Refusal Actions by FDA as Recorded in OASIS
Country of Origin Entry # DOC Line Suffix
Manufacture Name
City / Country or region District
Product Code Product Description
Date Reason
China BQL-0016074-5 1 1 A
Shenzhen Huajianfa Trading Co Ltd
Beijing , CN NYK-DO
53AC-02 Shilibao Milk Whitening Peeling Gel
30-JUN-2008 LABELING
COSMETLBLG
China BQL-0016074-5 1 1 B
Shenzhen Huajianfa Trading Co Ltd
Beijing , CN NYK-DO
53AC-02 Shilibao Strawberry Nourish Peeling Gel
30-JUN-2008 LABELING
COSMETLBLG
China BQL-0016074-5 1 1 C
Shenzhen Huajianfa Trading Co Ltd
Beijing , CN NYK-DO
53AC-02 Shilibao Pearl Tender Peeling Gel
30-JUN-2008 LABELING
COSMETLBLG
China BQL-0016074-5 1 1 D
Shenzhen Huajianfa Trading Co Ltd
Beijing , CN NYK-DO
53AC-02 Shilibao Ginseng Peeling Gel
30-JUN-2008 LABELING
COSMETLBLG
China BQL-0016074-5 1 1 E
Shenzhen Huajianfa Trading Co Ltd
Beijing , CN NYK-DO
53AC-02 Shilibao Green Tea Peeling Gel
30-JUN-2008 LABELING
COSMETLBLG
China BQL-0016074-5 1 1 F
Shenzhen Huajianfa Trading Co Ltd
Beijing , CN NYK-DO
53AC-02 Shilibao Dogfish Oil Peeling Gel
30-JUN-2008 LABELING
COSMETLBLG
China BQL-0016074-5 1 1 G
Shenzhen Huajianfa Trading Co Ltd
Beijing , CN NYK-DO
53AC-02 Whitening Cream 60s
30-JUN-2008 LABELING
COSMETLBLG
China BQL-0016074-5 1 1 H
Shenzhen Huajianfa Trading Co Ltd
Beijing , CN NYK-DO
53AC-02 Sheep Placenta
30-JUN-2008 CSTIC LBLG
LABELING
COSMETLBLG
United Kingdom 112-1319309-0 3 3
Nougat London Ltd
London , GB 21T3LW NOL-DO
53BY-99 949511019120 Nougat London Soothing Bath Pearls Tuberose &
30-JUN-2008 COSMETLBLG
Germany M76-6096634-3 15 1
Schwan Cosmetics Gmbh & Co. KG
Heroldsberg , DE 90562 NYK-DO
53CK-02 PRO PENCILS (COSTUME MAKEUP - EYE LINERS)
09-JUN-2008 COSMETLBLG
Korea, Republic Of (South) J06-0026513-5 2 1
Park Young Jib.
Seoul , KR BLT-DO
53EA-02 HAIR SPRAY
06-JUN-2008 CSTIC LBLG
Mexico BKM-0016670-2 1 1
Cayuni Cosmeticos
Mexico , MX SWI-DO
53EC-01 SHAMPOO JALAPENO
06-JUN-2008 NOT LISTED
UNAPPROVED
Mexico BKM-0016670-2 1 3
Cayuni Cosmeticos
Mexico , MX SWI-DO
53EC-01 SHAMPOO CACAHUANACHE
06-JUN-2008 NOT LISTED
Spain 112-0989645-8 2 5
Loreal
Madrid , ES 28007 NOL-DO
53EC-06 947904308620 SHAMPOO
26-JUN-2008 CSTIC LBLG
Korea, Republic Of (South) J06-0026513-5 4 2
Park Young Jib.
Seoul , KR BLT-DO
53EC-07 HAIR CREAM
06-JUN-2008 CSTIC LBLG
Spain 112-0989645-8 2 4
Loreal
Madrid , ES 28007 NOL-DO
53EC-99 947904308620 GEL HAIR
26-JUN-2008 CSTIC LBLG
United Arab Emirates 399-0933237-9 7 1 B
Gulf Center For Soap And Chemical Industries
Dubai , AE MIN-DO
53ED-06 Sunsilk Shampoo - 2 types
17-JUN-2008 UNSAFE COL
Korea, Republic Of (South) J06-0026513-5 4 1
Park Young Jib.
