DONG TIAN YANG INDUSTRIAL CO., LTD · 66-41 · CHINA
For DONG TIAN YANG INDUSTRIAL CO., LTD · 66-41 · CHINA, import alert is 66-41; import alert name is Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S; country is CHINA; product is Whitening Mask | Aloe Mask | Aloe Mask | Whitening Mask | Powder Soft Mask Vitamin C Whitening | Powder Soft Mask Vitamin C Whitening | Whitening Mask | Aloe Mask | Whitening Mask | Powder Soft Mask Vitamin C Whitening | Aloe Mask | Whitening Mask | Aloe Mask | Powder Soft Mask Vitamin C Whitening; product code is 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 - - 06 Moisturizing (Skin Care Preparations) | 53 L - - 06 Moisturizing (Skin Care Preparations) | 53 L - - 06 Moisturizing (Skin Care Preparations) | 53 L - - 08 Paste Masks (Mud Packs) (Skin Care Preparations) | 53 L - - 08 Paste Masks (Mud Packs) (Skin Care Preparations) | 53 L - - 08 Paste Masks (Mud Packs) (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. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 Y - - 99 Exhibits - Other Drug Related Items N.E.C; date published is 01/29/2020; address is Town, Nanhai , Lishui; Dachong Industrial District , Foshan, Guangdong CHINA, verified against its source on 2026-09-16.
- Firm
- DONG TIAN YANG INDUSTRIAL CO., LTD verified
- Import alert
- 66-41 verified
- Import alert name
- Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S.
- Country
- CHINA verified
- Address
- Town, Nanhai , Lishui; Dachong Industrial District , Foshan, Guangdong CHINA verified
- Date published
- 01/29/2020 verified
- Product code
- 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 - - 06 Moisturizing (Skin Care Preparations) | 53 L - - 06 Moisturizing (Skin Care Preparations) | 53 L - - 06 Moisturizing (Skin Care Preparations) | 53 L - - 08 Paste Masks (Mud Packs) (Skin Care Preparations) | 53 L - - 08 Paste Masks (Mud Packs) (Skin Care Preparations) | 53 L - - 08 Paste Masks (Mud Packs) (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. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 Y - - 99 Exhibits - Other Drug Related Items N.E.C. each item verified
- Product
- Whitening Mask | Aloe Mask | Aloe Mask | Whitening Mask | Powder Soft Mask Vitamin C Whitening | Powder Soft Mask Vitamin C Whitening | Whitening Mask | Aloe Mask | Whitening Mask | Powder Soft Mask Vitamin C Whitening | Aloe Mask | Whitening Mask | Aloe Mask | Powder Soft Mask Vitamin C Whitening each item verified
- FDA notes
- The product appears to be an unapproved new drug as the product labeling includes claims such as (not an all-inclusive list): 'It can reduce the face skin pigments.'; '[H]elp the skin improve activates cells, repair skin thoroughly, endows skin with elasticity and firmness.'; 'It also strengthens skin blood circulation.'; '[M]akes skin recover its luster and elasticity.'; 'It can accelerate skin metabolism, ... anti-aging, lightening colour spots, whitening skin.' | The product appears to be an unapproved new drug as the product labeling includes claims such as (not an all-inclusive list): '[D]iminishes inflammation, and resists allergy.'; '[I]mprove grease exudation.'; 'Aloe Vera essence heals wounds.'; '[R]egrowing capability for skin deep cells.'; 'It can accelerate skin metabolism, ... anti-aging, lightening colour spots, whitening skin.' | The product appears to be an unapproved new drug as the product labeling includes claims such as (not an all-inclusive list): '[D]iminishes inflammation, and resists allergy.'; '[I]mprove grease exudation.'; 'Aloe Vera essence heals wounds.'; '[R]egrowing capability for skin deep cells.'; 'It can accelerate skin metabolism, ... anti-aging, lightening colour spots, whitening skin.' | The product appears to be an unapproved new drug as the product labeling includes claims such as (not an all-inclusive list): 'It can reduce the face skin pigments.'; '[H]elp the skin improve activates cells, repair skin thoroughly, endows skin with elasticity and firmness.'; 'It also strengthens skin blood circulation.'; '[M]akes skin recover its luster and elasticity.'; 'It can accelerate skin metabolism, ... anti-aging, lightening colour spots, whitening skin.' | The product appears to be an unapproved new drug and is 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 Cosmetics Act (FD&C Act or the Act) in