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
United States BGK-0612939-0 6 1
L'Oreal USA Dba Luxury Prod
SAVANNAH, GA 31407-3036 NYK-DO
53CC-04 Circle Eraser Eye Lotion (Soin Hydratant Yeux)
08-JUL-2008 COSMETLBLG
United States BGK-0612939-0 15 1
L'Oreal USA Dba Luxury Prod
SAVANNAH, GA 31407-3036 NYK-DO
53CC-04 Eye Lotion Preps - Advanced Revitalift Double Lifting Yeux
08-JUL-2008 COSMETLBLG
Taiwan 112-3271434-8 1 1
Cho Chuang Ind
Yung Kan City , TW SEA-DO
53CH-03 865076205803/EYE SHADOW
22-JUL-2008 COSM COLOR
United Kingdom T77-1030734-1 4 1
Coty Manufacturing UK Ltd.
Ashford Kent, GB TN25 4AQ NYK-DO
53CH-03 EYE SHADOW (EYE MAKEUP PREPARATIONS);POWDER;
24-JUL-2008 HELD INSAN
United Kingdom T77-1031518-7 4 1
Coty Manufacturing UK Ltd.
Ashford Kent, GB TN25 4AQ NYK-DO
53CH-03 EYE SHADOW (EYE MAKEUP PREPARATIONS);POWDER;
24-JUL-2008 HELD INSAN
Taiwan NV3-0021096-4 2 1
Bella Co. Ltd.
Taipei , TW 11600 NYK-DO
53CH-07 COLORS (EYE BLUSH)
10-JUL-2008 COSM COLOR
Philippines BDD-0774010-9 7 1
TBN FOOD PRODUCTS
Tanauan PH-BTG, PH 4232 LOS-DO
53DD-01 MILK WHITENING ROLL-ON DEODORANT & ANTI-PERSPIRANT
16-JUL-2008 UNAPPROVED
Nicaragua CCB-0000853-1 6 1 A
Colgate Palmolive Sa De Cv
San Jose Iturbide, Gto. , MX FLA-DO
53DD-01 Baby Magic Mennen Cologne
18-JUL-2008 CSTIC LBLG
Nicaragua CCB-0000853-1 6 1 B
Colgate Palmolive Sa De Cv
San Jose Iturbide, Gto. , MX FLA-DO
53DH-03 Baby Magic Mennen Pack
18-JUL-2008 CSTIC LBLG
United Arab Emirates G08-0025003-0 4 1 A
Wikfikd International
Alsharjah , AE MIN-DO
53ED-01 Vatika Hair Oil - Olive
24-JUL-2008 UNSAFE COL
Nigeria XXX-0154941-0 1 1 C
VIRGIN BEAUTY INDUSTRIES LTD.
SANGO-OTA , NG SWI-DO
53ED-01 Virgin Hair Fertilizer
24-JUL-2008 UNAPPROVED
Panama BOZ-0007123-9 3 1
Consolidadora Central Sa
Panama City , PA FLA-DO
53ED-06 SHAMPOO
21-JUL-2008 NOT LISTED
India U16-2709774-8 9 1
Babulal Brijbhushan
Sojat City , IN LOS-DO
53F--02 Henna
16-JUL-2008 UNSAFE COL
China 002-2118971-5 1 1 B
Huadu Liani Ling Handicrafts Ltd
Guang Dong , CN LOS-DO
53GC-05 SPARKLE 5PC LIPGLOSS POUCH KR
02-JUL-2008 UNSAFE COL
China 002-2118971-5 1 1 E
Huadu Liani Ling Handicrafts Ltd
Guang Dong , CN LOS-DO
53GC-05 PINK LIP GLOSS-5 ON ONE RING SET
02-JUL-2008 UNSAFE COL
China 002-2118971-5 1 1 L
Huadu Liani Ling Handicrafts Ltd
Guang Dong , CN LOS-DO
53GC-05 GLITTER LIP GLOSS/TUBE KEYRING
02-JUL-2008 UNSAFE COL
China 002-2118972-3 1 1 B
Huadu Shuai Ling Handicrafts Enterprise Co., Ltd.
Guangdong , CN LOS-DO
53GC-05 SPARKLE 5PC LIPGLOSS POUCH KR
02-JUL-2008 UNSAFE COL
China 002-2118972-3 1 1 E
Huadu Shuai Ling Handicrafts Enterprise Co., Ltd.
