CFDA Notification of 24 Batches of Disqualified Sunscreen Cosmetics (November and December) No. 182 and No. 196, 2017 - Regulatory News - Personal and Home Care Products

On 13 November and 5 December, 2017, CFDA carried out two spot checks of sunscreen cosmetics and issued notifications of the results: notification of 20 batches of disqualified sunscreen cosmetics (No. 182 in November) and notification of 4 batches of disqualified sunscreen cosmetics (No. 196 in December). No. 182 indicates that, after inspected by Qinghai Provincial Drug Inspection and Testing Institute, General Technology Centre of Inspection and Quarantine of Ningxia Entry-Exit Inspection and Quarantine Bureau and Shandong Institute for Food and Drug Control, 20 batches of sunscreen cosmetics produced by 18 enterprises including Yangfeng (Shanghai) Biotech Co., Ltd and Guangzhou Homar Cosmetics Manufacturing Co., Ltd. are judged to be disqualified (see table 1); and No. 196 indicates that, after inspected by Jiangxi Institute for Drug Control, Xizang Food and Drug Inspection Office, Shaanxi Institute for Food and Drug Control and Chongqing Institute for Food and Drug Control, 4 batches of sunscreen cosmetics produced by 3 enterprises including Guangzhou Qiaomei Cosmetics Co., Ltd., Guangzhou Chariano Commercial and Trading Co., Ltd. and Shenzhen Lantern Technology Group Ltd. are judged to be disqualified (see table 2). Detailed information is revealed as follows:

According to notification No. 182, there are 18 enterprises involved and 20 batches of products are revealed to be disqualified. Among them, 10 batches of products produced by 8 enterprises are judged to be bogus products after on-site inspection by local provincial FDA and confirmed by the manufacturer. Please see table 1 for more details.
According to notification No. 196, there are 3 enterprises involved and 4 batches of products are revealed to be disqualified. Please see table 2 for more details.
The products and enterprises in the below table violate the Regulations Concerning the Hygiene Supervision of Cosmetics and Regulations on the Management of Cosmetics Labeling. Shanghai and Guangdong FDA is currently examining the involved enterprises. CFDA commands all cosmetics companies to stop selling all products in the above table. Relevant provincial (municipality) FDA should urge related enterprises according to law to take steps like recall the products that are already on the market after examining, file and investigation, punish seriously according to law, and disclose relevant information in time. Products with only labeling that are not in accordance with regulations can be sold after the relevant manufacturers complete modifications in a limited time period ordered by FDAs. Regarding suspected bogus products, the local FDAs should deeply trace and investigate the supply channels of relevant enterprises, strike hard on the activity of producing and selling bogus and shoddy cosmetics, and transfer suspected crimes to the Public Security Department. Relevant provincial (municipality) FDA should report to CFDA about the investigation and results by 7 December (No. 182) and 29 December (No. 196), 2017.

CIRS Summary

Among the 24 batches of disqualified products produced by 21 enterprises, 19 batches of products produced by 17 enterprises have sunscreen agents listed on product labels that are not detected; 11 batches of products produced by 10 enterprises have been detected out sunscreen agents that are not listed on product labels or submitted formula. In addition, there is 1 batch of product with incorrect label, 2 batch of product with inconsistent information on certificate, and 1 batch of product with inconsistent batch number.

