Egypt Regulation UV Portfolio 130510

Global Norms, Standards and
Test Methods in UV Protection
Global Norms & Standards / SPF
SPF
Range
Proposed
Monograph
SPF 50+
Max.
Claims
In-vivo SPF
= Claimed
SPF
Relevant
Test
Method
In-vivo SPF
FDA Method
Max. SPF
50+
Max. SPF
30+
In-vivo SPF In-vivo SPF

= Claimed
= Claimed
SPF
SPF
Max. SPF
50+
Max. SPF
50+
Categories: low, medium,

high & very high protection
SPF claim specified: 6, 10,
15, 20, 25, 30, 50 and 50+
In-vivo SPF ISO24444 Method
Max. SPF
99
Categories
like EU but
individual
SPF claim
possible
Colipa and
ISO method
Erythemal Effectiveness of Sunlight
EA( ), SI( ) / arbitrary units
UVB
UVA
308nm
Erythemal Action Spectrum

Standard Sun Spectrum
Erythemal Effectiveness
0
290
310
330
350
/ nm
3
Technical Service SunCare E-EMV/GU
370
390
SPF measurement in vivo

SPF represents mainly a protection in the UVB range
UVAII contributes to 20 % to SPF
E
I
SPF
E I T
400
290
400
290
Biological response
= sunburn
= max at 308nm (UVB)
T = Sunscreen Transmittance at
E = Spectral irradiance of UV source at
I = Erythemal action spectrum at

Principle:
Measurement of the UV induced erythema 20 4h after irradiation
Conditions:
Xenon lamp solar simulator with Cosmetic Europe Standard UV spectrum
Application: 2 mg/cm
Choice of an adequate panel of human volunteers
10 to 20 subjects max., skin types I, II and III
(screening only on 5 volunteers)
Impact of Application Amount on SPF
60
SPF (calc.)
50
40
30
20
10
0
In-vivo SPF measurement
=35g / Application =
2mg/cm2
Reality
1.5mg/cm2
1mg/cm2
0.5mg/cm2
Linear correlation between SPF and film thickness

6
Technical Service SunCare E-EMV/DU

Principle:
Measurement of the UV induced erythema 20 4h after irradiation
Conditions:
Xenon lamp solar simulator with COLIPA Standard UV spectrum
Application: 2 mg/cm
Choice of an adequate panel of human volunteers
10 to 20 subjects max., skin types I, II and III
(screening only on 5 volunteers)
The different skin types
Self Protection Time /

Minutes
80
70
>70
60
50
40
30
Skin types for in-vivo SPF testing
20
10
<10
10-15
15-30
30-60
20-45
Type 1
Type 2
Type 3
Type 4
Type 5
Type 6
data based on the conditions of a clear day in early July at noon time, 32 latitude North
(T.B. Fitzpatrick, Archives of Dermatology, 124, 1988, p.869)
BASF Personal Care

Determination:
UV exposure in defined MED steps
Pretest: Determination of Minimal Erythemal Dose = MED
MED: quantity of UV radiation required to produce the first perceptible,

unambiguous redness reaction with clearly defined borders
SPF = MED p / MED up

P = Protected aera
Up = Unprotected aera
SPF 50 protects five times better than

SPF10
10
http://www.youtube.com/watch?v=8cc8qRr7oMQ

Limitations:
Reproducibility from institute to institute
Reproducibility from day to day
SPF (US) not the same as SPF (EU) not the same as SPF (Asia)
Ethics
Price
Does not represent protection over the whole UV
(Sunburn protection = UVB mainly)
Application rate (2 mg/cm) not used by consumers
0.5-1 mg/cm is the amount used => less protection as indicated !
11
SPF measurement in vitro

Principle:
In vitro SPF calculated from the spectral transmittance of UV light from

290 to 400nm
Measurement through a sunscreen film on a rough surface (PMMA
plates).
12

Equipment: Labsphere UV Transmittance analyzer UV-2000S
13

BASF Conditions:
Application: 1.2 mg/cm on sandblasted PMMA
plates (Helioscience)
4 plates with 11 measurements on each plate
Blank with glycerin
15

Limitations:
Different methods no harmonized method
Equipment and application techniques not harmonized

Strong influence of individual application technique
Photostability is not taken into account by most of the methods
Influence of product rheology
Conclusion:
In vitro SPF suitable for comparison and evaluation of similar formulations.
Determination of absolute SPF level difficult
16
Global Norms & Standards / UVA-PF

UVA
protection
Claims
Test
Method
Max. UVA
needed
17
Critical
Wavelength
UVA-PF
UVA-PF
UVA-PF
CW >370 =
Broad
spectrum
SPF>15
decreases risk
of skin cancer
PA+
PA++
PA+++
PA+
PA++
PA+++
PA++++
(01.2013)
UVA-PF/SPF
1/3 / CW
>370
CW / FDA final
rule 2011
PPD invivo ISO

24442
PPD invivo ISO

24442
>8
>8
>16
UVA/
UVB ratio
UVA-PF
UVA-PF/SPF
1/3 / CW
>370
ULTRA
UVA-PF invitro
ISO24443
(PPD ISO 24442
EU only)
>20
UVA/UVB
ratio
(incl.
Photostability)
>30
UVA-PF invitro
ISO24443 or
PPD ISO
24442
>33
UVA Test Methods

In vivo method
UVA PF (PPD)
In vivo / in vitro method
UVA-PF in vitro / SPF label
(EC recommendation Cosmetic Europe Method)
In vitro methods
UVA/UVB ratio
18
In vivo: UVA-PF (PPD) acc. to JCIA

Measurement Persistent Pigment Darkening = PPD
E
I
UVA PF
E I T
400
320
400
320
= Biological Action
Spectrum
Where :
T = Sunscreen Transmittance at
E = Spectral irradiatance of UV source at
I = Biological action spectrum at
= Persitent Pigment
Darkening
19
In vivo: UVA-PF (PPD)

Conditions:
Xenon lamp, spectrum: 320 to 400 nm
10 volunteers of skin types II, III and IV
The Minimal Pigmenting Dose (MPD) corresponds to the minimal UVA

dose producing a minimal darkening effect 2 hours after exposure to 6
increasing doses of UVA.
UVA PF = MDPp / MPD up