that it is 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. Therefore, the product must meet the regulatory requirements of both a cosmetic and a drug. The product is not generally recognized as safe and effective for the above referenced uses and therefore, the product is a "new drug" under section 201(p) of the Act [21 U.S.C. § 321(p)]. New drugs may not be legally marketed in the U.S. without prior approval from the FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)]. The product appears to be a new drug within the meaning of Section 201(p) of the Act without an effective new drug application (NDA) [Unapproved New Drug, Section 505(a)]. Powder Soft Mask Vitamin C Whitening is subject to DWPE under Import Alert # 66-41. Shipments of this product appear to have been transmitted under various product codes to FDA; therefore, please verify the true identity of product shipments from this firm offered for entry into the US. | The product appears to be an unapproved new drug and is 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 Cosmetics Act (FD&C Act or the Act) in that it is 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. Therefore, the product must meet the regulatory requirements of both a cosmetic and a drug. The product is not generally recognized as safe and effective for the above referenced uses and therefore, the product is a "new drug" under section 201(p) of the Act [21 U.S.C. § 321(p)]. New drugs may not be legally marketed in the U.S. without prior approval from the FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)]. The product appears to be a new drug within the meaning of Section 201(p) of the Act without an effective new drug application (NDA) [Unapproved New Drug, Section 505(a)]. Powder Soft Mask Vitamin C Whitening is subject to DWPE under Import Alert # 66-41. Shipments of this product appear to have been transmitted under various product codes to FDA; therefore, please verify the true identity of product shipments from this firm offered for entry into the US. | The product appears to be an unapproved new drug as the product labeling includes claims such as (not an all-inclusive list): 'It can reduce the face skin pigments.'; '[H]elp the skin improve activates cells, repair skin thoroughly, endows skin with elasticity and firmness.'; 'It also strengthens skin blood circulation.'; '[M]akes skin recover its luster and elasticity.'; 'It can accelerate skin metabolism, ... anti-aging, lightening colour spots, whitening skin.' | The product appears to be an unapproved new drug as the product labeling includes claims such as (not an all-inclusive list): '[D]iminishes inflammation, and resists allergy.'; '[I]mprove grease exudation.'; 'Aloe Vera essence heals wounds.'; '[R]egrowing capability for skin deep cells.'; 'It can accelerate skin metabolism, ... anti-aging, lightening colour spots, whitening skin.' | The product appears to be an unapproved new drug as the product labeling includes claims such as (not an all-inclusive list): 'It can reduce the face skin pigments.'; '[H]elp the skin improve activates cells, repair skin thoroughly, endows skin with elasticity and firmness.'; 'It also strengthens skin blood circulation.'; '[M]akes skin recover its luster and elasticity.'; 'It can accelerate skin metabolism, ... anti-aging, lightening colour spots, whitening skin.' | The product appears to be an unapproved new drug and is 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 Cosmetics Act (FD&C Act or the Act) in that it is 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. Therefore, the product must meet the regulatory requirements of both a cosmetic and a drug. The product is not generally recognized as safe and effective for the above referenced uses and therefore, the product is a "new drug" under section 201(p) of the Act [21 U.S.C. § 321(p)]. New drugs may not be legally marketed in the U.S. without prior approval from the FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)]. The product appears to be a new drug within the meaning of Section 201(p) of the Act without an effective new drug application (NDA) [Unapproved New Drug, Section 505(a)]. Powder Soft Mask Vitamin C Whitening is subject to DWPE under Import Alert # 66-41. Shipments of this product appear to have been transmitted under various