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
France XXX-0152493-4 1 5
Laboratoire Ht26
Paris , FR 75010 ATL-DO
53AD-02 HT26 Paris (Anti -Spot) Lotion/ body milk
07-MAR-2008 CSTIC LBLG
Togo XXX-0152493-4 1 3
Picos
Lome , TG ATL-DO
53AD-02 Lait De Beaute Esclaircissant (Bio 26)
07-MAR-2008 LABELING
COSMETLBLG
United Kingdom 946-0605102-0 206 1
Sara Lee Household & Body Care
Slough FN, GB LOS-DO
53BD-01 RADOX STRESS RELIEF HERBAL BATH SOAP 500ML/6BO
20-MAR-2008 LACKS N/C
UNAPPROVED
Korea, Republic Of (South) WIB-1212918-8 32 1
Hanbul Cosmetics Co.
Seoul , KR LOS-DO
53CC-04 LUICHEL E GOLDEN RICH EYE BALM
27-MAR-2008 UNAPPROVED
France 554-3421327-2 2 1
Institut Esthederm
Paris , FR BLT-DO
53CC-05 CYCLO REFINER GL YOUTH EYE CR JAR 0.5OZ
26-MAR-2008 UNAPPROVED
Taiwan ANP-0009073-9 8 1
Daiso Industries Co., Ltd.
Higashihiroshima , JP 739-0008 SEA-DO
53CC-08 EYEBROW PENCIL
04-MAR-2008 COSM COLOR
Pakistan XXX-0151310-1 1 1
A.Q. & Company
Karachi , PK ATL-DO
53CG-02 Kajal eyeliner (Hashmi)
13-MAR-2008 UNSAFE COL
Germany P09-3045001-3 3 1
Helena Rubinstein Inc
Etkrath Unterfeldhauf De , DE 4006 LOS-DO
53CK-02 KHOL EYE PENCIL BRUN
05-MAR-2008 UNSAFE COL
Germany P09-3045001-3 3 2
Helena Rubinstein Inc
Etkrath Unterfeldhauf De , DE 4006 LOS-DO
53CK-02 KHOL EYE PENCIL NOIR
05-MAR-2008 UNSAFE COL
Germany P09-3044734-0 2 1
Helena Rubinstein Inc
Etkrath Unterfeldhauf De , DE 4006 LOS-DO
53CK-02 KHOL EYE PENCIL BRUN
05-MAR-2008 UNSAFE COL
Germany P09-3044734-0 2 2
Helena Rubinstein Inc
Etkrath Unterfeldhauf De , DE 4006 LOS-DO
53CK-02 KHOL EYE PENCIL NOIR
05-MAR-2008 UNSAFE COL
Germany P09-3044833-0 2 1
Helena Rubinstein Inc
Etkrath Unterfeldhauf De , DE 4006 LOS-DO
53CK-02 KHOL EYE PENCIL BRUN
05-MAR-2008 UNSAFE COL
Germany P09-3044833-0 2 2
Helena Rubinstein Inc
Etkrath Unterfeldhauf De , DE 4006 LOS-DO
53CK-02 KHOL EYE PENCIL NOIR
05-MAR-2008 UNSAFE COL
Germany P09-3044824-9 2 1
Helena Rubinstein Inc
Etkrath Unterfeldhauf De , DE 4006 LOS-DO
53CK-02 KHOL EYE PENCIL BRUN
05-MAR-2008 UNSAFE COL
Germany P09-3044824-9 2 2
Helena Rubinstein Inc
Etkrath Unterfeldhauf De , DE 4006 LOS-DO
53CK-02 KHOL EYE PENCIL NOIR
05-MAR-2008 UNSAFE COL
Germany 112-5907677-5 3 1
Swan Stabilo
Heroldsberg , DE 90562 NYK-DO
53CK-02 EYE PENCIL
19-MAR-2008 POISONOUS
Germany 112-5907677-5 22 1
Swan Stabilo
Heroldsberg , DE 90562 NYK-DO
53CK-02 EYE PENCIL
19-MAR-2008 POISONOUS
Germany 112-5907677-5 45 1
Swan Stabilo
Heroldsberg , DE 90562 NYK-DO
53CK-02 EYE PENCIL
19-MAR-2008 POISONOUS
Germany 112-5907677-5 51 1
Swan Stabilo
Heroldsberg , DE 90562 NYK-DO
53CK-02 EYE PENCIL
19-MAR-2008 POISONOUS
Japan ANP-0009117-4 15 1 A
Daiso Industries Co., Ltd.