The MPD for the protected area (MPDp) is then compared with the
MPD for the unprotected area (MPDup).
20
The different skin types
Self Protection Time /

Minutes
80
70
>70
60
50
Test subjects for in-vivo UVA-PF
40
30
30-60
20
10
0
<10
Type 1
10-15
Type 2
15-30
Type 3
20-45
Type 4
Type 5
Type 6
data based on the conditions of a clear day in early July at noon time, 32 latitude North
(T.B. Fitzpatrick, Archives of Dermatology, 124, 1988, p.869)
21

PPD is the standard method in Japan for UVA assessment
Japan Cosmetic Industry Association adopted a classification scheme
rather than numerical values for expressing UVA protection
UVA-PF
<2
No
protection
Classification
against
UVA
Claims
4-8
8 16
>16*
PA +
PA ++
PA +++
PA ++++
Protection
Considerable
High
Greatest
No claims
against
Protection protection protection
UVA
* From 13 January 2013

22
2-4

Benefit:
Takes photostability into account

PPD is the skins response to UVA (connected to skin damage via free
radicals)
Limitation:
Difficulty to standardize
23
In-vitro UVA-PF (Cosmetic EU Guideline 2011)

Principle:
In vitro transmission measurement ( measurement in vitro SPF

(solar spectrum erythema action spectrum)
Mathematical adjustment of the transmission spectrum such that the
in vitro SPF equals the labeled in vivo SPF, by applying a constant c as
exponent for the transmissions
1,2
Absorbance
1
0,8
0,6
14
13
12
0,4
In-vitro measured
absorption spectrum
0,2
11
Calculated SPF
Adapted Spectrum
would reach claimed
SPF
10
290
300
310
320
330
340
350 360 370 380 390 400

24

Calculation of the UVA-PF in vitro between 320 and 400 nm using the
adjusted transmission curve (together with the PPD action spectrum and the
spectrum of the UVA lamp)
Irradiation linked to UVA-PF static D = 1,2 J/cm X UVA-PF static
In vitro transmission measurement after irradiation
calculation of the UVA-PF in vitro after irradiation using the same coefficient c
Calculation of the Colipa ratio :
SPF label / UVA-PF in vitro a.i.
< 3
25
Conditions:
Blank: Glycerin
Application:
1.3 mg/cm on moulded HD6 plates (2011 revision)
3 plates with 4 measurements on each plate
Irradiation dose is UVA-PF dependent (UVA-PF X 1.2J/cm)
Critical wavelength is measured after irradiation
If Lc >370nm AND
Cosmetic EU ratio
method 2011
UVA-PF / SPF 1/3
26
In-vitro UVA-PF - EC recommendation

Benefits
Expression of the UVA protection in relation to the SPF
Photostability is taken into account
27
In vitro: BOOTS STAR RATING UVA/UVB-ratio

(2011 revision)
Conditions:
In vitro transmission measurement
Blank with Glycerin

Quartz or PMMA plates (2 4m)
Application amount: 1 mg/cm
Irradiation dose: 17,5 J/cm (3MED)
28

(2011 revision)
Ratio of the average absorption in the UVA- (320-400 nm) to that in

the UVB-(290-320 nm) range of the absorption spectrum of a product
Before and after 17.5J/cm
700
600
E (1%,1cm)
500
400
300
200
UV-A
UV-B
100
0
290
310
330
350
370
390
Wavelength / nm
29

(2011 revision)
Allocation of star ratings from to stars
UVA/UVB RATIO
after irradiation
0.0 - 0.56
0.57 - 0.75
0.76 - 0.85
0.86 -
0.0 to 0.59
No Rating
No Rating
No Rating
No Rating
INITIAL UVA/UVB RATIO

0.6 to 0.79
0.8 to 0.89
No Rating
No Rating
0.9 and over

No Rating
ratio of zero :
No UVA absorbance
ratio of < 0,5
UVB absorber
ratio of 1,0 :
Equal UVA and UVB absorbance (broad spectrum filter system)
ratio of > 1,0
UVA absorber
30
Overview Sun Care Portfolio

2013
Global Technical Service Sun Care E-EMC/DU
UV Filter Performance
Overview
35
Why a new UV filter?

320 - 340nm
1600
UVB
UVAII
UVAI
E (1,1)
1200
800
400
0
290 295 300 305 310 315 320 325 330 335 340 345 350 355 360 365 370 375 380 385 390 395 400
Wavelenght [nm]
UVB absorber
UVA absorber
Current lack of performance in UVA II

36
E-EMC/DU Technical Service SunCare
Why a new UV filter?

320 - 340nm
1600
UVB
UVAII
UVAI
E (1,1)
1200
800
400
0
290 295 300 305 310 315 320 325 330 335 340 345 350 355 360 365 370 375 380 385 390 395 400
Wavelenght [nm]
UVB absorber
Tinosorb A2B (Active)
UVA absorber
High performance of Tinosorb A2B in UVA II

37
Tinosorb A2B - Product data

Form
Aqueous dispersion ~50% active ingredient
Structure
N
N
INCI
Tris-Biphenyl Triazine (nano) (Abbr: TBPT)
Emax. (1,1)
1100
max
315 nm
Concentration maximum
20% (=10% TBPT)
Molecular mass
537.22 g/mol
Melting Point
261C
38
TinosorbA2B - Particle Size and Efficacy

Absorbance spectrum dependent
on the particle size
Optimal performance achieved with
a particle size of around 100nm
Same effect observed for organic
as well as inorganic particulate UV
filters
40
Tinosorb A2B
Boosting effect with soluble UV filters
Performance by:
Absorption, Reflection & Scattering
UV Light
Other non
particulate filters
Tinosorb A2B
Skin
42
Tinosorb A2B - Total UV Absorbance

Comparison to other UVB Filters
600
Area = Total absorbance

Area- 400 nm
from 290
500
400
300
200
100
0
HMS
EHS
BMP
OCR
(Uvinul
N539T)
TiO2
B3
PBSA
EHMC
(Uvinul MC
80)
IMC
DBT
EHT
TBPT
(Uvinul T (Tinosorb
150)
A2B-active)
Tinosorb A2B (TBPT) most efficient contributor to SPF

