spectra colors corp. · 2013. 11. 7. · 1.fc.0060g0 f d & c yellow 6 granules 20% is 2.50% is
TRANSCRIPT
& Applications
FDA Colorants Formulations
Prod
uct C
ode
Descri
ption
Dye Fo
rm /
Lake
Streng
th
Wate
r
Etha
nol 1
00%
Etha
nol 2
5%
Glycer
ol
Prop
ylene
Glycol
Ethy
l Ace
tate
Aceton
e
DMFMet
hano
l
Veget
able
Oil
Toluen
e
Benz
ene
N-Buty
l Ace
tate
Ammonia
Powde
rs
Fats
Light
Fastn
ess
Heat S
tabilit
y of
Color
pH Stab
ility
Stable at pH 2 - 11 Stable <210 C (>210
C dark tint)Stable at pH 2 - 11
Stable <210 C (>210C dark tint)
SISI%05.2SISISISISISISISI%1SI%05.2SI%02redwoP5 WOLLEY C & D F0P0500.CF.1 6
SISISISISISISI%1SI%05.2SI%02selunarG5 WOLLEY C & D F0G0500.CF.1 IS 2.50% IS IS 6
1.FC.005LL0 F D & C YELLOW 5 ALUM LAKE LL (15-17%) IS IS IS IS IS SS IS IS IS IS IS IS IS S DP DP NA NA NA
1.FC.005LM0 F D & C YELLOW 5 ALUM LAKE LM (24-26%) IS IS IS IS IS SS IS IS IS IS IS IS IS S DP DP NA NA NA
1.FC.005LS0 F D & C YELLOW 5 ALUM LAKE LS (29-31%) IS IS IS IS IS SS IS IS IS IS IS IS IS S DP DP NA NA NA
SISI%1SISISISI%1SISISI%1.0<SI%05.2SI%02redwoP6 WOLLEY C & D F0 P0600.CF.1 4
SISISI%1SISISI%1.0<SI%05.2SI%02selunarG6 WOLLEY C & D F0G0600.CF.1 IS 1% IS IS 4
1.FC.006LL0 F D & C YELLOW 6 ALUM LAKE LL (15-17%) IS IS IS IS IS SS IS IS IS IS IS IS IS S DP DP NA NA NA
1.FC.006LM0 F D & C YELLOW 6 ALUM LAKE LM (21-23%) IS IS IS IS IS SS IS IS IS IS IS IS IS S DP DP NA NA NA
1.FC.006LL0 F D & C YELLOW 6 ALUM LAKE LS (35-37%) IS IS IS IS IS SS IS IS IS IS IS IS IS S DP DP NA NA NA
ANANSIANANANANANANANANANredwoP7 WOLLEY C & D000700.DF.1 NA NA NA NA NA NA NA
SISISI%09.8%03.1SISI%1.0<%1.0<%00.7%33.3%01redwoP8 WOLLEY C & D000800.DF.1 IS IS IS IS 4 Stable <210 C (>210C powder burns)
Stable at pH 2-11
SISISISI%5SISI%1%05.0%5SI%5redwoP01 WOLLEY C & D000010.DF.1 IS 1.20% IS IS 4 Stable <150 C (>150C reddish tint)
Stable at pH 2-11
1.FD.010LM0 D & C YELLOW 10 ALUM LAKE (22-25%) IS IS IS IS IS SS IS IS IS IS IS IS IS S DP DP NA NA NA
SISISSSI%2%1%06.1SI%06.0SISISIredwoP11 WOLLEY C & D000110.DF.1 1.60% IS IS IS NA NA NA
SISISI%1%1SISISI%52.0%5%1%5redwoP4 EGNARO C & D000400.DF.2 IS 1.60% IS IS 4 Stable <250 C Stable at pH 2-11
SISISI%2%06.1%52.1SI%05.0SI%02.0%1SIredwoP5 EGNARO C & D000500.DF.2 IS 5% IS IS NA NA NA
SISI%5SISISISI%1%5SISI%06.1SI%05.2SI%7selunarG 3 DER C & D F0G0300.CF.4 3
SISISI%1%5SISI%06.1SI%05.2SI%7redwoP 3 DER C & D F0P0300.CF.4 IS 5% IS IS 3
SISISISI%1SISISISI%1SI%5redwoP4 DER C & D F000400.CF.4 IS 5% IS IS NA NA NA
SISISI%2%1SISI%01.0SI%06.1SI%07.22selunarG04 DER C & D F0G0040.CF.4 IS 3.30% IS IS 5
SISISI%2%1SISI %01.0SI%06.1SI%07.22redwoP04 DER C & D F0P0040.CF.4 IS 3.30% IS IS 5
4.FC.040LL0 F D & C RED 40 ALUM LAKE LL (13-16%) IS IS IS IS IS SS IS IS IS IS IS IS IS S DP DP NA NA NA
4.FC.040LM0 F D & C RED 40 ALUM LAKE LM (21-24%) IS IS IS IS IS SS IS IS IS IS IS IS IS S DP DP NA NA NA
4.FC.040LS0 F D & C RED 40 ALUM LAKE LS (39-42%) IS IS IS IS IS SS IS IS IS IS IS IS IS S DP DP NA NA NA
SISISISI%01.1SISI%1.0<SISISI%05.0redwoP6 DER C & D000600.DF.4 IS 0.50% IS IS NA NA NA
4.FD.007LC0 D & C RED 7 Ca LAKE, 45%BaFree (41-46%) IS IS IS IS IS SS IS IS IS IS IS IS IS S DP DP NA NA NA
4.FD.007LD0 D & C RED 7 Ca LAKE (60-70%) IS IS IS IS IS SS IS IS IS IS IS IS IS S DP DP NA NA NA
%07.0SISISI%05.0SI%03.0SISISISISIredwoP71 DER C & D000710.DF.4 0.20% IS IS IS NA NA NA
SISI%06.1%05.2%06.1%1SISISI%24.1SIredwoP12 DER C & D000120.DF.4 1.42% 1% 1% IS IS NA NA NA