product codes to FDA; therefore, please verify the true identity of product shipments from this firm offered for entry into the US. | The product appears to be an unapproved new drug as the product labeling includes claims such as (not an all-inclusive list): '[D]iminishes inflammation, and resists allergy.'; '[I]mprove grease exudation.'; 'Aloe Vera essence heals wounds.'; '[R]egrowing capability for skin deep cells.'; 'It can accelerate skin metabolism, ... anti-aging, lightening colour spots, whitening skin.' | The product appears to be an unapproved new drug as the product labeling includes claims such as (not an all-inclusive list): 'It can reduce the face skin pigments.'; '[H]elp the skin improve activates cells, repair skin thoroughly, endows skin with elasticity and firmness.'; 'It also strengthens skin blood circulation.'; '[M]akes skin recover its luster and elasticity.'; 'It can accelerate skin metabolism, ... anti-aging, lightening colour spots, whitening skin.' | The product appears to be an unapproved new drug as the product labeling includes claims such as (not an all-inclusive list): '[D]iminishes inflammation, and resists allergy.'; '[I]mprove grease exudation.'; 'Aloe Vera essence heals wounds.'; '[R]egrowing capability for skin deep cells.'; 'It can accelerate skin metabolism, ... anti-aging, lightening colour spots, whitening skin.' | The product appears to be an unapproved new drug and is 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 Cosmetics Act (FD&C Act or the Act) in that it is 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. Therefore, the product must meet the regulatory requirements of both a cosmetic and a drug. The product is not generally recognized as safe and effective for the above referenced uses and therefore, the product is a "new drug" under section 201(p) of the Act [21 U.S.C. § 321(p)]. New drugs may not be legally marketed in the U.S. without prior approval from the FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)]. The product appears to be a new drug within the meaning of Section 201(p) of the Act without an effective new drug application (NDA) [Unapproved New Drug, Section 505(a)]. Powder Soft Mask Vitamin C Whitening is subject to DWPE under Import Alert # 66-41. Shipments of this product appear to have been transmitted under various product codes to FDA; therefore, please verify the true identity of product shipments from this firm offered for entry into the US. each item verified
What the source says
DONG TIAN YANG INDUSTRIAL CO., LTD Date Published : 01/29/2020 Town, Nanhai , Lishui; Dachong Industrial District , Foshan, Guangdong CHINA 53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations) Date Published: 05/11/2020 Desc: Whitening Mask Notes: The product appears to be an unapproved new drug as the product labeling includes claims such as (not an all-inclusive list): 'It can reduce the face skin pigments.'; '[H]elp the skin improve activates cells, repair skin thoroughly, endows skin with elasticity and firmness.'; 'It also strengthens skin blood circulation.'; '[M]akes skin recover its luster and elasticity.'; 'It can accelerate skin metabolism, ... anti-aging, lightening colour spots, whitening skin.' 53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations) Date Published: 05/11/2020 Desc: Aloe Mask Notes: The product appears to be an unapproved new drug as the product labeling includes claims such as (not an all-inclusive list): '[D]iminishes inflammation, and resists allergy.'; '[I]mprove grease exudation.'; 'Aloe Vera essence heals wounds.'; '[R]egrowing capability for skin deep cells.'; 'It can accelerate skin metabolism, ... anti-aging, lightening colour spots, whitening skin.' 53 L - - 06 Moisturizing (Skin Care Preparations) Date Published: 05/11/2020 Desc: Aloe Mask Notes: The product appears to be an unapproved new drug as the product labeling includes claims such as (not an all-inclusive list): '[D]iminishes inflammation, and resists allergy.'; '[I]mprove grease exudation.'; 'Aloe Vera essence heals wounds.'; '[R]egrowing capability for skin deep cells.'; 'It can accelerate skin metabolism, ... anti-aging, lightening colour spots, whitening skin.' 53 L - - 06 Moisturizing (Skin Care Preparations) Date Published: 05/11/2020 Desc: Whitening Mask Notes: The product