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Status:
Possibly Marketed Outside US
Source:
21 CFR 333D
(2013)
Source URL:
First approved in 2013
Source:
21 CFR 333D
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Status:
First approved in 2013
Source:
21 CFR 352
Source URL:
Class (Stereo):
CHEMICAL (RACEMIC)
Targets:
Conditions:
Chlorphenesin is a preservative and cosmetic biocide that helps prevent the growth of microorganisms. In cosmetics and personal care products, Chlorphenesin is used in the formulation of aftershave lotions, bath products, cleansing products, deodorants, hair conditioners, makeup, skin care products, personal cleanliness products, and shampoos. Chlorphenesin has been reported to cause irritation and contact dermatitis in some people, particularly those with sensitive and dry skin. The Cosmetic Ingredient Review (CIR) expert panel released a safety assessment in October 2012, however, that stated chlorphenesin at 0.3 percent (as it exists in personal care products) was classified as having “negligible dermal irritation potential.”
Status:
Possibly Marketed Outside US
Source:
21 CFR 352
(2013)
Source URL:
First approved in 2013
Source:
21 CFR 352
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Gamma-cyclodextrin is cycloamylose composed of eight alpha-(1-4) linked D-glucopyranose units and is formed by bacterial digestion of starch. Gamma-cyclodextrin is a hydrophilic molecule that does not readily permeate biological membranes and is rapidly digested by bacteria in the gastrointestinal tract. In humans, it is metabolized by α-amylase that is found in, for example, saliva, bile fluid, and tears. Gamma-cyclodextrin is generally recognized as safe by the FDA. It is used in bread spreads, frozen dairy desserts, ready-to-eat dairy desserts, desserts prepared from dry mixes, fruit fillings, cheese, and cream fillings, and chewing gum as a stabilizer, emulsifier, carrier and formulation aid at varying levels.
Status:
Possibly Marketed Outside US
Source:
21 CFR 352
(2013)
Source URL:
First approved in 2013
Source:
21 CFR 352
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Status:
Possibly Marketed Outside US
First approved in 2013
Source:
21 CFR 333E
Source URL:
Class (Stereo):
CHEMICAL (RACEMIC)
Targets:
Alpha-terpineol is a monoterpene found in the essential oils of several aromatic plant species. It has an anti-inflammatory and antioxidant effects. alpha-Terpineol is a fragrance ingredient used in decorative cosmetics, fine fragrances, shampoos, toilet soaps, and other toiletries as well as in non-cosmetic products such as household cleaners and detergents. alpha-Terpineol was approved by the FDA as a flavor.
Status:
Possibly Marketed Outside US
Source:
21 CFR 352
(2013)
Source URL:
First approved in 2013
Source:
21 CFR 352
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Targets:
L-Theanine is a relaxing and nondietary amino acid found pretty much exclusively in teas from Camellia sinensis (alongside green tea catechins and caffeine) and is known to promote relaxation without sedation. It appears to be effective at this as well as reducing stress at standard dosages. L-theanine was discovered as a constituent of green tea in 1949 and was approved in Japan in 1964 for unlimited use in all foods, including chocolates, soft drinks, and herb teas, except infant foods. It also provides a unique umami (brothy or savory) taste and flavor to green tea infusion. L-theanine may help relieve stress by inducing a relaxing effect without drowsiness and may also possess immunologic attributes. Theanine may also have effects on the cardiovascular system and play a preventative role in cancer; however, limited clinical information is available to support these claims. L-Theanine and its positive effects on cognitive performance is one of its most important
functions. Because of chemical structure of L-Theanine similar to glutamate it can act as a neurotransmitter
related to memory. In a study made on rats, it was found out that L-Theanine
modulated the serotonin and dopamine levels and increased learning skills with memory. In addition, it is stated that L-Theanine increases neuro - throphine mRNA level by
activating its neuro - transmitter inhibiting system and supports the central nervous system that
helps the development of brain functions. L-Theanine had a positive effect on memory
and had positive effects on the treatment and prevention of Alzheimer. Theanine is an antagonist of the NMDA receptors (albeit with fairly weak efficacy) and can inhibit synaptic release of glutamate via blocking the transporter competitively. Theanine may also reduce glutamate levels, but this is also a fairly weak mechanism requiring a high concentration of theanine.
Status:
Possibly Marketed Outside US
First approved in 2013
Source:
21 CFR 352
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Conditions:
Oxaceprol, a structural analog of hydroxyproline, has been used for several years for the treatment of osteoarthritis and rheumatoid arthritis, showing good gastrointestinal safety, particularly in comparison with NSAIDs. It was shown that oxaceprol does not inhibit the synthesis of prostaglandins in vitro, but acts predominantly by inhibiting leukocyte adhesion and migration, thus inhibiting inflammation at an early stage and helps in pain relief.
Status:
Possibly Marketed Outside US
Source:
21 CFR 358H
(2023)
Source URL:
First approved in 2013
Source:
M016
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Edetate dipotassium is a salt of edetic acid (ethylenediaminetetraacetic acid or EDTA). It is used in pharmaceutical formulations (excipient ingredient), cosmetics and foods as chelating agent.
Status:
Possibly Marketed Outside US
Source:
21 CFR 352
(2013)
Source URL:
First approved in 2013
Source:
21 CFR 352
Source URL:
Class (Stereo):
CHEMICAL (RACEMIC)
Status:
Possibly Marketed Outside US
Source:
TMCA HAIR COLOR Number Six (Natural dark brown) by Gahwa Well Food Co.,Ltd
Source URL:
First approved in 2013
Source:
BEAUTIFUL WOMANS HAIR LOVES COLORFUL BUBBLES HAIR DYE 5N NATURAL BROWN by Modlina Cosmetics Co., Ltd
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Conditions:
p-Phenylenediamine is one of the simplest aromatic diamine primarily used as a component of engineering polymers, composites, dye intermediate and as a hair dye. p-Phenylenediamine is easily oxidized, and for this reason derivatives of p-Phenylenediamine are used as antiozonants in the production of rubber products. The substituents, naphthyl, isopropyl etc. affect the effectiveness of their antioxidant roles as well as their properties as skin irritants. Acute (short-term) exposure to high levels of p-phenylenediamine may cause severe dermatitis, eye irritation and asthma, gastritis, renal failure, vertigo, tremors, convulsions, and coma in humans. Eczematoid contact dermatitis may result from chronic (long-term) exposure in humans. In rats and mice chronically exposed to p-phenylenediamine in their diet, depressed body weights, but no other clinical signs of toxicity were observed in several studies. No information is available on the reproductive, developmental, or carcinogenic effects of p-phenylenediamine in humans. EPA has not classified p-phenylenediamine with respect to carcinogenicity.