4.FD.021LL0 D & C RED 21 ALUM LAKE (13-15%) IS IS IS IS IS SS IS IS IS IS IS IS IS S DP DP NA NA NA
SISISI%1%5SISI%05.0%03.0%5SI%5redwoP22 DER C & D000220.DF.4 IS 5% IS IS 4 Stable <250 C Stable at pH 4-11
%05.0SISI%1%05.2%05.2%02.1SISI%03.0%1SIredwoP72 DER C & D000720.DF.4 1% 1% IS IS 4 Stable <250 C Water Insoluble
SISISI%9%18.2%52.0%01.0<%03.0%1.0<%00.01%1%02redwoP82 DER C & D000820.DF.4 IS 8.7% IS IS 4 Stable <250 C Stable at pH 5-11
SISISISISI%1.0<SISISISISISIredwoP03 DER C & D000030.DF.4 IS IS IS IS NA NA NA
4.FD.030LS0 D & C RED 30 ALUM LAKE (29-31%) IS IS IS IS IS SS IS IS IS IS IS IS IS S DP DP NA NA NA
4.FD.030LT0 D & C RED 30 TALC LAKE (31-33%) NA NA NA NA NA NA NA NA NA NA NA NA NA NA DP DP NA NA NA
4.FD.030LX0 D & C RED 30 TALC LAKE (19-21%) NA NA NA NA NA NA NA NA NA NA NA NA NA NA DP DP NA NA NA
SISISI%1%5SISI%05.0%05.0%1SI%5redwoP33 DER C & D000330.DF.4 IS 1% IS IS 4Stable <210 C (>210 C turns
brownish)
Stable at pH 4-10 (pH <4, pH >10 turns orange)
4.FD.033LS0 D & C RED 33 ALUM LAKE (18-20%) IS IS IS IS IS SS IS IS IS IS IS IS IS S DP DP NA NA NA
SISI%1SISISISI%1%05.2SISI%03.2SI%1SI%02selunarG1 EULB C & D F0G0100.CF.5 5
SISISI%1%05.2SISI%03.2SI%1SI%02redwoP1 EULB C & D F0P0100.CF.5 IS 1% IS IS 5
5.FC.001LL0 F D & C BLUE 1 ALUM LAKE LL (11-13%) IS IS IS IS IS SS IS IS IS IS IS IS IS S DP DP NA NA NA
5.FC.001LM0 F D & C BLUE 1 ALUM LAKE LM (19-23%) IS IS IS IS IS SS IS IS IS IS IS IS IS S DP DP NA NA NA
5.FC.001LS0 F D & C BLUE 1 ALUM LAKE LS (39-44%) IS IS IS IS IS SS IS IS IS IS IS IS IS S DP DP NA NA NA
SISI%1SISISISI%1%05.2SISI%66.1%03.0%1SI%54.1selunarG2 EULB C & D F0G0200.CF.5 3
SISISI%1%05.2SISI%66.1%03.0%1SI%54.1redwoP2 EULB C & D F0P0200.CF.5 IS 1% IS IS 3
5.FC.002LL0 F D & C BLUE 2 ALUM LAKE LL (11-15%) IS IS IS IS IS SS IS IS IS IS IS IS IS S DP DP NA NA NA
5.FC.002LM0 F D & C BLUE 2 ALUM LAKE LM (17-19%) IS IS IS IS IS SS IS IS IS IS IS IS IS S DP DP NA NA NA
5.FC.002LS0 F D & C BLUE 2 ALUM LAKE LS (31-35%) IS IS IS IS IS SS IS IS IS IS IS IS IS S DP DP NA NA NA
SISISI%1%1SISI%1%52.0%02.1%03.0%01.9redwoP3 NEERG C & D F0N0300.CF.6 IS 1.60% IS IS 3 Stable <250 CStable at pH 2-11
(pH >9 turns bluish)
SISISI%05.0%1SISI%05.0%03.0%06.1SI%5redwoP5NEERG C & D000500.DF.6 IS 1% IS IS 7 Stable <250 C Stable pH 5-11
%07.0SISSSI%03.0SI%03.0%41.0SISISISIredwoP6NEERG C & D000600.DF.6 0.50% IS IS IS NA NA NA
SISI%5SISISISI%02.1SISISI%06.1SI%05.2%52.0%01redwoP8NEERG C & D000800.DF.6 3 Stable <210 C (>210C turns brownish)
Stable at pH 2-11 (pH <4, pH >9 turns
yellowish)
%05.0%05.0%05.0SI%03.0%02.0SISISISISI.S.IredwoP2 TELOIV C & D000200.DF.7 IS IS IS IS NA NA NA
SISISI%05.0%1%1SI%1%1%03.0%1%03.0redwoPLANRETXE 2 TELOIV C & D0E0200.DF.7 IS 0.60% IS IS 5 Stable <250 C Stable at pH 2-11
IS = Insoluble
SS = Slightly Soluble
S = Soluble
DP = Dispersible
Stable <210 C (>210 C turns dark)
Stable at pH 2-11 (pH >11 turns dull
yellowish)
Stable at pH 2 - 11 Stable <210 C (>210
C dark tint)
Stable <210 C (>210C turns dark)
Stable at pH 5-12 (pH 1&2 completely
precipitates)
Stable <210 C (>210C becomes dull)
Stable at pH 2-11 (pH >9 turns dark)
DISCLAIMER: This data is intended as a guideline only, and may vary based on formulation variables. We make no claim as to the accuracy or absolute value in customer applications. Please confirm any findings in your products or formulas.
