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Bismuth oxychloride (
) is a permanently listed color additive, exempt from batch certification, widely used in cosmetics and externally applied drugs, including eye area products, under FDA regulations (21 CFR 73.1162, 73.2162). It is generally considered safe but, while not inherently toxic, can cause skin irritation or allergic reactions in sensitive individuals, often leading to its avoidance in specific "natural" makeup lines.
Key Regulations and Specifications (FDA):
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21 CFR 73.1162 -- Bismuth oxychloride.
eCFR (.gov)
https://www.ecfr.gov › part-73 › subpart-B › section-73
eCFR (.gov)
https://www.ecfr.gov › part-73 › subpart-B › section-73
(2) Color additive mixtures for drug use made with bismuth oxychloride may contain only those diluents that are suitable and that are listed in this subpart ...Read more
Regulatory Status of Color Additives - hfpappexternal.fda.gov
hfpappexternal.fda.gov
https://hfpappexternal.fda.gov › scripts › fdcc › id=Bism...
hfpappexternal.fda.gov
https://hfpappexternal.fda.gov › scripts › fdcc › id=Bism...
Bismuth Oxychloride. Status: Permanently listed, exempt from certification. Use: Drugs, Cosmetics. Restrictions: Externally applied drugs including eye area use ...Read more
21 CFR § 73.1162 - Bismuth oxychloride. - Cornell Law School
LII | Legal Information Institute
https://www.law.cornell.edu › ... › Subpart B—Drugs
LII | Legal Information Institute
https://www.law.cornell.edu › ... › Subpart B—Drugs
The color additive bismuth oxychloride may be safely used in coloring externally applied drugs, including those intended for use in the area of the eye, in ...Read more
21 CFR § 73.2162 Bismuth oxychloride
LawStack
https://law.lawstack.com › laws › 21-cfr_s_73-2162_bis...
LawStack
https://law.lawstack.com › laws › 21-cfr_s_73-2162_bis...
(b) Uses and restrictions. The color additive bismuth oxychloride may be safely used in coloring cosmetics generally, including cosmetics intended for use in ...Read more
Bismuth Oxychloride
Making Cosmetics
https://www.makingcosmetics.com › fact-sheets
Making Cosmetics
https://www.makingcosmetics.com › fact-sheets
PDF
Oct 6, 2023 — Regulatory Information: Bismuth oxychloride is a FDA-approved color additive but is exempt from batch certification. It is safe for use in ...Read more
2 pages
The Safety and Regulatory Landscape of Bismuth ...
NINGBO INNO PHARMCHEM CO.,LTD.
https://www.nbinno.com › ... › Bismuth Oxychloride
NINGBO INNO PHARMCHEM CO.,LTD.
https://www.nbinno.com › ... › Bismuth Oxychloride
An overview of the safety and regulatory status of Bismuth Oxychloride, focusing on its approval and guidelines for use in cosmetics and other consumer products
Scholarly articles for Regulations on Bismuth oxychloride usage | |
Bismuth: Uses, Supply, and Technology - Jasinski - Cited by 3 … through solid solutions of bismuth oxyhalide/bismuth … - Gembo - Cited by 17 Sustainable production of layered bismuth oxyhalides … - Gordon - Cited by 22 | |
Web results
Regulations on Bismuth oxychloride usage
Anhui Fitech Material Co.,Ltd
https://www.fitechem.com › tag › regulations-on-bismu...
Anhui Fitech Material Co.,Ltd
https://www.fitechem.com › tag › regulations-on-bismu...
Our Regulations on Bismuth oxychloride usage are highly valued across diverse international markets, capable of fulfilling a wide array of custom ...
People also ask
What are the hazards of bismuth oxychloride?
Potential Health Hazards:
Eyes: Eye contact may cause eye irritation. Inhalation: Lungs - Prolonged inhalation may cause respiratory irritation, including chronic pulmonary fibrosis with repeated exposure Skin: May be irritant. Ingestion: May be irritant.
Eyes: Eye contact may cause eye irritation. Inhalation: Lungs - Prolonged inhalation may cause respiratory irritation, including chronic pulmonary fibrosis with repeated exposure Skin: May be irritant. Ingestion: May be irritant.
Bismuth Oxychloride - SDS (Safety Data Sheet)
SDS
https://www.makingcosmetics.com › default › msds › sds...
SDS
https://www.makingcosmetics.com › default › msds › sds...
Is bismuth oxychloride harmful?
Skin Discomfort & Sensations: Some individuals may report feelings of heat, tingling, or discomfort when using cosmetics with bismuth. This sensation is often referred to as the "bismuth oxychloride itch." While not harmful in itself, it can be uncomfortable and bothersome for those who experience it.
Why You Should Avoid Bismuth in Cosmetics | withSimplicity
withSimplicity
https://withsimplicitybeauty.com › withsimplicity-blog
withSimplicity
https://withsimplicitybeauty.com › withsimplicity-blog
What is the difference between bismuth and bismuth oxychloride?
Bismuth oxychloride is an inorganic compound of bismuth, which is found naturally in the rare mineral bismoclite. Bismuth is a heavy and brittle metal, whereas bismuth oxychloride is a pigment that comes in either a pearl or diamond finish, and is used to give mineral makeups either a matte or shimmery appearance.Mar 4, 2024
Ingredient Watch List: Bismuth Oxychloride
Annmarie Gianni
https://www.annmariegianni.com › ingredient-watch-list...
Annmarie Gianni
https://www.annmariegianni.com › ingredient-watch-list...
Web results
Material Safety Data Sheet
Spectrum Chemical
https://www.spectrumchemical.com › media › sds
Spectrum Chemical
https://www.spectrumchemical.com › media › sds
PDF
Aug 11, 2006 — Do NOT induce vomiting unless directed to do so by medical personnel. Never give anything by mouth to an unconscious person.Read more
6 pages
The Controversial Comedogenic Rating of Bismuth ...
Hylan Minerals
https://hylanminerals.com › blogs › clean-beauty › the-c...
Hylan Minerals
https://hylanminerals.com › blogs › clean-beauty › the-c...
Apr 4, 2026 — While generally considered safe by regulatory bodies, bismuth oxychloride can cause irritation and breakouts in sensitive individuals due to its ...Read more
Ingredient Watch List: Bismuth Oxychloride
Annmarie Gianni
https://www.annmariegianni.com › ingredient-watch-list...
Annmarie Gianni
https://www.annmariegianni.com › ingredient-watch-list...
Mar 4, 2024 — In the U.S., cosmetics have to meet certain standards for bismuth chloride, but in other countries, those regulations may not be as strict ...Read more