Table 1. Information of 20 Batches of Disqualified Sunscreen Cosmetics

No.	Name of Manufacturer/ Import Distributor	Product Name (Chinese)	Batch Number/ Production Date/ Expire Date	Number of Hygiene License/ Approval Certificate/ Record Keeping	Result	Remark
1	Yangfeng (Shanghai) Biotech Co., Ltd.; Consignor: Shanghai Mengzhidui International Trade Co.. Ltd.	銳度水感防曬凝露SPF30PA++	YF070602/ 20180705	GD·FDA (2008) 衛妝準字06-XK-0018/ 國妝特字G20140908	Sunscreen agent detected but not on label: PHENYLBENZIMIDAZOLE SULFONIC ACID, ETHYLHEXYL SALICYLATE; Sunscreen agent on label but not detected: ETHYLHEXYL TRIAZONE, METHYLENE BIS-BENZOTRIAZOLYL TETRAMETHYLBUTYLPHENOL	/
2	Guangzhou Homar Cosmetics Manufacturing Co., Ltd.	科瑪防曬霜SPF30+	HPC221H/ 20190408	GD·FDA (2005) 衛妝準字29-XK-2655號/ 國妝特字G20101324	Sunscreen agent on submitted formula and label but not detected: BENZOPHENONE-4 and BENZOPHENONE-5, ETHYLHEXYL SALICYLATE; Sunscreen agent detected but not on submitted formula and label: BUTYL METHOXYDIBENZOYLMETHANE	/
3	Guangzhou Kanier Cosmetics Co., Ltd.	卡妮爾美白防曬霜（白皙焦點防曬乳）	KNE-0260/ 20180208	GD·FDA (2005) 衛妝準字29-XK-2727號/國妝特字G20080139	Sunscreen agent on submitted formula but not detected: BENZOPHENONE-3, 4-METHYLBENZYLIDENE CAMPHOR, BUTYL METHOXYDIBENZOYLMETHANE, ETHYLHEXYL METHOXYCINNAMATE	After on-site inspection by Guangzhou Baiyun Food and Drug Administration, the manufacturer confirms that the product is bogus.
4	Guangzhou Tenzo Cosmetics Co., Ltd.; Consignor: Guangzhou Weicai Cosmetics Co., Ltd.	萊妮雅美白輕透隔離防曬乳	AA2303B/ 20200304	GD?FDA (2012) 衛妝準字29-XK-3579號/國妝特字G20131031	Sunscreen agent detected but not on submitted formula and label: BENZOPHENONE-3	/
5	Guangzhou Jiuke Fine Chemical Co., Ltd.	美白抗汗防曬乳	GZJK0425/ 20200425	GD?FDA (2007) 衛妝準字29-XK-2960號國妝特字：G20090949	Sunscreen agent on submitted formula and label but not detected: 4-METHYLBENZYLIDENE CAMPHOR, ETHYLHEXYL SALICYLATE	After on-site inspection by Guangzhou Baiyun Food and Drug Administration, the manufacturer confirms that the product is bogus.
6	Guangzhou Zunai Daily Cosmetics Co., Ltd.; Consignor: Guangzhou Happiness Enterprise Cosmetics Co., Ltd.	尊愛防曬霜（清透水感噴霧型）	YOUXI0216/ 20200216	國妝特字G20150872	Sunscreen agent on submitted formula and label but not detected: BUTYL METHOXYDIBENZOYLMETHANE, OCTOCRYLENE	/
7	Guangzhou Jiaolan Cosmetics Co., Ltd.	婷美多重量美白防曬乳SPF25/PA+++	A6LM2902/ 20180203	GD·FDA (1999) 衛妝準字29-XK-1693/衛妝特字 (2008) 第0443號	Sunscreen agent detected but not on label: ETHYLHEXYL SALICYLATE	After on-site inspection by Guangdong Food and Drug Administration, the manufacturer confirms that the product is bogus.
8	Guangzhou Caisy Cosmetics Co., Ltd.	采詩美白防曬乳	31703/ 20180317	GD·FDA (1995) 衛妝準字29-XK-1041號/ 國妝特字G20101232	Sunscreen agent on label but not detected: ETHYLHEXYL SALICYLATE	/
9	Guangzhou Jinyang Cosmetics Co., Ltd.; Consignor: Guangzhou Jinjieyuan Biotech Co., Ltd.	瑾泉清新薄透防曬乳	NOE16004/ 20200105	GD·FDA (2007) 衛妝準字29-XK-2964/ 國妝特字G20121687	Sunscreen agent on submitted formula and label but not detected: BENZOPHENONE-3; Sunscreen agent detected but not on submitted formula and label: OCTOCRYLENE (content 1%), BIS-ETHYLHEXYLOXYPHENOL METHOXYPHENYL TRIAZINE (content 1%)	/
10	Guangzhou Baiyun Yadun Cosmetic Factory	凝蔻完美凈白防曬乳SPF30PA+++	YZM1703AI02/ 20220321	GD·FDA (2009) 衛妝準字29-XK-3173號/ 國妝特字G20140377	Sunscreen agent on submitted formula but not detected: 4-METHYLBENZYLIDENE CAMPHOR, OCTOCRYLENE, BUTYL METHOXYDIBENZOYLMETHANE, ETHYLHEXYL METHOXYCINNAMATE; Sunscreen agent on sample packaging labeled as UV absorber, 15 sunscreen agents are not detected	After on-site inspection by Guangzhou Baiyun Food and Drug Administration, the manufacturer confirms that the product is bogus.
