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Titanium Dioxide
SUNJIN BEAUTY SCIENCEAUG 2020Ver3.0
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https://www.youtube.com/watch?v=BcgMqJO_1dU&t=7s
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Inspection Site:
Janghang Factory
Inspection Date:
09/16/2019 – 09/19/2019
Inspection Result:
“No action indicated” (‘NAI’).
Based on this inspection, this facility is considered to be in an acceptable state of compliance with regards to current good manufacturing practice (CGMP).
FDA Inspection
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https://www.accessdata.fda.gov/scripts/cder/ndc/dsp_searchresult.cfm
NDC: National Drug Code
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Nano Non-Nano ParticleSize
TiO2 Overview
T-80LL
500nm
Silica
Lauroyl Lysine
TX-85
30nm
Silica
Dimethicone
T-80SA
500nm
Silica
Stearic acid
T-80AS
500nm
Silica
Alkyl Silane
COSMOS
Nat
ura
l
Coating
No
n-N
atu
ral
MT-100SJTV
15 nm
Aluminum Hydroxide
Stearic acid
TA-90
80 nm
Aluminum Hydroxide
Stearic acid
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TiO2 Overview
MT-100SJTV
TX-85 TA-90 T-80SA T-80LL T-80AS
TiO2 Purity % 82% 80% 80% 80% 80% 80%
TiO2 CoatingAluminum
Hydroxide & Stearic Acid
Silica & Dimethicone
Aluminum Hydroxide & Stearic Acid
Silica & Stearic Acid
Silica & LauroylLysine
Silica & Triethoxycap
rylylsilane
Particle size 15nm 30nm 80nm 500nm 500nm 500nm
Shape(Morphology)
Needle Round Round Round Round Round
Transparency by White index 46.47 48.81 60.91 - - 67.73
Remarks
Transparent SCCS Opinion Compliat
Nano TiO2
COSMOSRSPO
Non-NanoCOSMOS
RSPO
Non-NanoCOSMOS
RSPO
Non-Nano
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TiO2 Overviewby SEM
MT-100SJTV TA-90
TX-85
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T-80ASTA-90
WI : 60.91 WI : 67.73
NIPPON DENSHOKUCOLOR METER ZE 2000
The Higher White index, the less transparent
SJF-1921-W/O COSMOS
SUNCARE SPF30 PA+++_ver1.0
Tested W/O fomula
MT-100SJTV
WI : 46.47
TX-85
WI : 48.81
TiO2 Overviewby White Index
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#1Company : SUNJINProduct : MT-100SJTV#2Company : SUNJINProduct : TX-85#3Company : SUNJINProduct : TA-90 #4Company : SUNJINProduct : T-80AS
Tested Titanium Oxide
SJF-1921-W/O COSMOS
SUNCARE SPF30 PA+++_ver1.0
Tested W/O fomula
0
50
100
150
200
250
290 310 330 350 370 390
Wavelength
MP
F
TiO2 Overviewby In-vitro
MT-100SJTV
TX-85
TA-90
T-80AS
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Test Result MT-100SJTV TX-85 TA-90 T-80AS
in vivo SPF 40 43.2 37.04 37.04
Determine
in vivo PA 8 8 9.19 9.19
Determine
SPF Testing 601 V2.5 Multiport UV Solar Simulator
SJF-1921-W/O COSMOS
SUNCARE SPF30 PA+++_ver1.0
Tested W/O fomula
TiO2 Overviewby In-vivo
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*SCCS: Scientific Committee on Consumer Safety
** http://ec.europa.eu/health/scientific_committees/consumer_safety/docs/sccs_o_136.pdf
TX-85 Series
TEM Data
TX-85
TiO2 85%Silica 10%Dimethicone 5%
Particle Size30 nm
SCCS Nano TiO2
TX-85AQ
TiO2 90%Silica 10%
Particle Size30 nm
SCCS Nano TiO2
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* http://ec.europa.eu/health/scientific_committees/consumer_safety/docs/sccs_o_136.pdf** page 8, Table 1
▪ Purity >99%, Anatase <5%▪ Median primary particle size 30~100nm by number based size
distribution▪ Aspect ratio <4.5▪ Volume specific surface area <460m2/cm3
▪ Photo-stable▪ Approved coating ingredients**
SCCS* conformity summary for TiO2
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C12-15 Alkyl Benzoate
Dicaprylyl Carbonate
Caprylic/Capric Triglyceride
Sun Flower Oil
Cyclomethicone
Liquid Paraffin
#1 #2 #3 #4 #5
Test condition
Powder 40% ,
Different oil solution 90%
Tested TiO2
#1Company “T” Product “M”TiO2, Alumina, Stearic Acid