Seoul , KR BLT-DO
53ED-07 HAIR GEL
06-JUN-2008 CSTIC LBLG
United Arab Emirates 399-0933237-9 7 1 A
Gulf Center For Soap And Chemical Industries
Dubai , AE MIN-DO
53ED-07 Sunsilk Hair Oil - 3 different types
17-JUN-2008 UNSAFE COL
India 399-0933237-9 7 1 F
Dabur India Ltd. Pant Nagar Unit
Pant Nagar IN-UL, IN 263146 MIN-DO
53ED-07 Vatika - Hot Oil Treatment
17-JUN-2008 UNSAFE COL
India BMK-0606316-6 40 1
Popat Raja & Sons
Mumbai , IN ATL-DO
53ED-07 HIMANI NAVRATNA OIL(HAIR OIL)
26-JUN-2008 NO ENGLISH
UNAPPROVED
India BMK-0606316-6 41 1
Popat Raja & Sons
Mumbai , IN ATL-DO
53ED-07 HIMANI NAVRATNA OIL(HAIR OIL)
26-JUN-2008 NO ENGLISH
UNAPPROVED
India AEK-9501804-6 4 1
Amanacare Intl
Beirut , LB CIN-DO
53EY-06 HAIR SHAMPOO
16-JUN-2008 NOT LISTED
Italy 112-0944556-1 1 1
Casre Sas
San Gennarello Di Ottav , IT NOL-DO
53EY-99 864078106858/REMOVER
25-JUN-2008 CSTIC LBLG
United States M76-6096634-3 14 1
Mehron Inc
Chestnut Ridge, NY 10977-7049 NYK-DO
53GD-99 LIQUID MAKE UP (COSTUME MAKEUPS)
09-JUN-2008 COSMETLBLG
China U79-0063143-4 1 1 C
Wing Fung Trading Intl Co Ltd
Tsuen Wan , CN NYK-DO
53GH-02 Fruit Acid Soft Mask
03-JUN-2008 CSTIC LBLG
China U79-0063143-4 1 1 D
Wing Fung Trading Intl Co Ltd
Tsuen Wan , CN NYK-DO
53GH-02 Lime Soft Mask
03-JUN-2008 CSTIC LBLG
China U79-0063143-4 1 1 E
Wing Fung Trading Intl Co Ltd
Tsuen Wan , CN NYK-DO
53GH-02 Chloraphyll Soft Mask
03-JUN-2008 CSTIC LBLG
China U79-0063143-4 1 1 F
Wing Fung Trading Intl Co Ltd
Tsuen Wan , CN NYK-DO
53GH-02 Honey Soft Mask
03-JUN-2008 CSTIC LBLG
China U79-0063143-4 1 1 I
Wing Fung Trading Intl Co Ltd
Tsuen Wan , CN NYK-DO
53GH-02 Pearl soft Mask
03-JUN-2008 CSTIC LBLG
China 231-5456175-0 17 1
N.F.T.Z. Evershine Int'L Trading Co
Ningbo , CN SEA-DO
53JD-99 HAND SANITIZER W/PUMP 237ML
10-JUN-2008 UNAPPROVED
Thailand 442-0142944-4 141 1
Siam Yoko Co.,Ltd
Samutprakarn TH-11, TH 10270 LOS-DO
53JY-01 ANTI WRINKLE SOAP SODIUM STEARALE,SODIUM LA
10-JUN-2008 NOT LISTED
Benin AT1-0806798-7 12 1 B
UNILEVER CI
Abidjan , FR BLT-DO
53JY-01 Bar Soap
12-JUN-2008 CSTIC LBLG
United Kingdom 399-0933237-9 8 1 A
Univar Plc
Hampshire Rg24 9qb , GB MIN-DO
53JY-01 LUX - 5 types
17-JUN-2008 UNSAFE COL
United Kingdom 399-0933237-9 8 1 B
Evyap Egypt
Alexandria , EG MIN-DO
53JY-01 Duru Soap - 2 types
17-JUN-2008 UNSAFE COL
Spain 112-0989645-8 1 1
Loreal
Madrid , ES 28007 NOL-DO
53KC-01 947904308620 AFTERSHAVE
26-JUN-2008 CSTIC LBLG
Spain 112-0989645-8 1 2
Loreal
Madrid , ES 28007 NOL-DO
53KC-05 947904308620 SHAVING CREAM
26-JUN-2008 CSTIC LBLG