Higashihiroshima , JP 739-0008 SEA-DO
53DD-02 Cool Sheet
03-MAR-2008 CSTIC LBLG
LABELING
China 231-7152327-0 18 1
Yumark Enterprises Co.,Ltd
Guangzhouguangzhou , CN 509999 CHI-DO
53DH-03 2710 @COSMETICS - BODY MA
03-MAR-2008 UNSAFE COL
China 231-7152327-0 18 2
Yumark Enterprises Co.,Ltd
Guangzhouguangzhou , CN 509999 CHI-DO
53DH-03 2710 @COSMETICS - BODY M
03-MAR-2008 UNSAFE COL
France 112-1677222-1 1 1
Henkel France
Boulogne Billancourt , FR 92100 NOL-DO
53EA-02 862031264680/ OSIS SPARKLER
20-MAR-2008 CSTIC LBLG
LABELING
France 112-1677222-1 1 2
Henkel France
Boulogne Billancourt , FR 92100 NOL-DO
53EA-02 BC Bonacure hair therapy
20-MAR-2008 CSTIC LBLG
LABELING
France 112-1677222-1 1 3
Henkel France
Boulogne Billancourt , FR 92100 NOL-DO
53EA-02 OSIS Syick Up
20-MAR-2008 CSTIC LBLG
LABELING
France 112-1677222-1 1 4
Henkel France
Boulogne Billancourt , FR 92100 NOL-DO
53EA-02 Osis 4-Play
20-MAR-2008 CSTIC LBLG
LABELING
France 112-1677222-1 1 5
Henkel France
Boulogne Billancourt , FR 92100 NOL-DO
53EA-02 OSIS+ Shape
20-MAR-2008 CSTIC LBLG
LABELING
France 112-1677222-1 1 6
Henkel France
Boulogne Billancourt , FR 92100 NOL-DO
53EA-02 SILHOUETTE PURE FORMULA invisable hold
20-MAR-2008 CSTIC LBLG
LABELING
Spain BTL-0010451-2 19 1
Almenar Exportaciones, S.L.
Valencia , ES SJN-DO
53ED-05 FACE MASK
05-MAR-2008 UNAPPROVED
Togo XXX-0152493-4 1 2
Lux Beaute Bamako
Unknown , TG ATL-DO
53ED-06 Plaisir A3 Lait Eclaircissant (shampoo)
07-MAR-2008 LABELING
Canada 336-4242534-5 1 1 A
Nisim International
Brampton ON, CA L6T4M4 NYK-DO
53ED-06 SHAMPOO 2 oz
26-MAR-2008 COSMETLBLG
Canada 336-4242534-5 1 1 B
Nisim International
Brampton ON, CA L6T4M4 NYK-DO
53ED-06 SHAMPOO 8 oz
26-MAR-2008 COSMETLBLG
Canada 336-4242534-5 1 1 E
Nisim International
Brampton ON, CA L6T4M4 NYK-DO
53ED-06 SHAMPOO SAMPLES
26-MAR-2008 COSMETLBLG
India KM6-0102815-2 19 1
Veerprabhu Export House
Mumbai , IN 400003 BLT-DO
53ED-07 COCONUT HAIR OIL
25-MAR-2008 CSTIC LBLG
India KM6-0102815-2 19 2
Veerprabhu Export House
Mumbai , IN 400003 BLT-DO
53ED-07 COCNUT HAIR OIL
25-MAR-2008 CSTIC LBLG
India KM6-0102815-2 19 3
Veerprabhu Export House
Mumbai , IN 400003 BLT-DO
53ED-07 COCONUT HAIR OIL
25-MAR-2008 CSTIC LBLG