44
INTERN - TinosorbA2B Challenge Session
Tinosorb A2B - Contribution to SPF

Comparison to EHMC, EHT and PBSA
14
12
SPF
10
TBPT in vivo
TBPT
6
EHMC
4
PBSA
EHT
2
0
In silico data calculated on BASF Sunscreen Simulator

(www.basf.com/sunscreen-simulator)
10
12
Concentration %
By incorporating Tinosorb A2B higher SPF

with lower UV filter concentration more formulation flexibility
45
Tinosorb A2B - Photostability

Comparison to other UVB Filters
Determined by HPLC method
Tinosorb A2B is photostable

46
INTERN - E-EMV/GU - BASF confidential
Tinosorb A2B
Incorporation Instructions
Emulsifiers
Recommended incorporation process

Generally, possible with all incorporation methods
O/W
Recommended incorporation:
Non ionic
After emulsification (predilution into water), below 50C, under

stirring final high shear homogenization possible
Anionic
Cationic
Possible with all incorporation methods with tested emulsifiers

final high shear homogenization possible
Incompatibility with cationic emulsifiers whatever the incorporation

process is
Cationics with low charge might work
W/O
emulsifiers
47
After emulsification (with predilution into water), below 50C, under

stirring final high shear homogenization possible
Tinosorb A2B
Performance in a Sunscreen Formulation
2,5
320 - 340nm
SPF 30
Absorbance
1,5
SPF 20
1
Base
Base + 4% TinosorbA2B
0,5
0
290
310
330
350
370
390
Wavelength (nm)
High contribution of Tinosorb A2B to UVB & UVA II performance

48
INTERN - E-EMV/GU - BASF confidential
Tinosorb A2B performance

in a photostable UVA base SPF 30
UVA-PF in vitro /
Addition of UVB filter
SPF in vivo
SPF claimed 30
Base (UV09071-1-1)
17.2
>1/3
+ 3% PBSA (UV09071-1-4)
28.8
< 1/3
25.1
< 1/3
+ 3% TiO2 active ingr.

(UV09071-1-6)
+ 3% EHMC (UV09071-1-3)
Base:
3% UvinulT150
1% TinosorbS
28.2
< 1/3
4% UvinulA Plus
+ 3% DBT (UV12103-1-1)
37.2
< 1/3
43.0
> 1/3
+ 6% TinosorbA2B
(3% active) (UV12103-1-4)
By incorporating TinosorbA2B significant increase of SPF without

unbalancing the absorbance in the UVA
The filter combination above is for research purpose only. The combination of Uvinul A Plus and Tinosorb A2B is blocked by the patent rights of EP2196189 and the
equivalent patent rights thereof in many countries.
49
Tinosorb A2B performance

in a photostabilized UVA base SPF 30
Addition of UVB
filter
UVA-PF in vitro /
SPF in vivo
SPF claimed 30
Base
20.3 +/- 4.4
>1/3
+ 3% EHMC
28.7 +/- 3.5
< 1/3
+ 3% PBSA
33.4 +/- 3.8
< 1/3
+ 3% EHT
39.4 +/- 5.7
< 1/3
+ 3% DBT
27,0 +/- 6.1
<1/3
+ 3% TiO2
28.3 +/- 7.5
> 1/3 10.1
+ 6% Tinosorb A2B
(3% active)
36.9 +/- 3.7
> 1/3 13.5
Base:
6.0% OCR
2.0% BMDBM
1.0% Tinosorb S
4.5% Tinosorb M
By incorporating Tinosorb A2B significant increase of SPF without

unbalancing the absorbance in the UVA fills the gap
50
in-cosmetics 2013
Photostable UVA Protection

15
20
30
50
UV12063-1-3
UV12063-2-2
UV12063-3-3
UV12063-4-6
UvinulMC80
5.0
5.0
7.5
7.5
TinosorbA2B
1.5
3.0
4.0
8.0
UVA
UvinulA Plus
2.0
3.0
5.0
5.0
B-S
TinosorbM
---
---
---
5.0
Colipa
5.1
> 1/3
7.1
> 1/3
10.4
> 1/3
16.8
> 1/3
PA claim cal.
PA++
PA++
P+++
PA ++++
SPF cal.
16.3
21.6
32.7
52.4
Claimed SPF
UVB
UVA-PF in vitro a.i.
a.i.- after irradiation

51
Light Feeling Sun Care Cream

SPF 50
GEUV12063-4-6
52
Highest Performance
For high SPFs with high UVA protection high amount of crystalline UV filters
are required
Solubility limitations of crystalline UV filters require high amounts of

emollients
High emollient loads leads to heavy formulations and are difficult to stabilize
Particulate UV filters for the water phase can help to reduce the load of
emollients
53
High Performance Sun Screens

with Dry Touch Appearance
50
50
50
10.0%
10.0%
10.0%
---
4.0%
4.0%
DBT
4.5%
---
---
UVA
BMDBM
5.0%
3.0%
3.0%
B-S
Tinosorb S
3.5%
2.0%
1.0%
---
---
1.0%
Total Filter concentration
23%
19%
19%
UVA-PF calc.
17.1
18.9
19.6
UVA-PF / SPF
>1/3
>1/3
>1/3
SPF calc.
49.7
52.0
50.8
Required Cetiol AB Equivalents
23%
10%
7%
Claimed SPF
UVB
Uvinul N539T (OCR)

Tinosorb A2B (active)
Tinosorb M (active)
Identical performance, reduced oil phase by the use of particulated UV filters

54
Tinosorb A2B - Summary

Benefits of Tinosorb A2B
Unique absorbance spectrum
By addition of Tinosorb A2B, the SPF is increased and the absorbance
spectrum is kept balanced to still meet the required UVA protection
Its introduction to the water phase offers more flexibility for the formulator
Thanks to its particulate form, Tinosorb A2B offers a boosting effect of other
dissolved UV filters
Compatible with all commonly used UV filters
Compatible with commonly used cosmetic raw materials including Ethanol

