BPOM Regulation No. 30 Year 2020 - Cosmetic Marking Technical Requirements

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NATIONAL AGENCY OF DRUG AND FOOD CONTROL

REPUBLIC OF INDONESIA
REGULATION OF THE DRUG AND FOOD CONTROL AGENCY

NUMBER 30 YEAR 2020
ABOUT
COSMETICS MARKING TECHNICAL REQUIREMENTS
BY THE GRACE OF GOD ALMIGHTY
HEAD OF THE DRUG AND FOOD CONTROL AGENCY,
Considering: a. that the provisions of the marking technical requirements

cosmetics as stipulated in the Regulations
Head of the Food and Drug Supervisory Agency Number 19
2015 concerning Cosmetic Technical Requirements,
is no longer in accordance with legal requirements and
development of science and technology in
cosmetic sector so that it needs to be replaced;
b. that based on the considerations as
referred to in letter a, as well as to implement
provisions of Article 5 paragraph (3) of the Regulation of the Minister of Health
Number 1176/MENKES/PER/VIII/2010 of 2010

regarding Cosmetic Notifications, it is necessary to set
Regulation of the Food and Drug Supervisory Agency regarding
Cosmetic Marking Technical Requirements;
In view of: 1. Presidential Regulation Number 80 of 2017 concerning

Food and Drug Supervisory Agency (State Gazette
Republic of Indonesia Year 2017 Number 180);
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2. Rules Minister Health Number
1176/MENKES/PER/VIII/2010 of 2010 concerning

Cosmetics Notification (State Gazette of the Republic of Indonesia
Year 2010 Number 397);
3. Regulation of the Food and Drug Supervisory Agency Number
33 of 2018 concerning the Application of 2D Barcodes in
Drug and Food Control (State Gazette of the Republic of Indonesia
Indonesia Year 2018 Number 1599);
21 of 2020 concerning Organization and Work Procedures of the Agency
Drug and Food Control (State Gazette of the Republic of Indonesia

Indonesia Year 2020 Number 1002);
22 of 2020 concerning Unit Organization and Work Procedures
Technical Executor within the Drug Supervisory Agency
and Food (State Gazette of the Republic of Indonesia Year
2020 Number 1003);
DECIDE:
To stipulate: REGULATION OF THE DRUG AND FOOD SUPERVISORY AGENCY

CONCERNING COSMETICS MARKING TECHNICAL REQUIREMENTS.
article 1
In this Agency Regulation what is meant by:

1. Cosmetics are materials or preparations which
intended for use on the outside of the body
human beings such as the epidermis, hair, nails, lips, and
external genital organs, or teeth and membranes
oral mucosa, especially for cleaning,
perfuming, changing appearance, and/or
correct body odor or protect or
keep the body in good condition.
2. The owner of the Notification Number is the Cosmetics industry,
Cosmetics importer, and individual/entity business
a business that carries out a production contract that
receive notification Cosmetics has been notified.
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3. Cosmetic Ingredients are ingredients or mixtures of ingredients

derived from natural and/or synthetic
is a component of Cosmetics, including ingredients
colorants, preservatives and sunscreen agents.
4. Cosmetic Marking, hereinafter referred to as
Marking is any information regarding Cosmetics
in the form of images, text, a combination of both,
or other forms included in Cosmetics
inserted into, affixed to, or
is part of the packaging, as well as the printed one
directly on the product.
5. Packaging is the material used for
accommodate and/or wrap Cosmetics, whether
direct or indirect contact.
6. Primary Packaging is Packaging that intersects
directly with Cosmetics.
7. Secondary Packaging is Packaging that protects
Primary Packaging.
8. The Head of the Agency is the Head of the Drug Supervisory Agency and
Food.
Section 2
The marking must meet the following criteria:

a. complete by including all the information
required;
b. objectively by providing information in accordance with the existing
reality and must not deviate from the
the nature of safety and usefulness of Cosmetics;
c. do not mislead by providing information that
honest, accurate, accountable, and not
may take advantage of public concerns about
a health problem; and
d. does not pretend to be a drug or
aims to prevent a disease.
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Article 3
Marking other than meeting the provisions as
referred to in Article 2 must also:
a. clear and easy to read; and
b. not easily separated or separated from the packaging, faded,

and broken.
Article 4
(1) The owner of the Notification Number must meet the criteria
as referred to in Article 2 and the provisions
as referred to in Article 3 as well as guaranteeing
Cosmetics produced for distribution in the region
Indonesia has complied with the Marking technical requirements.

(2) Marking technical requirements as intended
in paragraph (1) must comply with the information on the Marking.
Article 5
(1) Information on Marking as referred to in
Article 4 paragraph (2) at least in the form of information
about:
a. name Cosmetics;
b. benefit/usage;
c. how to use;
d. composition;
e. producing country;
f. full name and address of the Notification Number Owner;
g. batch number ;
h. size, content, or net weight;
i. expiration date;
j. notification number;
k. 2D Barcodes; and
l. warning and/or attention.
(2) Benefit/usage and how to use
as referred to in paragraph (1) letter b and letter c are excluded for clear
Cosmetics
benefits or uses and how to use them.

