Suppose one request covers isopropyl myristate and white mineral oil. Under FDA’s OTC Monograph M016, mineral oil can be the active in a product labeled as an over-the-counter (OTC) skin protectant, at 50-100%; the ester cannot. Before comparing emollient suppliers, put four things on every line: INCI name, class, the claim the product will make, and the use level.

How do the emollients compare on safety finding, use level and US status?

Every emollient here that the Cosmetic Ingredient Review (CIR) lists in its December 2025 Quick Reference Table carries a safe finding; many alkyl esters and dicaprylyl carbonate carry the qualifier “when formulated to be non-irritating”. Reported leave-on use runs from 3% (hexyl laurate) to 95.6% (caprylic/capric triglyceride). Only mineral oil and lanolin here are OTC skin-protectant actives.

A CIR finding describes the ingredient, never a lot; where the table and the CIR report behind a use level disagree, the row carries a dagger. A reported use level is what industry surveys found between 2008 and 2016, so size a formula on your own data.

Ester emollients: IPM, IPP, CCT, ethylhexyl palmitate and C12-15 alkyl benzoate

Ester use levels spread widely in CIR’s alkyl esters report (2012 survey data), from 3% for hexyl laurate to 78% for ethylhexyl palmitate, with isopropyl myristate (IPM) at 77.3%, so the same class covers a main oil phase and an additive. Caprylic/capric triglyceride (CCT) reached 95.6% in the 2015-2016 data in CIR’s triglycerides report. Butyl oleate had no current use reported in the 2012-2013 data. Ask your formulator to justify a specification built around it before you qualify a source.

An INCI name can describe a mixture. CIR defines isopropyl palmitate (IPP) as a mixture of isopropyl esters with a minimum 60% isopropyl palmitate. Two lots can therefore carry the same name and differ in composition. Quote on the ester content the lot certifies.

Physical form changes the plant work. Cetyl palmitate melts at 46-54 °C and myristyl myristate at 37-39 °C, so both go into a heated oil phase. Isopropyl palmitate melts at 11 °C and hexyl laurate at -3.4 °C, so both stay liquid at room temperature. Dicaprylyl carbonate is a white liquid. Sensory choice between near-equivalents is a formulation question; the emollient ester selection guide covers spreading and feel.

