Suncreen safety

Myriam Sohn, Ph.D

The „Safe“ Beauty E-Summit by The Eco Well

September 18th, 2022
Sunscreens‘ Requirements

Dr. Myriam Sohn | Global Technical Center SunCare

Four Main Pillars for UV Filters / Sunscreens

Efficacy Registration Safety Freedom-to-operate

▪ Absorb UV light (prevent UV ▪ Sunscreens are either classified ▪ Sunscreens must be safe for ▪ Relevant for UV filter and
damages e.g. erythema, as cosmetics (e.g. in Europe) or humans sunscreen manufacturers
reduce skin cancers risks, as OTC (e.g. in the USA)
premature photoageing…) ▪ Each UV filter molecule must be ▪ The UV filter molecule or
▪ In each case, UV filter first approved to be used sunscreen product must not
▪ Photostable molecules must be registered to infringe intellectual property of a
be used in sunscreens ▪ Safety may be reviewed when third party
▪ Compatible with other UV new data are available / new
filters ▪ Registration consists in a series requirements appear (e.g.
of tests to ensure the safety of endocrine disrupting properties)
▪ Water-resistant (keep the UV filters for humans
protection during swimming,
sweating…) ▪ Registration is region-wise

▪ Compatible with other

cosmetic ingredients

▪ Sensory appealing to improve

compliance (non sticky, non
greasy, non colored,…)

Dr. Myriam Sohn | Global Technical Center SunCare

Safety of Sunscreens

Human safety Environmental Safety

▪ UV filter molecules must be registered to be ▪ Growing requirement (authorities, industry, end

used in sunscreens consumer)
▪ Registration consists in a series of toxicological ▪ Environmental damage is often mainly
tests to ensure the UV filters are safe for connected to coral reef damages
humans
▪ Most of coral damages are due to climate
▪ Registration is performed separately in each changes
region, which explains why the number and
type of approved filters may differ between the ▪ No global harmonized criterium to evaluate
regions safety of ingredients for corals

▪ In EU: EU commission with Scientific ▪ In EU, environmental safety is monitored by

committee consumer safety (SCCS) evaluates ECHA (CoRAP list for substances which need
the safety before approval / review after further investigations)
approval

▪ In USA: FDA evaluates the safety before

approval

Dr. Myriam Sohn | Global Technical Center SunCare

Absorbance of Main Approved UV Filters

Europe Classification Cosmetics USA Classification OTC

Regulatory body EU commission Regulatory body FDA

1600 Nr filters approved 16
Nr filters approved 29 1600

Last filter approved in 2020 Last filter approved in Beg. 2000s

1400
Safety control EU commission / Corap List 1400 Safety control FDA

1200
1200

1000
1000
Absorbance

Absorbance
800
800

600
600

400
400

200
200

0
290 300 310 320 330 340 350 360 370 380 390 400 0
290 300 310 320 330 340 350 360 370 380 390 400

Wavelength (nm) Wavelength (nm)

Variety of UV filter molecules approved Limited number of filters approved

Dr. Myriam Sohn | Global Technical Center SunCare
Remaining UV Filters not under Concern

Europe Classification Cosmetics USA Classification OTC

Regulatory body EU commission Regulatory body FDA

1600 Nr filters approved 16
Nr filters approved 29 1600

Last filter approved in 2020 Last filter approved in Beg. 2000s

1400
Safety control EU commission / Corap List 1400 Safety control FDA - Final tentative
monograph (FTM) 2019
1200
1200
▪ Only TiO2 / ZnO as GRASE in FTM 2009
1000
1000
▪ Very restricted choice of GRASE UV filters
Absorbance

Absorbance
800
800

600
600

400
400

200
200

0
290 300 310 320 330 340 350 360 370 380 390 400 0
290 300 310 320 330 340 350 360 370 380 390 400

Wavelength (nm) Wavelength (nm)

