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PHN DNH CHO C QUAN QUN L(FOR OFFICIAL USE)>

Phiu cng b c gi tr 05 nm k t ngy nhn.

nh du vo thch hp (Tick where applicable)

THNG TIN SN PHM

PARTICULARS OF PRODUCT

1. Tn nhn hng v tn sn phm (Name of brand & product) :

1.1 Nhn hng (Brand)

Nu Skin

1.2 Tn sn phm (Product Name)

Nu Skin AP-24 Whitening Fluoride Toothpaste

1.3 Danh sch cc dng hoc mu (List of Variants or Shade). Tn (Names)

2. Dng sn phm (Product type(s)) -Sn phm chm sc rng v ming (Products for care of the teeth and the mouth)

Dng sn phm khc:

3. Mc ch s dng (Intended use)

PHIU CNG B SN PHM M PHM

TEMPLATE FOR NOTIFICATION OF COSMETIC PRODUCT

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Kem nh rng trng sng gip loi b vt , h tr lm trng rng v ngn nga

mng bm vi cng ngh c quyn AP24, mang n cm gic sch v thm mt di

lu cho khoang ming, h tr ngn nga su rng.

4. Dng trnh by (Product presentation(s)) -Dng n l (Single product)

Dng trnh by khc:

THNG TIN V NH SN XUT/ NG GI

( ngh nh km danh sch ring nu nh c nhiu hn mt cng ty tham gia sn xut/ ng

gi to ra mt sn phm hon chnh)

PARTICULARS OF MANUFACTURER (S)/ASSEMBLER(S) (Please attach in a separate sheet if there are more than one manufacturer/assembler)

5. Nh sn ut

STT Tn nh sn ut a ch S T Fax Nc sn

ut

1 Laclede, Inc.

2103 East

University

Drive, Rancho

Dominguez,

California

90220, USA

310-605-

4280 310-605-

4288 M

6. Cng ty ng g i

STT Tn V ng

gi Loi ng g i a ch S T Fax

Nc

ng g i

1 Laclede, Inc. ng gi chnh

2103 East

University

Drive,

Rancho

Dominguez,

California

90220, USA

310-605-

4280

310-

605-

4288 M

THNG TIN V T CHC, C NHN CHU TRCH NHIM

A SN PHM M PHM RA TH TRNG

PARTICULARS OF LOCAL COMPANY RESPONSIBLE FOR PLACING

THE COSMETIC PRODUCT IN THE MARKET

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7. Tn cng ty (Name of company):

CNG TY TNHH NU SKIN ENTERPRISES VIT NAM

a ch cng ty (Address of company):

S 201 ng Nam K Khi Ngha, Phng 7, Qun 3,TP. H Ch Minh

Tel: 02839324300 Fax: 02839320035

S giy php kinh doanh/S giy php hot ng (Business Registration Number/License to

Operate Number): 0311355044

THNG TIN V NGI I DIN THEO PHP LUT CA CNG TY

PARTICULARS OF PERSON REPRESENTING THE LOCAL COMPANY

8. H v tn (Name of person):

ONG-EA PANAUDOMSIN

Tel: 02839324300 Email: opanaudo@nuskin.com

Chc v cng ty (Designation in the company): Tng gim c

THNG TIN V CNG TY NHP KHU

PARTICULARS OF IMPORTER

9. Tn cng ty nhp khu/ Name of Importer:

CNG TY TNHH NU SKIN ENTERPRISES VIT NAM

a ch cng ty (Address of company):

S 201 ng Nam K Khi Ngha, Phng 7, Qun 3,TP. H Ch Minh

Tel: 02839324300 Fax: 02839320035

DANH SCH THNH PHN

PRODUCT INGREDIENT LIST

10. ngh kim tra sau y (Please check the following boxes)

Ti kim tra bn sa i t Ph luc II n Ph lc VII ca danh mc cc thnh

phn m phm ASEAN nh c cng b trn bn sa i gn y nht ca Hip nh

m phm ASEAN. Ti xin xc nhn rng sn phm c cp n trong bn cng b

ny khng cha bt c mt thnh phn b cm no v cng tun th vi danh mc hn

ch v cc iu kin quy nh trong cc ph lc.

I have examined the latest revisions of the Annexes II to VII of the ASEAN Cosmetic

Ingredient Listing as published in the latest amendment of the ASEAN Cosmetic

Directive and confirmed that the product in this notification does not contain any

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prohibited substances and is in compliance with the restrictions and conditions stipulated

in the Annexes.

Ti m nhn trch nhim tr li v hp tc ton din vi c quan c thm quyn v

bt k hot ng kim sot sau khi bn hng khi c yu cu bi c quan c thm quyn.

I undertake to respond to and cooperate fully with the regulatory authority with regard to

any subsequent post-marketing activity initiated by the authority.