appears to be an unapproved new drug as the product labeling includes claims such as (not an all-inclusive list): 'It can reduce the face skin pigments.'; '[H]elp the skin improve activates cells, repair skin thoroughly, endows skin with elasticity and firmness.'; 'It also strengthens skin blood circulation.'; '[M]akes skin recover its luster and elasticity.'; 'It can accelerate skin metabolism, ... anti-aging, lightening colour spots, whitening skin.' 53 L - - 06 Moisturizing (Skin Care Preparations) Date Published: 01/29/2020 Desc: Powder Soft Mask Vitamin C Whitening Notes: The product appears to be an unapproved new drug and is 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 Cosmetics Act (FD&C Act or the Act) in that it is 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. Therefore, the product must meet the regulatory requirements of both a cosmetic and a drug. The product is not generally recognized as safe and effective for the above referenced uses and therefore, the product is a "new drug" under section 201(p) of the Act [21 U.S.C. § 321(p)]. New drugs may not be legally marketed in the U.S. without prior approval from the FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)]. The product appears to be a new drug within the meaning of Section 201(p) of the Act without an effective new drug application (NDA) [Unapproved New Drug, Section 505(a)]. Powder Soft Mask Vitamin C Whitening is subject to DWPE under Import Alert # 66-41. Shipments of this product appear to have been transmitted under various product codes to FDA; therefore, please verify the true identity of product shipments from this firm offered for entry into the US. 53 L - - 08 Paste Masks (Mud Packs) (Skin Care Preparations) Date Published: 01/29/2020 Desc: Powder Soft Mask Vitamin C Whitening Notes: The product appears to be an unapproved new drug and is 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 Cosmetics Act (FD&C Act or the Act) in that it is 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. Therefore, the product must meet the regulatory requirements of both a cosmetic and a drug. The product is not generally recognized as safe and effective for the above referenced uses and therefore, the product is a "new drug" under section 201(p) of the Act [21 U.S.C. § 321(p)]. New drugs may not be legally marketed in the U.S. without prior approval from the FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)]. The product appears to be a new drug within the meaning of Section 201(p) of the Act without an effective new drug application (NDA) [Unapproved New Drug, Section 505(a)]. Powder Soft Mask Vitamin C Whitening is subject to DWPE under Import Alert # 66-41. Shipments of this product appear to have been transmitted under various product codes to FDA; therefore, please verify the true identity of product shipments from this firm offered for entry into the US. 53 L - - 08 Paste Masks (Mud Packs) (Skin Care Preparations) Date Published: 05/11/2020 Desc: Whitening Mask Notes: The product appears to be an unapproved new drug as the product labeling includes claims such as (not an all-inclusive list): 'It can reduce the face skin pigments.'; '[H]elp the skin improve activates cells, repair skin thoroughly, endows skin with elasticity and firmness.'; 'It also strengthens skin blood circulation.'; '[M]akes skin recover its luster and elasticity.'; 'It can accelerate skin metabolism, ... anti-aging, lightening colour spots, whitening skin.' 53 L - - 08 Paste Masks (Mud Packs) (Skin Care Preparations) Date Published: 05/11/2020 Desc: Aloe Mask Notes: The product appears to be an unapproved new drug as the product labeling includes claims such as (not an all-inclusive list): '[D]iminishes inflammation, and resists allergy.'; '[I]mprove grease exudation.'; 'Aloe Vera essence heals wounds.'; '[R]egrowing capability for skin deep cells.'; 'It can accelerate skin metabolism, ... anti-aging, lightening colour spots, whitening skin.' 53 L - - 99 Other Skin Care Preparations, N.E.C. Date Published: 05/11/2020 Desc: Whitening Mask Notes: The product appears to be an unapproved new drug as the product labeling includes claims such as (not an all-inclusive list): 'It can reduce the face skin pigments.'; '[H]elp the skin improve activates cells, repair skin thoroughly, endows