Still a significant number of filters available to achieve high
SPF and UVA protection
FDA Tentative Final Monograph / Feb 2019
▪ Only TiO2 and ZnO are GRASE
▪ Difficult to achieve the high SPF and UVA protection
required in the different regions
▪ Sensorial drawback of using only particulate filters
▪ Protection and aesthetics for sunscreens with
inorganics are highly dependent on formulation know
how and using the right inorganic UV filters (specific
dispersion might offer better sensory)
▪ Challenge for emulsion stability

▪ Additional (human tox) data requested for all

other organic filters incl. MUsT studies
▪ MUsT studies = Maximal Use Trial correspond to
dermal penetration studies
Based on human tox

Dr. Myriam Sohn | Global Technical Center SunCare

MUsT – Dermal Penetration Studies as New Requirement of FDA
▪ Is a standard requirement for topically applied pharmaceuticals Results of FDA Small-scale Pilot Studies
▪ Required even for grandfathered filters (not GRASE in FTM 2019)
▪ Triggered by life-long and frequent use of sunscreens
published on May 6, 2019 Journal of American Medical Association

▪ Looks for blood plasma concentration after repeated dose

▪ Includes all different skin types of human body ▪ Already after one application, the systemic absorption exceeds 0.5
▪ Includes different formulation compositions ng/ml blood plasma for all UV filters and were still above up to 21
days after study start
▪ Conducted under maximum use conditions: max. concentration,
max. application frequency, max. surface area ▪ Concentrations in blood and on the skin relatively independent of
formulation type (spray, lotion,…)
▪ FDA will require additional carcinogenic studies, when a threshold
of 0.5 ng filter/ml blood plasma is exceeded ▪ Highest amount by Oxybenzone followed by Homosalate
▪ Was performed as a small-scale pilot study by FDA after industry ▪ Good reproducibility between the 2 studies
had not committed to do so
▪ Study results will be used by FDA to request more systemic toxicity
data (carcinogenicity, reproduction, …), because a safety assessment
based on available studies not possible
BUT FDA also explicitly commented, that the presence of UV filters in blood
does not mean the filters are toxic!
Dr. Myriam Sohn | Global Technical Center SunCare
Skin Penetration – Dependencies
Factors which affect skin penetration Best Possible Practice for Low Skin Penetration
▪ Lipophilicity of test substance Parameter Objective for low Effect
▪ Molecular weight of test substance penetration
Molecular mass > 500 Dalton Large molecules don‘t penetrate
▪ Ionic charge of test substance (size)
▪ Concentration of the test substance Hydrophobicity Log Pow < 1 or > 4 Very polar or very unpolar
molecules don‘t penetrate
▪ Vehicle
Polarity Low to no functional No interaction with skin
▪ Skin area and time of exposure groups

▪ Thickness and integrity of the stratum corneum Melting point Substances with MP Low to no penetration
> 50 °C
▪ Temperature, blood flow
Wiechers, J.W., et al., Predicting Skin Penetration of Actives from Complex Cosmetic Formulations: an Evaluation of Inter Formulation
and Inter Active Effects during Formulation Optimization for Transdermal Delivery. International Journal of Cosmetic Science, 2012.
34(6): p. 525-35.
Bos, J.D. and Meinardi. M., The 500 Dalton Rule for the Skin Penetration of Chemical Compounds and Drugs. Experimental
Dermatology, 2000. 9(3): p. 165-9.

Dr. Myriam Sohn | Global Technical Center SunCare

Physico-chemical Parameters and Dermal Absorption
Examples of Different UV Filters

Filter Molecular mass Log Pow Melting point °C Water solubility Dermal
(Da) Penetration