Fill the GAP with Tinosorb A2B
55
Tinosorb M
Profile
INCI name:
Methylene Bis-Benzotriazolyl
Tetramethylbutylphenol (nano) (MBBT)
US FDA Drug name:
Bisoctrizole
Appearance:
Dispersion of microfine,
organic particles
CAS Number:
103597-45-1
Dispersion:
Tinosorb M
46.0 - 55.0 %
6.0 - 10.0 %
0.2 - 0.6 %
0.1 - 0.5 %
ad 100 %
pH value 11
UV Spectrum
Tinosorb M
MBBT particles
Decyl Glucoside
Propylene Glycol
Xanthan Gum
Water
Melting point:
195
Type:
Water dispersion
Molecular mass:
658.86 g/mol
Solubility in H2O:
< 10-8 g/l
Approved use conc.: 20% Tinosorb M (10 % active) EU, JP, Asia
US pending
56
Size of Common of UV Filters

UV Filter
Categories
Molecular
Weight
PBSA, EHMC
< 300 Da
< 1 nm
EHT, BEMT
> 500 Da
> 1 nm
6000Da
3 nm
>3000000 Da
20-500 nm
Polisilicone-15
(Polymer)
MBBT, TBPT
Microfine organic
particles, partially
Nano
Size
Molecule / Particle Diameter
(= smallest
particles)
Which UV Filters will penetrate

into the skin most?
For UV Filters Nano is BIG !
57
BASF Personal Care
20 nm
M
T
Tinosorb
Uvinul
150
Benefits
Tinosorb M, a broad-spectrum UV filter available for the water phase
Microfine organic particles in water
increases flexibility regarding the oil phase
Synergy effect with oil soluble UV filters

Absolutely photostable
The only UV-filter with significant absorbance close to visible light
High contribution to UVA-PF due to strong absorbance in long UVAI
The only completely white UVA filter
Positive impact formulation color
58
Tinosorb M
Triple Action
Tinosorb M provides absorption, reflection and scattering = Triple Action

59
Tinosorb M
SPF in vivo (International Method)
Combined with EHMC - Synergy Effect
8% Tinosorb M
Benefit:
5% EHMC
5% EHMC +
8% Tinosorb M
Synergistic effect with EHMC improves the SPF
5% EHMC +
16% Tinosorb M
Tinosorb M
Combination with oil soluble UV filters
Tinosorb M:
dispersion of the filter in the
water phase (O/W)
Oil droplets (black)

protection by oil soluble UV filter
By combination of Tinosorb M and oil soluble UV filter protection in both

emulsion phases = boosting effect
07.03.2012
62
Tinosorb M
Stabilization of EHMC
EHMC 2.4%
- 27%
3.4% EHMC &

10% Tinosorb M
- 8%
Tinosorb M provides efficient stabilization of EHMC

07.03.2012
63
Tinosorb M
Impact of Filter Composition on Formulation Color
Filter composition
UVA-PF (Colipa)
Gel cream
Gel cream
(UV09100-1-3)
(UV09100-1-4)
7% Uvinul MC80
5% Uvinul A Plus
1% Tinosorb S
5% Uvinul MC80
2% Uvinul A Plus
1% Tinosorb S
4% Tinosorb M
21.5
21.3
Impact on emulsion color
Identical UVA performance, difference in formulation colour

07.03.2012
65
Tinosorb M Modification of Skin Sensory

Reduction of skin stickiness
Stickiness
more
less
71
Tinosorb M
Formulation Tips
Add Tinosorb M to the final formulation at low temperature at efficient stirring
(or even homogenization)
Combine Tinosorb M with oil soluble UV filters in order to achieve synergy effect
Compensate potential stickiness by the use of light emollients or sensory

enhancers
Check stability carefully in case cationic emulsifiers are used
77
Tinosorb S
Profile
INCI-Name:
Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine (BEMT)
US FDA Drug Name (USP): Bemotrizinol

Appearance:
Slightly yellow powder
CAS Number:
187393 00 6
Melting point:
80C
Type:
Oil soluble
Molecular mass:
627.8 g/mol
Solubility in H2O:
10-7 g/l
Approved use conc.:
10% (EU), 10% (Asia), 3% (JP)

US pending
UV Spectrum
Tinosorb S
78
Tinosorb
Uvinul
T 150
Benefits
Tinosorb S, the only and most efficient oil soluble broadspectrum UV filter
High contribution to SPF
High UVA-PF already at low concentration
Best fit with all approaches in Sun Care
Outstanding photostability
Efficient stabilizer for photoinstable UV filters
79
Tinosorb S
Inherent Photostability by Photo-Tautomerism
R1
R4
O
N H
R2
N
R5
R3
h
R1
tc
=10-12
sec
R4
O
H
R2
N
07.03.2012
R5
R3
80
Tinosorb S
Contribution to UVA-PF
UVA-PF (PPD method)
Formulation Base
10
9
8
7
6
5
4
3
2
1
0
Addition of Tinosorb S
7% EHMC
1.5% ZnO
3.0% TiO2
Base
+ 1%
+ 2%
% Tinosorb S
+ 3%
Tinosorb S provides good UVA-PF at low concentration

81
Tinosorb S
Contribution to SPF
SPF in-vivo
(International Method)
34
32
Addition of Tinosorb S
Formulation Base
7.0% EHMC
1.5% ZnO
3.0% TiO2
30
28
26
24
22
20
18
Base
+ 1%
+ 2%
Tinosorb
+ 3%
TinosorbS provides good SPF at low concentration

82
Tinosorb S
Stabilization of EHMC
3.4% EHMC &

2% Tinosorb S
- 42%
EHMC 3.4%
- 19%
Tinosorb S provides efficient stabilization of EHMC

84
Tinosorb S
Solubility in selected Cosmetic Oils
Cosmetic Oils
86
Tinosorb S
Microscopic Evaluation of Crystals
Magnification, x 125
BEMT: Needle form crystals