India KM6-0102815-2 22 2
Veerprabhu Export House
Mumbai , IN 400003 BLT-DO
53ED-07 SIMCO HAIR FIXTURE
25-MAR-2008 CSTIC LBLG
India KM6-0102815-2 22 3
Veerprabhu Export House
Mumbai , IN 400003 BLT-DO
53ED-07 SIMCO HAIR FIXTURE
25-MAR-2008 CSTIC LBLG
India KM6-0102815-2 22 4
Veerprabhu Export House
Mumbai , IN 400003 BLT-DO
53ED-07 SIMCO HAIR FIXTURE
25-MAR-2008 CSTIC LBLG
Canada 336-4242534-5 4 1
Nisim International
Brampton ON, CA L6T4M4 NYK-DO
53ED-99 KALO INGROWN HAIR TREATMENT
26-MAR-2008 COSMETLBLG
Canada 336-4242534-5 2 1 A
Nisim International
Brampton ON, CA L6T4M4 NYK-DO
53EY-01 HAIR CONDITIONER 8 oz
26-MAR-2008 COSMETLBLG
Canada 336-4242534-5 2 1 B
Nisim International
Brampton ON, CA L6T4M4 NYK-DO
53EY-01 HAIR CONDITIONER Litre
26-MAR-2008 COSMETLBLG
Canada 336-4242534-5 2 1 C
Nisim International
Brampton ON, CA L6T4M4 NYK-DO
53EY-01 FAST CONDITIONER
26-MAR-2008 COSMETLBLG
Canada 336-4242534-5 2 1 D
Nisim International
Brampton ON, CA L6T4M4 NYK-DO
53EY-99 HAIR LOSS SURVIVAL KIT
26-MAR-2008 COSMETLBLG
Canada 336-4242534-5 3 1 A
Nisim International
Brampton ON, CA L6T4M4 NYK-DO
53EY-99 HAIR AND SCALP EXTRACTS
26-MAR-2008 COSMETLBLG
United Arab Emirates 112-1825576-1 5 1
Somalia Star Trading
Deria , AE NOL-DO
53FD-01 901814935649 HENNA
28-MAR-2008 COSMETLBLG
Mexico BVK-0023844-9 7 1 B
Colgate Palmolive SA de CV
Mexico City , MX 11500 SWI-DO
53FD-04 Shampoo (Caprice Manazana)
03-MAR-2008 COLOR LBLG
Korea, Republic Of (South) WIB-1212918-8 34 1
Hanbul Cosmetics Co.
Seoul , KR LOS-DO
53GC-06 LUICHEL SHINY W BASE
27-MAR-2008 UNAPPROVED
China 231-7159208-5 17 1
Almar China
Guangdong , CN CHI-DO
53GC-12 ALMAR LIPGLOSS IN POUCH
24-MAR-2008 UNSAFE COL
COSM COLOR
Taiwan EG6-1438153-1 2 1
Jia Hsing Enterprise Co.,Ltd.
Changhua , TW 50600 NYK-DO
53GG-05 Smile Brightening Lip Treatment
28-MAR-2008 COSM COLOR
COSMETLBLG
China CDU-0801128-5 5 1
Superier Traders International Ltdll Be Added
Taipei, Taiwan , C CHI-DO
53GI-05 MAKE-UP PREP,LIPSTICK,NOT FOR EYES
06-MAR-2008 COSM COLOR
China 231-7152327-0 36 1
A+B Cosmetics Co.
Dongguan, Guangdong , CN CHI-DO
53GK-05 2703 @COSMETICS - LIP MA
03-MAR-2008 UNSAFE COL
China 231-7152327-0 36 2
A+B Cosmetics Co.