LEGEND:
Stable <210 C (>210C turns dark)
Stable at pH 1-10 (pH >12 turns
greenish)
Stable at pH 2-11 (at pH 1 green
color)
Stable <180 C (>180C green shade)
Prod
uct C
ode
Descri
ption
Dye Fo
rm /
Lake
Streng
th
Food
Cosm
etics
exte
rnall
y app
lied
Eye P
rodu
cts
Lip Pr
oduc
ts
Dentif
rices
, Mou
thwash
Exte
rnall
y app
lied D
rugs
Inge
sted D
rugs
Drugs
appli
ed to
eye a
rea
Drugs
in Li
p Pro
ducts
Drugs
in D
entif
rices
, Mou
thwas
h
REDWOP5 WOLLEY C & D FP0500.CF.1 X X X X X X X X X XSELUNARG5 WOLLEY C & D FG0500.CF.1 X X X X X X X X X X
1.FC.005LL F D & C YELLOW 5 ALUM LAKE LL (15-17% ) X X X X X X X X X X1.FC.005LM F D & C YELLOW 5 ALUM LAKE LM (24-26% ) X X X X X X X X X X1.FC.005LS F D & C YELLOW 5 ALUM LAKE LS (29-31% ) X X X X X X X X X X
XXREDWOP6 WOLLEY C & D F P0600.CF.1 X X X X X XXXSELUNARG6 WOLLEY C & D FG0600.CF.1 X X X X X X
1.FC.006LL F D & C YELLOW 6 ALUM LAKE LL (15-17% ) X X X X X X X X1.FC.006LM F D & C YELLOW 6 ALUM LAKE LM (21-23% ) X X X X X X X X1.FC.006LL F D & C YELLOW 6 ALUM LAKE LS (35-37% ) X X X X X X X X
XXREDWOP7 WOLLEY C & D00700.DF.1XXREDWOP8 WOLLEY C & D00800.DF.1
XREDWOP01 WOLLEY C & D00010.DF.1 X X X X X X1.FD.010LM D & C YELLOW 10 ALUMINUM LAKE (22-25% ) X X X X X X X
XXREDWOP11 WOLLEY C & D00110.DF.1XXREDWOP4 EGNARO C & D00400.DF.2
XREDWOP5 EGNARO C & D00500.DF.2 X 1 X X 2 XXXXSELUNARG 3 DER C & D F G0300.CF.4 X **XXXREDWOP 3 DER C & D FP0300.CF.4 X **
XXREDWOP4 DER C & D F00400.CF.4XX XREDWOP6 DER C & D00600.DF.4 X 3 X 3 X 3 X 3
4.FD.007LC D & C RED 7 Ca LAKE , 45%BaFree (41-46% ) X X X X 3 X 3 X 3 X 34.FD.007LD D & C RED 7 Ca LAKE (60-70% ) X X X X 3 X 3 X 3 X 3
XXREDWOP71 DER C & D00710.DF.4XREDWOP12 DER C & D00120.DF.4 X X X X X X
4.FD.021LL D & C RED 21 ALUMINUM LAKE (13-15% ) X X X X X X XXREDWOP22 DER C & D00220.DF.4 X X X X X XXREDWOP72 DER C & D00720.DF.4 X X X X X XXREDWOP82 DER C & D00820.DF.4 X X X X X XXREDWOP03 DER C & D00030.DF.4 X X X X X X
4.FD.030LS D & C RED 30 ALUMINUM LAKE (29-31% ) X X X X X X X4.FD.030LX D & C RED 30 TALC LAKE (19-21% ) X X X X X X X4.FD.030LT D & C RED 30 TALC LAKE (31-33% ) X X X X X X X
XREDWOP33 DER C & D00330.DF.4 X 4 X X X 5 X 5 X4.FD.033LS D & C RED 33 ALUM LAKE (18-20% ) X X 4 X X X 5 X 5 X
REDWOP04 DER C & D FP0040.CF.4 X X X X X X X X X XSELUNARG04 DER C & D FG0040.CF.4 X X X X X X X X X X
4.FC.040LL F D & C RED 40 ALUM LAKE LL (13-16% ) X X X X X X X X X X4.FC.040LM F D & C RED 40 ALUM LAKE LM (21-24% ) X X X X X X X X X X4.FC.040LS F D & C RED 40 ALUM LAKE LS (39-42% ) X X X X X X X X X X
REDWOP1 EULB C & D FP0100.CF.5 X X X X X X X X X XSELUNARG1 EULB C & D FG0100.CF.5 X X X X X X X X X X
5.FC.001LL F D & C BLUE 1 ALUM LAKE LL (11-13% ) X X X X X X X X X X5.FC.001LM F D & C BLUE 1 ALUM LAKE LM (19-23% ) X X X X X X X X X X5.FC.001LS F D & C BLUE 1 ALUM LAKE LS (39-44% ) X X X X X X X X X X
XXXREDWOP2 EULB C & D FP0200.CF.5 X **XXXSELUNARG2 EULB C & D FG0200.CF.5 X **
5.FC.002LL F D & C BLUE 2 ALUM LAKE LL (11-15% ) XXX X **5.FC.002LM F D & C BLUE 2 ALUM LAKE LM (17-19% ) XXX X **5.FC.002LS F D & C BLUE 2 ALUM LAKE LS (31-35% ) XXX X **
XXREDWOP3 NEERG C & D FN0300.CF.6 X X X X X XREDWOP5 NEERG C & D00500.DF.6 X X X X X X X X X
XXREDWOP6 NEERG C & D00600.DF.6REDWOP8 NEERG C & D00800.DF.6 X 6 X 6
XXREDWOP2 TELOIV C & D00200.DF.7XREDWOPLANRETXE 2 TELOIV C & DE0200.DF.7
DISCLAIMER: This information is intended as a guideline only, and is not intended to replace the FDA Regulations as listed in the CFR as they pertain tothese FDA Certi�ed Colorants. We make no claim to the accuracy of the information on this chart. Please con �rm any allowed FDA usage for thesecolorants in your products and formulas.
** Currently the FDA does NOT allow F D&C Red 3 dye and F D&C Blue 2 dye and lakes in Cosmetic or Personal Care products. They are allowed in Food. Please consult us for Drug and Medical Device applications.
LEGEND:1 ) External Drugs: at most 5 mg per day
2) Cosmetics – Lip products: at most 5 % by weight of �nished product.
3) Drugs: combined total of D&C Red No. 6 and D&C Red No.7: < 5 mg per day.
4) Cosmetics – for Lip products: at most 3% by weight of �nished product
5) Drugs - ingested drugs other than mouthwashes and dentifrices: at most 0.75 mg per day.
6) Limit of less than or equal to 0.01 % by weight of �nished drug or cosmetic.
