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IA #53-06 - REVISED 3/7/96, "Automatic Detention of Cosmetics Containing
Illegal Colors", REVISED ATTACH A - 9/15/04, ATTACH B - 6/24/04

               NOTE: This alert has been revised to rename and reformat the
               alert.  In addition, the firms and products identified in
               Import Alert #53-11, "Automatic Detention of Cosmetics From
               Stargazer London Due to Illegal Colors" and Import Alert
               #53-13, "Automatic Detention of Eye Cosmetics Containing D&C
               Red #10" have been added to Attachment A of this alert.
               Upon the issuance of this revision, Import Alerts #53-11 and
               53-13 are cancelled.  Additional changes are bracketed by
               asterisks (***).

TYPE OF ALERT: Automatic Detention

               ***(Note:   This import alert contains guidance to FDA field
               personnel only.  It does not establish any requirements or
               create any rights or obligations on FDA or on regulated

PRODUCTS:      ***Cosmetics***

PRODUCT CODES: ***See attachment***

PROBLEM:       ***Illegal Colors (UCNC, UCET, MLLM)***

COLLECTION:         29002

COUNTRY:       ***See attachment***

SHIPPER:       ***See attachment***

SHIPPER I.D.#: ***See attachment***

I.D. #:        N/A

CHARGE:        "The article is subject to refusal of admission pursuant to
               Section 801(a)(3) in that it appears to contain ***a color
               additive which is unsafe*** within the meaning of Section
               721(a) which renders it adulterated under Section 601(e)."

OFFICE:        DIOP (HFC-170);
               Los Angeles District (HFR-PA250);
               Cincinnati District (HFR-MA440);
               New York District (HFR-NE1515).

ALERT:         ***This alert, which initially issued in 1985, was based on
               the detention of make-up kits with eye area cosmetics from
               Taiwan containing illegal color additives.  Problems with
               eye make-up products and other cosmetic products have
               continued and the list of responsible firms has grown.

               During the latter part of 1990, Cincinnati District sampled
               a shipment of cosmetics manufactured by A.Z. Nadar Cosmetics
               and Hair Products d/b/a Stargazer, London, England.
               Analysis of the samples, which included mascaras, eye dust,
               rouge, and lipstick, revealed the presence of prohibited
               FD&C Red #7 and FD&C Red #2, as well as other unidentified

               In 1993, analysis of an eye color compact collected by New
               York district revealed the presence of D&C Red, a delisted
               synthetic color additive.***

               ***In 1995 LOS-DO sampled and analyzed twenty samples of
               shampoo manufactured by CIA. Distribuidora Del Centro, San
               Jose GTO, Mexico in a six month time frame.  Of the twenty
               samples, six were refused and nine were detained for
               undeclared colors.  These samples all contained
               unsafe/illegal and/or undeclared colors.  The unsafe/illegal
               colors included non-permitted external D & C Red #10,
               Ponceau 4R and other undeclared colors.***

GUIDANCE:      Districts ***may detain, without physical examination,***
               shipments of identified products from those firms listed in
               Attachment A.

               Districts ***may detain, without physical examination, ***
               all entries of eye make-up and make-up kits containing eye
               make-up from Taiwan except from those shippers listed in
               Attachment B.

               The method for color analysis is from AOAC's book
               Newburger's Manual of Cosmetic Analysis 2nd edition, Chapter
               19, "Determination of Colors in Cosmetics" p.118.
               ***Fastips Issue #47, page 6, should also be consulted when
               analyzing for colors in shampoos, cream rinses and

               ***For questions of issues concerning science, science
               policy, sample collections, analysis, preparation, or
               analytical methodology, contact the Division of Field
               Science at (301) 443-3320 or 3007.***


FOI:           No purging is required.

KEYWORDS:      Illegal colors, colors, cosmetics, lipstick, eye make-up,
               shampoo, conditioner.

PREPARED BY:   Alwin Collins, DIOP, 301-443-6553.

