10% Benzoyl Peroxide Acne Foaming Wash

FDA OTC Acne Drug Products Monograph — Benzoyl Peroxide (21 CFR Part 333): Benzoyl peroxide is recognised by the FDA as a safe and effective OTC active ingredient for the treatment of acne vulgaris at concentrations of 2.5%, 5%, and 10%. It acts primarily as an antibacterial agent against Cutibacterium acnes and has mild keratolytic activity. The FDA monograph specifies labelling requirements including warnings about bleaching and skin irritation.

FDA Drug Safety Communication — Rare but serious hypersensitivity reactions with benzoyl peroxide (2019): In 2019, the FDA issued a safety communication warning that OTC topical acne products containing benzoyl peroxide have been associated with rare cases of serious hypersensitivity reactions, including anaphylaxis. The FDA updated product labelling to include warnings about these rare but potentially life-threatening reactions. Patients should discontinue use and seek emergency care if they experience symptoms of severe allergic reaction.

CIR Safety Assessment of Water as Used in Cosmetics: Water (Aqua) is widely accepted as safe for use in cosmetic products and is reviewed as such by the CIR Expert Panel. It functions as a solvent and vehicle for delivering other ingredients to the skin.

CIR Safety Assessment of Carbomers as Used in Cosmetics (2018): The CIR Expert Panel concluded that carbomers, including carbomer homopolymer and interpolymer types, are safe for use in cosmetics as thickening and suspending agents. They are not meaningfully absorbed through intact skin and have low irritation and sensitisation potential at concentrations used in finished products.

CIR Safety Assessment of Carbomers as Used in Cosmetics (2018): The CIR Expert Panel concluded that carbomers, including carbomer homopolymer and interpolymer types, are safe for use in cosmetics as thickening and suspending agents. They are not meaningfully absorbed through intact skin and have low irritation and sensitisation potential at concentrations used in finished products.

CIR Safety Assessment of Alkyl Glucosides as Used in Cosmetics (2013): The CIR Expert Panel concluded that alkyl glucosides, including decyl glucoside, are safe for use in cosmetics as surfactants and cleansing agents. They are derived from renewable plant-based sources and have a favourable safety profile with low irritation potential.

CIR Safety Assessment of Cyclomethicone and Dimethicone as Used in Cosmetics: The CIR Expert Panel concluded dimethicone is safe as used in cosmetic formulations. It functions as a skin protectant and emollient, forming a breathable barrier on skin that reduces transepidermal water loss.

CTPA Ingredient Library — Dimethicone: CTPA lists dimethicone as a safe skin-conditioning agent and emollient widely used in cosmetics to improve skin feel and texture. It is considered safe for all skin types and is non-sensitising.

CIR Safety Assessment of Dioctyl Sodium Sulfosuccinate as Used in Cosmetics: The CIR Expert Panel reviewed dioctyl sodium sulfosuccinate (docusate sodium) as a cosmetic ingredient and concluded it is safe for use as a surfactant and emulsifying agent at concentrations used in current cosmetic practice. It has a well-established safety record in pharmaceutical and cosmetic applications.

FDA GRAS Database — Glycerin: Glycerin (glycerol) is affirmed as Generally Recognized As Safe (GRAS) by the FDA. As a cosmetic ingredient, it is one of the most widely used and well-tolerated humectants, drawing moisture from the environment to the outer layers of the skin.

CIR Safety Assessment of Oleic Acid and Related Fatty Acids as Used in Cosmetics (2019): The CIR Expert Panel concluded that oleic acid and related fatty acids are safe for use in cosmetics as emollients and skin-conditioning agents at the concentrations used in current practice. They are naturally occurring fatty acids present in human sebum and plant oils.

CIR Safety Assessment of Palmitic Acid as Used in Cosmetics: The CIR Expert Panel concluded that palmitic acid is safe for use in cosmetics as an emollient and texture agent at the concentrations used in current practice.

CIR Safety Assessment of Acrylates Copolymers as Used in Cosmetics (2019): The CIR Expert Panel concluded that polyacrylate-based crosspolymers and copolymers are safe for use in cosmetics as rheology modifiers and thickening agents. These polymers are not meaningfully absorbed through intact skin and have low irritation potential at concentrations used in cosmetic formulations.

CIR Safety Assessment of PEG Stearates as Used in Cosmetics (2015): The CIR Expert Panel concluded that PEG stearates including polyoxyl 40 stearate (PEG-40 stearate) are safe for use in cosmetics as emulsifiers and solubilisers at the concentrations used in current practice. PEG derivatives of stearic acid have a well-established safety record in both cosmetic and pharmaceutical products.

CIR Safety Assessment of Propanediol as Used in Cosmetics (2015): The CIR Expert Panel concluded that propanediol is safe for use in cosmetic products. It functions as a humectant, solvent, and viscosity-controlling agent with a low sensitisation potential.

CIR Safety Assessment of Silica as Used in Cosmetics (2019): The CIR Expert Panel concluded that amorphous silica is safe for use in cosmetics as a thickening agent, absorbent, and anti-caking ingredient. Cosmetic-grade silica is amorphous (not crystalline) and does not present the respiratory hazards associated with occupational crystalline silica exposure.

CIR Safety Assessment of Sodium Chloride as Used in Cosmetics (2020): The CIR Expert Panel concluded that sodium chloride is safe for use in cosmetic products at the concentrations used as a viscosity-adjusting agent.

CIR Safety Assessment of Citric Acid and Sodium Citrate as Used in Cosmetics (2014): The CIR Expert Panel concluded that sodium citrate is safe for use in cosmetics as a buffering and chelating agent. Sodium citrate is the sodium salt of citric acid and is also FDA GRAS (Generally Recognised as Safe) for food use, reflecting its well-established safety profile.

CIR Safety Assessment of Sodium Hydroxide as a pH Adjuster: The CIR Expert Panel concludes that sodium hydroxide is safe in cosmetic formulations when used as a pH adjuster at concentrations that achieve the intended pH without elevating finished product pH above 11.

CTPA Cosmetic Ingredients — Sodium Hydroxide: Sodium hydroxide is listed in Annex III of EU Cosmetics Regulation 1223/2009 as a permitted pH adjuster. It is approved for use at levels necessary to adjust pH, ensuring the final product is not harmful at the concentrations present.

CIR/FDA Ingredient Assessment — Not Found in Regulatory Databases: No published safety assessment was found for this ingredient in the CIR (Cosmetic Ingredient Review), FDA, CTPA, or MFDS regulatory databases at the time of review. This does not necessarily indicate a safety concern; many ingredients in common use have not been formally assessed by these bodies.

CIR Safety Assessment of Sorbitan Esters as Used in Cosmetics (2016): The CIR Expert Panel concluded that sorbitan esters including sorbitan stearate are safe for use in cosmetics as emulsifiers and skin-conditioning agents at the concentrations used in current practice. They are derived from the reaction of sorbitol with fatty acids and have low irritation potential.

CIR Safety Assessment of Stearic Acid and Related Fatty Acids: The CIR Expert Panel concludes that stearic acid is safe as used in cosmetic formulations as an emollient and emulsifier.

CTPA Cosmetic Ingredients — Stearic Acid: Stearic acid is a naturally occurring saturated fatty acid approved for unrestricted use in EU cosmetics as an emollient, emulsifier, and surfactant.

FDA — Xanthan Gum Safety Assessment: FDA considers xanthan gum safe for use in cosmetics as a thickening and stabilising agent. It has a long history of safe use in both food and cosmetic products.