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(3) 2D Barcode as referred to in paragraph (1) letter k

carried out in accordance with the provisions of the regulations
legislation.
(4) Warning and/or attention as intended
in paragraph (1) letter l must be stated if
needed.
(5) The information as referred to in paragraph (1) must refer to the
Guidelines for Marking Technical Requirements
Cosmetics as listed in Appendix I which
is an integral part of the Regulations
this body.
Article 6
(1) Marking must be written in Indonesian.

(2) Writing in Indonesian as referred to in
paragraph (1) at least for information as
referred to in Article 5 paragraph (1) letter b, letter c, and
letter l.
(3) Information as referred to in Article 5 paragraph (1)

must use Indonesian or a foreign language
as long as it is written using Latin letters and/or Arabic numerals
except for the information as referred to in paragraph (2).
(4) In addition to the information as referred to in Article 5

paragraph (1), Marking can use:
a. Indonesian, or a foreign language as long as
written using Latin letters and/or numbers
Arab; and/or
b. foreign languages listed other than the letters
Latin and/or Arabic numerals.
Article 7
(1) Information on Marking as intended
in Article 5 paragraph (1) must be stated on the packaging
Primary and Secondary Packaging.
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(2) In the case of Cosmetics packaged in Primary Packaging

and Secondary Packaging or in terms of limitations
Primary Packaging size and shape, Marking on

Primary packaging must at least include information in the form of:
a. name Cosmetics;
b. batch number ; and
c. size, content or net weight.
(3) In the event that Cosmetics are packaged in Primary Packaging
with limitations in the size and shape of the packaging, information
in the form of data and/or information other than those referred to
in paragraph (2) must be included
on hanging tags, brochures, display panels or shrink
wrap or other Marking media included on the
Cosmetics.
Article 8
In addition to the Marking technical requirements as intended

in Article 4, for Cosmetics in the form of:
a. sunscreen preparations must refer to the Guidelines
Technical Requirements for Marking Cosmetics Preparations
Surya as listed in Appendix II which
this body;
b. Skin preparations containing Alpha Hydroxy Acid are mandatory
refers to the Guidelines for Technical Requirements for Marking
Cosmetics for Skin Preparations Containing Alpha Hydroxy
Acid as listed in Appendix III which
this body; and
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c. teeth whitening preparations containing and/or

releasing Hydrogen Peroxide must refer to
Cosmetic Marking Technical Requirements Guidelines
Teeth Whitening Preparations Contain and/or Release
Hydrogen Peroxide as listed in
Appendix IV which is an integral part
of this Agency Regulation.
Article 9
(1) The owner of the Notification Number who violates the provisions
as referred to in Article 4 paragraph (1), Article 5 paragraph (4),
Article 6 paragraph (1), Article 6 paragraph (3), Article 7
and/or Article 8 in this Agency Regulation is subject to
administrative sanctions in the form of:
a. written warning;
b. prohibition of distributing Cosmetics for
while a maximum of 1 (one) year;
c. orders for the withdrawal of Cosmetics that are not
meet the technical requirements of Marking from
circulation;
d. destruction of Markings;
e. temporary cessation of circulation activities
6 (six) months; and/or
f. revocation of Cosmetics notification.
(2) The administrative sanctions as referred to in paragraph
(1) imposed by the Head of the Agency.
Article 10
The procedure for imposing administrative sanctions as follows:
referred to in Article 9 is carried out in accordance with
Decision of the Head of the Agency that regulates the action
further monitoring results.
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Article 11
Owner of Notification Number who already has notification number

Cosmetics prior to the enactment of this Agency Regulation must
comply with the provisions in this Agency Regulation no later than 12
(twelve) months from the date of this Agency Regulation.
This body was promulgated.
Article 12
At the time this Agency Regulation comes into force, the Head Regulation
Food and Drug Supervisory Agency Number 19 of 2015
about Technical Requirements for Cosmetics (State Gazette of the Republic of Indonesia
Indonesia Year 2015 Number 1986) as long as it regulates

regarding Marking requirements, revoked and declared
not applicable.
Article 13
This Agency Regulation comes into force on the

invited.
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APPENDIX I
NUMBER 30 YEAR 2020
ABOUT
GUIDELINES FOR COSMETICS MARKING TECHNICAL REQUIREMENTS
I. Introduction
As Indonesia's commitment to the ASEAN Harmonization agreement in the field of Cosmetics,