88
Tinosorb S
Formulation Tips
Choose polar emollients with best solubility for Tinosorb S such as e.g. Ethylhexyl
Methoxycinnamate (Uvinul MC80), Ethylhexyl Salicylate (Neoheliopan Type OS),
Dicaprylyl Carbonate (Cetiol CC), C12-15 Alkyl Benzoate (Cetiol AB), Dibutyl
Adipate (Cetiol B)
The oil phase might be adapted in order to solubilize Tinosorb S and other oil
soluble filters completely.
Dissolve Tinosorb S completely in the oil phase
Check potential crystallization (microscopy) at low storage temperatures
94
Limitations in Sun Care Formulations

Formulations with high SPF need high load of filter concentration
Most filters are either oils or need to be dissolved in polar emollients
The oil phase has to be adapted depending on the oil soluble filters in
quantity as well as in quality
High oil phases reduce the flexibility to modify sensory of formulations
Use of filter mainly in one formulation phase often achieve lower
performance than expected
Tinosorb S Aqua = more formulation flexibility

96
Tinosorb S Aqua
Profile
INCI-Name:
Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine (and) Polymethyl Methacrylate
US FDA Drug Name (USP): Bemotrizinol

UV Spectrum
Appearance:
Slight yellow liquid dispersion
CAS Number:
187393006/
901114-7/ 1335-72-4/
124-68-5
Dispersion:
Tinosorb S Aqua
18.0 - 22.0 %
17.0 - 21.0 %
1.0 - 2.0 %
0.4 - 0.8 %
ad 100
pH value 8-11
Tinosorb S Aqua
Bis-Ethylhexyloxyphenol
Methoxyphenyl Triazine
Polymethylmethacrylate
Sodium Laureth Sulfate
Amino Methyl Propanol
Type:
Water dispersion
Molecular mass:
627.8 g/mol
Solubility in H2O:
10-7 g/l
Approved use conc.:
50% EU, Asia (10% acitve) 15% JP (3% active)

US pending
98
Tinosorb S Aqua
Benefits
Based on highly efficient Tinosorb S technology
Increased formulation flexibility

- Addition before or after emulsification, short term exposure to higher temperatures
possible
- Prevention of overload of the oil phase = more flexibility to adapt the oil phase
Improved efficacy due to more homogeneous filter distribution

- Water resistance of formulations is not negatively impacted and could even be
improved
99
Tinosorb S Aqua
Formulation Flexibility
Plus Point Lotion SPF50+
(GEUV09102-4-18)
Uvinul T150
PBSA
T-Lite SF-S
Uvinul A Plus
Tinosorb S
Filter composition
3.5%
4.0%
4.5%
9.0%
3.5%
Filter concentration
24.5%
Water Resistant Sun Matrix

SPF50+ (GEUV10080-4-1)
3.0%
3.0%
8.0%
2.0%
10%
Uvinul T150
PBSA
Uvinul A Plus
Tinosorb S
Tinosorb S Aqua
18.0%
Replacement of TiO2 = transparency
Filter Cost
100%
~85%
Emollient Concentration
needed
30%
20%
Performance
SPF (in vivo)

UVA-PF
53 / 73
22.2
SPF (in vivo)

59.6 / 68.4
UVA-PF (in vitro) 23.7
WR (2*20min)
63.9%
Increased formulation flexibility, reduced filter concentration, lower oil phase,

enhanced transparency, reduced filter cost
106
Tinosorb S Aqua
Manufacturing Process in O/W
Tinosorb S Aqua
Before
emulsification
75C
Macroscopic evaluation
Homogeneous
Tinosorb S Aqua
Tinosorb S Aqua
Emulsion
Emulsion
75C
Homogeneous
30C
Homogeneous
Microscopic evaluation X125

under cross polarized light
After 3 months
Independent from manufacturing process homogeneous distribution of

Tinosorb S Aqua is achieved.
Uvinul A Plus
Profile
INCI-Name:
Diethylamino Hydroxybenzoyl Hexyl Benzoate (DHHB)
US FDA Drug Name (USP):
--
Appearance:
CAS Number:
White to light salmon granular

UV Spectrum
302776-68-7
Melting point:
54C
Type:
Oil and alcohol soluble
Molecular mass:
397.5 g/mol
Approved use conc.:
10% EU, Asia, JP
Uvinul A Plus
113
113
Uvinul A Plus
Benefits
Uvinul A Plus, the only photostable UVA filter on the market
Absolute photostable UVA protection
High formulation flexibility due to excellent solubility

Good compatibility with other UV filters and cosmetic ingredients
Excellent performance in radical protection
114
Uvinul A Plus
and BMDBM
Uvinul A Plus can easily replace BMDBM in formulations
Comparable absorption curve
Better solubility
1200
Perfect photostability
1000
DHHB
BMDBM
BMDBM after 12MED irradiation
E (1,1)
800
600
400
200
390
370
350
330
310
290
Wavelength (nm)
07.03.2012
116
Uvinul A Plus
Contribution to SPF and UVA-PF
Base: 10% EHMC
addition of Uvinul A Plus
Uvinul A Plus
Solubility in various cosmetic oils compared to BMDBM
45
Solubility of in Selected Cosmetic Oils (%) at 25C
40
Uvinul A Plus
35
Solubility %
30
BMDBM
25
20
15
10
5
0
Cosmetic Oils
Uvinul A Plus has superior solubility in selected cosmetic oils than BMDBM
07.03.2012
124
Uvinul A Plus
Influence of emulsifier on emulsion color
Summary
L*: 92.0
a*: -7.3
b*: 17.5
L*: 93.1
a*: -5,8
b*: 15.0
5.0% Eumulgade PL 68/50

1.0% Eumulgin Prisma
3.5% Cremophor A6
1.5% Cremophor A25
5/10/2013
1.5% Eumulgin Prisma
L*: 89.3
a*: -10.0
b*: 26.8
L*: 93.6
a*: -7.0
b*: 17,2
magnification x 400
L*: 94.4
a*: -7.0
b*: 16.1
3.5% Eumulgin BA 25
1.5% Lameform TGI
2.0% Tinovis ADE

Technical Service SunCare E-EMC/DU
Spectrometer Lambda 650;