“You’ll Know Us By Our Colors”
Water insoluble
Water insoluble
Water insoluble
Water insoluble
Water insoluble
Product Code DescriptionDye Form / Lake
Strength WaterEthanol100%
Ethanol25% Glycerol
PropyleneGlycol
EthylAcetate Acetone
VegetableOil
Heat Stabilityof Color pH Stability
Product Code DescriptionDye Form / Lake
Strength WaterEthanol100%
Ethanol25% Glycerol
PropyleneGlycol
EthylAcetate Acetone
VegetableOil Powders Fats
LightFastness
Heat Stabilityof Color pH Stability
Stable <210 C & >210C
color turns dark
1.FC.0050P0 F D & C YELLOW 5 Powder 20% IS 2.50% 10% 5% IS IS IS
1.FC.0050G0 F D & C YELLOW 5 Granules 20% IS 2.50% 10% 5% IS IS IS
1.FC.005LL0 F D & C YELLOW 5 ALUM LAKE LL (15-17%) IS IS IS IS IS SS IS DP NA Water Insoluble
1.FC.005LM0 F D & C YELLOW 5 ALUM LAKE LM (24-26%) IS IS IS IS IS SS IS DP NA Water Insoluble
1.FC.005LS0 F D & C YELLOW 5 ALUM LAKE LS (29-31%) IS IS IS IS IS SS IS DP NA Water Insoluble
1.FC.0060P0 F D & C YELLOW 6 Powder 20% IS 2.50% 10% 1% IS IS IS
1.FC.0060G0 F D & C YELLOW 6 Granules 20% IS 2.50% 10% 1% IS IS IS
1.FC.006LL0 F D & C YELLOW 6 ALUM LAKE LL (15-17%) IS IS IS IS IS SS IS DP NA Water Insoluble
1.FC.006LM0 F D & C YELLOW 6 ALUM LAKE LM (21-23%) IS IS IS IS IS SS IS DP NA Water Insoluble
1.FC.006LS0 F D & C YELLOW 6 ALUM LAKE LS (35-37%) IS IS IS IS
IS
IS SS IS DP NA Water Insoluble
Water Insoluble
Water Insoluble
1.FD.007000 D & C YELLOW 7 Powder IS 0.25% IS IS ISISISIS Excellent up to 200C Good: stable at pH 5 -10
1.FD.008000 D & C YELLOW 8 Powder 10% 1% <0.1% <0.1% IS IS ISStable <210C & >210C
color pwd burnsStable at pH 2-11
1.FD.010000 D & C YELLOW 10 Powder 5% IS 5%
5%
0.50% 1% IS IS ISStable <150C & >150C
gives reddish tintStable at pH 2-11
1.FD.010LM0 D & C YELLOW 10 ALUM LAKE (22-25%) IS IS IS IS IS SS IS DP NA
1.FD.011000 D & C YELLOW 11 Powder IS IS IS 0.5% IS 1.60% 1% DP NA
2.FD.004000 D & C ORANGE 4 Powder S 0.5% 5% 1% 1% IS IS IS Stable up to 250C Stable at pH 2-11
2.FD.005000 D & C ORANGE 5 Powder IS <1% <1% IS 0.50% 1.60% 1% DP NA NA
IS IS NA NA
IS IS
IS IS
IS NA
IS NA
IS NA
IS IS NA
IS DP NA
IS NA
IS NA
1.60%
NA
IS
IS
IS
IS
S NA
DP
Stable up to 250 C
Stable up to 250 C
Stable up to 250 C
Stable at pH 4-11
Water Insoluble
Water Insoluble
Water Insoluble
Water Insoluble
Water Insoluble
Water Insoluble
Water Insoluble
Water Insoluble
Water Insoluble
NA
NA
Water Insoluble
Water Insoluble
Water Insoluble
Water Insoluble
Water Insoluble
Water Insoluble
IS
Stable at pH 5-11
2.50%
0.25%
0.50%
<0.1%
DP
DPDP
NA
NA
IS
IS
Stable <210 C: >210 C is brown in water
Stable up to 150 C:>150 C turns more red
>250 C color burns
Stable at pH 4-10, pH <4 & pH >10 turns orange
IS
IS
Powders FatsLight
Fastness
IS IS 4
IS IS 4
DP DP NA
DP DP NA
DP DP NA
IS IS 4
IS IS 4
DP DP NA
DP DP NA
DP DP NA
NA Fair
IS1.FD.0070E0 D & C YELLOW 7 External Powder <0.10% 0.75%1.00% IS ISISISIS Excellent up to 200C Good: stable at pH 5 -10NA Fair
IS IS 4
IS IS 4
DP DP NA
DP DP NA
IS IS 4
DP DP NA
IS IS NA
IS IS 5
IS IS 5
DP DP NA
DP DP NA
DP
DP
DP
DP
DP
DP
DP
DP DP
DP DP
DP
DP
DP
DP DP
NA
IS IS
IS DP
NA
NA
NA
NA
NA
S NA
NA
NA
IS
IS
DP
4
DP DP
4
IS IS
4
IS DP
DP DP
DP DP NA
DP DP NA
IS DP DP DP NA
IS IS 4
7
DP DP NA
DP DP
NA NA
NA NA
IS = Insoluble SS = Slightly Soluble S = Soluble DP = Dispersible
Disclaimer: This data is intended as a guideline only, and may vary based on formulation variables. We make no claim as to the accuracy or absolute value in customer applications. Please confirm any findings in your products or formulas.
LEGEND:
Stable at pH 2 - 11 Stable <210 C
Stable <210 C & >210 C turns dark Stable at pH 2-11,
pH >11 turns dull yellowish
Stable <210 C & >210 C turns dark Stable at pH 2-11,
pH >11 turns dull yellowish
Stable <210C & >210C
becomes dull
Stable at pH 2-11 & turns
dark pH >9
5.FC.0010P0 F D & C BLUE 1
Granules
20% 0.1% 10% 15% 15% 0.5% 0.5%
10% 15% 15% 0.5% 0.5%
IS IS IS 5
5.FC.0010G0 F D & C BLUE 1
Powder
20% 0.1% IS IS IS 5
5.FC.001LL0 F D & C BLUE 1 ALUM LAKE LL (11-13%) IS IS IS IS IS SS IS DP DP NA NA
Water insoluble
Water insoluble5.FC.001LM0 F D & C BLUE 1 ALUM LAKE LM (19-23%) IS IS IS IS IS SS IS DP DP NA NA
5.FC.001LS0 F D & C BLUE 1 ALUM LAKE LS (39-44%) IS IS IS IS IS SS IS DP
DP
DP
DP DP NA NA
5.FC.0020P0 F D & C BLUE 2
Granules
1.45% IS 1% 0.30% 0.1% IS IS IS IS IS 3
5.FC.0020G0 F D & C BLUE 2
Powder
1.45% IS 1% 0.30% 0.1% IS IS IS IS IS 3
5.FC.002LL0 F D & C BLUE 2 ALUM LAKE LL (11-15%) IS IS IS IS IS SS IS DP DP NA NA
5.FC.002LS0 F D & C BLUE 2 ALUM LAKE LS (31-35%) IS IS IS IS IS SS IS DP
DP
DP DP NA NA
6.FC.0030N0 F D & C GREEN 3 Powder 23.20% 0.30% 5% 10% 10% IS IS IS IS IS 3 Stable <250 C Stable at pH 2-11, pH >9 turns blue
6.FD.005000 D & C GREEN 5 Powder 5% IS 1.60% 0.30% 0.50% IS IS IS IS IS 5 Stable <250 C Stable pH 5-11
6.FD.006000 D & C GREEN 6 Powder IS SS IS IS 0.14% 0.30% IS <1% IS <1% NA NA
6.FD.008000 D & C GREEN 8 Powder 10% 0.25% 2.50% IS 1.60% IS IS IS IS IS 3Stable <210 C: >210 C is
brown in water
Stable at pH 2-11,
pH >9 & pH <4 turns yellow
7.FD.002000 D & C VIOLET 2 Powder I.S. IS IS IS IS IS 0.20% DP DP DP NA NA
7.FD.0020E0 D & C VIOLET 2 EXTERNAL Powder 0.30% 1% 0.30% 1% 1% IS 1% IS IS IS 5 Stable up to 250 C Stable at pH 2-11
IS = Insoluble
SS = Slightly Soluble
S = Soluble
DP = Dispersible
DISCLAIMER: This data is intended as a guideline only, and may vary based on formulation variables. We make no claim as to the accuracy or absolute value in customer applications. Please confirm any findings in your products or formulas.