INTO FIARS:         March 7, 1996

                Attachment A - Import Alert #53-06    Revised 9/15/04

                 Manufacturers/Shippers on Automatic Detention

FIRM                     PRODUCT     CODE              PROBLEM

                       CHINA (CN, 280)

Elle Jewelry "Corp.           Eye Shadow               Lithol Rubine BCA,
37-3 Nong Gong Road           53C- - 03                Phloxine
Yiwu City                          3/28/03                  Brilliant Blue FCF
Zhejiang, China
FEI # 3003727191

Fuzhou Jianing Cosmetic Co.,Ltd.  Make-up Kits     Illegal Colors
First Road, Taijiang Area          53C--08          (see below)
Fuzhou, Fujian                               4/3/97
FEI# 1000404863

PROBLEM: Undeclared D&C Red #6 or #7 in the lip pencil and blush
components; D&C Red #6 or #7, and D&C Red #27 or #28, and
undeclared FD&C Red #40 in the eye shadow component.

Guangzhou (Sino Foreign)   Make Up Kits   53C08     See below
Irene Cosmetic Co., Ltd.   #A28, #A30, &            for specific
No. 39, Yuan Thiu 4th         #A203                 problems.
 Hein Road
Guangzhou, China (Mainland)
FEI #3000129222


Make up kit #28 - Contains one or more non-permitted colors (e.g., Lake Red C
the Sodium Salt, C.I. 15585, was formerly certified as D & C Red No.8; and the
Barium Salt, C.I. 15585:1, formerly certifiable as D & C Red No.9).

Make up kit #A30 - Contains one or more non-permitted colors (e.g., Hansa
Yellow formerly certifiable as EXT. D & C Yellow No.5).

Make up kit #A203 - Contains one or more non-permitted colors (e.g., Rhodamine
B, the Chloride Salt, C.I. 45170, was formerly certifiable as D & C Red No.
19; and the Stearate Salt was formerly certifiable as D & C Red No. 37).

Guangzhou Win Kale Stationry Co    Face Paint Crayons  Lithol Rubin
26 Centre Rd. Cand-Tou             53G 09              B or Lithol
Nan-Kang, Huang Pu            53G 04              Rubin BCA
Guangzhou, China                   4/2/03
FEI #3003806832

Shenzhen Yada Cosmetic Co. Ltd.    Eye Shadow Kit      Rhodamine B,
4/F 02 Bld Fuzhao Center Buxin Rd. Press Powder        Red AC
Shenzhen, China                    53C-  03
FEI # 3003177305                   53C- -08
                              53G- -02

Yiwu Siya Cosmetics Co., Ltd.      Lip Glitter              ** See Below
109-1 Cosmetic Market              (Lil' Divas Club)
Binwang Road                  53G[][]05
Yiwu, Zhejiang                53G[][]99
China                              4/12/04
FEI #3004107014


Art Craft Ltd.
309 Pennsylvania Avenue
Concord, Ontario
FEI #3004044701

* Contains non-permitted Rhodamine B (CI 45170, formerly certifiable as D&C
Red No. 19); non-permitted Ponceau 4R, (CI 16255) and undeclared Brilliant
Blue FCF (CI 42090, certifiable as FD&C Blue No. 1)

Zhejiang Yiwu Meixue          Eye Shadow               non-permitted color
Makeup Co. Ltd.               53C[][]03           additive Phloxine B
Qingkou Industrial Park       7/22/03
Qingkou Yiwu Zhejiang China
FEI #3003700280

Tana Cosmetics Manoa          Self Tanning Solution         Brilliant
Box 102801                    "Egypt Wonder Quicktan"       Black,
Bielefeld, Germany       53M- - 02                Amaranth,
FEI # 1000386802              53M- - 99                Tartrazine

                    HONG KONG (HK, 435)

Carlon Industries Ltd         Sweet & Lovely Beauty    Non-permitted
Blk H. 4/F Century Ind        Sets                Erythrosine and
 Centre                  53C[][]03           Sunset Yellow
33-35 Au Pui Wan Street       11/16/01            FCF
Fo Tan. Shatin, Hong Kong
FEI# 3003344438

Chen's Industrial Co.    Eye Repair     53C[][]04      D&C Red #33
Front Portion 5/FL       Complex
16 Granville Road        (Monsfalay)
Kowloon, Hong Kong  7/11/97
FEI #1000427204