Guangdong , CN LOS-DO
53GC-05 PINK LIP GLOSS-5 ON RING SET
02-JUL-2008 UNSAFE COL
China 002-2118972-3 1 1 L
Huadu Shuai Ling Handicrafts Enterprise Co., Ltd.
Guangdong , CN LOS-DO
53GC-05 GLITTER LIP GLOSS/TUBE KEYRING
02-JUL-2008 UNSAFE COL
China 002-2118986-3 1 1 B
Huadu Shuai Ling Handicrafts Enterprise Co., Ltd.
Guangdong , CN LOS-DO
53GC-05 SPARKLE 5PC LIPGLOSS POUCH KR
02-JUL-2008 UNSAFE COL
China 002-2118986-3 1 1 E
Huadu Shuai Ling Handicrafts Enterprise Co., Ltd.
Guangdong , CN LOS-DO
53GC-05 PINK LIP GLOSS-5 ON ONE RING SET
02-JUL-2008 UNSAFE COL
China 002-2118986-3 1 1 L
Huadu Shuai Ling Handicrafts Enterprise Co., Ltd.
Guangdong , CN LOS-DO
53GC-05 GLITTER LIP GLOSS/TUBE KEYRING
02-JUL-2008 UNSAFE COL
Hong Kong SAR AGT-0004037-9 2 1
Beatrice Anderson
Hong Kong , HK NYK-DO
53GC-99 COSMETIC CREAM
01-JUL-2008 LABELING
Canada 551-7616195-3 2 1
Demco Manufacturing Inc
Saint-Hubert QC, CA J3Y2S3 NYK-DO
53GD-04 FACE PAINT MARKERS (MULTIPLE COLORS) - DEMCO, Chunkie
02-JUL-2008 POISONOUS
Korea, Republic Of (South) 657-1012455-6 4 1
Rosee Cosmetic
Seoul , KR NYK-DO
53GY-99 SKIN COVER
09-JUL-2008 CSTIC LBLG
Pakistan KM6-0037117-3 13 1
SA TRADING COMPANY
KARACHI PK-SD, PK 75300 NYK-DO
53IG-01 MISWAK DENTIFRICES
01-JUL-2008 NOT LISTED
UNAPPROVED
Pakistan KM6-0037117-3 13 2
SA TRADING COMPANY
KARACHI PK-SD, PK 75300 NYK-DO
53IG-01 REVAND DENTIFRICES
01-JUL-2008 NOT LISTED
UNAPPROVED
Korea, Republic Of (South) 657-1012455-6 5 1
Rosee Cosmetic
Seoul , KR NYK-DO
53JY-01 CLEANSING FOAM
09-JUL-2008 CSTIC LBLG
Belgium BGK-0612939-0 9 1
Loreal Services
Brueles , BE NYK-DO
53KD-04 Shaving Prep, Mousse Soin De Rasage Anti-irritant
08-JUL-2008 COSMETLBLG
Belgium BGK-0612939-0 10 1
Loreal Services
Brueles , BE NYK-DO
53KY-05 Shaving Prep, Creme Gel A Raser
08-JUL-2008 COSMETLBLG
Mexico 112-1316309-3 1 1 A
Edelia Rodriguez
Leon , MX 37360 NOL-DO
53LC-01 864736761644 crema conchanacar
02-JUL-2008 CSTIC LBLG
COSMETLBLG
United States 551-7236640-8 1 1 A
Clientele Beauty Inc
Sunrise, FL 33325-6209 NYK-DO
53LC-01 LOTUS FIRMING SERUM PLUS Bonus Elastology Lotus Firming Seru
03-JUL-2008 CSTIC LBLG
United States 551-7236640-8 1 1 B
Clientele Beauty Inc
Sunrise, FL 33325-6209 NYK-DO
53LC-01 Lotus Restorative Cream Plus BONUS Estro-lift Lotus Resorati
03-JUL-2008 CSTIC LBLG
United States 551-7236640-8 1 1 C
Clientele Beauty Inc
Sunrise, FL 33325-6209 NYK-DO
53LC-01 Elastology YOUTH 5 pc Kit PLUS Bonus Gentle Soy Antioxidant
03-JUL-2008 CSTIC LBLG
United States 551-7236640-8 1 1 D
Clientele Beauty Inc
Sunrise, FL 33325-6209 NYK-DO
53LC-01 Perfect Coverage Tan (Elastology Perfect Coverage Compact Ma
03-JUL-2008 CSTIC LBLG
United States 551-7236640-8 1 1 E
Clientele Beauty Inc
Sunrise, FL 33325-6209 NYK-DO
