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