G T Plus Limited              Deluxe cosmetic set      Rhodamine B, C.I.
29-43 Ashley Road, 4/F        53C[][]03           Solvent Blue 14
Kowloon Centre, Tsimshatsui    6/17/03
Kowloon, Hong Kong
FEI# 1000146371

Laptide Industries Ltd.       Yellow Glitter Body   Unidentified Yellow Color
Room 1505                Wash (Shower Gel)
Nan Fung Commercial Centre    53J [][] 01
19 Lam Lok Street             Pink Glitter Body        Non-permitted color
Kowloon Bay, Hong Kong        Wash (Shower Gel)        (Former D&C Red No. 19,
FEI #3004044703               53J [][] 01              Rhodamine B)
                         Orange Glitter Body Non-permitted color
                         Wash (Shower Gel)        (Former D&C Red No. 19,
                         53J [][] 01              Rhodamine B)

Art Craft Ltd.
309 Pennsylvania Avenue
Concord, Ontario, Canada
FEI #3004044701

Law Tai Hang Products Ltd.    Face paints         Tartrazine (certifiable
12-22 Tai Yuen Street         53G[][]09      as FD&C Yellow #5);
Blk. B, 4/F, Shui Wing   1/11/01        Sunset Yellow FCF (cert-
  Ind. Bldg.                            ifiable as FD&C Yellow
Kwai Chung, Hong Kong                   #6); Allura Red AC
FEI# 3003211186                         (certifiable as FD&C Red #40

Wapiti International               Body Glitter and         Rhodamine B,
Rm 821, Nan Fung Comm. Ctr.   Hair Highlighter         and a mixture
19 Lam Lok St., Kowloon Bay   53Y- - 99           of synthetic
Kowloon, Hong Kong            53G- - 99           organic colors
FEI# 3003734899               53G- - 04           not specifically
                         53F- - 99           permitted for use
                         53F- - 06           in the area of
                         2/23/04             the eye.

                                ITALY (IT, 480)

***ROAN S.p.A.          Pupa Elypsis eye  53C[][]03   D&C Red #10
Via De Gasperi 22       color compact
Casatenovo, Italy       8/10/93
FEI# 1000140862***

                                KOREA (KR, 515)

Charmzone Co., Ltd.      NCS232 New Control Cream Amaranth
106-16 Chungdam-Dong          Special Set                   (formerly
Kangnam-ku,              50A--60                  certifiable
Seoul,Korea                                            as FD&C Red
Republic of (South)                               #2)
FEE #3000086069
                         Color Eye Cream          FD&C Red No. 4
                         53L 01              (Non-permitted
                         9/22/02             Color)

Julia Limited           Eye shadow        53C[][]03   FD&C Yellow #6 and
656-54 Duengchon-Dong                                 colors resembling
Kangseo-Gu                                            D&C Red #30 and
Seoul, 157-030, Korea                                 D&C Red #7
FEI# 1000288973

Mycosmetic Co. Ltd.      Eye Shadow                    Illegal Colors
14-2 Yeoido-Dong         (Light Yellow            (see below)
Yeungdeungpo-Gu          ES-27)
Seoul, Korea             53C[][]03
FEI #3003514597          10/9/02

Problem:  Undeclared Tartrazine (certifiable as FD&C Yellow # 5; aka CI 19140, E102), non-
permitted Sunset Yellow FCF (certifiable as FD&C Yellow # 6; aka CI 15985, E110), non-
permitted Lithol Rubine BCA (certifiable as D&C Red # 7; aka CI 15850)

                                         ***MEXICO (MX, 595)

Colgate Palmolive SA De CV    M              Bath Bar Soap/
Presa De La Angostura 225 P 3                53J--01
Carretera Mexico-Toluca Km 15.5              10/01/99
Mexico D.F. Mexico
FEI# 1000300384

Verde 7(i.e. Green 7) - non-permitted color additives
Amarillo 74(i.e. yellow 74) - non-permitted color additives