Indonesia has implemented a notification mechanism for:
Cosmetics since January 1, 2011 (in lieu of the registration mechanism
previously applied).
Consequences of the notification mechanism, the Drug Supervisory Agency and
Food does not conduct comprehensive premarket evaluation
as done during the registration mechanism. Therefore the perpetrator
Cosmetics businesses are required to have the ability to make an assessment
independent of the completeness of the Cosmetic Marking that will be circulated (after obtaining
the Cosmetics notification number).
Cosmetic Marking Technical Requirements Guidelines can be used

as a guide for:
1. Business actors in the field of Cosmetics; and
2. POM Agency Officer
II. COSMETICS MARKING TECHNICAL REQUIREMENTS
Information that must be included in the Marking shall at least relate to:
a. Cosmetics Name
Cosmetics name is a series of names consisting of brands and cosmetics

product name as stated in the notification template .
Example of Cosmetics name: NOOR Body Lotion Jasmine
brand name type variant

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b. Benefits/Usagep
Benefits / uses must be listed using the language
Indonesia on Marking, except for the obvious Cosmetics
usefulness/usefulness is seen from the name or appearance of the product,
such as lipstick, powder, toothpaste, bath soap, shampoo, perfume and others
other.
Examples of Cosmetics that must include benefits/usage:

No. Category Benefits/usage
1. Moisturizer keep skin moist
2. Night cream treat skin moisture at night
day
c. How to use
How to use it must be stated in Indonesian
on Marking, except for Cosmetics which are clear way
its use is seen from the name or appearance of the product, such as lipstick,
powder, toothpaste, bath soap, shampoo, perfume and others.
Examples of Cosmetics that must include how to use:

No. Category How to use
1. Day cream apply evenly on the face
before starting the activity in the morning.
2. Sunscreen Apply on the exposed body part
sunshine before work
d. Composition
The compositions listed on the Marking must meet
the following conditions:
1. According to the formula listed in the notification template
Cosmetics.
2. Using the name of the Cosmetic Ingredients according to the name

International Nomenclature of Cosmetic Ingredients (INCI), except
For cosmetic ingredients that don't have an INCI name yet, you can
use another name according to the applicable reference
international.
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3. Using the name of the genus and species for Cosmetic Ingredients derived from
plants or plant extracts.
Example: Pyrus Malus Juice, Camellia Sinensis Oil, and others.
4. Sorted from the largest to the smallest, except
for Cosmetic Ingredients with levels of less than 1% and/or
Coloring ingredients can be written out of order, after Ingredients
Other cosmetics with levels of more than 1%.
5. The coloring matter is listed using the dye index number
(color index/ CI) or the name of the coloring matter for those that are not
have a CI number.
6. Fragrance or aromatic ingredients can use the word
“perfume”, “perfume”, “fragrance”, “aroma”, or “flavour”.
7. Colorants used in a series of Cosmetics
decorative can include the words “may contain”, “may
contain”, or “+/-“ on the Marking.
8. Cosmetics containing nanomaterials include names
Cosmetic Ingredients are followed by the description “nano” in parentheses.
Example: Titanium dioxide (nano)
e. Producer Country
Cosmetics must include the country of manufacture.
Example :
- Produced in Indonesia
- Made in Germany
In addition to the country of manufacture, the name of the industry that performs the packaging
primary and/or secondary should also be listed, if packaging

carried out by different industries.
f. Full Name and Address of Owner of Notification Number

The name and address of the Notification Number Owner must be included with the
complete on the Marking and in accordance with the name and address
stated in the notification letter has been notified.
Domestic cosmetics can include the full address of the owner
Notification Number in the form of the full address of the factory. This doesn't happen
for Contract Cosmetics and Imported Cosmetics.
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Example of the inclusion of the name and address of the Notification Number Owner for:
1) Domestic cosmetics:
Issued by : PT. CITA, Jl. Rose no. 23B, Jakarta-Indonesia
2) Imported cosmetics:
- Imported and circulated by : PT. CITA, Jl. Rose no. 23B,

Jakarta, Indonesia
- Imported by : PT. CITA, Jl. Rose no. 23B, Jakarta-Indonesia
- Circulated by : PT. CITA, Jl. Rose no. 23B, Jakarta-Indonesia
3) Contract cosmetics:
Produced : PT. ANITA, Indonesia
For : PT. CITA, Jl. Rose no. 23B, Jakarta-Indonesia
g. Batch Number
Batch number is a number and/or letter or a combination
both identify complete batch manufacturing history including quality control and distribution.
Numbering system
batch made specific.
h. Size, Content, or Net Weight
The size, content or net weight must be listed on the Marking and
written in an easy-to-read place. Size, content or net weight
listed on the Marking must match the notification data

Cosmetics.
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The unit of measure, content, or net weight listed must be in

metric units or imperial units accompanied by metric units.
Writing size, content or weight Example
clean using:
Metric unit 50 liters or 50 L
100 milliliters or 100 mL
10 milligrams or 10 mg
20 grams or 20 g
2 kilograms or 2 kg
Accompanied imperial units 1 fl Oz - 30 mL
metric unit 1 fl Oz/30 mL
i. Expiration Date
Writing the expiration date begins with the word "date"
expired” or “either used before” or a word in the language
the usual English in accordance with the conditions in question such as "exp",
"exp. date”, “best before”, “expired date”, and others.
The expiration date is written in the following order:
- date, month and year; or
- month and year.
Example: Expiration date 12-13-2019, exp 041119, or best before

