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 Kingdom 112-1831044-2 2 1
Nougat London Ltd
Enfieldenfield , GB EN03 NOL-DO
53BC-03 949511021369 CREAM BATH AND BATH PEARLS
04-APR-2008 COSM COLOR
COLOR LBLG
United Kingdom 112-1831012-9 1 2
Nougat London Ltd
Enfieldenfield , GB EN03 NOL-DO
53BC-03 949511021667 CREAM BATH, SHOWER GEL, BODY SHIMMER
04-APR-2008 COSM COLOR
COSMETLBLG
United Kingdom 946-0605602-9 134 1
Sara Lee Household & Body Care
Slough FN, GB LOS-DO
53BD-01 RADOX HERBAL LIQUID SOAP 6/500ML
01-APR-2008 LACKS N/C
United Kingdom 946-0605602-9 244 1
Sara Lee Household & Body Care
Slough FN, GB LOS-DO
53BD-01 RADOX HERBAL SOAP
01-APR-2008 LABELING
United Kingdom 946-0605603-7 173 1
Sara Lee Household & Body Care
Slough FN, GB LOS-DO
53BD-01 RADOX HERBAL LIQUID SOAP 500M
11-APR-2008 CSTIC LBLG
United Kingdom 946-0605101-2 211 1
Sara Lee Household & Body Care
Slough FN, GB LOS-DO
53BD-01 RADOX SLEEP EASY HERBAL BATH
19-APR-2008 NOT LISTED
Taiwan 315-7682134-7 6 1
Vast Gem International Co Ltd
Tainantainan , TW 70000 LOS-DO
53CH-03 EYESHADOW
19-APR-2008 UNSAFE COL
Taiwan 880-1000104-3 2 1
Lian Co., Ltd.
Tainan , TW LOS-DO
53CH-03 EYE SHADOW (EYE MAKEUP PREPARATIONS);POWDER;
22-APR-2008 UNSAFE COL
United Kingdom 112-1846023-9 6 5
Coty Manufacturing UK Ltd.
Ashford Kent, GB TN25 4AQ NYK-DO
53CH-03 EYESHADOW
30-APR-2008 FILTH
United Kingdom 112-1822370-2 2 6
Coty Manufacturing UK Ltd.
Ashford Kent, GB TN25 4AQ NYK-DO
53CH-03 EYE SHADOW
30-APR-2008 FILTH
United Kingdom 112-1822370-2 2 8
Coty Manufacturing UK Ltd.
Ashford Kent, GB TN25 4AQ NYK-DO
53CH-03 EYE SHADOW
30-APR-2008 FILTH
United Kingdom 112-1813798-5 8 7
Coty Manufacturing UK Ltd.
Ashford Kent, GB TN25 4AQ NYK-DO
53CH-03 EYE SHADOW
30-APR-2008 FILTH
Taiwan 880-1000104-3 3 1
Lian Co., Ltd.
Tainan , TW LOS-DO
53CK-01 EYEBROW PENCIL (EYE MAKEUP PREPARATIONS);STICKS;
22-APR-2008 UNSAFE COL
India 300-1971166-0 17 1
Thakar Exports
Trinagar-Delhi , IN 110035 CHI-DO
53DD-01 WOODVARD GRIP WATER
14-APR-2008 NOT LISTED
UNAPPROVED
France NL7-0104778-8 3 1 A
Novafrica
Bordeaux , FR 33000 FLA-DO
53ED-01 Hair Nourishing Care Treatment with Jojoba
28-APR-2008 COSM COLOR
India UPS-0685639-1 23 1
Grandways
New Delhi , IN 110025 SEA-DO
53FD-01 BEGIN HAIR COLOR with placeholders for quantity and value
22-APR-2008 CSTIC LBLG
COSMETLBLG
Canada 551-7355706-2 2 1
Demco Manufacturing Inc
Saint-hubert Quebec, CA J3Y2S3 NYK-DO
53GD-04 FACE PAINT
01-APR-2008 POISONOUS
Canada 551-7355706-2 2 2
Demco Manufacturing Inc
Saint-hubert Quebec, CA J3Y2S3 NYK-DO
53GD-04 FACE PAINT - YELLOW
01-APR-2008 POISONOUS
Canada 551-7355706-2 2 3
Demco Manufacturing Inc
Saint-hubert Quebec, CA J3Y2S3 NYK-DO
53GD-04 FACE PAINT - ORANGE
01-APR-2008 POISONOUS
Canada 551-7355706-2 2 4
Demco Manufacturing Inc
Saint-hubert Quebec, CA J3Y2S3 NYK-DO
53GD-04 FACE PAINT - RED
01-APR-2008 POISONOUS
Canada 551-7355706-2 2 5
Demco Manufacturing Inc
Saint-hubert Quebec, CA J3Y2S3 NYK-DO
53GD-04 FACE PAINT - GREEN
01-APR-2008 POISONOUS
Canada 551-7355706-2 2 6
Demco Manufacturing Inc
Saint-hubert Quebec, CA J3Y2S3 NYK-DO
53GD-04 FACE PAINT - BLUE
01-APR-2008 POISONOUS
Canada 551-7355706-2 2 8
Demco Manufacturing Inc
Saint-hubert Quebec, CA J3Y2S3 NYK-DO
53GD-04 FACE PAINT - BLACK
01-APR-2008 POISONOUS
Canada 551-7355706-2 2 7
Demco Manufacturing Inc
Saint-hubert Quebec, CA J3Y2S3 NYK-DO
53GD-04 FACE PAINT - BROWN
01-APR-2008 POISONOUS
Korea, Republic Of (South) ANP-0009485-5 18 1
Daiso Industries Co., Ltd.