LEGEND:
Stable <210 C & >210 C turns dark
Stable <210 C & >210 C turns dark
Stable at pH 1-10, pH >12 turns green
Stable at pH 1-10, pH >12 turns green
Stable at pH 2-11, at pH 1 is greenStable <180 C: >180 C is green in water
Stable at pH 2-11, at pH 1 is greenStable <180 C: >180 C is green in water
Granules
IS IS IS IS 3 Stable <210 C & >210 C turns dark Stable at pH 5-12,
pH 1-2 completely precipitates4.FC.0030G0 F D & C RED 3 Granules 5% IS 3% 15% 15% IS
4.FC.004000 F D & C RED 4 Powder 10%
20%
20%
IS 1% 1.5% 1%
1%
1%
IS
4.FC.0400P0 F D & C RED 40 Powder IS 5% 2%
2%
IS
4.FC.0400G0 F D & C RED 40 IS 5% IS
4.FC.040LL0 F D & C RED 40 ALUM LAKE LL (13-16%) IS IS IS IS IS SS
4.FC.040LM0 F D & C RED 40 ALUM LAKE LM (21-24%) IS IS IS IS IS SS
4.FC.040LS0 F D & C RED 40 ALUM LAKE LS (39-42%) IS IS IS IS IS SS
4.FD.006000 D & C RED 6 Powder S IS IS S S IS
4.FD.007000 D & C RED 7 Powder SS IS IS IS IS4.FD.007LC0 D & C RED 7 Ca Lake, Barium Free (41-46%) IS
IS
IS IS IS IS SS
4.FD.070LD0 D & C RED 7 Ca LAKE ~70% (70%)
(33%)
IS IS IS IS IS SS
4.FD.017000 D & C RED 17 Powder IS SS IS IS IS 0.30%
0.60%
4.FD.007LE0 D & C RED 7 Ca LAKE 33% IS IS IS IS IS ??
4.FD.021000 D & C RED 21 Powder IS SS IS IS IS 1%
4.FD.021LL0 D & C RED 21 ALUM LAKE (13-16%) IS IS IS IS IS SS
4.FD.022000 D & C RED 22 Powder 5% IS 5% 0.30% 0.50% IS
4.FD.027000 D & C RED 27 Powder IS SS 0.30% IS IS 1.20%
4.FD.028000 D & C RED 28 Powder 20% 1% 10.00% 3%3% <0.10%
4.FD.030000 D & C RED 30 Powder IS IS IS IS IS IS
4.FD.030LS0 D & C RED 30 ALUM LAKE (34-38%) IS
IS
IS IS IS IS
IS IS IS
NA
4.FD.030LT0 D & C RED 30 TALC LAKE (34-38%) IS NA
4.FD.033000 D & C RED 33 Powder 5% IS 1% 0.50% 0.50%
0.14%
IS
4.FD.033LM0 D & C RED 33 ALUM LAKE
Powder
IS IS SS
4.FD.036000 D & C RED 36
(18-20%)
IS IS IS IS
IS IS IS
IS IS NA NAIS IS NA15% 15%4.FC.0030P0 F D & C RED 3 Powder 5% IS IS3%
DP
DPUSA: 800.527.8588 Fax: 800.635.1811 Intl.: 201.997.0606 Fax: 201.997.0504
E-mail: [email protected]
“This catalog outlines the
broad spectrum of our FDA
certified dyes and lakes.
Spectra Colors Corp.
also provides custom color
matching, re-packing and
unsurpassed technical
support for all your color
applications.”
25 Rizzolo RoadKearny NJ 07032 U.S.A.
SpectraColors.com
FDA Colorants Formulations
“You’ll Know Us By Our Colors”
SPECTRA COLORS CORP.