INCI and finding: CIR Quick Reference Table, Dec 2025. HS: 6-digit subheading of the US Harmonized Tariff Schedule as of October 2026. Max leave-on use: highest leave-on concentration reported to CIR. † Coded S in the table; CIR’s 2013 alkyl esters report qualifies it. – not specified; ask the desk.
Ester INCI CAS Class HS code Max leave-on use, % CIR finding
Isopropyl Myristate IPM Isopropyl Myristate 110-27-0 Ester 2915.90 77.3 Safe as used †
Isopropyl Palmitate IPP Isopropyl Palmitate 142-91-6 Ester 2915.70 60 Safe as used †
Isopropyl Isostearate Isopropyl Isostearate 68171-33-5 Ester 2915.90 19 Safe if non-irritating
Caprylic/Capric Triglyceride CCT Caprylic/Capric Triglyceride 65381-09-1 Triglyceride – 95.6 Safe as used
Ethylhexyl Palmitate (Octyl Palmitate) Ethylhexyl Palmitate 29806-73-3 Ester 2915.70 78 Safe as used †
Ethylhexyl Isononanoate (Octyl Isononanoate) Ethylhexyl Isononanoate 84878-30-8 Ester 2915.90 75 Safe if non-irritating
Isononyl Isononanoate Isononyl Isononanoate 59219-71-5 Ester 2915.90 53 Safe if non-irritating
Cetearyl Isononanoate Cetearyl Isononanoate 111937-03-2 Ester – 40 Safe if non-irritating
Ethylhexyl Stearate (Octyl Stearate) Ethylhexyl Stearate 22047-49-0 Ester 2915.70 38 Safe if non-irritating
Cetyl Ethylhexanoate (Cetyl Octanoate) Cetyl Ethylhexanoate 59130-69-7 Ester – 52 Safe if non-irritating
Cetearyl Ethylhexanoate (Cetearyl Octanoate) Cetearyl Ethylhexanoate 90411-68-0 Ester – 35 Safe if non-irritating
Isocetyl Stearate Isocetyl Stearate 25339-09-7 Ester 2915.70 34 Safe if non-irritating
Hexyldecyl Stearate Hexyldecyl Stearate 17618-45-0 Ester 2915.70 13 Safe if non-irritating
Hexyl Laurate Hexyl Laurate 34316-64-8 Ester 2915.90 3 Safe if non-irritating
Decyl Oleate Decyl Oleate 3687-46-5 Ester 2916.15 4 Safe if non-irritating
Butyl Stearate Butyl Stearate 123-95-5 Ester 2915.70 12 Safe if non-irritating
Butyl Oleate Butyl Oleate 142-77-8 Ester 2916.15 No current use reported Safe if non-irritating
Cetyl Palmitate Cetyl Palmitate 540-10-3 Ester – 11 Safe as used †
Myristyl Myristate Myristyl Myristate 3234-85-3 Ester 2915.90 17 Safe as used †
Myreth-3 Myristate Myreth-3 Myristate 59686-68-9 Ester – – Not in CIR’s table
C12-15 Alkyl Benzoate C12-15 Alkyl Benzoate 68411-27-8 Ester 2916.31 – Safe as used
Dicaprylyl Carbonate Dicaprylyl Carbonate 1680-31-5 Ester 2920.90 34.5 Safe if non-irritating
Diisopropyl Adipate Diisopropyl Adipate 6938-94-9 Ester 2917.12 8 Safe as used
Diisopropyl Sebacate Diisopropyl Sebacate 7491-02-3 Ester 2917.13 10 Safe as used
Pentaerythrityl Tetracaprylate/Tetracaprate Pentaerythrityl Tetracaprylate/Tetracaprate 68441-68-9 Ester – 5 Safe as used
Pentaerythrityl Tetraisostearate Pentaerythrityl Tetraisostearate 62125-22-8 Ester – 55 Safe as used
Ester emollient product pages (26)
Isononyl IsononanoatePentaerythrityl TetraisostearateCaprylic/Capric Triglyceride (CCT)Ethylhexyl Palmitate (Octyl Palmitate)Cetearyl IsononanoateCetyl PalmitateDecyl OleateC12-15 Alkyl BenzoateDicaprylyl CarbonateButyl StearateIsopropyl Palmitate (IPP)Diisopropyl AdipateEthylhexyl Stearate (Octyl Stearate)Cetyl Ethylhexanoate (Cetyl Octanoate)Hexyl LaurateIsopropyl Myristate (IPM)Myristyl MyristateDiisopropyl SebacateHexyldecyl StearateEthylhexyl Isononanoate (Octyl Isononanoate)Pentaerythrityl Tetracaprylate/TetracaprateIsocetyl StearateButyl OleateIsopropyl IsostearateCetearyl Ethylhexanoate (Cetearyl Octanoate)Myreth-3 Myristate

Hydrocarbon emollients: mineral oil, squalane and isoparaffins

Mineral oil carries the most regulation in this class. FDA’s OTC Monograph M016 lists it as a skin-protectant active at 50-100%, and 21 CFR 172.878 defines white mineral oil as a mixture of liquid hydrocarbons, essentially paraffinic and naphthenic, obtained from petroleum.

CIR’s December 2025 Quick Reference Table has no entry for mineral oil. For food use, 21 CFR 172.878 requires white mineral oil to pass the United States Pharmacopeia (USP) XX test for readily carbonizable substances, the USP XVII test for sulfur compounds and an ultraviolet absorbance limit; put those three on the purchase order. For a cosmetic purchase no CFR section sets the specification: the Certificate of Analysis (CoA) for the lot governs.

The isoparaffins run at high loadings. In the 2010 survey in CIR’s draft final isoparaffins report, isododecane reached 90% and isohexadecane 42% in leave-on products. CIR’s polyene group report (2015) puts hydrogenated polyisobutene at 95% in lip products. At those loadings the hydrocarbon is the base of the formula, not an additive, so its specification carries the product’s.