CIELab; D65 / 10 o
131
Uvinul A Plus
Formulation Tips
It is possible to use Uvinul A Plus in a wide spectrum of polar oils due to its
excellent solubility in a wide range of emollients
Good solubility also in Ethanol
Check cristallization at low temperatures
153
BASF Portfolio
Zinc Oxide
Trade Name
INCI
Product description
Z-COTE
Zinc Oxide
Water and Oil dispersible

(amphiphilic character)
Z-COTE HP1
Zinc Oxide (and)

Triethoxycaprylylsilane
Oil / Silicone phase

dispersible
154
BASF Personal Care
Z-COTE HP1
Description
Chemical name
Hydrophobic Zinc Oxide
INCI-name
Zinc Oxide (and) Triethoxycaprylylsilane
CAS-numbers
1314-13-2, 63148-62-9
Structural formula
ZnO
Molar mass
81.37 g/mol (for ZnO)
Appearance
white powder
Odor
none
Purity
99%
Particles size
mean is 140nm (laser scattering particles size distribution analyser)
20% < 100nm
155
BASF Personal Care
Z-COTE HP1
Approval Situation
EU:
Positive SCCS opinion on ZnO (nano form)

SCCS (Scientific Committee on Consumer Safety), Opinion on ZnO (nano form),
18 September 2012
USA:
ZnO is approved in the Cat.I of the FDA Final Monograph for Sunscreen Drug product for
OTC Human Use.

Upper limit = 25%
Not allowed in combination with BMDBM
Japan
Not considered as UV absorbers

Use without limitation (except eyeliner, lip, oral & bath preparation)
156
BASF Personal Care
Z-COTE HP1
Formulation Tips
Choose appropriate dispersant aids:

Uvinul MC80 / Uvinul N539T
Cetiol B / Cetiol AB
Disperse the ZnO under

homogenizer
(high energy needed)
Disperse each powder

separatly
157
BASF Personal Care
Add 0.05% PBSA to avoid

pH shift
If pH adjustement is
necessary use Citric Acid
only when emulsion is finish
Anionic surfactant
(low levels 0.2% Lanette E)
helps to stabilise emulsion
Z-COTE HP1
Formulation Tips
Disperse ZnO in appropriate hot
Homogenizer
ZnO
75C - 80C
158
BASF Personal Care
(75-80C) oil phase under high speed

homogenizer
Add rest of hot oil phase

Prepare formulation
Adjust pH with Citric Acid
Uvinul T 150
Profile
INCI-Name:
Ethylhexyl Triazone (EHT)
Ethylhexyl Triazone
UV Spectrum
Appearance:
White powder
CAS Number:
88122-99-0
Melting point:
128-132C
Type:
Oil Soluble
Molecular mass:
823 g/mol
Approved use conc.:
5% EU, JP, Asia

US pending
Uvinul T150
159
Uvinul T 150
Benefits
Uvinul T 150, the most powerful and photo stable UVB filter
Highest efficient UVB filter in the market
Excellent compatibility with all UV filters
Excellent photo stability
Odor free (PC12/118) and colorless
Combine with broad-spectrum filters and/or UVA filters in order to achieve
better performance also in respect of SPF
160
Uvinul T 150
Solubility in Selected Cosmetic Oils
Uvinul T 150 Solubility in Selected Cosmetic Oils (%) 25C
*Beware
of patent
restrictions
18
16
14
Solubility %
12
10
8
6
4
2
0
Cosmetic Oils
164
Uvinul T 150
Formulation Tips
Choose emollients with best solubility for Uvinul T 150 like Ethylhexyl
Methoxycinnamate (Uvinul MC 80), Dibutyl Adipate (Cetiol B)
Dissolve Uvinul T 150 completely in the oil phase (at elevated temperature)
Check potential crystallization (microscopy) at low storage temperatures
The formulation itself (emulsifiers, stabilizers and thickeners) has a positive impact
(less re-crystallization of Uvinul T 150)
169
Uvinul MC 80
Profile
INCI-Name:
Ethylhexyl Methoxycinnamate (EHMC)
Octinoxate
Appearance:
Colourless liquid
UV Spectrum
CAS Number:
5466 77 - 3
Type:
Oil soluble
Molecular mass:
290 g/mol
Approved use conc.:
10.0% EU, JP
7.5% KR, US
20.0% JP
Uvinul MC 80
170
Uvinul MC 80
Formulation Tips
Avoid combination with BMDBM due to photo degradation
O
O
O
EHMC
O
O
O
OH
OH
Increased photoinstability
because of 2+2-heterophotocycloaddition of
BMDBM and EHMC
BMDBM
Stabilize Uvinul MC 80 by the use of stabilizers like Tinosorb S

Use Uvinul MC 80 as excellent solubilizer for oil soluble UV filters
172
Uvinul MC 80
Impact of photostability in formulations
Filter composition (%)
10% Uvinul MC80 (EHMC)
5% BMDBM

3% Uvinul A Plus (DHHB)
1% Tinosorb S (BEMT)

4% Tinosorb M (MBBT)
Lack of photostability result in changed performance during use and high filter
concentration needed
07.03.2012
173
Uvinul N 539 T
Profile
INCI-Name:
Octocrylene
Octocrylene
Appearance:
Clear yellow viscous liquid
CAS Number:
6197 30 - 4
Type:
Oil soluble
Molecular mass:
361 g/mol
Approved use conc.:
10% EU, US, JP, Asia
UV Spectrum
Uvinul 539 T
174
Uvinul N 539 T
Benefit
Uvinul N 539 T wide UVB absorbance band and efficient photo stabilization
High photo stability
Efficient stabilizer for photo instable filters
Contribution to UVAII absorbance of the final product
175
Uvinul N 539 T
Formulation Tips
Easy to use
Due to the low spreading behaviour high spreading emollients are
recommended for a better sensory
176
Best Emollients for Sun Care

Overview
Remarks
Hair
Color
Body
Face
Applications
Deodorant
Wax
High
Medium
Refractive Viscosity
index **
mPas
at 20 oC
at 20 oC
Antiperspirant
Spreading Polarity
Value
mm2/10 min
Spreading
Sun
INCI Name
Slow
Tradename
Propylheptyl Caprylate
1900
medium
1.444
The Happy Emollient