skin with elasticity and firmness.'; 'It also strengthens skin blood circulation.'; '[M]akes skin recover its luster and elasticity.'; 'It can accelerate skin metabolism, ... anti-aging, lightening colour spots, whitening skin.' 53 L - - 99 Other Skin Care Preparations, N.E.C. Date Published: 01/29/2020 Desc: Powder Soft Mask Vitamin C Whitening Notes: The product appears to be an unapproved new drug and is 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 Cosmetics Act (FD&C Act or the Act) in that it is 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. Therefore, the product must meet the regulatory requirements of both a cosmetic and a drug. The product is not generally recognized as safe and effective for the above referenced uses and therefore, the product is a "new drug" under section 201(p) of the Act [21 U.S.C. § 321(p)]. New drugs may not be legally marketed in the U.S. without prior approval from the FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)]. The product appears to be a new drug within the meaning of Section 201(p) of the Act without an effective new drug application (NDA) [Unapproved New Drug, Section 505(a)]. Powder Soft Mask Vitamin C Whitening is subject to DWPE under Import Alert # 66-41. Shipments of this product appear to have been transmitted under various product codes to FDA; therefore, please verify the true identity of product shipments from this firm offered for entry into the US. 53 L - - 99 Other Skin Care Preparations, N.E.C. Date Published: 05/11/2020 Desc: Aloe Mask Notes: The product appears to be an unapproved new drug as the product labeling includes claims such as (not an all-inclusive list): '[D]iminishes inflammation, and resists allergy.'; '[I]mprove grease exudation.'; 'Aloe Vera essence heals wounds.'; '[R]egrowing capability for skin deep cells.'; 'It can accelerate skin metabolism, ... anti-aging, lightening colour spots, whitening skin.' 66 V - - 99 Miscellaneous Patent Medicines, Etc. Date Published: 05/11/2020 Desc: Whitening Mask Notes: The product appears to be an unapproved new drug as the product labeling includes claims such as (not an all-inclusive list): 'It can reduce the face skin pigments.'; '[H]elp the skin improve activates cells, repair skin thoroughly, endows skin with elasticity and firmness.'; 'It also strengthens skin blood circulation.'; '[M]akes skin recover its luster and elasticity.'; 'It can accelerate skin metabolism, ... anti-aging, lightening colour spots, whitening skin.' 66 V - - 99 Miscellaneous Patent Medicines, Etc. Date Published: 05/11/2020 Desc: Aloe Mask Notes: The product appears to be an unapproved new drug as the product labeling includes claims such as (not an all-inclusive list): '[D]iminishes inflammation, and resists allergy.'; '[I]mprove grease exudation.'; 'Aloe Vera essence heals wounds.'; '[R]egrowing capability for skin deep cells.'; 'It can accelerate skin metabolism, ... anti-aging, lightening colour spots, whitening skin.' 66 Y - - 99 Exhibits - Other Drug Related Items N.E.C. Date Published: 01/29/2020 Desc: Powder Soft Mask Vitamin C Whitening Notes: The product appears to be an unapproved new drug and is 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 Cosmetics Act (FD&C Act or the Act) in that it is 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. Therefore, the product must meet the regulatory requirements of both a cosmetic and a drug. The product is not generally recognized as safe and effective for the above referenced uses and therefore, the product is a "new drug" under section 201(p) of the Act [21 U.S.C. § 321(p)]. New drugs may not be legally marketed in the U.S. without prior approval from the FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)]. The product appears to be a new drug within the meaning of Section 201(p) of the Act without an effective new drug application (NDA) [Unapproved New Drug, Section 505(a)]. Powder Soft Mask Vitamin C Whitening is subject to DWPE under Import Alert # 66-41. Shipments of this product appear to have been transmitted under various product codes to FDA; therefore, please verify the true identity of product shipments from this firm offered for entry into the US.
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_190.html
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