10	Guangzhou Baiyun Yadun Cosmetic Factory	綠植®Osmocomplex防曬霜（清爽防護）SPF28	LZ1702AE13/ 效期：20200223	GD·FDA (2009) 衛妝準字29-XK-3173號/ 國妝特字G20140377	Sunscreen agent on submitted formula but not detected: 4-METHYLBENZYLIDENE CAMPHOR, BUTYL METHOXYDIBENZOYLMETHANE, OCTOCRYLENE, ETHYLHEXYL METHOXYCINNAMATE
11	Guangdong Marubi Biotech Group Ltd.; Consignor: Guangdong Marubi Biotech Co., Ltd	丸美激白防曬精華隔離乳	20150107/ 20180106	GD·FDA (2014) 衛妝準字29-XK-3896號/ 國妝特字G20090289	Sunscreen agent on submitted formula and label but not detected: BUTYL METHOXYDIBENZOYLMETHANE; Sunscreen agent detected but not on submitted formula and label: BIS-ETHYLHEXYLOXYPHENOL METHOXYPHENYL TRIAZINE	After on-site inspection by Guangzhou Food and Drug Administration, the manufacturer confirms that the product is bogus.
11		丸美嫩白防曬乳SPF30+ PA+++	20150112/ 20180111	GD·FDA (2014) 衛妝準字29-XK-3896號/ 國妝特字G20090191	Sunscreen agent on submitted formula and label but not detected: 4-METHYLBENZYLIDENE CAMPHOR and BUTYL METHOXYDIBENZOYLMETHANE
12	Guangzhou Jiameng Cosmetics Co., Ltd.	MINISO高倍持久防曬乳SPF30+	JM8321026/ 2019.05.13	GD·FDA (2002) 衛妝準字29-XK-2204號/ 國妝特字G20131032	Sunscreen agent on label but not detected: 4-METHYLBENZYLIDENE CAMPHOR, BUTYL METHOXYDIBENZOYLMETHANE, OCTOCRYLENE, ETHYLHEXYL METHOXYCINNAMATE; Cannot find the submitted formula; Name on certificate is inconsistence with product name.	/
13	Shantou Xueqi Cosmetics Co., Ltd.	邦頓男士保濕防曬乳SPF30PA++	BD0308/ 2021/3/8	粵妝20161688	Sunscreen agent on label but not detected: BENZOPHENONE-3, OCTOCRYLENE, ETHYLHEXYL METHOXYCINNAMATE	After on-site inspection by Shantou Food and Drug Administration, the manufacturer confirms that the product is bogus.
14	Xiandidashou Cosmetics (Shenzhen) Co., Ltd.; Consignor: Shenzhen Xiandi Cosmetics Co., Ltd.	伊貝詩美白隔離防曬霜SPF30PA+++	20150411 (Outer) O1801H (Sample)/ 3yrs (Outer)	GD·FDA (2003) 衛妝準字29-XK-2385號/國妝特字G20140253	Sunscreen agent on submitted formula and label but not detected: BUTYL METHOXYDIBENZOYLMETHANE	/
15	Guangzhou Qiya Fine Chemcal Co., Ltd.	顏寇高倍美白防曬露	160328115/ 20190328	GD·FDA (2003) 衛妝準字29-XK-2435號/國妝特字G20100115	Sunscreen agent on label but not detected: ETHYLHEXYL METHOXYCINNAMATE	After on-site inspection by Guangzhou Baiyun Food and Drug Administration, the manufacturer confirms that the product is bogus.
16	Guangzhou Langsi Cosmetics Co., Ltd.	貝曼姿朗斯亮白防曬隔離乳	Q213111/ 20190113	GD·FDA (2001) 衛妝準字29-XK-2056/國妝特字G20091447	Sunscreen agent on submitted formula but not detected: ETHYLHEXYL METHOXYCINNAMATE	/
17	Guangzhou Biying Cosmetics Co., Ltd.	韓佳妮防曬霜	BY-010301V/ 2019.01.15	GD·FDA (2006) 衛妝準字29-XK-2810/國妝特字G20141116	Sunscreen agent on submitted formula and label but not detected: OCTOCRYLENE, BUTYL METHOXYDIBENZOYLMETHANE	After on-site inspection by Guangzhou Baiyun Food and Drug Administration, the manufacturer confirms that the product is bogus.
18	Guangzhou Qiaomei Cosmetics Co., Ltd.	溫碧泉透清瑩防曬乳 SPF30 PA++	BBIZ0905/ 20190104	GD·FDA (2002) 衛妝準字29-XK-2211號/國妝特字：G20110770	Sunscreen agent on submitted formula and label but not detected: BIS-ETHYLHEXYLOXYPHENOL METHOXYPHENYL TRIAZINE	Batch number on out packaging (BBIZ0905) is inconsistence with the minimum packaging (BIZ090503).

