Product Information

Hamburg, 27-Jun-2024
Page 1 of 5

Product number: 101299

Product name: Neo Heliopan® Hydro USP

Product Description

INCI Names : Global INCI Name : Phenylbenzimidazole Sulfonic Acid

EU INCI Name : Phenylbenzimidazole Sulfonic Acid
China INCI Name (1) : Phenylbenzimidazole Sulfonic Acid

1) China INCI means product ingredients are listed in the Inventory of Existing Cosmetic Ingredients in China
(IECIC) in the version in force.
When China INCI Name shows "---" at least one ingredient is not listed in the IECIC list.

CAS Number : 27503-81-7

Molecular weight : 274,3 g/mol

Molecular formula : C13-H10-N2-O3-S

1. Regulatory status
a. Composition

Please refer to the INCI-Key

b. Preservatives and Antioxidants and Incidental Ingredients

None

c. Conformity Declaration to Regulation (EC) NO 1223/2009

This product complies with the Cosmetics Regulation (EC) No 1223/2009 and its annexes in force.

d. Inventories and Registrations

Ingredient
NICNAS
EINECS

ELINCS

TSCA*

PICCS

IECSC
NDSL

ENCS
AICS

ISHL
KECI
AIIC
DSL

Phenylbenzimidazole Sulfonic Acid Y N Y Y N N N N N Y N Y Y

Y = Yes ; N = No ; R = Registration by Symrise * TSCA registration not required for cosmetics

Custom Tariff 29339980900

e. SVHC

This product has not been formulated with musk xylene and / or any other substances listed in the current
candidate list of Substances of Very High Concern published by the European Chemicals Agency (ECHA),
including the first candidate list published on the 28th of October 2008 through the latest published list.
(Declaration Limit: 0.1 %)
Product Information
Hamburg, 27-Jun-2024
Page 2 of 5

Product number: 101299

Product name: Neo Heliopan® Hydro USP

f. China NMPA submission code

Symrise has submitted this product via the NMPA (National Medical Products Administration) cosmetic
ingredient online submission portal. The following submission code has been assigned: 001270-00943-8174

g. CANADA Hotlist

This product has not been formulated with ingredients listed in the Cosmetic Ingredient Hotlist of Health
Canada which are prohibited or restricted for use in cosmetics.

h. California SB 484

This product has not been formulated with materials that are reportable within SB484, the California Safe
Cosmetics Act as causing cancer or reproductive toxicity.

i. Nanomaterials

For cosmetic products, 'nanomaterial' refers to an insoluble or biopersistent and intentionally manufactured
material. A nanomaterial has one or more external dimensions, or an internal structure, on the scale from 1 to
100 nm.

This product does not contain any intentionally added ingredients considered as nanoparticle as defined by
Cosmetic Regulation (EC) No 1223/2009 on cosmetic products.

j. Animal testing

We hereby confirm that our product has not been tested on animals for cosmetic purpose by or on behalf of
Symrise after 11 March 2009 for all human health effects and after 11 March 2013 for the repeated-dose
toxicity, reproductive toxicity, and toxicokinetics according to Cosmetic Regulation (EC) No 1223/2009.
The product or any of its components has been tested on animals by or on behalf of Symrise for the safety
purpose or for legislative requirements.

k. GMO

This product has not been produced with genetically modified organisms (GMO) ingredients or by-products.

2. ORIGIN

Please refer to the Product Description section and to the Origin statement

a. Naturalness calculation according ISO 16128

Please refer to the ISO 16128 calculation statement

b. CITES

Please refer to : http://checklist.cites.org/#/en: http://checklist.cites.org/#/en

c. BSE/TSE

This product does not contain any ingredients of animal origin and is therefore not concerned by BSE/TSE.
Product Information
Hamburg, 27-Jun-2024
Page 3 of 5

Product number: 101299

Product name: Neo Heliopan® Hydro USP

d. Biodegradability

Biodegradability describes the potential of organic substances to be degraded by microorganisms.

