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Mineral oil cleansing oil OEM/ODM manufacturing
Mineral Oil Cleansing Oil · OEM/ODM
Mineral oil (INCI Paraffinum Liquidum, also called liquid paraffin) is a mixture of liquid saturated hydrocarbons refined from petroleum. It is a familiar base for cleansing oils because it is almost odorless and does not oxidize or go rancid like plant oils: on the like-dissolves-like principle, the oil phase lifts makeup and sunscreen off the skin surface, then the emulsifier system turns the mixture into a milky emulsion in water so it rinses away. Mineral oil is often labeled as “pore-clogging” and “carcinogenic”. The data paint a different picture: in a rabbit-ear study, “paraffin” was not among the comedogenic substances, but there is no human trial of cosmetic-grade mineral oil alone, so this page does not promise “non-comedogenic”; the International Agency for Research on Cancer (IARC) classifies “mineral oils, untreated or mildly treated” (IARC’s refining terms) in Group 1 and “mineral oils, highly-refined” in Group 3 — not classifiable, which is not a finding of “safe” either. The deciding factor is therefore the refining grade: Butter-C only accepts mineral oil with a COA, a CAS number and refining records to check against ASEAN Annex II. As a rinse-off product, the promise is cleansing and how skin feels after rinsing, measured on the finished product. Butter-C offers turnkey OEM/ODM manufacturing, from formulation and testing to a labeled finished product with its notification dossier.
Formula base
Mineral oil in the oil phase, emulsifiers chosen together
The principle, base-oil groups and emulsifier systems of cleansing oils are covered on the general cleansing oil page; this page puts mineral oil in the name. The oil phase and the emulsifier system must be chosen together, not separately.
Refined mineral oil
INCI Paraffinum Liquidum; PubChem lists CAS 8012-95-1 (paraffin oils) and 8042-47-5 (white mineral oil, petroleum), and suppliers may declare other CAS numbers. As a mixture it has no single molecular formula; several viscosity grades exist. CIR has no report on liquid mineral oil, so there are no survey concentrations to cite; the level in a cleansing oil is set by emulsification and sensory tests (formulation experience).
Supporting esters
Ethylhexyl Palmitate, Caprylic/Capric Triglyceride (MCT oil) — lighten the oil phase and spread quickly (formulation experience). Ethylhexyl Palmitate: CIR records reported use in rinse-off products up to 50%.
Emulsifier system
Following the general cleansing oil page: a PEG-based system (PEG-20 Glyceryl Triisostearate, Sorbeth-30 Tetraoleate) or a PEG-free system (Polyglyceryl-10 Laurate, Polyglyceryl-4 Oleate), chosen around HLB 10–14 at typically 8–20% depending on the oil phase — too little leaves an oily film, too much feels drying and can sting the eyes. Ethoxylated emulsifiers need a COA with a 1,4-dioxane limit.
Antioxidant — only when needed
Mineral oil is oxidation-stable and needs no antioxidant for itself; when the formula contains plant oil or an unsaturated emulsifier (Polyglyceryl-4 Oleate), Tocopherol is added to the oil phase and the peroxide value is tracked.
Key technical points
Refining grade, Annex II, rinse-off and young children
Cosmetic- or pharmacopeia-grade refined mineral oil is quite different from technical mineral oil used as lubricant or metalworking fluid. The four items below are settled before sampling.
Refining records checked against Annex II
ASEAN Annex II (release 2026-1, 22 June 2026) has no entry for Paraffinum Liquidum or the two CAS numbers above, but lists many petroleum fractions by name and CAS with conditions, for example Ref 789: “Paraffin oils (petroleum), catalytic dewaxed heavy, if they contain > 3 % w/w DMSO extract” (CAS 64742-70-7), and Ref 875: “Distillates (petroleum), hydrotreated middle, except if the full refining history is known and it can be shown that the substance from which it is produced is not a carcinogen” (CAS 64742-46-7). If a supplier declares a CAS in these entries, the matching condition must be demonstrated. Butter-C requires a lot COA, CAS, pharmacopeia certificate where available, and DMSO-extract (IP346) or PAH data — a strict reading, to be confirmed by regulatory affairs.
Cancer: refining grade decides
IARC: “mineral oils, untreated or mildly treated” — Group 1, based on occupational exposure (mule spinning, metalworking); “mineral oils, highly-refined” — Group 3, and IARC notes Group 3 is not a determination of non-carcinogenicity or overall safety. Authors from Germany’s Federal Institute for Risk Assessment (BfR) saw no indication of carcinogenicity in animals exposed dermally or orally to highly refined mineral oils and waxes (Pirow et al., 2019). Whole oils appear to penetrate skin poorly, while PAH fractions penetrate considerably (Hadrup et al., 2026) — another reason to use only PAH-free grades.