Higashihiroshima , JP 739-0008 SEA-DO
53ID-02 MOUTH MASH
22-APR-2008 CSTIC LBLG
India 411-8162557-9 11 1 B
Swastik Trading Co.
Mumbai IN-MH, IN 400092 SWI-DO
53IY-02 CHANDAN Mouth Fresheners Tower Pack
25-APR-2008 COLOR LBLG
China BGK-0611023-4 9 1
Jets Sets & Elephants Beauty Cor
Montreal QC, CA H2P2T4 NYK-DO
53JD-01 SHOWER GEL
10-APR-2008 COSM COLOR
Israel T94-0047924-0 19 1
Yakov Baron
Kiryat Ono , IL 55226 FLA-DO
53JG-01 HAWAII SOAP BAR
15-APR-2008 CSTIC LBLG
LABELING
Mexico BVK-0025257-2 3 1
Colgate Palmolive SA de CV
Mexico City , MX 11500 SWI-DO
53JG-01 PALMOLIVE BATH BAR SOAPS
17-APR-2008 COLOR LBLG
CSTIC LBLG
Australia 603-1080182-8 77 1
Reckitt Benckiser
New South Whales , AU SEA-DO
53JI-02 REXONA DEOD ICE COOL
23-APR-2008 NOT LISTED
Australia 603-1080182-8 85 1
Reckitt Benckiser
New South Whales , AU SEA-DO
53JI-02 REDWIN/REXONA DEODRANT
23-APR-2008 NOT LISTED
Chile W16-5013968-8 3 1
Laboratories Coesam
La Reina , CL FLA-DO
53JY-01 UVATHERAPY SOAP BAR
03-APR-2008 COL ADDED
Switzerland 112-1816663-8 1 1 A
Dr Paul Et Kain Herzog Sa
Lutry , CH 1095 NOL-DO
53LC-01 Karin Herzog Vitamin H
03-APR-2008 COSM COLOR
COSMETLBLG
United Kingdom 112-1831044-2 3 1
Nougat London Ltd
Enfieldenfield , GB EN03 NOL-DO
53LC-03 949511021369 MY HANDS GIFT SET AND HAND CREAM
04-APR-2008 COSM COLOR
COLOR LBLG
United Kingdom 112-1831012-9 1 1
Nougat London Ltd
Enfieldenfield , GB EN03 NOL-DO
53LC-03 949511021667 HAND CREAMS AND HAND POLISH
04-APR-2008 COSM COLOR
COSMETLBLG
Thailand 277-0116646-7 21 1
Cm Cosmetic Ltd.
Khonkaen , TH LOS-DO
53LC-03 ARCHE PEARL CREAM
18-APR-2008 NOT LISTED
United Kingdom 946-0605602-9 56 1
Reckitt Benkiser Ltd
Swindon , GB SN57XZ LOS-DO
53LC-99 DETTOL DISINFECTANT-LIQUID 12/9 OZ (250ML)
01-APR-2008 LABELING
Lebanon 112-2025124-6 2 1 C
Diana De Beaute s.a.l.