1118.
j. Notification Number
Cosmetics that have been notified will get a notification number
The cosmetics listed in the notification letter have been notified.
The notification number consists of 2 letters and 11 digit numbers, in the form of
NX12345678901, where : X = A/B/C/D/E.
Cosmetic kits that have been notified will get a notification number
The cosmetic kit listed in the notification letter has been notified of a combination/kit
product. The cosmetic kit notification number consists of 4 letters and 9 digit numbers,
in the form of NKIT123456789.
Cosmetic kit in the form of:

1. Cosmetics in 1 (one) Primary Packaging consists of:
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• more than 1 (one) Cosmetics with the same category or

different and have more than 1 (one) notification number; or
• more than 1 (one) Cosmetics with different categories where
each of these cosmetics already has a notification number.
On the Cosmetic Packaging kit, it must be stated:

a. Cosmetic kit notification number; and
b. pictures and/or descriptions explaining their respective positions
each Cosmetics in the kit.
Example 1:
Cosmetics which in 1 (one) Primary Packaging consist of more than

1 (one) Cosmetics with the same category and has more than 1 (one)
notification number:
Cosmetic kit in the form of a palette containing eye shadows
red, yellow and green, where the eye shadow
red and yellow are notified in 1 (one) notification number
and deep notified green eye shadow
notification number is different. This cosmetic kit consists of 2 (two) numbers
notification.
Example 2:

1 (one) Cosmetics with different categories and has more
from 1 (one) notification number:
Cosmetic kit in the form of a palette containing 2 (two) blush colors
(blush on) and 3 (three) lip colors where 2 (two) blush colors
cheeks (blush on) are notified in 1 (one) notification number and 3 (three) lip
colors are notified in 1 (one) notification number.
This cosmetic kit consists of 2 (two) notification numbers.
Example 3:

1 (one) Cosmetics with different categories where each
Each of these Cosmetics already has a notification number:
The cosmetic kit is in the form of a palette containing 2 (two) colors of compact
powder and 3 (three) colors of blush (blush on) .
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each Cosmetics has a notification number. Cosmetics kit
This consists of 5 (five) notification numbers.
2. Cosmetics in 1 (one) Secondary Package consists of more than
from 1 (one) Cosmetics with the same or different categories
and has more than 1 (one) notification number.
On the secondary packaging must include a notification number

Cosmetics kit.
Example 1:
Cosmetics which in 1 (one) Secondary Packaging consist of more than
from 1 (one) Cosmetics with the same category and has more
from 1 (one) notification number:

The cosmetic kit is in the form of a box consisting of 4 (four) solid soaps
where each solid soap has a notification number.
Example 2:
Cosmetics which in 1 (one) Secondary Packaging consist of more than
of 1 (one) Cosmetics with different categories and have
more than 1 (one) notification number:

Cosmetics hair dye kit consisting of hair dye,
oxidizing agent and neutralizer.
k. 2D Barcode
2D Barcode is a graphical representation of digital data in a two . format
dimensions of high decoding capacity that can be read by optical devices
used for identification, tracking, and tracking.
Inclusion of 2D Barcode is carried out in accordance with the provisions
legislation.
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l. Warning and/or Caution.

Warnings and/or attention and other information must be stated clearly, easily readable
and proportional to the area of the Marking
Cosmetics. Warnings and/or cautions and other information must be
meet the following conditions:
(1) Warnings as regulated in laws and regulations
invitation;
(2) Warnings for aerosol preparations in the warning box as

following:
Attention! Avoid contact with eyes and do not inhale.
Watch out! High pressure contents, may explode at temperatures above

50oC, do not pierce, do not store in hot places or in
near a fire, and do not dispose of in a landfill.
(3) Warnings for mouthwash preparations containing fluoride or

alcohol by including the following text:
"Not used for children under 6 (six) years old"
(4) Warning for Cosmetics containing ingredients derived from

Pigs must include a special sign in the form of colored writing
black “CONTAINS PIG” in the black box above
white base, as follows:
CONTAINS PIG
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(5) Warning for Cosmetics whose manufacturing process

in contact with materials derived from pigs must include black writing “In the
manufacturing process it is in contact with materials sourced from pigs”
in a black box on a white base, as follows:
In the manufacturing process it intersects

with pork sourced ingredients
signed.
PENNY K. LUKITO
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APPENDIX II
NUMBER 30 YEAR 2020
ABOUT
GUIDELINES FOR COSMETICS MARKING TECHNICAL REQUIREMENTS