Desarrollo de Mercados   RYT Cherry Blossom       Color - FD&C Red No. 1
 de Mexico, S.A. de C.V. Shampoo                  1/14/99
Privada Rhin         53ED-06
650-A Col. Mirador
Monterrey N.L., Mexico   RYT Conditioner/Cream Rinse   Color - FD&C Red No. 2
FEI# 3000188907          53ED-05                  1/14/99

Fabrica de Jabones Mariano    "Anti Bacterial" Soaps/53J[][]01
 Salgado S.A. de C.V.         a) Tip Fresh (Green Label)*
Paseo Tollocan y Marie Curie  b) Tip Joven (Yellow Label)*
Toluca, Mexico           01/12/00
FEI #3000239603

* Tip Fresh (Green Label) lists the following colors: "Green 7" and "Blue 15."  Tip Joven
(Yellow Label) lists "Yellow 1" and "Orange 4."  These color additives as listed are neither
permitted nor do they appear to come from certified batches.

Industrias Wet Line S.A. de C.V.   Extreme Hair Gel         Undeclared
Privada del Gallo 1525, Col.       (Green)             Tartrazine
Aurora                        53ED-99             (Certifiable as
Guadalajara, Jalisco, Mexico       4/6/04              FD&C) Yellow #5)
FEI #3004163751

Sanborn Hermanos              Theatrical Body Cream    Ponceau 4R,
Viaducto Miguel Alemanno 705  53L   03            and color additives
Mexico City, Mexico      8/20/01             resembling
FEI # 3002874996                                  Sunset Yellow FCF
                                             and Tartrazine

                              TAIWAN (TW, 281)

***All firms            Eye make-up       53C[][]03   Illegal colors***
                        and kits          53C[][]08
                        containing eye make-up

Color Shine Cosmetic     Lip Gloss      53GC05    Red 27
Industry Co.        7/11/03                  Yellow 6
NO. 48, Nan Kung St.                              Blue 1
Yung Kang City                               Organic Red
Manganese Violet                                  Organic Pink
Tain,Hsien 710
Taiwan, R.O.C.
FEI# 3003749513

De Evan International Limited      Lip Color           Contains
10 F/4, No. 171                    53G -- 05           Non-Permitted
Chang An East Rd., Sec. 2          53G -- 99           Rhodamine B
Taipei, Taiwan                8/24/04
FEI# 3004437172

First and Best Co., Ltd.      Body Glitter   Contains non-permitted
Rm 4B-05, No. 5, Hsin-Yi Rd.  53G[][]99      Ponceau 4R and synthetic
Sec. 5 (PO Box 109-0531) 11/9/01        color additives resembling
Taipei, Taiwan                          Xylene Red B and
FEI# 1000268603                              erythrosine

Golden Benz & Co., Ltd.       Makeup Kits              CI 15825
6F No. 114 Sec 2              53C--08             (certifiable as
Chung Shan North Road         53G--09             D & C Red #7)
Taipei, Taiwan           6/12/01
FEI# 1000455987                                   CI 47005
                                             (certifiable as
                                             D & C Yellow

                                             CI 42090
                                             (certifiable as
                                             FD & C Blue #1)

JMU Ching Enterprise Co., Ltd.   Make-up Kits          Illegal Color
No. 36 Lane 222 Ming Shen Rd.
Hsinchu City                       53G--09             D&C Orange
Taiwan                             3/24/97             #17 in the
FEI# 3000226133                                        lip pencil

Superier Traders              Lip Glitter              Contains Erythrosine
International Ltd.       53G--05             (Certifiable as FD&C Red
2 Fl. #415 Hsinyi Rd.         8/13/01             No. 3)and Brilliant Blue
Sec. 4                                       FCF(certifiable as FD&C
Taipei, Taiwan                               Blue No.1 in part for
FEI #6635                                    Eye area only)

                         Body Glitter        Contains Erythrosine
                         53Y[][]99           (Certifiable as FD&C
                         10/2/01             Red No. 3) and
                                             Brilliant Blue FCF
                                             (Certifiable as FD&C
                                             No. 1 in eye-area only)

Taiwan Ox Burning        Make-up Kit (Lipstick w/Glitter)   (See below
 Prods. Co.                   53GY-09                       for expla-
6/F No. 32 Lane 39 Sec. 2     Lipstick/53GK-05                    nation)
Keelung Rd. Taipei       Body Glitter/53GC-99
Taiwan                   8/23/01
FEI #3003105008

Lipstick portion of the make-up kit was found to contain Lithol Rubin B Ca (certifiable as D&C
Red #7); it was also reported to contain an unidentified yellow color.