Dongguan, Guangdong , CN CHI-DO
53GK-05 2703 @COSMETICS - LIP MAK
03-MAR-2008 UNSAFE COL
China 682-2502187-9 5 1
Zhejiang Yasi Cosmetics Co
Yiwu , CN SEA-DO
53GK-05 LIP BALM
24-MAR-2008 CSTIC LBLG
Korea, Republic Of (South) ANP-0008965-7 17 1 B
Daiso Industries Co., Ltd.
Higashihiroshima , JP 739-0008 SEA-DO
53ID-02 MOUTHWASH
03-MAR-2008 CSTIC LBLG
Korea, Republic Of (South) ANP-0008993-9 20 1
Daiso Industries Co., Ltd.
Higashihiroshima , JP 739-0008 SEA-DO
53ID-02 MOUTH WASH
03-MAR-2008 CSTIC LBLG
China GV8-0103793-0 1 1
Holly Ind Prod Co Ltd
Ningboningbo , CN 315000 LOS-DO
53IG-99 WHITENING GEL, 25 RETAIL PKG/CTN, 250 G/PKG NET, 275 G/PKG G
18-MAR-2008 NO 510(K)
India HA9-0700163-0 20 1
Vicco laboratories
Hinga Nagpur, IN 440016 LOS-DO
53IH-01 Vajradanti Powder - Ayurvedic Medicine
19-MAR-2008 UNAPPROVED
Germany EI5-5495507-6 1 1
Unilever Lever Faberge Deutschland
Mannheim , DE 68219 NYK-DO
53JB-01 Dove Bar Soap
03-MAR-2008 COSM COLOR
COSMETLBLG
Mexico BVK-0023844-9 3 1 A
Unilever de Mexico S.A. de C.V.
Tultitlan Mx-Mex, MX 54900 SWI-DO
53LC-01 Body Cream (PONDS Suavizante)
03-MAR-2008 CSTIC LBLG
Mexico BVK-0023844-9 5 1 A
Colgate Palmolive SA de CV
Mexico City , MX 11500 SWI-DO
53LC-01 Hinds Body Cream (Rosa Piel Reseca)
03-MAR-2008 COLOR LBLG
France 554-3421327-2 1 4
Institut Esthederm
Paris , FR BLT-DO
53LC-03 WHITE R N IGHT REFINER CREAM JAR 1.7 OZ
26-MAR-2008 UNAPPROVED
Poland 112-1670787-0 1 1
Energy Cosmetic
Lominaki , PL NOL-DO
53LC-10 Repair Complex #1
18-MAR-2008 LABELING
Poland 112-1670787-0 1 2
Energy Cosmetic
Lominaki , PL NOL-DO
53LC-10 799807376162/EMULSION
18-MAR-2008 LABELING
Argentina 112-1720860-5 1 1
Marcelo Futerman
Santa Fe , AR NOL-DO
53LC-99 ESTRIA NON CREMA
13-MAR-2008 CSTIC LBLG
COSMETLBLG
Argentina 112-1720165-9 1 1
Marcelo Futerman
Santa Fe , AR NOL-DO
53LC-99 ESTRIA NON CREMA
18-MAR-2008 CSTIC LBLG
COSMETLBLG
Argentina 112-1720165-9 1 2
Marcelo Futerman
Santa Fe , AR NOL-DO
53LC-99 EXTRA FIRM
18-MAR-2008 CSTIC LBLG
COSMETLBLG
United Kingdom 946-0605102-0 203 1
Reckitt Benkiser Ltd
Swindon , GB SN57XZ LOS-DO
53LC-99 DETTOL ANTISEPTIC-DISINFECTANT LIQUID 500ML/6BO
20-MAR-2008 LACKS N/C
UNAPPROVED
Poland 112-1670787-0 1 4
Energy Cosmetic
Lominaki , PL NOL-DO
53LD-03 Slim and Shape.