53LC-01 Elastology Envious Skin KIT with bonus (Elastology Skin Envy
03-JUL-2008 CSTIC LBLG
United States 551-7236640-8 1 1 F
Clientele Beauty Inc
Sunrise, FL 33325-6209 NYK-DO
53LC-01 Estrolift Winter Therapies KIT (Estro-lift Body Skin Therapy
03-JUL-2008 CSTIC LBLG
United States 551-7236640-8 1 1 G
Clientele Beauty Inc
Sunrise, FL 33325-6209 NYK-DO
53LC-01 Estrolift Total Beauty 5PC Kit w/Bonuses (Facial wash; day t
03-JUL-2008 CSTIC LBLG
United States 551-7236640-8 1 1 H
Clientele Beauty Inc
Sunrise, FL 33325-6209 NYK-DO
53LC-01 Treat the signs of Aging 3PC Kit (Estro-lift Intensive Serum
03-JUL-2008 CSTIC LBLG
Korea, Republic Of (South) 657-1012455-6 1 1
Rosee Cosmetic
Seoul , KR NYK-DO
53LC-01 BODY SET
09-JUL-2008 CSTIC LBLG
Korea, Republic Of (South) 657-1012455-6 2 1
Rosee Cosmetic
Seoul , KR NYK-DO
53LC-01 PEELING GEL
09-JUL-2008 CSTIC LBLG
Korea, Republic Of (South) 657-1012455-6 3 1
Rosee Cosmetic
Seoul , KR NYK-DO
53LC-01 HAEYOONDAN CREAM
09-JUL-2008 CSTIC LBLG
Korea, Republic Of (South) 657-1012455-6 7 1
Rosee Cosmetic
Seoul , KR NYK-DO
53LC-01 3 PC SET
09-JUL-2008 CSTIC LBLG
Korea, Republic Of (South) 657-1012455-6 8 1
Rosee Cosmetic
Seoul , KR NYK-DO
53LC-01 2 PC SET
09-JUL-2008 CSTIC LBLG
Korea, Republic Of (South) 657-1012455-6 9 1
Rosee Cosmetic
Seoul , KR NYK-DO
53LC-01 ESSENCE
09-JUL-2008 CSTIC LBLG
Korea, Republic Of (South) 657-1012455-6 10 1
Rosee Cosmetic
Seoul , KR NYK-DO
53LC-01 AMPLE ESSENCE
09-JUL-2008 CSTIC LBLG
Korea, Republic Of (South) 657-1012455-6 11 1
Rosee Cosmetic
Seoul , KR NYK-DO
53LC-01 FOR MEN 2 PC SET
09-JUL-2008 CSTIC LBLG
Korea, Republic Of (South) 657-1012455-6 12 1
Rosee Cosmetic
Seoul , KR NYK-DO
53LC-01 PEELING GEL
09-JUL-2008 CSTIC LBLG
United States BGK-0612939-0 19 1
L'Oreal USA Dba Luxury Prod
SAVANNAH, GA 31407-3036 NYK-DO
53LC-03 Men Expert Vital Lift SPF 15
08-JUL-2008 COSMETLBLG
Korea, Republic Of (South) DQ7-0171857-8 2 14
Somang Cosmetics Co Ltd
Inchon City , KR LOS-DO
53LC-06 EYE LOTION (EYE MAKEUP PREPARATIONS);CREAM;
30-JUL-2008 NOT LISTED
Korea, Republic Of (South) AEK-9520692-2 1 2
Caregen Co Ltd
Gyeongi-Do , KR CIN-DO
53LC-06 COSMETIC CREAM
31-JUL-2008 NOT LISTED
Korea, Republic Of (South) AEK-9520692-2 1 1
Caregen Co Ltd
Gyeongi-Do , KR CIN-DO
53LC-08 COSMETIC CREAM
31-JUL-2008 CSTIC LBLG
Korea, Republic Of (South) 657-1012455-6 6 1
Rosee Cosmetic
Seoul , KR NYK-DO
53LC-99 MASSAGE CREAM
09-JUL-2008 CSTIC LBLG
Canada 300-2545141-8 1 1
Procter & Gamble
Belleville ON, CA K8N5E9 NYK-DO
53LD-06 Regenerist Daily Thermal Mini-Peel
14-JUL-2008 NOT LISTED
UNAPPROVED
China 113-4241302-5 5 1
Shenzhen Xiyunda Import & Export
Shenzhen , CN BLT-DO
53LD-06 6 PCS COSMETIC BAG SET. CONSISTS OF 100% COTTON CANVAS COSM
23-JUL-2008 CSTIC LBLG