Multidimensional Softness
Dicaprylyl Carbonate
1600
medium
1.436
The Benchmark for dry

emollients
Cetiol RLF
CaprylylCaprylate/Caprate
1400
medium
1.436
The emollient for sensitive

skin
Cetiol C 5
Coco-Caprylate
1300
medium
1.437
High spreading emollient

The silicon alternative
Cetiol B
Dibutyl Adipate
1000
high
1.435
Very good solubility

properties for crystalline UV
filter
Commonly used emollient in

Sun care
Cetiol Sensoft
Cetiol CC
Cetiol AB
Myritol 331
C12-15 Alkylbenzoate
700
high
1.485
30
Cocoglycerides
750
high
1.455
45
* Anhydrous formulations only

177
BASF Personal Care
Medium spreading emollient

with good solubility properties
for crystalline UV filter
Best Emulsifiers for Sun Care

Overview
Sprayable
Emulsion
++
++
++
++
++
Flexible emulsifier for

different applications
and ingredients
Eumulgin SG
++
++
++
++
++
++
Strong emulsifier especially for high

amount of electrolytes
Eumulgin VL 75
++
++
++
++
++
Liquid emulsifier for

sprayable applications
Emulgade PL 68/50
++
++
++
++
Mild emulsifier with

good sensoric
++
++
++
Flexible W/O emulsifier
++
++
W/O emulsifier for

liquid emulsions
++
Dehymuls LE
++
++
184
BASF Personal Care
++
Remarks
Sun Care
W/O
++
Body Care
Fluid
Emulsion
++
Dehymuls PGPH
Application
Face Care
Gel
Cream
Texture
Creamy
Emulsion
Eumulgin Prisma
P.I.T.
Technology
O/W
Emulsifier
Skin Care Leave-On

Polymers Guide
Contains EO/PO
Ethanol
Compatibility
Salt Tolerance
Sensory Profile
Thickening
Emulsion
Stabilization
Body Care
Face Care
Sun Care
>88
Anionic
0.2 1
6 12
No
++
++
++
++
Cosmedia Triple C
Polyquaternium-37
(and) Dicaprylyl
Carbonate (and)
Lauryl Glucoside
~50
Cationic
0.5 3
3 11
No
+++
+++
++
Cosmedia Ultragel 300
Polyquaternium-37
> 92
Cationic
0.5 1.5
3 11
No
+++
+++
++
Luvigel EM
Caprylic/Capric
Triglycerides (and)
Sodium Acrylates
Copolymer
~25
Anionic
0.5 3
69
Yes
++
++
Luvigel STAR AT
Polyurethane-39
~20
Non-Ionic
0.5 5
2 12
Yes
++
+++
++
Tinovis
Sodium Acrylates
Copolymer (and)
Hydrogenated
Polydecene (and)
PPG-1 Trideceth-6
~55
Anionic
0.5 1.5
5 12
Yes
++
++
++
Carbomer
>97
Anionic
0.1 1.0
4 12
No
+++
++
+++
++
>97
Anionic
0.1 1.0
3 10
No
++
+++
++
ADE
Rheocare C Plus
Rheocare XG
Physical form:
191
Xanthan Gum
P = Powder L = Liquid
Performance:
o Low
+ Good ++ Very Good
AP/Deo
pH application
range
Sodium Polyacrylate
INCI Name
Self Tanning
Recommended
dosage as is in %
Cosmedia SP
Trade Name
Clear Gels
Type
Application
Physical form
Performance
Active Polymer %
Product Information
Remarks
Improve cushion
High
transparency
Associative
thickener,
Tolerant to H2O2
High
transparency,
improves
peaking
+++ Excellent
Importance of Efficient UVA

Protection
Factors Influencing Skin Aging

Intrinsic (genetic, life-age related) factors - they cant be influenced
Extrinsic (environmental) factors can contribute to a much higher extent to the visible signs of
aging than intrinsic factors but they can be influenced !
UV LIGHT
NUTRITION
LIFESTYLE
POLLUTION
208
UV light damages
Erythema
Contribution
to skin
cancer
Skin
aging
Skin
pigmentation
Imunosuppression
20
Action spectrum of ROS formation in

human
1,0
Arb. Units
0,8
0,6
0,4
0,2
0,0
290
315
340
365
WL (nm)
Gary Haliday, ESP Conference 2011

(ESP = European Society of Photobiology)
390
Correlation of UVA-PFsim and RSFexp
UVA-PF (sim)
20
n = 17
15
r = 0.932
10
slope = 0.51
5
0
0
10
20
30
40
RSF (exp)
Correlation of UVA-PF and RSF Confirmed

211
UVA Protection for Daily Sun Care

Options
UVA protection
Minimal
UVA Protection
Optimal
UVA Protection
Spectral
Homeostasis
Same requirements for UVA

protection as in SunCare
EC recommendation for UVA
protection (Sept. 2006)
Attenuation in intensity but without
altering the quality of the natural
spectrum of sunlight reaching the
skin
Criterion
UVA-PF / SPF 1/3
Very well balanced absorbance homoeostasis

1,2
0,9
Extinction
Options
0,6
0,3
Before Irradiation
(adjusted)
After Irradiation
(adjusted)
0,0
290
310
330
350
370
390
/ nm
Radical
Protection
(anti-ageing claims)
212
Small amounts of photostable UVA

filters reduce free radical formation
and long term UVA damage
significantly
For Day Care without SPF claim
An in vivo study on Asian volunteers