Table 2. Information of 4 Batches of Disqualified Sunscreen Cosmetics

No.	Name of Manufacturer/Import Distributor	Product Name (Chinese)	Batch Number/ Production Date/ Expire Date	Number of Hygiene License/ Approval Certificate/ Record Keeping	Result	Remark
1	Guangzhou Qiaomei Cosmetics Co., Ltd.	溫碧泉超感0動防曬兩件套（溫碧泉透清瑩防曬乳+溫碧泉水凝柔皙曬后修復冰晶）	DBJ01403/20190126	GD·FDA（2002）衛妝準字29－XK－2211號/國妝特字G20110770	Sunscreen agent detected but not on submitted formula and label: BIS-ETHYLHEXYLOXYPHENOL METHOXYPHENYL TRIAZINE (0.1%)	After re-inspection by Guangdong Institute for Drug Control, the product is judged to be disqualified.
1	Guangzhou Qiaomei Cosmetics Co., Ltd.	溫碧泉超感0動防曬兩件套（溫碧泉透清瑩防曬乳+溫碧泉深睡舒緩面膜）	BMJ01107	GD·FDA（2002）衛妝準字29－XK－2211號/國妝特字G20130879	Sunscreen agent on label but not detected: BUTYL METHOXYDIBENZOYLMETHANE; Sunscreen agent detected but not on label: BIS-ETHYLHEXYLOXYPHENOL METHOXYPHENYL TRIAZINE (0.27%)	After re-inspection by Guangdong Institute for Drug Control, the product is judged to be disqualified.
2	Guangzhou Chariano Commercial and Trading Co., Ltd	奇姬晶瑩遮瑕隔離防曬乳	PD08/ 202004	國妝特進字J20131312	Sunscreen agent on label but not detected: 4-METHYLBENZYLIDENE CAMPHOR, BUTYL METHOXYDIBENZOYLMETHANE; Sunscreen agent detected but not on label: ETHYLHEXYL METHOXYCINNAMATE (5.4%)	Formula on label is inconsistence with submitted formula; submitted formula is consistence with inspection result
3	Shenzhen Lantern Technology Group Ltd.	蘭亭防曬露SPF30	11AY6001/ 20190118	GD?FDA(1994)衛妝準字29-XK-0925號/國妝特字G20100800	Sunscreen agent detected but not on submitted formula and label: PHENYLBENZIMIDAZOLE SULFONIC ACID (0.3%)	Contain exogenous ingredient; specific situation has been explained.

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Source

http://www.sda.gov.cn/WS01/CL1753/216771.html

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