The biodegradability assessment of our product is based on experimental data of the individual organic
ingredients (declaration limit: 0.1%). Data are obtained from tests performed according to OECD 301/310,
OECD 302 and equivalent ISO guidelines.

The category “Biodegradable” is the sum of the percentages (by weight) of ingredients which are readily or
inherently biodegradable.
The category “Not biodegradable” is the sum of the percentages (by weight) of ingredients which are not
readily or not inherently biodegradable.
The category “Not reviewed” is the sum of the percentages (by weight) of ingredients without experimental
biodegradation data.

 Not biodegradable: 100,0 %

3. Other documents available

Impurities statement
CMR statement
California Prop. 65 statement
Allergens (26 allergens)
SDS
Flow Chart
Origin information
Kosher Certificate : Symrise Germany

4. Product Characteristics

Organoleptic Properties

Code Parameter Unit Lower Upper

Limit Limit

0223 Initial odor

Odor comparable to standard

0864 Visual evaluation in sample vial

Appearance powder

0864 Visual evaluation in sample vial

Color white to light beige

Chemical-Physical Properties

Code Parameter Unit Lower Upper

Limit Limit

0855 Assay (USP / NF) Neo Heliopan Hydro

Assay (Pharmacopoeia) % 98,0 102,0

0253 IR identity USP/NF Diamond ATR-Unit with

planar Press Tip
Identity (IR) passed test
Product Information
Hamburg, 27-Jun-2024
Page 4 of 5

Product number: 101299

Product name: Neo Heliopan® Hydro USP

0855 Loss on drying (USP / NF)

Loss on drying (Pharmacopoeia) % 2,0

0495 Examination supplier certificate

Extinction (E1%,1cm) 920,0 990,0

0855 USP-NF 2023

Pharmacopoeia passed test

0829 Identity (USP / NF)

UV/VIS spectrum passed test

Microbiological Properties
Due to the composition of the product no microbiological control will be carried out prior to shipping.

Cosmetic Regulation
Country / Region Status Application
Mexico approved max. 8,00 %
Mercosur approved max. 8,00 %
USA approved max. 4,00 %
Taiwan approved max. 4,00 %
China approved max. 8,00 %
ASEAN approved max. 8,00 %
South Korea approved max. 4,00 %
South Africa approved max. 8,00 %
Brazil approved max. 8,00 %
Japan approved max. 3,00 % rinse-off products
approved max. 3,00 % leave-on products
not approved applied to mucous membranes
Canada approved max. 4,00 %
Australia approved max. 4,00 %
EU approved max. 8,00 %

Shelf life and Storage conditions

In the original, unopened container, dry, 5 to 40°C storage: 36 months
Product Information
Hamburg, 27-Jun-2024
Page 5 of 5

Product number: 101299

Product name: Neo Heliopan® Hydro USP

The use of this product sample is limited to evaluation purposes alone; all intellectual property rights relating to
this product are and shall remain the exclusive property of the copyright owner. If you wish to use this product
for any other purpose, you need to enter into an appropriate agreement with the copyright owner.

The information provided to you in this Product Information is to the best of our knowledge and has been
compiled with the utmost reasonable care. The facts contained herein are based on our own examinations or
have been provided to us by third parties and shall only be read as a comprehensive description of the quality
of the respective product. Nothing herein shall be interpreted as a guarantee. It is your responsibility to ensure
that the usage of this cosmetic raw material, and the levels of such usage, are permitted at all times according
to the relevant laws and regulations. You hereby acknowledge that you are not entitled to rely on the accuracy
or completeness of any information provided herein and that you shall be entitled to rely solely on such
representations and warranties regarding information provided to you as may be made to you in any final
definitive agreement subject to the terms and conditions of such agreement.

This Product Information shall not be updated automatically.

Symrise AG

This is a computer printout and has therefore not been signed by hand.