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Ao7 Spectra

D&C Orange 4 is a certified orange powder colorant used in cosmetics and externally applied drugs. It has a bright reddish orange hue and absorbs maximally at 487nm. The product is specified to contain at least 87% pure dye and have less than specified limits of heavy metals like arsenic, lead, and mercury. It can be safely used in amounts consistent with good manufacturing practices and has a shelf life of 8 years if stored properly.

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21 views

Ao7 Spectra

D&C Orange 4 is a certified orange powder colorant used in cosmetics and externally applied drugs. It has a bright reddish orange hue and absorbs maximally at 487nm. The product is specified to contain at least 87% pure dye and have less than specified limits of heavy metals like arsenic, lead, and mercury. It can be safely used in amounts consistent with good manufacturing practices and has a shelf life of 8 years if stored properly.

Uploaded by

DHRUV
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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Download as PDF, TXT or read online on Scribd
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TECHNICAL DATA SHEET

Rev Date: 25-Nov-19

D & C ORANGE 4
2.FD.004000
Product Data
Category / Description: FDA Certified Colorant
Appearance / Odor: ORANGE POWDER, NO ODOR
Hue: Bright Reddish Orange
Chemical Family: MONOAZO
CAS Number: 633-96-5
EINECS Number: 211-199-0
Color Index Name: ACID ORANGE 007
Color Index Number: 15510
INCI Name: CI 15510 - Orange 4

Applications
USE STATEMENT:
Properties /Specifications
D&C Orange No. 4 may be safely used
Max Absorbance Wavelength (nm+/-5nm): 487 for coloring externally applied drugs
Molecular Weight:……………………………… 350.32 and externally applied cosmetics in
pH:……………………..……..…………………………. 6-8 amounts consistent with good
Pure Dye Content, (%):………………………………. not less than 87% manufacturing practice.
Light Fastness:…………………….…………………… fair (3-5, AATCC)
Arsenic (As):……………………………….………….. <3 ppm
Lead (Pb):……………………..…………….……………. <20ppm
Mercury (Hg):…………..………………………………. <1ppm

Microbiological Analysis: TOTAL VIABLE BACTERIAL COUNT: <1000cfu/g


TOTAL YEAST FUNGI (MOLD) COUNT: <100cfu/g
STAPHYLOCOCCUS AUREUS: ABSENT IN 10g
E-COLI: ABSENT IN 10g
SALMONELLA: ABSENT IN 10g
PSEUDOMONAS: ABSENT IN 10g

Shelf Life
 8 years (unopened container)

Storage Instructions
 Store the product in original packaging with the original seal intact, in a dry environment, protected from heat and light
 Store material sealed; recommended storage temperature between 60°F and 85°F (15°C and 30°C)
 Keep the original label intact and legible; keep container in good condition, protect from physical damage
 Keep all opened containers tightly sealed in an area that is secure and clean

Regulatory
TSCA Status:……………………………………….. IN COMPLIANCE
DSL Status:………………………………………. LISTED

25 Rizzolo Road, Kearny, NJ 07032 ■ Intl: +1 201 997 0606 ■ F: +1 201 997 0504 ■ USA: 800 527 8588 ■ F: 800 635-1811
Page 1 of 2

[email protected] www.SpectraColors.com
TECHNICAL DATA SHEET
Rev Date: 25-Nov-19

D & C ORANGE 4
2.FD.004000

CFR 21, SEC. 74.1254 & 74.2254


Field of Application Definition, as per EC directive 76/768/EEC for use of colours in cosmetics: 2 - Colouring agents allowed in
all cosmetic products except those intended to be applied in the vicinity of the eyes, in particular eye make-up and eye-make-
up remover.

Japan MHLW Ordinance No. 126 of July 29, 2003 - Coal-Tar Colors

ASEAN Cosmetic Directive, Annex IV, part 1 - allowed to use in Cosmetic as per field of Application 1.

China Technical Safety Standards for Cosmetics (TSSC 2015)

HS Code: 3204.12.0000

For more information about this product, contact [email protected]

WARRANTY, DISCLAIMER OF WARRANTIES AND LIMITATIONS OF REMEDY: SPECTRA COLORS CORP. makes every effort to assure that the information herewith
enclosed in this transmission is accurate and current, to the best of our knowledge. Beyond the scope of these claims, Spectra Colors makes no promises as to the performance of our
products in our customers finished applications; neither can we anticipate end-use characteristics. Likewise it is the end-user's responsibility to assure that Spectra Colors dye products are
in compliance with all local, federal and global regulations regarding the storage, the use and the disposal of these same dye products. Spectra Colors Corp. provides these materials for
informational purposes only and does not hereby make any express or implied warranty regarding merchantability, fitness for a particular purpose, regulatory compliance, or any other matter.

25 Rizzolo Road, Kearny, NJ 07032 ■ Intl: +1 201 997 0606 ■ F: +1 201 997 0504 ■ USA: 800 527 8588 ■ F: 800 635-1811
Page 2 of 2

[email protected] www.SpectraColors.com

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