling include but are not limited to the following;anti-bacterial formula; Whitens; Micro-cleanse Anti-bacterial Formula; With pure Papaya Extract and Vitamin B3 to whiten skin in as early as 1 week. 53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations) Date Published: 04/17/2015 Desc: Eskinol Spot-less White Facial Deep Cleanser Notes: The aforementioned product appears to be an unapproved new drug as the product label implies the product is intended for use in the diagnosis; cure; mitigation; treatment; or prevention of disease. Examples of the products intended use from the product labeling include but are not limited to the following;anti-bacterial formula; Whitens; Lightens dark spots in as early as 1 week; Micro-cleanse Anti-bacterial Formula; With pure Calamansi Extract known to whiten skin; With Vitamin C derivative to help lighten dark spots in as early as 1 week. 53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations) Date Published: 12/10/2019 Desc: Eskinol Refreshing Facial Deep Cleanser with Pure Cucumber Extract Notes: These products appear to be unapproved new drugs and they are promoted in labeling to meet the definition of a cosmetic under section 201(i), and a drug under section 201(g) of the Federal Food, Drug and Cosmetic Act (FD&C Act or the Act) in that they are intended for use in the cure, mitigation, treatment or prevention of disease and/or are intended to affect the structure of any function of the human body. Ingredients and products, when used as a cosmetic and a drug must meet the regulatory requirements of both a cosmetic and a drug. Statements of intended use meeting the definition of a drug that are identified in the labeling, but are not limited to: "micro cleanse anti-bacterial formula". These products also appear to be "new drugs" within the meaning of section 201(p) without an effective new drug application (NDA) [Unapproved New Drug, section 505(a)]. There are no approved applications in effect for these products. In addition, based on a preliminary search and review of the literature, there do not appear to be adequate and well controlled clinical studies sufficient to support a GRAS/E finding for the referenced products. 53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations) Date Published: 12/10/2019 Desc: Eskinol Oil Control Facial Deep Cleanser with Pure Lemon Extract Notes: These products appear to be unapproved new drugs and they are promoted in labeling to meet the definition of a cosmetic under section 201(i), and a drug under section 201(g) of the Federal Food, Drug and Cosmetic Act (FD&C Act or the Act) in that they are intended for use in the cure, mitigation, treatment or prevention of disease and/or are intended to affect the structure of any function of the human body. Ingredients and products, when used as a cosmetic and a drug must meet the regulatory requirements of both a cosmetic and a drug. Statements of intended use meeting the definition of a drug that are identified in the labeling, but are not limited to: "micro cleanse anti-bacterial formula". These products also appear to be "new drugs" within the meaning of section 201(p) without an effective new drug application (NDA) [Unapproved New Drug, section 505(a)]. There are no approved applications in effect for these products. In addition, based on a preliminary search and review of the literature, there do not appear to be adequate and well controlled clinical studies sufficient to support a GRAS/E finding for the referenced products. 53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations) Date Published: 04/17/2015 Desc: Eskinol Papaya Smooth White Facial Deep Cleanser Notes: The aforementioned product appears to be an unapproved new drug as the product label implies the product is intended for use in the diagnosis; cure; mitigation; treatment; or prevention of disease. Examples of the products intended use from the product labeling include but are not limited to the following;anti-bacterial formula; Whitens; Micro-cleanse Anti-bacterial Formula; With pure Papaya Extract and Vitamin B3 to whiten skin in as early as 1 week. 53 L - - 99 Other Skin Care Preparations, N.E.C. Date Published: 04/17/2015 Desc: Eskinol Spot-less White Facial Deep Cleanser Notes: The aforementioned product appears to be an unapproved new drug as the product label implies the product is intended for use in the diagnosis; cure; mitigation; treatment; or prevention of disease. Examples of the products intended use from the product labeling include but are not limited to the following;anti-bacterial formula; Whitens; Lightens dark spots in as early as 1 week; Micro-cleanse Anti-bacterial Formula; With pure Calamansi Extract known to whiten skin; ?With Vitamin C derivative to help lighten dark spots in as early as 1 week. 53 L - - 99 Other Skin Care Preparations, N.E.C. Date Published: 12/10/2019 Desc: Eskinol Refreshing Facial Deep Cleanser with Pure Cucumber Extract Notes: These products appear to be unapproved new drugs and they are promoted in labeling to meet the definition of a cosmetic under section 201(i), and a drug under section 201(g) of the Federal Food, Drug and Cosmetic Act (FD&C Act or the Act) in that they are intended for use in the cure, mitigation, treatment or prevention of disease and/or are intended to affect the structure of any function of the human body. Ingredients and products, when used as a cosmetic and a drug must meet the regulatory requirements of both a cosmetic and a drug. Statements of intended use meeting the definition of a drug that are identified in the labeling, but are not limited to: "micro cleanse anti-bacterial formula". These products also appear to be "new drugs" within the meaning of section 201(p) without an effective new drug application (NDA) [Unapproved New Drug, section 505(a)]. There are no approved applications in effect for these products. In addition, based on a preliminary search and review of the literature, there do not appear to be adequate and well controlled clinical studies sufficient to support a GRAS/E finding for the referenced products. 