Oxybenzone 228 3.45 62.5 3 mg/L 3-4 %

Avobenzone 310 6.1 84 < 1 mg/L < 0.5 %

Part of the FDA MUsT Ecamsule 562 1.35 255 > 600 g/L 0.16 %
studies Octocrylene 361 6.1 < 30 << 1 mg/L 0.12 %
Octinoxate 290 >6 < 30 << 1 mg/L 4%
Octisalate 250 >6 < 30 < 1 mg/L 1.1 %
Bisoctrizole (Tinosorb® M) 659 > 12 195 << 1 mg/L < 0.1 %
Filters of newest Bemotrizinol (Tinosorb® S) 627 >>6 80 << 1 mg/L < 0.1 %
generation approved
in EP, BR, … TBPT (Tinosorb® A2B) 537 10.4 281 << 1 mg/L < 0.1%
Octyl Triazone (Uvinul® T150) 823 >>6 130 << 1 mg/L 0.1 %

TBPT, Tris-Biphenyl Triazine

Dr. Myriam Sohn | Global Technical Center SunCare

Current Situation in the US
▪ FDA FTM of 2019 defines Titanium Dioxide and Zinc Oxide as only GRASE filters
▪ Additional toxicological tests required for all other grandfather (& organic) filters – costly & time consuming (no
rapid final outcome expected)
▪ Difficult to achieve high performance, acceptable sensory, and emulsion stability with Titanium Dioxide and / or
Zinc Oxide only
▪ Sunscreen manufacturers use boosters to reach UV performance
▪ Boosters can be scattering particles or film formers
▪ However, boosters can also be molecules with UV absorbing function and are in that case illegal UV
filters

Illegal UV filters are similar to UV filters but have not went through the approval process
for safety evaluation
Dr. Myriam Sohn | Global Technical Center SunCare
Comparison of Absorbance of Registered UV Filters vs Boosters

▪ Octocrylene (OCR), registered UV filter under

Ethylhexyl salicylate (approved) focus by US FDA due to lacking MuST data
Butyloctyl salicylate
Octocrylene (approved)
Ethylhexyl methoxycrylene

400

350
▪ Ethylhexyl Methoxycrylene, similar structure
Absorbance (1%/1cm)

300
to OCR, non-registered UV filter no focus by
250 FDA as not approved as UV filter

200

150

100

50

0
290 300 310 320 330 340 350 360 370 380 390 400

Wavelength
US Market Product Examples

By asking for additional data to prove safety of already registered organic UV filters,
FDA opens the door to use UV molecules not tested at all
Dr. Myriam Sohn | Global Technical Center SunCare
Situation in Europe
EU Cosmetic Directive
▪ Market products can not use UV filters other than those
listed in annex VI
▪ Boosters with inherent absorbance exceeding the one of
registered UV filters not listed in annex VI of EC
regulation are forbidden
▪ Boosters have no SCCS opinion and were not tested
regarding their safety …

▪ This issue of using non official registered UV filters was

addressed by several organizations

▪ Market products had to be removed from the market due to

the use of non-registered molecules showing UV
absorbance

Dr. Myriam Sohn | Global Technical Center SunCare

Safety Alert of EU Commission (July 13, 2022)

INCI:
dicaprylyl carbonate, Aloe barbadensis gel*,
titanium dioxide, zinc oxide, coconut alkanes,
polyglyceryl-2 dipolyhydroxystearate,
propanediol, Pongamia glabra (karanja) seed
oil*, polyglyceryl-3 diisostearate,
polyhydroxystearic acid, stearic acid, aluminum
hydroxide, sodium chloride, Brassica campestris
(rapeseed) oil*, Daucus carota sativa (carrot)
root extract*, Helianthus annuus (sunflower)
seed oil*, coco-caprylate/caprate, alumina,
potassium sorbate, sodium benzoate, parfum,
lactic acid, tocopherol
* ingredients from organic farming

Dr. Myriam Sohn | Global Technical Center SunCare

Safety of Sunscreens
Situation in Europe

70%
OCR , EHMC free
SCCS for Human safety 60%

% launched sunscreens
OCR, EHMC free,
▪ Approves / reviews registered UV filters 50% with environmental claim