Rinses clean, no oily film
Mineral oil is non-polar; the emulsifier system is balanced for the viscosity grade and mineral oil level, and checked by emulsification time and residual film after rinsing (formulation experience). In a small study of 20 people, with water-resistant sunscreen only the cleansing oil brought the residue down to a level not different from the control; each category tested a single product (Chen et al., 2020, per the double-cleansing article) — this formula’s makeup removal must be tested on the finished product. Contact lens wearers should remove lenses before cleansing (double-cleansing article).
Young children: aspiration risk
Aspirating mineral oil can cause lipoid pneumonia; a 1985 report cited 1983 US FDA data with 36 cases of baby oil ingestion, and the case it described had a severe course (Reyes de la Rocha et al., 1985). Cleansing oils high in mineral oil should have a child-resistant cap and a keep-out-of-reach-of-children warning (practical recommendation from the mineral oil article). For export to the US: non-emulsion liquid cosmetics containing 10% or more hydrocarbons with a viscosity below 100 SUS at 100 °F require child-resistant packaging (16 CFR 1700.14(a)(32)) — check viscosity on the COA.
Three formulation directions
Three ways to place mineral oil in a cleansing oil
Mineral oil as the main oil, PEG system
Mineral oil makes up most of the oil phase with Ethylhexyl Palmitate, emulsified with PEG-20 Glyceryl Triisostearate – Sorbeth-30 Tetraoleate. Odorless, stable, cost-effective; no antioxidant needed for the oil phase.
Mineral oil – light ester, PEG-free
Mineral oil and MCT oil with a Polyglyceryl-10 Laurate – Polyglyceryl-4 Oleate system. Can be labeled “PEG-free”; thicker emulsion, higher emulsifier cost, tocopherol added because the emulsifier is unsaturated.
Mineral oil with a plant-oil accent
Mineral oil remains most of the oil phase, with a small share of jojoba oil for the ingredient story. The plant-oil portion needs tocopherol and peroxide-value checks; the product name must still reflect that it is a mineral oil cleanser.
Packaging is designed with the formula
Pump or screw-cap bottle, preferably with a child-resistant cap; bottle, pump and gasket materials are compatibility-tested with the formula because the oil is in long contact with plastic.
Parameters we monitor
What our R&D team measures on every sample
These are the parameters Butter-C tracks during formulation and scale-up. Specific limits are agreed with you on the approved sample and then written into the product’s in-house specification.
- Mineral oil incoming check
- Against the COA: CAS, grade (pharmacopeia, cosmetic), viscosity, IP346 or PAH data, refining records; a change of supplier means a new file.
- Appearance
- Color, clarity and odor against the reference sample — refined mineral oil is nearly colorless and odorless.
- Density & refractive index
- Two quick identity checks that catch blending errors between lots.
- Viscosity
- Rotational viscometer, recording spindle and speed; for US export, viscosity also guides packaging choice.
- Emulsification time
- Seconds from adding water until the mixture turns fully opaque; shows whether the emulsifier system is balanced for the mineral oil.
- Residual film after rinsing
- Assessment of oil left on skin after rinsing with water — the basis for “leaves no oily film”.
- Makeup removal
- Tested on matte lipstick and water-resistant sunscreen by in-house procedure against a control.
- Stability
- Accelerated aging at 40 °C, freeze–thaw cycling and centrifugation in the final pack; watching for separation, haze, color or odor change; peroxide value when plant oil is present.
- Microbiology & safety
- Tested at a GLP / ISO 17025-accredited laboratory; microbial risk assessment of an anhydrous system per ISO 29621; skin irritation testing, plus eye irritation if the label claims eye-area use.
Claims
Claims for a rinse-off product with mineral oil
A cleansing oil is emulsified and rinsed away, so claims rest on cleansing performance and skin feel measured on the finished product. Skin data on mineral oil are mostly leave-on, with mineral oil usually the comparator (for example a randomized double-blind trial in 34 people with dry skin, Agero and Verallo-Rowell, 2004); its occlusion is moderate, close to plant oils and well below petrolatum (Stamatas et al., 2008). Butter-C reviews label and marketing wording when preparing the notification dossier.