FDA Colorants Applications
Product Code DescriptionDye Form
Lake Strength Food
CosmeticsExternallyApplied
EyeProducts
LipProducts
Dentifrices,Mouthwash
ExternallyAppliedDrugs
IngestedDrugs
Drugs appliedto eye area
Drugs inLip Products
Drugs inDentifrices,Mouthwash
1.FC.0050P0 F D & C YELLOW 5 POWDER X X X X X X X X X X1.FC.0050G0 F D & C YELLOW 5 GRANULES X X X X X X X X X X1.FC.005LL0 F D & C YELLOW 5 ALUM LAKE LL (15-17%) X X X X X X X X X X1.FC.005LM0 F D & C YELLOW 5 ALUM LAKE LM (24-26%) X X X X X X X X X X1.FC.005LS0 F D & C YELLOW 5 ALUM LAKE LS (29-31%) X X X X X X X X X X1.FC.0060P0 F D & C YELLOW 6 POWDER X X X X X X X X1.FC.0060G0 F D & C YELLOW 6 GRANULES X X X X X X X X1.FC.006LL0 F D & C YELLOW 6 ALUM LAKE LL (15-17%) X X X X X X X X1.FC.006LM0 F D & C YELLOW 6 ALUM LAKE LM (21-23%) X X X X X X X X1.FC.006LS0 F D & C YELLOW 6 ALUM LAKE LS (35-37%) X X X X X X X X1.FD.007000 D & C YELLOW 7 POWDER X X
1.FD.008000 D & C YELLOW 8 POWDER X X1.FD.0070E0 D & C YELLOW 7 External POWDER X X
1.FD.010000 D & C YELLOW 10 POWDER X X X X X X X1.FD.010LM0 D & C YELLOW 10 ALUM LAKE (22-25%) X X X X X X X1.FD.011000 D & C YELLOW 11 POWDER X X2.FD.004000 D & C ORANGE 4 POWDER X X2.FD.005000 D & C ORANGE 5 POWDER X XX 11 X XX 22 X4.FC.0030P0 F D & C RED 3 POWDER X X X X4.FC.0030G0 F D & C RED 3 GRANULES X X X X4.FC.004000 F D & C RED 4 POWDER X X
4.FD.00600 D & C RED 6 POWDER X X X X 3 X 3 X 3 X 34.FD.007000 D & C RED 7 POWDER X X X X 3 X 3 X 3 X 34.FD.006000 D & C RED 6 POWDER X X X
4.FD.070LD0 D & C RED 7 Ca LAKE ~70% (70%) X X X X 3 X 3 X 3 X 34.FD.007LC0 D & C RED 7 Ca LAKE, Barlum Free (41-46%) X X X X 3 X 3 X 3 X 3
4.FD.007LE0 D & C RED 7 Ca LAKE 33% (33%) X X X X 3 X 3 X 3 X 34.FD.017000 D & C RED 17 POWDER X X4.FD.021000 D & C RED 21 POWDER X X X X X X X4.FD.021LL0 D & C RED 21 ALUM LAKE (13-16%) X X X X X X X4.FD.022000 D & C RED 22 POWDER X X X X X X X4.FD.027000 D & C RED 27 POWDER X X X X X X X4.FD.028000 D & C RED 28 POWDER X X X X X X X4.FD.030000 D & C RED 30 POWDER X X X X X X X4.FD.030LS0 D & C RED 30 ALUM LAKE (34-38%) X X X X X X X4.FD.030LT0 D & C RED 30 TALC LAKE (34-38%) X X X X4.FD.033000 D & C RED 33 POWDER X X 4 X X X 4.FD.033LS0 D & C RED 33 ALUM LAKE (18-20%) X X 4 X X X
X4.FD.036000 D & C RED 36 POWDER X X 7 X X X 6
5.FC.0010G0 F D & C BLUE 1 GRANULES X X X X X XX X X5.FC.001LL0 F D & C BLUE 1 ALUM LAKE LL (11-13%) X X X X X X X X X5.FC.001LM0 F D & C BLUE 1 ALUM LAKE LM (19-23%) X X X X X X X X X5.FC.001LS0 F D & C BLUE 1 ALUM LAKE LS (39-44%) X X X X X X X X X5.FC.0020P0 F D & C BLUE 2 POWDER X X X X5.FC.0020G0 F D & C BLUE 2 GRANULES X X X X5.FC.002LL0 F D & C BLUE 2 ALUM LAKE LL (11-15%) X X X X5.FC.002LS0 F D & C BLUE 2 ALUM LAKE LS (31-35%) X X X
X
XXXX
X6.FC.0030N0 F D & C GREEN 3 POWDER X X X X X X X6.FD.005000 D & C GREEN 5 POWDER X X X X X X X X X6.FD.006000 D & C GREEN 6 POWDER X6.FD.008000 D & C GREEN 8 POWDER X 8 X 87.FD.002000 D & C VIOLET 2 POWDER X X7.FD.0020E0 D & C VIOLET 2 EXTERNAL POWDER X
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4.FC.0030P0 4.FC.0030G04.FC.004000
4.FD.0070004.FD.0060004.FD.006004.FD.00600
4.FD.070LD04.FD.007LC0
4.FD.007LE04.FD.0170004.FD.0210004.FD.021LL04.FD.0220004.FD.0270004.FD.0280004.FD.030000 XXXXXXXPOWDERD & C RED 30
XXXXXXXPOWDERD & C RED 28XXXXXXXPOWDERD & C RED 27XXXXXXXPOWDERD & C RED 22XXXXXXX(13-16%)D & C RED 21 ALUM LAKEXXXXXXXPOWDERD & C RED 21
XXPOWDERD & C RED 17X 3X 3X 3X 3XXX(33%)D & C RED 7 Ca LAKE 33%X 3X 3X 3X 3XXX(70%)D & C RED 7 Ca LAKE ~70%X 3X 3X 3X 3XXX(41-46%)D & C RED 7 Ca LAKE, Barlum FreeX 3X 3X 3X 3XXXPOWDERD & C RED 7X 3X 3X 3X 3XXXXXX POWDERPOWDERD & C RED 6D & C RED 6
XXPOWDERF D & C RED 4XXXXGRANULESF D & C RED 3XXXXPOWDERF D & C RED 3
4.FD.030LS0 D & C RED 30 ALUM LAKE (34-38%) X X X X X X X4.FD.030LT0 D & C RED 30 TALC LAKE (34-38%) X X X X4.FD.033000 D & C RED 33 POWDER X X 4 X X X4.FD.033LS0 D & C RED 33 ALUM LAKE (18-20%) X X 4 X X X
X4.FD.036000 D & C RED 36 POWDER X X 7 X X X 6
4.FC.0400P0 F D & C RED 40GRANULES
POWDER X X X X X X X X X4.FC.0400G0 F D & C RED 40 X X X X X X X X X4.FC.040LL0 F D & C RED 40 ALUM LAKE LL (13-16%) X X X X X X X X X4.FC.040LM0 F D & C RED 40 ALUM LAKE LM (21-24%) X X X X X X X X X4.FC.040LS0 F D & C RED 40 ALUM LAKE LS (39-42%) X X X X X X X
XXXXX X X
1) Cosmetics – Lip products: at most 5% by weight of finished product.2) External Drugs: at most 5 mg per day.3) Drugs: combined total of D&C Red No. 6 and D&C Red No.7: < 5 mg per day.4) Cosmetics – for Lip products: at most 3% by weight of finished product5) Drugs - ingested drugs other than mouthwashes and dentifrices: at most 0.75 mg per day.