Body glitter portion of the make-up kit was found to contain Rhodamine B (formerly certifiable as
FD&C Red #19) and Brilliant Blue FCF (certifiable as FD&C Blue #1).  In addition, it was also
indicated that this product also contains an unidentified color additive declared as "glitter" whose
identity has not been determined.

Lithol Rubin B Ca (certifiable as D&C Red #7), and Brilliant Blue FCF (certifiable as FD&C Blue
#1) are not permitted on cosmetic products unless they come from FDA-certified batches.

Timesource Enterprise         Duo Blue/Pink            Non-permiited Brillant
Co., Ltd.                Eye Pens            Blue FCF and mixture of
2F No. 156 Hei-An Street 53C[][]99/53C[][]03 synthetic fluorescent
Taipei, Taiwan           09/19/01            color additives
FEI# 3003049035                                   including dibromofluorescein

Touchstone Trading      Lipstick          53G[][]05   FD&C Red #19 and
Keelung, Taiwan         10/29/92                      FD&C Red #8
FEI# 1000110074

Yumark Enterprises Corp.      Roll on glitter          Contains nonpermitted
67 Tun Haw South Road         53Y[][]99           color additives Xylene
Taipei, Taiwan           6/10/04             Red B, Allura Red AC,
FEI# 3004468579                                   Brilliant Blue FCF and

Shipper/ Labeled distributor for the above:
Art Craft Ltd.
633 Edgeley Blvd.
Concord, Ontario, Canada
FEI# 3001649897

Wingo International Co. Ltd.       Lip Tint Amazing Glaze   Non-permitted
AKA: Metro Cosmetics               (Strawberry Blast)       unidentified
Industry Co.                       (Strawberry Dazzle) red oil soluble
6th Floor-1 No. 60                 (Tangerine Tickle)       color detected
Section 4                     53G[][]05           in all three
Chung Shiang East Rd.              9/29/03             products.
Taipei, Taiwan                                    Undeclared
FEI# 3004006490                    6/24/04             Quinoline Yellow
                              (Name change)       Detected in
                                                  Tangerine Tickle.

Wingo International Co. Ltd. (Factory)
No. 423, Zhong (Chung) Shan South Rd.
Tainan Hsien 710
Yung Kang City, Taiwan
FEI# 12654

                         UNITED KINGDOM (GB, 925)

***A.Z. Nadar Cosmetics Eye dust          53C[][]03   FD&C Red #7 and
 and Hair Products                                    two unidentified
d/b/a STARGAZER                                       colors
P.O. BOX 609            Gypsy Rose rouge  53G[][]07   FD&C Red #2
London, SW3 4NS, England
MID# GBAZNAD609LON      Mascara           53C[][]06   one to three
FEI# 1000359677                                       unidentified colors
                        Lipstick          53G[][]05   One unidentified color

Stargazer has also used the following shipping address on some entries.
      Unit 5B
      9 Brighton Terrace
      London SW9 8DJ, England
      FEI# 1000269231***

Beauty Without Cruelty, Ltd.  Lipstick-   53G[][]05  D & C RED #19
37 Avebury Avenue             Ice Melon
Tonbridge, Kent
TN9 ITL United Kingdom
FEI #1000504949

          Attachment B  - Import Alert #53-06   Revised   6/24/04

Manufacturers/Shippers Of Eye Make-up From Taiwan Exempt from Automatic Detention

Chao Ling Chemical Industry Co., Ltd.                 2/28/91
P.O. Box 442
Hsinchu, Taiwan
FEI# 12658

Manufacturing Plant:  Chin Ming Chemical Co., Ltd.
                      9, Lane 8, Gong Shyue Rd.
                      Taichung, Taiwan
                      MID# TWCHIMIN9TAI
                      FEI# 12659