Korea, Republic Of (South) DQ7-0171857-8 2 10
Somang Cosmetics Co Ltd
Inchon City , KR LOS-DO
53LD-06 MOISTURIZING (SKIN CARE PREPARATIONS);LOTION;
30-JUL-2008 NOT LISTED
Korea, Republic Of (South) DQ7-0171857-8 2 18
Somang Cosmetics Co Ltd
Inchon City , KR LOS-DO
53LD-06 MOISTURIZING (SKIN CARE PREPARATIONS);LOTION;
30-JUL-2008 NOT LISTED
Mexico BKM-0017508-3 1 5
Cayuni Cosmeticos
Mexico , MX SWI-DO
53LD-09 BELAYAA Facial Cream with SPF20
25-JUL-2008 NOT LISTED
Korea, Republic Of (South) AEK-9515800-8 1 1
Caregen Co Ltd
Gyeongi-Do , KR CIN-DO
53LD-10 SMOOTHING CREAM
21-JUL-2008 CSTIC LBLG
Germany 112-1149145-4 1 1
Klapp Cosmetics Gmbh
Hessisch Lichtenau , DE NOL-DO
53LD-99 Power Effect Clearing Active Concentrate
01-JUL-2008 CSTIC LBLG
Germany 112-1149145-4 1 3
Klapp Cosmetics Gmbh
Hessisch Lichtenau , DE NOL-DO
53LD-99 EXTREME HYDRA COMPLETE
01-JUL-2008 COSM COLOR
CSTIC LBLG
Germany 112-1149145-4 1 4
Klapp Cosmetics Gmbh
Hessisch Lichtenau , DE NOL-DO
53LD-99 EXTREME LIFTING CRAEAM DAY & NIGHT
01-JUL-2008 CSTIC LBLG
Germany 112-1149145-4 1 5
Klapp Cosmetics Gmbh
Hessisch Lichtenau , DE NOL-DO
53LD-99 IMMUN GENTLE EYE PROTECTION
01-JUL-2008 COSMETLBLG
India 112-1386221-5 1 1
Kama Ayurveda Pvt Ltd
New Delhi , IN 110014 NOL-DO
53LD-99 860314947450 Rejuvenating Body Treatment Swagandhadi & Inv
01-JUL-2008 CSTIC LBLG
COSMETLBLG
China 113-4241302-5 5 2
Shenzhen Xiyunda Import & Export
Shenzhen , CN BLT-DO
53LD-99 6 PCS COSMETIC BAG SET. CONSISTS OF 100% COTTON CANVAS COSM
23-JUL-2008 CSTIC LBLG
Korea, Republic Of (South) DQ7-0171857-8 2 11
Somang Cosmetics Co Ltd
Inchon City , KR LOS-DO
53LD-99 OTHER SKIN CARE PREPARATIONS, N.E.C.;LOTION;
30-JUL-2008 NOT LISTED
China 112-2020189-4 1 1
Changzhou Nanxiashu Tool Factory
Shanghai, China , CN 202006 NYK-DO
53LF-04 GREEN TEA FOOT PATCH
28-JUL-2008 CSTIC LBLG
Germany 112-1149145-4 1 2
Klapp Cosmetics Gmbh
Hessisch Lichtenau , DE NOL-DO
53LG-08 CLEAN & ACTIVE ENZYME PEELING
01-JUL-2008 CSTIC LBLG
United Kingdom 112-3130373-9 1 1 A
Metabolics Ltd
Devizes , GB SN104PL NOL-DO
53LY-01 714393564532 AA CREAM
30-JUL-2008 CSTIC LBLG
LABELING
United Kingdom 112-3130373-9 1 1 C
Metabolics Ltd
Devizes , GB SN104PL NOL-DO
53LY-01 714393564532 GAC Cream
30-JUL-2008 CSTIC LBLG
LABELING
United Kingdom 112-3130373-9 1 2
Metabolics Ltd
Devizes , GB SN104PL NOL-DO
53LY-01 714393564532 COLLAGEN
31-JUL-2008 COSMETLBLG
United Kingdom 112-3130373-9 1 3
Metabolics Ltd
Devizes , GB SN104PL NOL-DO
53LY-01 714393564532 ELASTIN CREAM
31-JUL-2008 LABELING
COSMETLBLG
United Kingdom 112-3130373-9 1 4
Metabolics Ltd
Devizes , GB SN104PL NOL-DO
53LY-01 714393564532 GAC CREAM
31-JUL-2008 CSTIC LBLG
LABELING
Korea, Republic Of (South) E8L-1003905-0 9 1
Inel Cosmetics Co.