Aruba 112-2954052-4 1 1
Spa Management
Oranjestad , AW NOL-DO
53LC-01 865811056089 ANTI AGING CREAM
24-JUN-2008 CSTIC LBLG
COSMETLBLG
Thailand AEK-9501804-6 3 1
Amanacare Intl
Beirut , LB CIN-DO
53LC-03 FACE CREAM
16-JUN-2008 NOT LISTED
Peru 231-0295047-7 6 1
Agroindustria I&F Natures
Lima , PE FLA-DO
53LC-03 Sangre de Grado Cream
23-JUN-2008 LABELING
India AEK-9501804-6 2 1
Amanacare Intl
Beirut , LB CIN-DO
53LC-06 BODY CREAM
16-JUN-2008 NOT LISTED
Serbia WJJ-0008639-8 4 1 B
Kirka Pharma Corporation D O O
Belgrade , RS 11070 FLA-DO
53LC-06 REUM ART
23-JUN-2008 NOT LISTED
Serbia WJJ-0008639-8 4 1 A
Kirka Pharma Corporation D O O
Belgrade , RS 11070 FLA-DO
53LC-06 PLANTA VENOL
23-JUN-2008 NOT LISTED
Spain 112-0989645-8 2 1
Loreal
Madrid , ES 28007 NOL-DO
53LC-06 947904308620 EYECREAM
26-JUN-2008 CSTIC LBLG
Spain 112-0989645-8 2 2
Loreal
Madrid , ES 28007 NOL-DO
53LC-06 947904308620 CREAM DERMAQ
26-JUN-2008 CSTIC LBLG
Spain 112-0989645-8 2 6
Loreal
Madrid , ES 28007 NOL-DO
53LC-06 947904308620 MASK
26-JUN-2008 CSTIC LBLG
Spain 112-0989645-8 2 7
Loreal
Madrid , ES 28007 NOL-DO
53LC-06 947904308620 MAKE-UP
26-JUN-2008 CSTIC LBLG
Dominican Republic M21-0737695-8 31 1 B
Laboratorios Dr.Collado
Santo Domingo , DO FLA-DO
53LC-99 CONCHA - De Nacar Creama Aclarante
17-JUN-2008 CSTIC LBLG
United Arab Emirates 112-1346120-8 6 1
Al Harmoodi Computer Systems
Dubai , AE NOL-DO
53LC-99 927160754215 HAND CREAM
27-JUN-2008 COSMETLBLG
United Arab Emirates 112-1346120-8 6 2
Al Harmoodi Computer Systems
Dubai , AE NOL-DO
53LC-99 927160754215 FACE CREAM
27-JUN-2008 COSMETLBLG
United States 231-7678244-2 1 1
Kao Brands Company
Cincinnati, OH 45214-1729 NYK-DO
53LD-01 BIORE 140G PORE UNCLOGGING SCRUB
04-JUN-2008 LABELING
COSMETLBLG
Mexico MJ3-0144040-4 2 1
Industrializadora de Cacahuananche, S.A. de C.V.
Zapopan MX-JAL, MX 45220 SWI-DO
53LD-03 COLAGRN CREAM WITH VITAMIN E
20-JUN-2008 COSM COLOR
India 235-1454052-7 3 1
Vikas Laboratories Pvt.Ltd.Manufactures & Exporters Of Gu
Navi Mumba , IN 400 701 LOS-DO
53LD-03 BODY LOTION
30-JUN-2008 POISONOUS
Korea, Republic Of (South) J06-0026513-5 10 1
Park Young Jib.
Seoul , KR BLT-DO
53LD-06 LOTION FOR MEN
06-JUN-2008 CSTIC LBLG
Korea, Republic Of (South) J06-0026513-5 10 2
Park Young Jib.
Seoul , KR BLT-DO
53LD-06 LOTION FOR WOMEN
06-JUN-2008 CSTIC LBLG
Korea, Republic Of (South) J06-0026513-5 10 3
Park Young Jib.
Seoul , KR BLT-DO
53LD-06 SKINLOTION FOR MEN
06-JUN-2008 CSTIC LBLG
Korea, Republic Of (South) J06-0026513-5 10 4
Park Young Jib.