Danh sch thnh phn y (product full ingredient list)

(Yu cu ghi y danh sch tt c cc thnh phn v t l % ca nhng cht c gii hn v

nng , hm lng s dng trong m phm - To submit ingredient list with percentages of

restricted ingredients)

STT

Tn y thnh phn (tn danh php quc t hoc

s dng tn khoa hc chun c cng nhn)

Full Ingredient name (use INCI or approved

nomenclature in standard references)

T l % ca

nhng cht c

gii hn v

nng , hm

lng

Ghi ch

1 Water (Aqua) 39.75000000

2 Hydrated Silica 20.00000000

3 Sorbitol 13.30000000

4 Aluminum Hydroxide 9.95000000

5 Glycerin 7.96000000

6 Tetrasodium Pyrophosphate 2.00000000

7 PEG-12 1.00000000

8 Flavor (Aroma) 0.98000000

9 Cellulose Gum 0.80000000

10 Poloxamer 338 0.80000000

11 Poloxamer 407 0.80000000

12 Sodium Lauryl Sulfate 0.80000000

13 Sodium Monofluorophosphate 0.76000000

14 Dimethicone 0.40000000

15 Titanium Dioxide 0.40000000

16 Sodium Saccharin 0.30000000

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CAM KT (DECLARATION)

1. Thay mt cho cng ty, ti xin cam kt sn phm c cp trong Phiu cng b ny t -c tt c cc yu cu ca Hip nh m phm ASEAN v cc ph lc ca n.

I hereby declare on behalf of my company that the product in the notification meets all the

requirements of the ASEAN Cosmetic Directive, its Annexes and Appendices.

2. Ti xin chu trch nhim tun th cc iu khon sau y (I undertake to abide by the followin conditions):

i. m bo c sn cung cp cc thng tin k thut v tnh an ton khi c quan c thm quyn yu cu v c y h s v cc sn phm c phn phi bo co trong

trng hp sn phm phi thu hi.

Ensure that the products technical and safety information is made readily available to

the regulatory authority concerned (the Authority) and to keep records of the

distribution of the products for product recall purposes;

ii. Phi thng bo ngay cho c quan c thm quyn v cc tc dng ph nghim trng gy cht ngi hoc e do tnh mng ca sn phm bng in thoi, fax, th in t hoc

vn bn trc 7 ngy k t ngy bit thng tin.

Notify the Authority of fatal or life threatening serious adverse event1 as soon as

possible by telephone, facsimile transmission, email or in writing, and in any case, no

later than 7 calendar days after first knowledge;

iii. Phi hon thnh bo co tc dng ph ca sn phm (theo mu quy nh) trong vng 8 ngy lm vic k t ngy thng bo cho c quan c thm quyn v nhng tc dng ph

nghim trng nh nu trong mc 2ii ni trn v cung cp bt c thng tin no theo

yu cu ca c quan c thm quyn.

Complete the Adverse Cosmetic Event Report Form1 within 8 calendar days from the

date of my notification to the Authority in para 2ii. above, and to provide any other

information as may be requested by the Authority;

iv. Thng bo ngay cho c quan c thm quyn v cc phn ng ph nghim trng nhng khng gy cht ngi hoc e do n tnh mng ca sn phm v trong bt c trng

hp no, vic bo co (s dng mu bo co) v tc dng ph phi c tin hnh trc

15 ngy k t ngy bit v tc dng ph ny.

Report to the Authority of all other serious adverse events that are not fatal or life

threatening as soon as possible, and in any case, no later than 15 calendar days after

first knowledge, using the Adverse Cosmetic Event Report Form;

v. Cng b vi c quan c thm quyn khi c bt c s thay i no trong bn cng b ny.

Notify the Authority of any change in the particulars submitted in this notification;

3. Ti xin cam oan rng nhng thng tin c a ra trong bn cng b ny l ng s tht. Tt c cc ti liu, cc thng tin lin quan n ni dung cng b s c cung cp v cc ti

liu nh km l bn hp php hoc sao y bn chnh.

1 Nh c nh ngha r rng trong ti liu hng dn cho cc cng ty v bo co tc dng ph ca sn phm m phm.

As defined in the Guide Manual for the Industry on Adverse Event Reporting of Cosmetics Products 1 Trnh by trong ph lc I trong ti liu hng dn cho cc cng ty v bo co tc dng ph ca sn phm m phm.

Set out in Appendix I to the Guide Manual for the Industry on Adverse Event Reporting of Cosmetics Products

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I declare that the particulars given in this notification are true, all data, and information of

relevance in relation to the notification have been supplied and that the documents enclosed

are authentic or true copies.

4. Ti hiu rng ti s c trch nhim m bo tt c cc l sn phm ca chng ti u p ng cc yu cu php lut, v tun th tt c tiu chun v ch tiu sn phm c cng b vi c quan c

thm quyn.

I understand that I shall be responsible for ensuring that each consignment of my product continues to

meet all the legal requirements, and conforms to all the standards and specifications of the product

that I have declared to the Authority.

5. Ti hiu rng trong trng hp c tranh chp php lut, ti khng c quyn s dng bn cng b sn phm m phm c c quan c thm quyn chp nhn nu sn phm ca chng ti khng t

c cc yu cu v tiu chun, ch tiu m chng ti cng b.

I understand that I cannot place reliance on the acceptance of my product notification by the authority

in any legal proceedings concerning my product, in the event that my product has failed to conform to

any of the standards or specifications that I had previously declared to the Authority.

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