Seoul , KR LOS-DO
53MD-99 NEW IPKN WSUCCESS S-BLOCK
11-JUL-2008 NOT LISTED
CSTIC LBLG
Kenya 112-0814142-7 1 1
Iffa Jirewya
Nairobi , KE NOL-DO
53PH-02 926314338685 Dried Henna Leaves
02-JUL-2008 COSM COLOR
Kenya 112-0814392-8 1 1
Tolessa Wega Abdi
Nairobi , KE NOL-DO
53PH-99 926314338880 Dried Henna Leaves
03-JUL-2008 COSM COLOR
Kenya 112-0963587-2 1 1
Abdi Hakim
Nbo , KE NOL-DO
53PH-99 926314341957/HAND & LEG CULTURAL DEC
03-JUL-2008 COSM COLOR
Kenya 112-0963807-4 1 1
Abdi Hakim
Nbo , KE NOL-DO
53PH-99 926314342953/HAND & LEG CULTURAL DEC
03-JUL-2008 COSM COLOR
Kenya 112-0963353-9 1 1
Iffa Jirewya
Nairobi , KE NOL-DO
53PH-99 926314343401/HERBAL DYE
03-JUL-2008 COSM COLOR
Kenya 112-0964570-7 1 1
Iffa Jirewya
Nairobi , KE NOL-DO
53PH-99 926314343776/HERBAL DYE
03-JUL-2008 COSM COLOR
Kenya 112-1000013-2 1 1
Tolessa Wega Abdi
Nairobi , KE NOL-DO
53PH-99 926314344901/HENNA
03-JUL-2008 COSM COLOR
Kenya 112-1026290-6 1 1
Iffa Jirewya
Nairobi , KE NOL-DO
53PH-99 926314346536/ HENNA
03-JUL-2008 COSM COLOR
Mexico BRQ-0032659-6 1 1
Unilever de Mexico S.A. de C.V.
Cuernevaca, Morelos , MX 62500 SWI-DO
53YD-99 POND'S CLARANT B3 w/ UV FILTER 100 G
23-JUL-2008 UNAPPROVED
Mexico BRQ-0032659-6 1 2
Unilever de Mexico S.A. de C.V.
Cuernevaca, Morelos , MX 62500 SWI-DO
53YD-99 POND'S H Moisturizing Cream w/ Sunscreen Protector 200 G
23-JUL-2008 UNAPPROVED
Mexico BRQ-0032659-6 1 3
Unilever de Mexico S.A. de C.V.
Cuernevaca, Morelos , MX 62500 SWI-DO
53YD-99 POND'S CLARANT B3 w/ UV FILTER 50 G
23-JUL-2008 UNAPPROVED
Mexico BRQ-0032659-6 1 4
Unilever de Mexico S.A. de C.V.
Cuernevaca, Morelos , MX 62500 SWI-DO
53YD-99 POND'S CLARANT B3 w/ UV FILTER 200 g
23-JUL-2008 UNAPPROVED
Mexico BRQ-0032659-6 1 5
Unilever de Mexico S.A. de C.V.
Cuernevaca, Morelos , MX 62500 SWI-DO
53YD-99 POND's H Moisturizing Cream with Sunscreen Protector 400 g
23-JUL-2008 UNAPPROVED
China AKU-0014500-4 19 1
Shenzhen, Shennam Association Enterprises Co.
Shenzhen , CN 2914 SEA-DO
53YY-99 FAKE TATOO, OTHER COSMETIC PRODUCTS, N.E.C.
09-JUL-2008 CSTIC LBLG