SOLAR SCREEN PREPARATION
I. Introduction
Indonesia is a tropical country located in the equator

so you get enough sun exposure
can have an effect on the skin caused by ultra light
violet (UV) rays found in sunlight, including UV A and rays
UV B. Too much UV exposure will have an impact
harmful to human skin, including sunburn and
aging of the skin.
One way to protect the skin from sun exposure
is to use sunscreen preparations. Cosmetics
sunscreen preparations, namely cosmetics containing sunscreen ingredients
sun and serves to protect the skin from the bad effects of sunlight
UV by absorbing, reflecting and/or scattering
the UV light.
The sunscreen ingredients that are allowed to be used in Cosmetics in

Indonesia is listed in the POM Agency Regulation on Requirements
Technical Ingredients for Cosmetics in the Appendix to the List of Sunscreen Ingredients
What Is Allowed In Cosmetics.
The use of sunscreen preparations must be appropriate and
in accordance with the rules so as not to cause unwanted effects
desired. If it is not correct and does not comply with the rules, it can be
reduce the benefits where protection for the skin from the effects
sun exposure is not achieved. Business actors must ensure that sunscreen preparations
made and/or distributed must be
safe, useful and quality.
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Technical Requirements Guidelines for Marking Sunscreen Cosmetics Preparations

can be used as a guide for:
1. Business actors in the field of Cosmetics who will produce and
distributes sunscreen preparations; and
2. POM Agency Officer.
II. GUIDELINES
These guidelines apply only to cosmetic sunscreen preparations, which

has the main function of protecting the skin from UV rays and
can be shown from the content of the ingredients and the level of product claims.
These guidelines do not apply to:
1. Cosmetics with the main function not as cosmetic preparations

sunscreen but lists claims to protect against UV rays.
Example: Cosmetics moisturizing (moisturizer) has a main function
to moisturize facial skin, but also includes claims
protect from UV rays as an additional claim (secondary claim)
other than the main claim.
2. Cosmetics containing sunscreen ingredients to protect the contents

product from the influence of sunlight that can damage the product.
Marking requirements for sunscreen preparations:

1. Warnings listed:
a. Mandatory warning:
“Don't stay out in the sun too long, though
using sunscreen cosmetics. or another sentence
mean the same; and
Other caveats for each of the sunscreen ingredients that are
used, as stated in the Agency Regulations
POM on Technical Requirements for Cosmetic Ingredients.
b. Recommended warning:
Apply repeatedly to maintain protection
on the skin, especially if sweating, after swimming or
use towels;
Excessive sun exposure can be harmful to
health;
Do not use on broken skin;
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Keep away from the eye area when using the product
this. In case of contact with eyes, rinse with water;
Stop using and consult a doctor if
redness or an allergic reaction occurs on the skin; and/or
Use for infants under 6 (six) months old,
consulted with a doctor.
The owner of the Cosmetic Notification Number for sunscreen preparations can
choose to include additional caveats from the example
Suggested warning at no. 1b, according to the product that
owned.
2. How to use must be stated to ensure consumers

using cosmetics sunscreen preparations in large quantities
adequate, for example:
Use 15-30 minutes an adequate amount before skin

exposed to sunlight;
To obtain optimal benefits, do not apply a thin layer.
To get the SPF/PA value as listed
on marking, use a thickness of about 2 mg/cm2;
Applying sunscreen cosmetics should be evenly distributed on the area
areas unprotected by clothing or possibilities
exposed to sunlight; and/or
For consumers who are active in the sun
For example, when exercising outdoors (outdoor), swimming
or sunbathing on the beach, the use of sunscreen is recommended
performed repeatedly every 2 hours or after bathing or when sweating or as
listed in
Marking.
3. Prohibited claims are claims that imply that:

a. the product protects 100% from UV A and/or UV B rays;
b. the product does not need to be reapplied throughout the day; and/or
c. the product functions as a sunblock, except for
Sunscreen cosmetics contain ingredients that can protect
from UV A and UV B rays.
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4. The value of the Sun Protection Factor (SPF) listed in the Marking
sunscreen cosmetics:
Level SPF value
Low 6 - < 15
Currently 15 - < 30
Tall 30 - < 50
Very high 50
Note: If the SPF value is more than 50, then on Marking

listed SPF 50+.
Sunscreen protection against UV B rays is generally stated

with SPF strength on Marking. SPF value shows
how long does the sunscreen preparation cosmetics last?
protects the skin when compared to not wearing a veil
Sun.
For example, a person first experiences redness of the
skin when in direct sunlight for
10 minutes without using sunscreen, then when using sunscreen with SPF 15 the
skin will be protected for 10 x 15 = 150 minutes. Thus, if the person concerned
be in the sun for more than 150 minutes, then

Use of sunscreen cosmetics must be repeated.
signed.
PENNY K. LUKITO
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APPENDIX III
REGULATION OF THE HEAD OF THE DRUG AND FOOD CONTROL AGENCY
NUMBER 30 YEAR 2020
ABOUT
GUIDELINES FOR TECHNICAL REQUIREMENTS FOR MARKING COSMETICS PREPARATIONS
SKIN CONTAINS ALPHA HYDROXY ACID
I. Introduction
Indonesia is a tropical country with air temperatures ranging from

between 25° – 35°C and there is sunshine all year round.
Over time exposure to intense sunlight, ultraviolet radiation and other factors can
cause
skin aging characterized by reduced skin moisture,
skin elasticity, and facilitate the occurrence of pigmentation. Therefore,
Indonesian women use cosmetics a lot with
skin lightening purpose.
Cosmetics with the aim of skin lightening can use Ingredients

