Unilever Philippines, Inc. - Cavite Factory · 66-41 · PHILIPPINES
For Unilever Philippines, Inc. - Cavite Factory · 66-41 · PHILIPPINES, import alert is 66-41; import alert name is Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S; country is PHILIPPINES; 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 Refreshing Facial Deep Cleanser with Pure Cucumber Extract | Eskinol Oil Control Facial Deep Cleanser with Pure Lemon Extract | Eskinol Spot-less White Facial Deep Cleanser | Eskinol Papaya Smooth White Facial Deep Cleanser | Eskinol Spot-less White Facial Deep Cleanser | Eskinol Papaya Smooth 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 Oil Control Facial Deep Cleanser with Pure Lemon Extract | Eskinol Refreshing Facial Deep Cleanser with Pure Cucumber Extract | Cream Silk Dandruff Free Conditioner | Roll on Deodorant Rexona Antiperspirant | Eskinol Refreshing Facial Deep Cleanser with Pure Cucumber Extract | Eskinol Spot-less White Facial Deep Cleanser | New Vaseline Itch & Dandruff-Free (VASELINE ? PURPLE) | Eskinol Oil Control Facial Deep Cleanser with Pure Lemon Extract | Eskinol Papaya Smooth White Facial Deep Cleanser; 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 2026-09-16.
- 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 Refreshing Facial Deep Cleanser with Pure Cucumber Extract | Eskinol Oil Control Facial Deep Cleanser with Pure Lemon Extract | Eskinol Spot-less White Facial Deep Cleanser | Eskinol Papaya Smooth White Facial Deep Cleanser | Eskinol Spot-less White Facial Deep Cleanser | Eskinol Papaya Smooth 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 Oil Control Facial Deep Cleanser with Pure Lemon Extract | Eskinol Refreshing Facial Deep Cleanser with Pure Cucumber Extract | Cream Silk Dandruff Free Conditioner | Roll on Deodorant Rexona Antiperspirant | Eskinol Refreshing Facial Deep Cleanser with Pure Cucumber Extract | Eskinol Spot-less White Facial Deep Cleanser | New Vaseline Itch & Dandruff-Free (VASELINE ? PURPLE) | Eskinol Oil Control Facial Deep Cleanser with Pure Lemon Extract | Eskinol Papaya Smooth White Facial Deep Cleanser each item verified
- FDA 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. | 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; 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. | 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. | 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. | 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; 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. | 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. 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 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: 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 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: 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: 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: 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 - - 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. 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 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: 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. 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: 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. 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: 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: 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.
— accessdata.fda.gov, retrieved 2026-09-15
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.