18-MAR-2008 LABELING
Poland DP4-0420814-3 1 1
Lowell International Polska Sp. Z.Oo
Olsztyn , PL NYK-DO
53LD-06 Olive Moisturizing Cream
06-MAR-2008 CSTIC LBLG
Poland DP4-0420814-3 2 7
Lowell International Polska Sp. Z.Oo
Olsztyn , PL NYK-DO
53LD-06 Eye Make-Up Remover Lotion
06-MAR-2008 UNSAFE COL
CSTIC LBLG
Korea, Republic Of (South) WIB-1212918-8 33 1
Hanbul Cosmetics Co.
Seoul , KR LOS-DO
53LD-06 LUICHEL W NUTRY EMULSION
27-MAR-2008 UNAPPROVED
Korea, Republic Of (South) WIB-1212918-8 35 1
Hanbul Cosmetics Co.
Seoul , KR LOS-DO
53LD-06 LUICHEL W SILKY SERUM
27-MAR-2008 UNAPPROVED
Australia UPS-0523818-1 1 1
Vani-T Pty Ltd
Lonsdalelonsdale , AU 5160 CIN-DO
53MD-01 SUN TAN LIQUID
28-MAR-2008 COSM COLOR
Japan 112-8814121-3 1 1
Daito Kasei Kogyo Co Ltd
Osaka , JP 535 NOL-DO
53PD-99 859955321994 NFCB-3D-1R (Raw Material for Cosmetics)
07-MAR-2008 COLOR LBLG
Germany 279-0145745-0 1 1
Rovi Cosmetics Intern. Gmbh
Schluchtern , DE 36381 LOS-DO
53PD-99 RETINOL 50C
26-MAR-2008 CSTIC LBLG
LABELING
COSMETLBLG
COSMETLBLG
Germany 279-0145745-0 2 1
Rovi Cosmetics Intern. Gmbh
Schluchtern , DE 36381 LOS-DO
53PD-99 EMPROVE (CAFFEINE)
26-MAR-2008 NOT LISTED
COSMETLBLG
COSMETLBLG
Germany 279-0145745-0 3 1
Rovi Cosmetics Intern. Gmbh
Schluchtern , DE 36381 LOS-DO
53PD-99 PHOSPHOLIPON 85 G
26-MAR-2008 NOT LISTED
COSMETLBLG
COSMETLBLG
Germany 279-0145745-0 5 1 A
Rovi Cosmetics Intern. Gmbh
Schluchtern , DE 36381 LOS-DO
53PD-99 1,2 PENTANDIOL
26-MAR-2008 NOT LISTED
COSMETLBLG
COSMETLBLG
Germany 279-0145745-0 5 1 B
Rovi Cosmetics Intern. Gmbh
Schluchtern , DE 36381 LOS-DO
53PD-99 PHOSPHOLIPON 90 H(L)
26-MAR-2008 NOT LISTED
COSMETLBLG
COSMETLBLG
Germany 279-0145745-0 5 1 C
Rovi Cosmetics Intern. Gmbh
Schluchtern , DE 36381 LOS-DO
53PD-99 JAPANWACHS LT 845
26-MAR-2008 NOT LISTED
COSMETLBLG
Germany 279-0145745-0 5 1 D
CORUM INC
TAIPEI Neihu, TW LOS-DO
53PD-99 CORUM 9235
26-MAR-2008 NOT LISTED
COSMETLBLG
COSMETLBLG
China ND7-0053478-4 1 1
Beijing Brighty Instrument Co
Beijing , CN 100088 LOS-DO
53PH-99 ARBUTIN
18-MAR-2008 UNSFDIETSP
Kenya 112-8661749-5 1 1
Aman Mohd
Mombasa , KE NOL-DO
53YH-99 861118382132 HENNA
11-MAR-2008 COSM COLOR
China AT2-0029950-4 2 1
Chenghai Daeryi Toys Factory
Guangdong , CN LOS-DO
53YY-99 Cosmetics Series Let You More Beauty
19-MAR-2008 UNSAFE COL