Seoul , KR BLT-DO
53LD-06 SKINLOTION FOR WOMAN
06-JUN-2008 CSTIC LBLG
France MA7-0683540-6 1 1
Steiner Transocean Ltd
Middx , GB HA36BZ FLA-DO
53LD-06 CREAMS,
27-JUN-2008 COSM COLOR
France MA7-0683540-6 2 1
Steiner Transocean Ltd
Middx , GB HA36BZ FLA-DO
53LD-06 GEL
27-JUN-2008 COSM COLOR
Mexico BKM-0016670-2 2 1
Cayuni Cosmeticos
Mexico , MX SWI-DO
53LD-09 YOUTH CAPSULES
06-JUN-2008 NOT LISTED
UNAPPROVED
Mexico BKM-0016670-2 2 9
Cayuni Cosmeticos
Mexico , MX SWI-DO
53LD-09 GRAPEFRUIT SHAPING LOTION
06-JUN-2008 CSTIC LBLG
Dominican Republic M21-0737695-8 13 1 B
Laboratorio Capilo C Por A
Santo Domingo , DO FLA-DO
53LD-09 12 bottles Romero Rosemary Oil / 12 bottles Almendra Almond
17-JUN-2008 COSM COLOR
LABELING
China 112-1735707-1 1 1
Changzhou Nanfang Medical App
Jiangsu , CN LOS-DO
53LF-04 HR DETOXIFYING PATCH
17-JUN-2008 NOT LISTED
UNAPPROVED
China 112-2020435-1 1 1
Changzhou Nanxiashu Tool Factory
Shanghai, China , CN 202006 LOS-DO
53LF-04 DETOXIFYING PATCH
17-JUN-2008 NOT LISTED
UNAPPROVED
Korea, Republic Of (South) 112-2821338-8 1 1
Eunsung Global Cor
Seoul , KR SEA-DO
53LY-01 865695349027/CLEANSING MACHINE
16-JUN-2008 NOT LISTED
REGISTERED
India AEK-9501804-6 2 2
Amanacare Intl
Beirut , LB CIN-DO
53LY-03 FACE WASH
16-JUN-2008 NOT LISTED
China BQL-0016074-5 1 2 B
Shenzhen Huajianfa Trading Co Ltd
Beijing , CN NYK-DO
53LY-08 Shilibao Aloe Refreshing Sleep Mask
30-JUN-2008 LABELING
COSMETLBLG
China BQL-0016074-5 1 2 A
Shenzhen Huajianfa Trading Co Ltd
Beijing , CN NYK-DO
53LY-08 Shilibao Lavender Oil Sleep Mask
30-JUN-2008 LABELING
COSMETLBLG
China BQL-0016074-5 1 2 C
Shenzhen Huajianfa Trading Co Ltd
Beijing , CN NYK-DO
53LY-08 Shilibao Intensive Moisturizing Sleep Mask
30-JUN-2008 LABELING
COSMETLBLG
China BQL-0016074-5 1 2 D
Shenzhen Huajianfa Trading Co Ltd
Beijing , CN NYK-DO
53LY-08 Shilibao Strawberry & Yogurt Sleep Mask
30-JUN-2008 LABELING
COSMETLBLG
China BQL-0016074-5 1 2 E
Shenzhen Huajianfa Trading Co Ltd
Beijing , CN NYK-DO
53LY-08 Shilibao Lemon Moisture & Bright Sleep Mask
30-JUN-2008 LABELING
COSMETLBLG
China BQL-0016074-5 1 2 F
Shenzhen Huajianfa Trading Co Ltd
Beijing , CN NYK-DO
53LY-08 Shilibao Olive Young Mask
30-JUN-2008 LABELING
COSMETLBLG
China BQL-0016074-5 1 2 G
Shenzhen Huajianfa Trading Co Ltd
Beijing , CN NYK-DO
53LY-08 Shilibao Red Wine Ruddy Mask
30-JUN-2008 LABELING
COSMETLBLG
China BQL-0016074-5 1 2 H
Shenzhen Huajianfa Trading Co Ltd
Beijing , CN NYK-DO
53LY-08 Crystal Collagen Mask
30-JUN-2008 LABELING
China BQL-0016074-5 1 2 I
Shenzhen Huajianfa Trading Co Ltd
Beijing , CN NYK-DO
53LY-08 Pearl Anti-Wrinkle Eye Mask
30-JUN-2008 LABELING
COSMETLBLG
China BQL-0016074-5 1 2 J
Shenzhen Huajianfa Trading Co Ltd
Beijing , CN NYK-DO
53LY-08 Sheep Vegetable Mask
30-JUN-2008 COSMETLBLG