Cosmetics, namely Alpha Hydroxy Acid (AHA) which are generally used as
moisturizers, exfoliants and chemical peels. However
Inappropriate and excessive use of AHAs in Cosmetics
can cause harmful effects on skin health.
“Guidelines on Technical Requirements for Marking Cosmetic Skin Preparations

Contains Alpha Hydroxy Acid” can be used as a guide
for:
1. Business actors in the field of Cosmetics who will produce and distribute cosmetic
skin preparations containing Alpha
Hydroxy Acid (AHA); and
II. GROUPING
AHA is an organic acid consisting of 2 (two) carbon chains or

The longer the carbon chain, the bigger it will be
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its molecular weight. The effectiveness of AHA in cosmetic skin preparations

influenced by pH, concentration and availability of free acid. Which
AHAs referred to in this guideline are alpha hydroxy acids
carboxylate, consisting of:
a. glycolic acid;
b. lactic acid;
c. malic acid;
d. tartaric acid;
e. mandelic acid; and
f. citric acid,
including their salts and esters.
The use of AHAs in cosmetic skin preparations is grouped

into 3 (three) namely:
1. Applied alone, referred to as group 1.
The content of AHA in cosmetic skin preparations with levels of

up to 10%, the degree of acidity (pH) 3.5 or more.
2. Applied by doctors, referred to as group 2.

greater than 10% to 20%, degree of acidity (pH)
3.0 or more.
3. Applied by dermatology and venerology specialists,

referred to as group 3.

greater than 20%, the degree of acidity (pH) 3.0 or more for
total rate up to 30%.
The content is calculated as the acid content of a single ingredient or the number of levels
acid from a mixture of AHA ingredients.
III. TAgging
1. Warnings that must be included on the Cosmetics label

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Skin preparations containing AHAs consist of:
a. General warning
Warnings that must be included for Cosmetics with

AHA levels 2.5%:
• If a hypersensitivity reaction occurs (burning, redness,

or other signs of irritation) on the skin, discontinue use and
immediately come to the doctor;
• During use avoid direct contact with light

sun; and
• Do not use around eyes, mouth and membranes

other mucosa.
Additional warnings to include for

Cosmetics used on the affected body area
sunlight with AHA levels 2.5% and not
contain sunscreen ingredients or contain ingredients
sunscreen with levels that are not effective as a sunscreen
Sun:
This product contains Alpha Hydroxy Acid (AHA) which

can increase skin sensitivity to light
sun and in particular the possibility of sunburn.
Use sunscreen, clothes that protect from the sun
sun and limit sun exposure during
use and a week after using the product
this."
b. Special warning:
Warning for Cosmetics skin preparations contain AHA

group 2 other than the warning as stated in
letter a, added a warning:
"Only applied by doctors."
Warning for Cosmetics skin preparations contain AHA

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group 3 other than the warnings listed in

letter a, added a warning:
"Only applied by dermatologists and specialists

venerology."
IV. CIRCULATION OF COSMETICS CONTAINING SKIN PREPARATIONS

AHA
1. Group 1 can be distributed directly to the public;
2. Group 2 is only circulated to doctors;
3. Group 3 is only circulated to dermatologists and

venerology.
V. REPORTING
The owner of the Cosmetic Notification Number is required to report the distribution
Cosmetic skin preparations contain Alpha Hydroxy Acid (AHA)
group 2 and group 3 periodically in January,
April, July and October. Reports are submitted to the Head of the Agency
POM cq. Directorate of Cosmetics Supervision by electronic mail at the address
laporkosmetik@pom.go.id and/or written letter
using the reporting format as stated in the
number VI.
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VI. COSMETICS DISTRIBUTION REPORTING FORMAT

CONTAINS ALPHA HYDROXY ACID (AHA) GROUP 2 AND
GROUP 3
Dear,
Head of the Food and Drug Administration
Cq. Director of Cosmetics Supervision Jl.
State Printing No. 23
Jakarta
DISTRIBUTION REPORT
SKIN PREPARATION COSMETICS
CONTAINS ALPHA HYDROXY ACID (AHA)
A. General
Quarter*) : 1. JANUARY – MARCH

2. APRIL – JUNE
3. JULY – SEPTEMBER
4. OCTOBER – DECEMBER
Year : ………………………………………………..........
Company name : ………………………………………………..........
Office address : ………………………………………………..........
Warehouse Address : ………………………………………………..........
*): Select one