6) Drugs: ingested drugs, other than mouthwashes and dentifrices, if taken continuously for < 1 year (at most 1.7 mg per day); ingested drugs if taken continuously for > 1 year (at most 1.0 mg per day)7) Cosmetics: lipsticks (at most 3% by wt. of finished product)8) Limit of less than or equal to 0.01% by weight of finished drug or cosmetic.
X= Allowed Usage
For FDA AllowedUsage legend.
5.FC.0010P0 F D & C BLUE 1 POWDER X X X X X X XX XX X
XX 5X 5
X 6 X 5 X 5 XX
X
FDA Colorants Formulations
“You’ll Know Us By Our Colors”
Spectra Colors Corp.Is A Recognized GLOBAL Supplier of Specialty Dyes/ Colorants for the Household, Institutional & Industrial ChemicalCompounding Segment.
Water insoluble
Water insoluble
Water insoluble
Water insoluble
Water insoluble
Product Code DescriptionDye Form / Lake
Strength WaterEthanol100%
Ethanol25% Glycerol
PropyleneGlycol
EthylAcetate Acetone
VegetableOil
Heat Stabilityof Color pH Stability
Product Code DescriptionDye Form / Lake
Strength WaterEthanol100%
Ethanol25% Glycerol
PropyleneGlycol
EthylAcetate Acetone
VegetableOil Powders Fats
LightFastness
Heat Stabilityof Color pH Stability
Stable <210 C & >210C
color turns dark
1.FC.0050P0 F D & C YELLOW 5 Powder 20% IS 2.50% 10% 5% IS IS IS
1.FC.0050G0 F D & C YELLOW 5 Granules 20% IS 2.50% 10% 5% IS IS IS
1.FC.005LL0 F D & C YELLOW 5 ALUM LAKE LL (15-17%) IS IS IS IS IS SS IS DP NA Water Insoluble
1.FC.005LM0 F D & C YELLOW 5 ALUM LAKE LM (24-26%) IS IS IS IS IS SS IS DP NA Water Insoluble
1.FC.005LS0 F D & C YELLOW 5 ALUM LAKE LS (29-31%) IS IS IS IS IS SS IS DP NA Water Insoluble
1.FC.0060P0 F D & C YELLOW 6 Powder 20% IS 2.50% 10% 1% IS IS IS
1.FC.0060G0 F D & C YELLOW 6 Granules 20% IS 2.50% 10% 1% IS IS IS
1.FC.006LL0 F D & C YELLOW 6 ALUM LAKE LL (15-17%) IS IS IS IS IS SS IS DP NA Water Insoluble
1.FC.006LM0 F D & C YELLOW 6 ALUM LAKE LM (21-23%) IS IS IS IS IS SS IS DP NA Water Insoluble
1.FC.006LS0 F D & C YELLOW 6 ALUM LAKE LS (35-37%) IS IS IS IS
IS
IS SS IS DP NA Water Insoluble
Water Insoluble
Water Insoluble
1.FD.007000 D & C YELLOW 7 Powder IS 0.25% IS IS ISISISIS Excellent up to 200C Good: stable at pH 5 -10
1.FD.008000 D & C YELLOW 8 Powder 10% 1% <0.1% <0.1% IS IS ISStable <210C & >210C
color pwd burnsStable at pH 2-11
1.FD.010000 D & C YELLOW 10 Powder 5% IS 5%
5%
0.50% 1% IS IS ISStable <150C & >150C
gives reddish tintStable at pH 2-11
1.FD.010LM0 D & C YELLOW 10 ALUM LAKE (22-25%) IS IS IS IS IS SS IS DP NA
1.FD.011000 D & C YELLOW 11 Powder IS IS IS 0.5% IS 1.60% 1% DP NA
2.FD.004000 D & C ORANGE 4 Powder S 0.5% 5% 1% 1% IS IS IS Stable up to 250C Stable at pH 2-11
2.FD.005000 D & C ORANGE 5 Powder IS <1% <1% IS 0.50% 1.60% 1% DP NA NA
IS IS NA NA
IS IS
IS IS
IS NA
IS NA
IS NA
IS IS NA
IS DP NA
IS NA
IS NA
1.60%
NA
IS
IS
IS
IS
S NA
DP
Stable up to 250 C
Stable up to 250 C
Stable up to 250 C
Stable at pH 4-11
Water Insoluble
Water Insoluble
Water Insoluble
Water Insoluble
Water Insoluble
Water Insoluble
Water Insoluble
Water Insoluble
Water Insoluble
NA
NA
Water Insoluble
Water Insoluble
Water Insoluble
Water Insoluble
Water Insoluble
Water Insoluble
IS
Stable at pH 5-11
2.50%
0.25%
0.50%
<0.1%
DP
DPDP
NA
NA
IS
IS
Stable <210 C: >210 C is brown in water
Stable up to 150 C:>150 C turns more red
>250 C color burns
Stable at pH 4-10, pH <4 & pH >10 turns orange
IS
IS
Powders FatsLight
Fastness
IS IS 4
IS IS 4
DP DP NA
DP DP NA
DP DP NA
IS IS 4
IS IS 4
DP DP NA
DP DP NA
DP DP NA
NA Fair
IS1.FD.0070E0 D & C YELLOW 7 External Powder <0.10% 0.75%1.00% IS ISISISIS Excellent up to 200C Good: stable at pH 5 -10NA Fair
IS IS 4
IS IS 4
DP DP NA
DP DP NA
IS IS 4
DP DP NA
IS IS NA
IS IS 5
IS IS 5
DP DP NA
DP DP NA
DP
DP
DP
DP
DP
DP
DP
DP DP
DP DP
DP
DP
DP
DP DP
NA
IS IS
IS DP
NA
NA
NA
NA
NA
S NA
NA
NA
IS
IS
DP
4
DP DP
4
IS IS
4
IS DP
DP DP
DP DP NA
DP DP NA
IS DP DP DP NA
IS IS 4
7
DP DP NA
DP DP
NA NA
NA NA
IS = Insoluble SS = Slightly Soluble S = Soluble DP = Dispersible
Disclaimer: This data is intended as a guideline only, and may vary based on formulation variables. We make no claim as to the accuracy or absolute value in customer applications. Please confirm any findings in your products or formulas.