53 L - - 99 Other Skin Care Preparations, N.E.C. Date Published: 12/10/2019 Desc: Eskinol Oil Control Facial Deep Cleanser with Pure Lemon Extract Notes: These products appear to be unapproved new drugs and they are promoted in labeling to meet the definition of a cosmetic under section 201(i), and a drug under section 201(g) of the Federal Food, Drug and Cosmetic Act (FD&C Act or the Act) in that they are intended for use in the cure, mitigation, treatment or prevention of disease and/or are intended to affect the structure of any function of the human body. Ingredients and products, when used as a cosmetic and a drug must meet the regulatory requirements of both a cosmetic and a drug. Statements of intended use meeting the definition of a drug that are identified in the labeling, but are not limited to: "micro cleanse anti-bacterial formula". These products also appear to be "new drugs" within the meaning of section 201(p) without an effective new drug application (NDA) [Unapproved New Drug, section 505(a)]. There are no approved applications in effect for these products. In addition, based on a preliminary search and review of the literature, there do not appear to be adequate and well controlled clinical studies sufficient to support a GRAS/E finding for the referenced products. 53 L - - 99 Other Skin Care Preparations, N.E.C. Date Published: 04/17/2015 Desc: Eskinol Papaya Smooth White Facial Deep Cleanser Notes: The aforementioned product appears to be an unapproved new drug as the product label implies the product is intended for use in the diagnosis; cure; mitigation; treatment; or prevention of disease. Examples of the products intended use from the product labeling include but are not limited to the following;anti-bacterial formula; Whitens; Micro-cleanse Anti-bacterial Formula; With pure Papaya Extract and Vitamin B3 to whiten skin in as early as 1 week. 61 H - - 05 Zinc Pyrithione (Anti-Bacterial) Date Published: 03/02/2018 Desc: Cream Silk Dandruff Free Conditioner 62 W - - -- Astring/A-Perspirant Date Published: 10/10/2013 Desc: Roll on Deodorant Rexona Antiperspirant 66 V - - 99 Miscellaneous Patent Medicines, Etc. Date Published: 04/17/2015 Desc: Eskinol Spot-less White Facial Deep Cleanser Notes: The aforementioned product appears to be an unapproved new drug as the product label implies the product is intended for use in the diagnosis; cure; mitigation; treatment; or prevention of disease. Examples of the products intended use from the product labeling include but are not limited to the following;anti-bacterial formula; Whitens; Lightens dark spots in as early as 1 week; Micro-cleanse Anti-bacterial Formula; With pure Calamansi Extract known to whiten skin; With Vitamin C derivative to help lighten dark spots in as early as 1 week. 66 V - - 99 Miscellaneous Patent Medicines, Etc. Date Published: 04/17/2015 Desc: Eskinol Papaya Smooth White Facial Deep Cleanser Notes: The aforementioned product appears to be an unapproved new drug as the product label implies the product is intended for use in the diagnosis; cure; mitigation; treatment; or prevention of disease. Examples of the products intended use from the product labeling include but are not limited to the following;anti-bacterial formula; Whitens; Micro-cleanse Anti-bacterial Formula; With pure Papaya Extract and Vitamin B3 to whiten skin in as early as 1 week. 66 V - - 99 Miscellaneous Patent Medicines, Etc. Date Published: 12/19/2017 Desc: New Vaseline Itch & Dandruff-Free (VASELINE ? PURPLE) 66 V - - 99 Miscellaneous Patent Medicines, Etc. Date Published: 12/10/2019 Desc: Eskinol Oil Control Facial Deep Cleanser with Pure Lemon Extract Notes: These products appear to be unapproved new drugs and they are promoted in labeling to meet the definition of a cosmetic under section 201(i), and a drug under section 201(g) of the Federal Food, Drug and Cosmetic Act (FD&C Act or the Act) in that they are intended for use in the cure, mitigation, treatment or prevention of disease and/or are intended to affect the structure of any function of the human body. Ingredients and products, when used as a cosmetic and a drug must meet the regulatory requirements of both a cosmetic and a drug. Statements of intended use meeting the definition of a drug that are identified in the labeling, but are not limited to: "micro cleanse anti-bacterial formula". These products also appear to be "new drugs" within the meaning of section 201(p) without an effective new drug application (NDA) [Unapproved New Drug, section 505(a)]. There are no approved applications in effect for these products. In addition, based on a preliminary search and review of the literature, there do not appear to be adequate and well controlled clinical studies sufficient to support a GRAS/E finding for the referenced products. 66 V - - 99 Miscellaneous Patent Medicines, Etc. Date Published: 12/10/2019 Desc: Eskinol Refreshing Facial Deep Cleanser with Pure Cucumber Extract Notes: These products appear to be unapproved new drugs and they are promoted in labeling to meet the definition of a cosmetic under section 201(i), and a drug under section 201(g) of the Federal Food, Drug and Cosmetic Act (FD&C Act or the Act) in that they are intended for use in the cure, mitigation, treatment or prevention of disease and/or are intended to affect the structure of any function of the human body. Ingredients and products, when used as a cosmetic and a drug must meet the regulatory requirements of both a cosmetic and a drug. Statements of intended use meeting the definition of a drug that are identified in the labeling, but are not limited to: "micro cleanse anti-bacterial formula". These products also appear to be "new drugs" within the meaning of section 201(p) without an effective new drug application (NDA) [Unapproved New Drug, section 505(a)]. There are no approved applications in effect for these products. In addition, based on a preliminary search and review of the literature, there do not appear to be adequate and well controlled clinical studies sufficient to support a GRAS/E finding for the referenced products.
— all from accessdata.fda.gov, retrieved 2026-09-24
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_190.html
This one changes, and we watch it.FDA import alert red lists: firms subject to detention without physical examination is re-read on a schedule and every change is dated. Subscribe: Atom feed · JSON · what has changed so far.