- 28 -
B. Distribution of Cosmetics for Skin Preparations Containing Alpha Hydroxy Acid (AHA)
NO NAME FORM NUMBER STOCK PACKING RECEPTION EXPENDITURE FOR STOCK

COSMETICS PREPARATION NOTIFICATION BEGINNING END
From Amount Batch Number Name of Doctor Address Number of Batch Number
1 2 3 4 5 6 7 8 9 10 11 12 13 14
Thus this information report is made in truth.
………, ………………….
The head of the company Technical Responsible
( ) ( )
signed.
PENNY K. LUKITO
- 29 -
APPENDIX IV
NUMBER 30 YEAR 2020
ABOUT
GUIDELINES FOR TECHNICAL REQUIREMENTS FOR MARKING COSMETICS PREPARATIONS
TEETH WHITENING CONTAINS AND/OR REMOVES

HYDROGEN PEROXIDE
I. Introduction
Teeth whitening is not a new thing in dentistry.

even recently it has become popular and now it's wrong
one of the most frequently requested cosmetic procedures in practice
modern dentistry. Some people crave an attractive smile, so a pleasant tooth color is a
symbol of oral health. White teeth are believed to improve
self-image, self- confidence and have a positive impact on quality

life.
One of the ingredients used in cosmetic teeth whitening preparations

is hydrogen peroxide. Hydrogen peroxide is a strong oxidizing agent that is environmentally
friendly because it does not leave a harmful residue.
The strength of the oxidizing agent can also be adjusted as needed.
However, the use of hydrogen peroxide in teeth whitening preparations
inappropriately also has risks so that it can cause adverse effects
harmful to human health. Supervised hydrogen peroxide
is Hydrogen peroxide present or released in the preparation
teeth whitener.
- 30 -
Guidelines for Technical Requirements for Marking Cosmetics for Teeth Whitening Preparations
Containing and/or Releasing Hydrogen Peroxide can be used

as a guide for:
1. Business actors in the field of Cosmetics who will produce and
distributes teeth whitening cosmetics containing hydrogen
peroxide and/or contain compounds that can release
hydrogen peroxide; and
II.GROUPING
The use of hydrogen peroxide in teeth whitening preparations is grouped

into 3 (three) namely:
1. Self-applied is referred to as group 1.
Hydrogen peroxide in teeth whitening preparations up to
with 0.1%.
2. Used by consumers under the supervision of a dentist is called
as group 2.
Hydrogen peroxide in teeth whitening preparations with levels of more than
0.1% to 6%.
3. Only applied directly by the dentist is referred to as
group 3.
Hydrogen peroxide in teeth whitening preparations with levels of more than
6% to 35%.
Notes:
The level limit is calculated as the amount of Hydrogen peroxide present or not
released.
Examples of materials or compounds that can release Hydrogen peroxide
namely carbamide peroxide. Levels of 10% Carbamide peroxide equivalent to
3.6% Hydrogen peroxide.
III. TAgging
1. Warnings that must be included on the Cosmetic Marking

teeth whitening preparations containing and/or releasing Hydrogen
peroxide consists of:
a. Warning for Cosmetics teeth whitening preparations group 1:
• Not for use under 18 years old.
- 31 -
• Lists the percentage of Hydrogen peroxide.

b. Warning for Cosmetics teeth whitening preparations group 2:
• Not for direct sale to the general public.
• Can only be obtained through a dentist.
• Read and follow instructions, use as directed.
• Do not use this preparation 2 weeks before or
after dental repair.
• Not used by pregnant women, smokers and/or drinkers
alcohol.
• Immediately discontinue use if you experience sensitive teeth, gum irritation,

toothache, tooth decay repair, gingivitis, nausea,
and others.
• Keep out of reach of children.

c. Warning for Cosmetics teeth whitening preparations group 3:
• Not for direct sale to the general public.
• Only applied by dentists.
• Do not use this preparation 2 weeks before or
after dental repair.
• Not used by pregnant women, smokers and/or drinkers
alcohol.
• Immediately discontinue use if you experience sensitive teeth, gum irritation,

toothache, tooth decay repair, gingivitis, nausea,
and others.
IV. CIRCULATION OF COSMETICS FOR TOOTH WHITENING
CONTAINS AND/OR REMOVES HYDROGEN PEROXIDE

1. Group 1 can be sold directly to the general public.
2. Groups 2 and 3 can only be circulated to doctors
teeth, and are not sold directly to the general public.
- 32 -
V.REPORTING
The owner of the Cosmetic Notification Number is required to report the distribution of Cosmetics
teeth whitening preparations containing and/or releasing Hydrogen

group 2 and group 3 peroxide periodically in January,
April, July and October. The report is submitted to the Head of the POM
cq. Directorate of Cosmetics Supervision by e-mail with
laporkosmetik@pom.go.id address and/or written letter using
reporting format as stated in number VI.
- 33 -
VI. REPORTING FORMAT OF BLEACH COSMETICS DISTRIBUTION
TEETH CONTAINS AND/OR REMOVES HYDROGEN PEROXIDE