Removes makeup and sunscreen
Instead of: detoxifies, draws out toxins, deep-cleans pores.
Rinses clean with water, leaves no oily film (once tested on the finished product)
“Tested non-comedogenic” only with a test on the finished product itself. Instead of: non-comedogenic or non-pore-clogging based on the ingredient name.
Does not leave skin feeling tight after rinsing (once sensory results are available)
Instead of: restores damaged skin, restores the skin barrier, seals in moisture like petrolatum.
Contains refined mineral oil (Paraffinum Liquidum)
“Pharmacopeia grade” only when the COA proves it. Instead of: non-toxic, non-carcinogenic, unconditionally safe.
Label reminders
Keep out of reach of children; keep oil away from a child’s nose and mouth; avoid contact with eyes (unless eye irritation has been tested); remove contact lenses before use; stop use if skin becomes red or itchy. A case of allergic contact dermatitis to mineral oil in a child has been reported (2026, short letter without abstract). Instead of: hypoallergenic, gentle for every skin type.
Young children, pregnancy
The cleansing oil is not positioned for young children. Pregnant or breastfeeding women: data are insufficient — ask a doctor. An observational study of 142 women having planned cesarean sections linked saturated mineral oil hydrocarbons (MOSH) in fat tissue with age and use of certain cosmetics; that is an association, with no health effect measured (Concin et al., 2011).
Manufacturing specifications
Available capabilities
- Texture
- Clear liquid oil, nearly colorless and odorless; turns into a milky emulsion in water.
- Format
- Pump or screw-cap bottle, preferably child-resistant. Volume agreed when choosing packaging.
- Minimum order quantity
- Agreed per order — depends on the formula direction and format chosen.
- Testing
- At a GLP / ISO 17025-accredited laboratory; a certificate of analysis delivered with every lot.
- Documentation
- Product Information File (PIF) and cosmetic product notification dossier prepared by Butter-C, with the mineral oil COA and refining records for checking against ASEAN Annex II.
- Packaging
- Label design, printing and packing run in parallel with formulation.
Suggested product concept
Fragrance-free mineral oil – light ester cleansing oil
One product direction to help you picture the idea — not a ready-made product for sale. The actual formula is built around your brand’s positioning and price range.
Refined mineral oil
Most of the oil phase; COA states CAS, grade, viscosity, IP346 or PAH data.
Ethylhexyl Palmitate
A light ester that helps the oil phase spread quickly and feel less heavy.
PEG-20 Glyceryl Triisostearate emulsifier system
Fast emulsification, clean rinse; COA with a 1,4-dioxane limit; no fragrance.
Pump bottle with locking cap
Directions: apply to dry skin, add water to emulsify, rinse off, avoid the eyes, keep out of reach of children.
Customization options
What you can specify
The same format can serve very different customers. Tell us your requirements in the areas below and our pharmacists will build the matching formula.
Mineral oil viscosity grade
Light and fast-spreading or richer — decides feel, emulsifier system and packaging for export.
Emulsifier system
PEG-based or PEG-free, depending on ingredient positioning and budget.
Supporting oils
Esters only, or a plant-oil accent with tocopherol.
Eye area
Whether the label claims eye-area use — if so, eye irritation testing is added.
Fragrance and packaging
Fragrance-free (recommended) or a light fragrance with fragrance allergens declared as required; pump or screw cap, with a child-resistant closure.
Target market
US export needs a viscosity check to decide on child-resistant packaging; brands that want “mineral-oil-free” should choose the olive cleansing oil page instead.
Further reading
Related knowledge
Mineral oil (Paraffinum Liquidum) in cosmetics
Acne, refining grade and IARC, aspiration risk in children and ASEAN Annex II (in Vietnamese).
Cleansing oil OEM/ODM manufacturing
The principle, base-oil groups and PEG / PEG-free emulsifier systems.
Double cleansing
When an oil-based first step is needed, contact lenses and the skin barrier (in Vietnamese).
Olive oil cleansing oil OEM/ODM manufacturing
A plant-oil option for brands that want “mineral-oil-free”.
Petrolatum balm OEM/ODM manufacturing
A semi-solid mineral hydrocarbon: refining records under Annex II Ref 904.
How we work
From idea to finished batch
Eight steps and three milestones signed off by both sides: approved sample, notification number, finished batch. Step-by-step details (in Vietnamese) →
Get started
Tell us about the product you plan to launch
Send us your product direction and expected volume. Our team will get back to you during business hours (Vietnam time, GMT+7).
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