Chian Zong International Co., Ltd.                    11/21/94
7 Hsing Kung Road, Wang Tang Tsun
Yung Kang Hsiang, Tainan Hsien, Taiwan
FEI# 1000255152

Ever Bilena Cosmetics, Inc.                           1/12/95
No. 17 Lane 77 Chang
An Rd., Hsi China
P.O. Box 111 Nan Kang
Taipei, Taiwan
FEI# 1000204084

Galisa Cosmetics International Corp.                  8/25/92
No. 72 Pao-Chung Rd.
Taipei, Taiwan
FEI# 1000109489

Gold Regency Trading International                    3/3/95
P O Box 957
Tainan, Taiwan
FEI# 1000311593

Golden Aristocrat Enterprise Company                  3/3/95
#2 Lane 26, Hwu-Meei First Street
Tainan, Taiwan
FEI# 1000311592

Healthcome Cosmetics Corp.                            1/22/90
4-5/F. No. 528 Chung Yan Rd.
Nankang, Taipei, Taiwan
FEI# 12651

Imei Chemical Enterprise      Makeup Kits              9/24/96
 Limited                 53C03 and 53C08
No. 171 Tahu Road
Haishan Li,
Hsinchu City, Taiwan
FEI #12646

International Cosmograce Corp.                        10/5/93
F. 8-1, No. 65, Sung Te Road
Taipei, Taiwan
FEI# 1000145049

Kwai Yu International Corp.                           10/2/91
P.O. Box 32-10
Taipei, Taiwan
FEI# 12652

Mei Kuai Cosmetics Company                            2/28/94
No. 121 Lane, 145 Sec. 1 An Ho Road
Tainan, Taiwan
FEI# 1000153156

Mei Shual Cosmetics Co. Ltd.                          12/22/92
No. 71, Lane 96 Da Shing St.
Tainan, Taiwan                               Change in Address
FEI# 1000114498                                   9/19/01

Michitoy International        Petite Miss Compact 9/4/97
 Co., Ltd.                    Blue Eye Shadow
11F #159 Sec 2                53C[][]08
Hsin Hai Road
Taipei, Taiwan
FEI #1000234163

Mostwell Co., Ltd.                                    2/16/90
P.O. Box 39 HSI-CHIN
Taipei, Taiwan
FEI# 12630

Obtain Ideal Chemistry Company (OIC)                  2/12/90
4 Fl., No. 39, Lane 697
Tun Hwa South Road
Taipei, Taiwan
FEI# 1000182419

Parnasse Chemical Industrial                          9/1/93
Sec 3 Nan Kang Rd
Taipei, Taiwan
FEI# 1000144685

Prince Chemical Ind. Co., Ltd.                        3/9/90
No. 12 Hsin Jen Road
Tainan, Taiwan
FEI# 12631

Rich Corty Industrial Corporation                     8/14/89
4F, 299 Section 4, Chung Shiao Road
Taipei, Taiwan
FEI# 12628

Shiseido Asia Pacific Co.,              Eye Shadow
  Ltd.                             53C[][]08
37 Bao-Ching Road                  7/24/03
Taipei, Taiwan
FEI# 3002718885

Sun Beauty Cosmetic Co., Ltd.                         9/25/92
(Subsidiary of Prince Chemical Industrial Co., Ltd.)
Tainan, Taiwan
FEI# 1000109579

Thai Ho Cosmetics Co., Ltd.                           2/14/92
39 Da Ye Street
Da Fa Industrial District
Da Liau Hsiang, Kaohsiung Hsien, Taiwan
FEI# 1000285570

Tonnie Cosmetics Co., Ltd.              Eyeshadow
29 Hsin Chung Rd.                  53C--03
An Pin Industrial District              5/11/04
702 Tainan
FEI# 1000297401

Wingo International Co., Ltd. (Factory)      3/19/90
No. 423, Zhong (Chung) Shan South Rd.
Tainan Hsien 710                             6/24/04
Yung Kang City, Taiwan                  (Name and address change)
FEI# 12654

Wu Reng Trading Co., Ltd.                             8/30/89
1st Floor, No. 1-4, Lane 7
Ching Tien ST., Taipei 10619, Taiwan