China BQL-0016074-5 1 2 K
Shenzhen Huajianfa Trading Co Ltd
Beijing , CN NYK-DO
53LY-08 Moisten the Bleach Mask
30-JUN-2008 LABELING
China BQL-0016074-5 1 2 L
Shenzhen Huajianfa Trading Co Ltd
Beijing , CN NYK-DO
53LY-08 Milk Mask milk and egg white
30-JUN-2008 LABELING
COSMETLBLG
China BQL-0016074-5 1 2 M
Shenzhen Huajianfa Trading Co Ltd
Beijing , CN NYK-DO
53LY-08 Pearl Whitening Hydrating Mask
30-JUN-2008 LABELING
China BQL-0016074-5 1 2 N
Shenzhen Huajianfa Trading Co Ltd
Beijing , CN NYK-DO
53LY-08 Alga Element Nourishing Anti-Wrinkle Mask
30-JUN-2008 LABELING
China BQL-0016074-5 1 2 P
Shenzhen Huajianfa Trading Co Ltd
Beijing , CN NYK-DO
53LY-08 Proskin Ginseng Nutrition Mask
30-JUN-2008 COSMETLBLG
Italy BNO-0009585-2 1 1 C
Phitoderm Magic Cosmetics
Roma Fn, IT SJN-DO
53LY-99 Caldo Gel
13-JUN-2008 CSTIC LBLG
Italy BNO-0009585-2 1 1 G
Phitoderm Magic Cosmetics
Roma Fn, IT SJN-DO
53LY-99 Acneis Serum 30 ML
13-JUN-2008 NOT LISTED
Kenya 112-1051386-0 1 1
Abdi Hakim
Nbo , KE NOL-DO
53LY-99 926314345665 HENNA
25-JUN-2008 COSM COLOR
United Arab Emirates 112-1346120-8 6 3
Al Harmoodi Computer Systems
Dubai , AE NOL-DO
53LY-99 927160754215 FACE SCRUB
27-JUN-2008 COSMETLBLG
Spain 112-0989645-8 2 3
Loreal
Madrid , ES 28007 NOL-DO
53MC-01 947904308620 SUNCREAM
26-JUN-2008 CSTIC LBLG
Kenya 112-0949869-3 1 1
Hilo
Nairobi , KE NOL-DO
53PY-99 926314341100 Henna Leaves
25-JUN-2008 COSM COLOR
Germany 112-2578310-2 1 1
Schwan Cosmetics Gmbh & Co. KG
Heroldsberg , DE 90562 NOL-DO
53RY-03 957338302603/COSMETIC PENCILS
11-JUN-2008 COSMETLBLG
United Kingdom 112-1319309-0 1 2
Nougat London Ltd
London , GB 21T3LW NOL-DO
53YC-99 949511019120 Nougat London Nurturing Hand Cream Tuberose &
30-JUN-2008 CSTIC LBLG
COSMETLBLG
United Kingdom 112-1319309-0 3 2
Nougat London Ltd
London , GB 21T3LW NOL-DO
53YD-99 949511019120 Nougat London Dry Oil Mist
30-JUN-2008 COSMETLBLG
United States M76-6096634-3 10 1
Mehron Inc
Chestnut Ridge, NY 10977-7049 NYK-DO
53YH-99 GLITTER DUST (COSTUME MAKEUP)
09-JUN-2008 COSMETLBLG
United States M76-6096634-3 12 1
Mehron Inc
Chestnut Ridge, NY 10977-7049 NYK-DO
53YH-99 METALLIC POWDER, (COSTUME MAKEUP)
09-JUN-2008 COSMETLBLG
China M76-6096105-4 3 1 B
Tattoo Manufacturing, Inc.
Tucson, AZ 85713-5343 NYK-DO
53YY-99 TEMPORARY TATTOOS (PRINTED MATTER)
04-JUN-2008 COSM COLOR
China M76-6096105-4 3 1 C
Tattoo Manufacturing, Inc.
Tucson, AZ 85713-5343 NYK-DO
53YY-99 TEMPORARY TATTOOS (PRINTED MATTER)
04-JUN-2008 COSM COLOR
Kenya 112-0949811-5 1 1
Iffa Jirewya
Nairobi , KE NOL-DO
53YY-99 926314341648 HAND & LEG DECORATION
25-JUN-2008 UNSAFE COL
United Kingdom 112-1319309-0 1 14
Nougat London Ltd
London , GB 21T3LW NOL-DO
53YY-99 949511019120 Nougat London Moisturizing Body Butter T
30-JUN-2008 CSTIC LBLG
COSMETLBLG