▪ The maximum concentration of some registered 40%

UV filters has been adjusted recently

▪ List of UV filters to be reviewed in respect of their 30%

endocrine disrupting potential risk
20%

10%

ECHA for environmental aspects 0%

2015 2016 2017 2018 2019 2020 2021 2022
▪ Reach registration and compliance of chemicals
Search for products
▪ CoRAP list of substances that may pose a risk to human where Region matches Europe
health or the environment and Sub-Category matches Sun - Sun/Sunbed Exposure
and Claims matches one or more of [Biodegradable; Carbon Neutral; Ethical - Environmentally
Friendly Package; Ethical - Recycling; Ethical - Environmentally Friendly Product] as the claim
▪ No official / harmonized test for the impact on corals
and Date Published is between Jan xxxx and Dec xxxx

Dr. Myriam Sohn | Global Technical Center SunCare

 Environmental Aspects

Dr. Myriam Sohn | Global Technical Center SunCare

Current Status
▪ Discussion on potential damages UV filters may have on the ecosystem since they are likely to be directly
released into the environment

▪ A major recent public concern is related to global coral bleaching

▪ Current coral damaging factors are mainly due to the climate change with the increase of the water temperature, and ocean
acidification, to marine debris and pollution, to physical stress by hurricanes, or fishing practices

▪ Independently, some authors investigated the impact of UV filters on reef corals initiating the discussion on the
impact of sunscreens on corals
▪ Those study protocols however do not follow approved principals of standardized test guidelines and thus important and
relevant parameters (i.e. water quality) may have not been measured

Dr. Myriam Sohn | Global Technical Center SunCare

Current Status

▪ Some governments already took drastic regulatory Region Banned / under discussion UV filters
actions by prohibiting the sale of sunscreens Haiwaii Benzophenone 3, Octyl Methoxycinnamate
containing some of the worldwide registered UV From Oct 2022 ban of all organic UV filters
filters on base of those studies approved in the US
Palau Benzophenone 3, Octyl Methoxycinnamate,
Octocrylene, 4-Methyl-Benzylidene
Camphor
▪ Such decisions are problematic since the use of
Key West Florida US Benzophenone 3, Octyl Methoxycinnamate
sunscreens was demonstrated highly valuable for
human health e.g. prevention skin cancers
US Virgin Islands Benzophenone 3, Octyl Methoxycinnamate

Brazil Under discussion: Benzophenone 3, Octyl

Methoxycinnamate, Octocrylene, 4-Methyl-
Benzylidene Camphor
Europe Currently 11 UV filters on CoRap list with
open requests for further evaluation

Dr. Myriam Sohn | Global Technical Center SunCare

Environmental Effect of UV Filters
EcoSun Pass of BASF

Environmental parameters Ecosun pass EcoSun Pass for more eco-

(WO2019207129)
compliant sunscreens

Biodegradation
Acute aquatic toxicity
Chronic aquatic toxicity
Bioaccumulation
Terrestrial toxicity
Sediment toxicity
Scientific based tool to assess the
Endocrine properties
environmental impact of UV-filters

By considering all relevant parameters, more eco-compliant

sunscreen formulation can be developed
Dr. Myriam Sohn | Global Technical Center SunCare
Summary
▪ Only after human safety assessment UV filters can be registered and used in sunscreens
▪ The regulatory status of approved UV filters can always be reviewed
▪ The choice of UV filters is reduced globally due to open questions of authorities regarding environmental and/or human
safety
▪ The lack of performance is sometimes filled using boosters, based on same chromophores as approved filters but have
not been assessed in respect of their safety
▪ Penetration of organic UV filters depends on their individual properties
▪ Reduced choice of possible UV filters (FDA TFM 2019) will finally negatively impact the protection of end consumers
which results in another health concern
▪ Modern organic UV filters are designed for highest UV absorption and best safety profile and outperform inorganic UV
filters
▪ Ecosun Pass offers a possibility to design more eco-compliant sunscreens

Dr. Myriam Sohn | Global Technical Center SunCare

 Thank you!
The Global Technical Center SunCare
Product Stewardship Personal Care - UV Filters