Testpanel:
22 Volunteers of Asian origin
(14 females and 8 males, between 28 and 42 years old, mother and father
originating either from Thailand or the Philippines).
Irradiation regime:
3x / week, 12 weeks with <1 MED
On volunteers back; Irradiation by Solar Light Simulator (SSR) for 12 weeks, i.e. 3x / week,
12 weeks with <1MED (dose monthly adjusted; effective dose UV-A 320 - 400 nm 24 -26 J/cm2,
UV-B 280 - 320 0,04 - 0,06 J/cm2) 30 min after cream application.
Control:
unprotected, irradiated skin area
Test Products
We tested 3 day creams with increasing amounts of TinosorbM,
i.e. of UV-A protection
2% EHMC
1% Tinosorb M
(SPFcalc 5.3)
2% EHMC
2% Tinosorb M
(SPFcalc 6)
2% EHMC
4% Tinosorb M
(SPFcalc 7)
Tinosorb M is an organic particulate broad-spectrum filter and such ideal for

combination with cosmetic actives used in day care cosmetics.
Further ingredients:
Aqua (up to 100%) ; Caprylic/Capric Triglyceride (5%) ; C12-15Alkyl Benzoate (5%), Cetearyl Isononanoate (5%); Glyceryl
Stearate (3%); Glycerin (3%); Potassium Cetyl Phosphate (2%); Cetyl Alcohol (1%); Cetyl Stearate (1%); Phenoxyethanol/
Parabenes (1%); Steareth-10 Allyl Ether/Acrylates Copolymer (0.5%).
Ethylhexyl Methoxycinnamate (2%) ; TinosorbM (1 4%)
UV Transmission of the test products

2% EHMC
1% TinosorbM
(SPFcalc 5.3)
2% EHMC
2% TinosorbM
(SPFcalc 6)
2% EHMC
4% TinosorbM
(SPFcalc 7)
100%
100%
100%
0%
0%
0%
60% of UVA I
is absorbed
70% of UVA I
is absorbed
80% of UVA I
is absorbed
High absorption of UVA light is achieved with low

concentrations of Tinosorb M
Test Results
Start
1st month 2nd month 3rd month

100%
2% EHMC/
1% Tinosorb M
SPFcalc. 5.3
60% UV-AI
is absorbed
2% EHMC/
2% TIinosorb M
SPFcalc. 6
2% EHMC/
4% Tinosorb M
SPFcalc. 7
UV Transmission
0%
100%
70% UV-AI
is absorbed
0%
100%
80% UV-AI
is absorbed
0%
100%
irradiated
(<1 MED)
No protection
290
320 340
0%
400 nm
The better UV-A protection, the more effective the cream
Conclusion
90% of UV induced free radicals are generated by UVA light
Free radicals in viable skin are a main factor of accelerated skin aging
UVA light is a main trigger for melanin synthesis and skin tanning
Efficient UVA protection provides an anti aging effect and is most

efficient in tanning prevention which is the first step for efficient skin
lightening.
5/10/2013
217
DISCLAIMER
This document, or any answers or information provided herein by BASF, does not constitute a legally binding
obligation of BASF. While the descriptions, designs, data and information contained herein are presented in good
faith and believed to be accurate, they are provided for your guidance only. Because many factors may affect
processing or application/use, we recommend that you make tests to determine the suitability of a product for your
particular purpose prior to use. It does not relieve our customers of the obligation to perform a full inspection of the
products upon delivery or any other obligation. The claims and supporting data provided in this publication have not
been evaluated for compliance with any jurisdictions regulatory requirements and the results reported may not be
generally true under other conditions or in other matrices. Users must evaluate what claims and information are
appropriate and comply with a jurisdictions regulatory requirements. NO WARRANTIES OF ANY KIND, EITHER
EXPRESS OR IMPLIED, INCLUDING WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR
PURPOSE, ARE MADE REGARDING PRODUCTS DESCRIBED OR DESIGNS, DATA OR INFORMATION SET
FORTH, OR THAT THE PRODUCTS, DESIGNS, DATA, OR INFORMATION MAY BE USED WITHOUT
INFRINGING THE INTELLECTUAL PROPERTY RIGHTS OF OTHERS. IN NO CASE SHALL THE DESCRIPTIONS,
INFORMATION, DATA, OR DESIGNS PROVIDED BE CONSIDERED A PART OF OUR TERM SAND CONDITIONS
OF SALE.
218
BASF Personal Care
219
BASF Personal Care

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Global Norms, Standards and

Test Methods in UV Protection

Global Norms & Standards / SPF

In-vivo SPF In-vivo SPF

Categories: low, medium,

In-vivo SPF ISO24444 Method

Erythemal Effectiveness of Sunlight

EA( ), SI( ) / arbitrary units

Erythemal Action Spectrum

Technical Service SunCare E-EMV/GU

SPF measurement in vivo

SPF measurement in vivo

(screening only on 5 volunteers)

Technical Service SunCare E-EMV/GU

Impact of Application Amount on SPF

In-vivo SPF measurement

Linear correlation between SPF and film thickness

Technical Service SunCare E-EMV/DU

SPF measurement in vivo

(screening only on 5 volunteers)

Technical Service SunCare E-EMV/DU

The different skin types

Self Protection Time /

Skin types for in-vivo SPF testing

BASF Personal Care

SPF measurement in vivo

Pretest: Determination of Minimal Erythemal Dose = MED

MED: quantity of UV radiation required to produce the first perceptible,

SPF = MED p / MED up

Technical Service SunCare E-EMV/DU

SPF 50 protects five times better than

SPF measurement in vivo

Technical Service SunCare E-EMV/GU

SPF measurement in vitro

In vitro SPF calculated from the spectral transmittance of UV light from

Technical Service SunCare E-EMV/GU

SPF measurement in vitro

Technical Service SunCare E-EMV/GU

SPF measurement in vitro

Technical Service SunCare E-EMV/GU

SPF measurement in vitro

Equipment and application techniques not harmonized

Technical Service SunCare E-EMV/GU

Global Norms & Standards / UVA-PF

PPD invivo ISO

PPD invivo ISO

UVA Test Methods

Technical Service SunCare E-EMV/GU

In vivo: UVA-PF (PPD) acc. to JCIA

I = Biological action spectrum at

Technical Service SunCare E-EMV/GU

In vivo: UVA-PF (PPD)

The Minimal Pigmenting Dose (MPD) corresponds to the minimal UVA

UVA PF = MDPp / MPD up

Technical Service SunCare E-EMV/GU

The different skin types

Self Protection Time /

Test subjects for in-vivo UVA-PF

Technical Service SunCare E-EMV/GU

In vivo: UVA-PF (PPD)

* From 13 January 2013

Technical Service SunCare E-EMV/GU

In vivo: UVA-PF (PPD)