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Work Reviewer > Cosmetics > Flashcards

Cosmetics Flashcards

1
Q

Administrative Order No. 2005-015

Laws, Policies and Issuances

A

Adoption of the Association of Southeast Asian Nation (ASEAN) Harmonized Cosmetic Regulatory Scheme and ASEAN Common Technical Documents

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2
Q

Administrative Order No. 2005-0025

Laws, Policies and Issuances

A

Implementation of the ASEAN Harmonized Cosmetic Regulatory Scheme and ASEAN Common Technical Documents

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3
Q

FDA Circular No. 2016-004

Laws, Policies and Issuances

A

Procedure on the Use of the New Application Form for License to Operate (LTO) thru the Food and Drug Administration (FDA) Electronic Portal (e-Portal)

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4
Q

FDA Memorandum Circular No. 2015-010

Laws, Policies and Issuances

A

Guidelines on the Issuance of Center for Cosmetics Regulation and Research (CCRR) User Account to Access e-Portal

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5
Q

FDA Memorandum Circular No. 2015-011

Laws, Policies and Issuances

A

Guidelines for Electronic Notification of Cosmetic Products (Cosmetic e-Notification Version 2.0) Using the FDA e-Portal)

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6
Q

FDA Circular No. 2018-001

Laws, Policies and Issuances

A

Reiterating the Mandatory Implementation of **Article 8 **of the ASEAN Cosmetic Directive “Product Information”

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7
Q

FDA Circular no. 2021-004

A

Revised Interim Guidelines for the Issuance of License to Operate (LTO) and Certificate of Product Notification (CPN) for Manufacturers, Distributors and Traders of Rubbing Alcohol Products Under the Center for Cosmetics and Household/Urban Hazardous Substances Regulation and Research

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8
Q

FDA Circular No. 2022-001

Laws, Policies and Issuances

A

Repealing FDA Circular No. 2021-004 “Revised Interim Guidelines for the Issuance of License To Operate (LTO) and Certificate of Product Notification (CPN) for Manufacturers, Distributors and Traders of Rubbing Alcohol Products Under the Center for Cosmetics and Household/Urban Hazardous Substances Regulation and Research”

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9
Q

FDA Advisory No. 2022-0383

Laws, Policies and Issuances

A

Reiterating the Article 8 of the ASEAN Cosmetic Directive as per FDA Circular No. 2018-001 Mandating the “Product Information File”

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10
Q

FDA Advisory No. 2022-1090

Laws, Policies and Issuances

A

Frequently-Asked Questions (FAQs) on FDA Circular (FC) No. 2022-001 “Repealing FDA Circular No. 2021-004 “Revised Interim Guidelines for the Issuance of License to Operate (LTO) and Certificate of Product Notification (CPN) for Manufacturers, Distributors and Traders of Rubbing Alcohol Products Under the Center for Cosmetics and Household/Urban Hazardous Substances Regulation and Research” dated 09 February 2021”

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11
Q

Administrative Order No. 2020-0017

Laws, Policies and Issuances

A

Revised Guidelines on the Unified Licensing Requirements and Procedures of the Food and Drug Administration Repealing Administrative Order No. 2016-0003

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12
Q

Validity of Cosmetic Product Notification

A

1, 2, 3 years (either initial or renewal)

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13
Q

Standards for Labelling

A

Appendix II, ASEAN Cosmetic Directive

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14
Q

Standards for Ingredients

A

Annex II, III, IV, VI, VII
ASEAN Cosmetic Directive

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15
Q

Standards for Cosmetic Claim

A

Appendix III, ASEAN Cosmetic Directive

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16
Q

Standards for Cosmetic Claim

A

Appendix III, ASEAN Cosmetic Directive

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17
Q

Annex II

A

Banned Ingredients

18
Q

Annex III

A

Restricted Ingredients

19
Q

Annex IV

A

Colorants

20
Q

Annex VI

A

Preservatives

21
Q

Annex VII

A

UV Filters

22
Q

Phenoxyethanol

Annex and Percentage limits

A

Annex VI: Preservatives
1%

23
Q

Methylisothiazolinone
Methylchloroisothiazolinone

Annex and Percentage Limits

A

Annex III: Restricted
MIT/MCIT (3:1) - 0.00015%

24
Q

Opium Poppy

Annex and Percentage Limits

A

Annex II: Banned Ingredient

25
Q

Malachite Green

Annex and Percentage Limits

A

Annex II: Banned Ingredient

26
Q

HICC / Hydroxyisohexyl 3-cyclohexene carboxaldehyde

Annex and Percentage Limits

A

Annex II: Banned Ingredient

27
Q

Formaldehyde as Nail Hardener

Annex and Percentage Limit

A

Annex III: Restricted Ingredient
2.2%

28
Q

Salicylic Acid

Annex and Percentage Limit

A

Annex III: Restricted Ingredient
3.0% (Rinse Off)
2.0% (Leave-On)

29
Q

Zinc Oxide

Annex and Percentage Limit

A

Annex VII: UV Filter
Restricted Ingredient
25%

30
Q

Glycolic Acid (w/ Lactic Acid)

Annex and Percentage Limits

A

Annex III: Restricted Ingredient
Less than or equal to 10-20%

31
Q

Benzalkonium Chloride as Haircare

Annex and Percentage Limit

A

Annex III: Restricted Ingredient
3% (Rinse-Off)
0.1% (Other Products)

32
Q

Tagetes minuta
Tagetes erecta
Tagetes patula

Annex and Percentage Limit

A

Annex III: Restricted Ingredient
0.01% (Leave-On)
0.1% (Rinse-Off)

33
Q

Behentrimonium Chloride

Annex and Percentage Limit

A

Annex III: Restricted Ingredient
2.5%(Rinse-Off)
1.0% (Leave-On)
0.5% (Face Products)

34
Q

Cetrimonium Chloride

Annex and Percentage Limit

A

Annex III: Restricted Ingredient
5.0% (Rinse-Off)
3.0% (Leave-On)

35
Q

Commonly Noted claims requiring substantiation

Annex and Percentage Limit

A

Borderline Products
Pimple Patches
Whitening Tooth Pen (CCHUHSRR) with LED Lights (CDRRHR)
Rubbing Alcohol (Sanitizing, Antibacterial, Antiseptic)
Sebo De Macho (for endorsement to CDRR)
Products with numerical claims

36
Q

Climbazole

Annex and Percentage Limit

A

Annex VI: Preservatives
Restricted Ingredient
0.5% rinse-off shampoo
0.2% leave-on face cream, hair lotion, foot care

37
Q

Thiomersal and Phenylmercuric salts

Annex and Percentage Limit

A

Annex II: Banned Ingredient (Ref No. 221)

38
Q

Paraformaldehyde, Formaldehyde and Methylene Glycol

Annex and Percentage Limit

A

Annex II: Banned Ingredient

39
Q

Silver Nitrate

Annex and Percentage Limit

A

Annex II: Banned Ingredient

40
Q

Methoxypropylamino Cyclohexenylidene Ethoxyethylcyanoacetate or BC-3

Annex and Percentage Limit

A

Annex VII: UV Filters
Restricted Ingredient
3%

41
Q

Dibutyltin Hydrogen Borate

Annex and Percentage Limit

A

Annex II

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