Beirut , LB NOL-DO
53LC-99 963172497895 Diana ( Redness cream)
09-APR-2008 CSTIC LBLG
United Kingdom 946-0605603-7 169 1
Reckitt Benkiser Ltd
Swindon , GB SN57XZ LOS-DO
53LC-99 DETTOL ANTISEPTIC LIQUID 500ML
11-APR-2008 CSTIC LBLG
China BGK-0611023-4 8 1
Jets Sets & Elephants Beauty Cor
Montreal QC, CA H2P2T4 NYK-DO
53LD-03 BODY LOTION
10-APR-2008 COSM COLOR
France NL7-0104778-8 1 1 D
Novafrica
Bordeaux , FR 33000 FLA-DO
53LD-03 Serum Ultra White
28-APR-2008 CSTIC LBLG
United Kingdom 112-1831044-2 1 1
Nougat London Ltd
Enfieldenfield , GB EN03 NOL-DO
53LD-06 949511021369 DRY OIL MIST
04-APR-2008 COLOR LBLG
China 220-1044396-2 1 2
American Hygienics Corporation
Shanghai , CN 201702 LOS-DO
53LF-01 ITCH STOP WIPES
11-APR-2008 NEW VET DR
Korea, Republic Of (South) 112-2349873-7 1 1
Natuzen Co
Incheon , KR SEA-DO
53LY-01 8624-8228-4293 NWC21 Collagen Cellulose Mask, 500 pcs
30-APR-2008 CSTIC LBLG
China AEK-9438323-5 1 1
Ab Hongkong Beauty & Health
Ningbo , CN 315000 CIN-DO
53LY-99 PULSED LIGHT FOR SKIN CARE TREATMENT
03-APR-2008 NOT LISTED
REGISTERED
NO 510(K)
Japan AJR-7266470-7 4 1 A
Dr. Ci Labo Co Ltd
Tokyo , JP LOS-DO
53LY-99 3D-DEEP BOTOLIUM Transdermal Facial Gel for Visible Wrinkle
15-APR-2008 NO ENGLISH
UNAPPROVED
Japan AJR-7266470-7 4 1 B
Dr. Ci Labo Co Ltd
Tokyo , JP LOS-DO
53LY-99 3D-DEEP BOTOLIUM Under-Eye Treatment Transdermal Under-Eye M
15-APR-2008 UNAPPROVED
Japan AJR-7266470-7 6 1
Dr. Ci Labo Co Ltd
Tokyo , JP LOS-DO
53LY-99 3D- Deep Botolium D-Trans-System Extra Deeper Formula
15-APR-2008 UNAPPROVED
Korea, Republic Of (South) AEK-9436818-6 1 3
Caregen Co Ltd
Gyeongi-Do , KR CIN-DO
53MC-99 ANTI AGING COSMETICS
03-APR-2008 NOT LISTED
India K80-0941427-8 12 2
Varun Exports
Ludhiana IN-PB, IN 141008 SAN-DO
53YG-99 HEHA MEHNDI BODY COLOR
15-APR-2008 COSM COLOR
United States M76-9077049-1 1 1 A
Tattoo Manufacturing, Inc.
Tucson, AZ 85713-5343 DET-DO
53YY-99 Kids Rule Tattoos
14-APR-2008 CSTIC LBLG
LABELING
COSMETLBLG
United States M76-9077049-1 1 1 B
Tattoo Manufacturing, Inc.
Tucson, AZ 85713-5343 DET-DO
53YY-99 WildFire Choppers Tattoos
14-APR-2008 CSTIC LBLG
LABELING
COSMETLBLG
United States M76-9077049-1 1 1 C
Tattoo Manufacturing, Inc.
Tucson, AZ 85713-5343 DET-DO
53YY-99 Muscle Tattoo Sets
14-APR-2008 CSTIC LBLG
LABELING
COSMETLBLG
United States M76-9077049-1 1 1 D
Tattoo Manufacturing, Inc.
Tucson, AZ 85713-5343 DET-DO
53YY-99 Colored Glitter Tattoos
14-APR-2008 CSTIC LBLG
LABELING
COSMETLBLG
United States M76-9077049-1 1 1 E
Tattoo Manufacturing, Inc.
Tucson, AZ 85713-5343 DET-DO
53YY-99 Tattoo Mix
14-APR-2008 CSTIC LBLG
LABELING
COSMETLBLG
China MY1-0339876-3 6 1
Gong Ming Tian Liao Wing Cheong Mfy
Shenzhen , CN BLT-DO
53YY-99 TATTOOS
16-APR-2008 UNSAFE COL
Estonia H42-0094009-0 1 1 A
Wellspa
Raplamaa , EE 78203 MIN-DO
53YY-99 Feng Shui Spa 2G machines - SG20801/2...
28-APR-2008 NO 510(K)