#2Company “S” Product “M”TiO2, Silica, Methicone
#3Company “D” Product “P”TiO2, Silica, Dimethicone
#4Company “M” Product “T”TiO2, Silica, Cetyl Phosphate
#5Company: SUNJIN Product: TX-85TiO2, Silica, Dimethicone
Dispersibility for TX-85
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Test condition
Powder 1g , Cyclomethicone (D5) 30g
2 Days Later, Upside down test
#1 #2 #3 #4 #5
Excellent
re-dispersibility
Tested TiO2
#1Company “T” Product “M”TiO2, Alumina, Stearic Acid
#2Company “S” Product “M”TiO2, Silica, Methicone
#3Company “D” Product “P”TiO2, Silica, Dimethicone
#4Company “M” Product “T”TiO2, Silica, Cetyl Phosphate
#5Company: SUNJIN Product: TX-85TiO2, Silica, Dimethicone
Re-Dispersibility for TX-85
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Test condition
Powder 10% ,Ascorbyl palmitate 2g,
Caprylic/capric triglycerides 88g
After 2hrs
SUNJIN,
TX-85
Tested TiO2
#1 #2 #3 #4
#1Company “T” Product “M”TiO2, Alumina, Stearic Acid
#2Company “S” Product “M”TiO2, Silica, Methicone
#3Company “D” Product “P”TiO2, Silica, Dimethicone
#4Company “M” Product “T”TiO2, Silica, Cetyl Phosphate
#5Company: SUNJIN Product: TX-85TiO2, Silica, Dimethicone
Photo-stability for TX-85
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MT-100SJTV
TEM Data
MT-100SJTV
TiO2 82%Al(OH)3 13%Stearic Acid 5%
Particle Size15 nm
Needle Shape
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MT-100SJTV Product “M” Test Method
COMPANY Sunjin Japan “T”
Lot No. 3240547
TiO2 purity (%) 78~88 By Catalog
Surface TreatmentAluminum Hydroxide 10%
Stearic Acid 5%Aluminum Hydroxide 10%
Stearic Acid 5%
TiO2 purity (%) 83.45 77.09 ICP Analysis by Sunjin
TiO2 purity (%)TiO2 - 92.801Al2O3 – 6.278
TiO2 - 93.50Al2O3 - 5.013
XRF Analysis by Sunjin
Loss on drying (%) 1.38 3.57 130 ºC 30m
Loss on ignition (%) 9.78 14.21 600 ºC 2h
Particle Size (µm) 2.037 2.728 DLS (Malvern)
Tap density (g/ml) 0.325 0.435 -
Surface Area (m2/g) 97.533 58.995 BET
Oil absorption (ml/gm) 0.85 0.8 -
MT-100SJTV Overview
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TA-90
TA-90
TiO2 90%Al(OH)3 5%Stearic Acid 5%
Particle Size80 nm
SCCS Nano TiO2
*SCCS: Scientific Committee on Consumer Safety
** http://ec.europa.eu/health/scientific_committees/consumer_safety/docs/sccs_o_136.pdf
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CoverageComparison
Part Ingredient #1 #2
A
Japan “X” 14.2 -
TA-90 - 14.2
IOY AS 1.3 1.3
IOR AS 0.4 0.4
IOB AS 0.2 0.2
SUNTALC-AS 1.7 1.7
DC345 7 7
B
ABIL EM90 3 3
Cetiol CC 4 4
Benton 38VCG 0.2 0.2
Parsol MCX 5 5
10cs 3 3
ININ 5.5 5.5
DC345 3 3
C KSG16 3 3
D
D.I Water 40.5 40.5
1,3 BG 7 7
NaCl 1 1
SPF 42.86 50.01
PA 8.00 8.00
TA-90 @ Air Cushion BB formula
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Primary TiO2
Silica Thin layer Coating to binder TiP2
T-80
Non nano
TEM Data
T-80
TiO2 84%SiO2 16%
Particle Size500 nm
Non Nano TiO2
T-80 series
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PERSONAL CARE
Nov. 2012
Released in 2012.
Published in ‘Personal Care
Magazine’ in Nov. 2012
Sales of T-80 is spiking
worldwide in 2013
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SilicaThin layer Coating
Aggregation
Nano TiO2 boundBy inorganic silica binderto from Micro size granule
TiO2
20~80nm
T-80TiO2 84%SiO2 16%
T-80ASTiO2 80%SiO2 15%Alkyl Silane 5%
T-80JJTiO2 80%SiO2 12%Jojoba Esters 8%
T-80LLTiO2 80%SiO2 12%Lauroyl Lysine 8%
T-80SATiO2 80%SiO2 12%Stearic Acid 8%
TiO2
T-80
T-80AS T-80JJ T-80LL T-80SA
T-80 series, Non Nano TiO2
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CategoryLabelled sun protection factor
Measured sun protection factor
% of T-80 series needed
Low protection
6 6 – 9.9 2.0
10 10 – 14.9 3.5
Medium protection
15 15 – 19.9 5.5
20 20 – 24.9 7.6
25 25 – 29.9 9.9
High protection
30 30 – 49.9 12.4
50 50 – 59.9 25.0
% Table of T-80 series for SPF