GROUP 2 AND GROUP 3
Dear,
Head of the Food and Drug Administration
Cq. Director of Cosmetics Supervision
Jl. State Printing No. 23
Jakarta
DISTRIBUTION REPORT
COSMETICS CONTAINS TOOTH WHITENING AND/OR

REMOVING HYDROGEN PEROXIDE
A. General
Quarter*) : 1. JANUARY – MARCH

2. APRIL – JUNE
3. JULY – SEPTEMBER
4. OCTOBER – DECEMBER
Year : ………………………………………………..........
Name Owner Number :

Notifications ………………………………………………………………..
Office address : ………………………………………………..........
Warehouse Address : ………………………………………………..........
*): Select one

- 34 -
B. Distribution of Cosmetic Teeth Whitening Preparations Containing and/or Releasing Hydrogen Peroxide
NO NAME FORM NUMBER STOCK PACKING RECEPTION EXPENDITURE FOR STOCK

COSMETICS PREPARATION NOTIFICATION BEGINNING END
From Amount Batch Number Name Address Amount Batch
Dentist number
1 2 3 4 5 6 7 8 9 10 11 12 13 14
Thus this information report is made in truth.
………………..,
……………….
The head of the company Technical Responsible
( ) ( )
signed.
PENNY K. LUKITO

BPOM Regulation No. 30 Year 2020 - Cosmetic Marking Technical Requirements

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BPOM Regulation No. 30 Year 2020 - Cosmetic Marking Technical Requirements

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NATIONAL AGENCY OF DRUG AND FOOD CONTROL

REGULATION OF THE DRUG AND FOOD CONTROL AGENCY

BY THE GRACE OF GOD ALMIGHTY

HEAD OF THE DRUG AND FOOD CONTROL AGENCY,

Considering: a. that the provisions of the marking technical requirements

provisions of Article 5 paragraph (3) of the Regulation of the Minister of Health

Number 1176/MENKES/PER/VIII/2010 of 2010

In view of: 1. Presidential Regulation Number 80 of 2017 concerning

2. Rules Minister Health Number

1176/MENKES/PER/VIII/2010 of 2010 concerning

Drug and Food Control (State Gazette of the Republic of Indonesia

To stipulate: REGULATION OF THE DRUG AND FOOD SUPERVISORY AGENCY

In this Agency Regulation what is meant by:

3. Cosmetic Ingredients are ingredients or mixtures of ingredients

The marking must meet the following criteria:

Marking other than meeting the provisions as

referred to in Article 2 must also:

a. clear and easy to read; and

b. not easily separated or separated from the packaging, faded,

as referred to in Article 2 and the provisions

as referred to in Article 3 as well as guaranteeing

Cosmetics produced for distribution in the region

Indonesia has complied with the Marking technical requirements.

in paragraph (1) must comply with the information on the Marking.

(1) Information on Marking as referred to in

Article 4 paragraph (2) at least in the form of information

f. full name and address of the Notification Number Owner;

h. size, content, or net weight;

l. warning and/or attention.

(2) Benefit/usage and how to use

benefits or uses and how to use them.

(3) 2D Barcode as referred to in paragraph (1) letter k

(1) Marking must be written in Indonesian.

(3) Information as referred to in Article 5 paragraph (1)

(4) In addition to the information as referred to in Article 5

(2) In the case of Cosmetics packaged in Primary Packaging

Primary Packaging size and shape, Marking on

In addition to the Marking technical requirements as intended

c. teeth whitening preparations containing and/or

Owner of Notification Number who already has notification number

Indonesia Year 2015 Number 1986) as long as it regulates

This Agency Regulation comes into force on the

GUIDELINES FOR COSMETICS MARKING TECHNICAL REQUIREMENTS

As Indonesia's commitment to the ASEAN Harmonization agreement in the field of Cosmetics,

Cosmetic Marking Technical Requirements Guidelines can be used

II. COSMETICS MARKING TECHNICAL REQUIREMENTS

Cosmetics name is a series of names consisting of brands and cosmetics

Example of Cosmetics name: NOOR Body Lotion Jasmine

brand name type variant

Examples of Cosmetics that must include benefits/usage:

Examples of Cosmetics that must include how to use:

2. Using the name of the Cosmetic Ingredients according to the name

Example: Titanium dioxide (nano)

primary and/or secondary should also be listed, if packaging

f. Full Name and Address of Owner of Notification Number

Issued by : PT. CITA, Jl. Rose no. 23B, Jakarta-Indonesia

- Imported and circulated by : PT. CITA, Jl. Rose no. 23B,

- Imported by : PT. CITA, Jl. Rose no. 23B, Jakarta-Indonesia

- Circulated by : PT. CITA, Jl. Rose no. 23B, Jakarta-Indonesia

Produced : PT. ANITA, Indonesia

For : PT. CITA, Jl. Rose no. 23B, Jakarta-Indonesia

Batch number is a number and/or letter or a combination