LEGEND:
Stable at pH 2 - 11 Stable <210 C
Stable <210 C & >210 C turns dark Stable at pH 2-11,
pH >11 turns dull yellowish
Stable <210 C & >210 C turns dark Stable at pH 2-11,
pH >11 turns dull yellowish
Stable <210C & >210C
becomes dull
Stable at pH 2-11 & turns
dark pH >9
5.FC.0010P0 F D & C BLUE 1
Granules
20% 0.1% 10% 15% 15% 0.5% 0.5%
10% 15% 15% 0.5% 0.5%
IS IS IS 5
5.FC.0010G0 F D & C BLUE 1
Powder
20% 0.1% IS IS IS 5
5.FC.001LL0 F D & C BLUE 1 ALUM LAKE LL (11-13%) IS IS IS IS IS SS IS DP DP NA NA
Water insoluble
Water insoluble5.FC.001LM0 F D & C BLUE 1 ALUM LAKE LM (19-23%) IS IS IS IS IS SS IS DP DP NA NA
5.FC.001LS0 F D & C BLUE 1 ALUM LAKE LS (39-44%) IS IS IS IS IS SS IS DP
DP
DP
DP DP NA NA
5.FC.0020P0 F D & C BLUE 2
Granules
1.45% IS 1% 0.30% 0.1% IS IS IS IS IS 3
5.FC.0020G0 F D & C BLUE 2
Powder
1.45% IS 1% 0.30% 0.1% IS IS IS IS IS 3
5.FC.002LL0 F D & C BLUE 2 ALUM LAKE LL (11-15%) IS IS IS IS IS SS IS DP DP NA NA
5.FC.002LS0 F D & C BLUE 2 ALUM LAKE LS (31-35%) IS IS IS IS IS SS IS DP
DP
DP DP NA NA
6.FC.0030N0 F D & C GREEN 3 Powder 23.20% 0.30% 5% 10% 10% IS IS IS IS IS 3 Stable <250 C Stable at pH 2-11, pH >9 turns blue
6.FD.005000 D & C GREEN 5 Powder 5% IS 1.60% 0.30% 0.50% IS IS IS IS IS 5 Stable <250 C Stable pH 5-11
6.FD.006000 D & C GREEN 6 Powder IS SS IS IS 0.14% 0.30% IS <1% IS <1% NA NA
6.FD.008000 D & C GREEN 8 Powder 10% 0.25% 2.50% IS 1.60% IS IS IS IS IS 3Stable <210 C: >210 C is
brown in water
Stable at pH 2-11,
pH >9 & pH <4 turns yellow
7.FD.002000 D & C VIOLET 2 Powder I.S. IS IS IS IS IS 0.20% DP DP DP NA NA
7.FD.0020E0 D & C VIOLET 2 EXTERNAL Powder 0.30% 1% 0.30% 1% 1% IS 1% IS IS IS 5 Stable up to 250 C Stable at pH 2-11
IS = Insoluble
SS = Slightly Soluble
S = Soluble
DP = Dispersible
DISCLAIMER: This data is intended as a guideline only, and may vary based on formulation variables. We make no claim as to the accuracy or absolute value in customer applications. Please confirm any findings in your products or formulas.
LEGEND:
Stable <210 C & >210 C turns dark
Stable <210 C & >210 C turns dark
Stable at pH 1-10, pH >12 turns green
Stable at pH 1-10, pH >12 turns green
Stable at pH 2-11, at pH 1 is greenStable <180 C: >180 C is green in water
Stable at pH 2-11, at pH 1 is greenStable <180 C: >180 C is green in water
Granules
IS IS IS IS 3 Stable <210 C & >210 C turns dark Stable at pH 5-12,
pH 1-2 completely precipitates4.FC.0030G0 F D & C RED 3 Granules 5% IS 3% 15% 15% IS
4.FC.004000 F D & C RED 4 Powder 10%
20%
20%
IS 1% 1.5% 1%
1%
1%
IS
4.FC.0400P0 F D & C RED 40 Powder IS 5% 2%
2%
IS
4.FC.0400G0 F D & C RED 40 IS 5% IS
4.FC.040LL0 F D & C RED 40 ALUM LAKE LL (13-16%) IS IS IS IS IS SS
4.FC.040LM0 F D & C RED 40 ALUM LAKE LM (21-24%) IS IS IS IS IS SS
4.FC.040LS0 F D & C RED 40 ALUM LAKE LS (39-42%) IS IS IS IS IS SS
4.FD.006000 D & C RED 6 Powder S IS IS S S IS
4.FD.007000 D & C RED 7 Powder SS IS IS IS IS4.FD.007LC0 D & C RED 7 Ca Lake, Barium Free (41-46%) IS
IS
IS IS IS IS SS
4.FD.070LD0 D & C RED 7 Ca LAKE ~70% (70%)
(33%)
IS IS IS IS IS SS
4.FD.017000 D & C RED 17 Powder IS SS IS IS IS 0.30%
0.60%
4.FD.007LE0 D & C RED 7 Ca LAKE 33% IS IS IS IS IS ??
4.FD.021000 D & C RED 21 Powder IS SS IS IS IS 1%
4.FD.021LL0 D & C RED 21 ALUM LAKE (13-16%) IS IS IS IS IS SS
4.FD.022000 D & C RED 22 Powder 5% IS 5% 0.30% 0.50% IS
4.FD.027000 D & C RED 27 Powder IS SS 0.30% IS IS 1.20%
4.FD.028000 D & C RED 28 Powder 20% 1% 10.00% 3%3% <0.10%
4.FD.030000 D & C RED 30 Powder IS IS IS IS IS IS
4.FD.030LS0 D & C RED 30 ALUM LAKE (34-38%) IS
IS
IS IS IS IS
IS IS IS
NA
4.FD.030LT0 D & C RED 30 TALC LAKE (34-38%) IS NA
4.FD.033000 D & C RED 33 Powder 5% IS 1% 0.50% 0.50%
0.14%
IS
4.FD.033LM0 D & C RED 33 ALUM LAKE
Powder
IS IS SS
4.FD.036000 D & C RED 36
(18-20%)
IS IS IS IS
IS IS IS
IS IS NA NAIS IS NA15% 15%4.FC.0030P0 F D & C RED 3 Powder 5% IS IS3%
DP
DP