INCI and finding: CIR Quick Reference Table, Dec 2025. HS: 6-digit subheading of the US Harmonized Tariff Schedule as of October 2026. Max leave-on use: highest leave-on concentration reported to CIR. † Coded S in the table; CIR’s 2010 draft final isoparaffins report qualifies it. – not specified; ask the desk.
Hydrocarbon INCI CAS Class HS code Max leave-on use, % CIR finding
White Mineral Oil – 8042-47-5 Hydrocarbon 2710.19 – Not in CIR’s table
Squalane Squalane 111-01-3 Hydrocarbon 2901.10 – Safe as used
Hydrogenated Polyisobutene Hydrogenated Polyisobutene 68937-10-0 Hydrocarbon 3902.20 95 Safe as used
Isohexadecane Isohexadecane – Hydrocarbon – 42 Safe as used †
Isododecane Isododecane 31807-55-3 Hydrocarbon 2901.10 90 Safe as used †
Hydrocarbon emollient product pages (5)
IsododecaneIsohexadecaneWhite Mineral OilHydrogenated PolyisobuteneSqualane

Natural oils, butters and lanolin: shea, mango, coconut, jojoba and lanolin

Natural emollients are bought on chemistry that the INCI name leaves open: iodine, saponification and peroxide values, and the melting point. Ask for those values on every lot’s CoA. Coconut oil melts at 22-26 °C, so it can arrive liquid in August and solid in January.

Use levels in CIR’s plant-oils draft final report vary as much as in the esters. Coconut oil reached 80% in the 2008 data. In the 2010 data, sweet almond oil reached 77%, shea butter 60% as a cuticle softener, and argan kernel oil 10% in body and hand creams.

Lanolin is the only natural emollient here with an OTC skin-protectant range: 12.5-50% under FDA’s OTC Monograph M016, and 15.5% in diaper-rash combinations. If the finished label claims skin protection, the lanolin content has to sit inside the range that applies.

INCI and finding: CIR Quick Reference Table, Dec 2025. HS: 6-digit subheading of the US Harmonized Tariff Schedule as of October 2026. Max leave-on use: highest leave-on concentration reported to CIR. – not specified; ask the desk.
Natural emollient INCI CAS Class HS code Max leave-on use, % CIR finding
Shea Butter Butyrospermum Parkii (Shea) Butter 194043-92-0 Butter 1515.90 60 Safe as used
Mango Butter Mangifera Indica (Mango) Seed Butter 90063-86-8 Butter 1515.90 5 Safe as used
Coconut Oil (76°) Cocos Nucifera (Coconut) Oil 8001-31-8 Oil 1513.19 80 Safe as used
Sweet Almond Oil Prunus Amygdalus Dulcis (Sweet Almond) Oil 8007-69-0 Oil 1515.90 77 Safe as used
Argan Oil Argania Spinosa Kernel Oil 223747-87-3 Oil 1515.90 10 Safe as used
Golden Jojoba Oil Simmondsia Chinensis (Jojoba) Seed Oil 61789-91-1 Oil 1515.90 100 Safe as used
Lanolin Lanolin 8006-54-0 Wax 1505.00 – Safe as used

Documents for every product above

  • Technical data sheet: on request
  • Safety data sheet: on request
  • Certificate of analysis: issued per lot with each shipment
Natural oil, butter and lanolin product pages (7)
Sweet Almond OilMango ButterShea ButterCoconut Oil (76°)Golden Jojoba OilLanolinArgan Oil

Industries served

Cosmetics buyers specify from CIR’s findings and reported use levels; food buyers of white mineral oil and petrolatum write to 21 CFR 172.878 and 172.880.

Documents and quotes

Add these lines to every request, after the INCI name, class, claim and use level:

  1. For an OTC skin-protectant or a food use, the rule the use falls under (OTC Monograph M016, or 21 CFR 172.878 or 172.880) and the specification your quality team requires.
  2. For esters sold as mixtures, the ester content the lot certifies: CIR describes isopropyl palmitate as a mixture with a minimum of 60% isopropyl palmitate.
  3. For natural butters and oils, iodine, saponification and peroxide values on each lot’s CoA.

A listing here is not a statement that a lot meets a food or drug specification; the lot’s CoA settles that. Send the request from the product page, which carries the quote form.

For formulation questions, see technical support. Supplied for industrial formulation and manufacturing use, not for retail or consumer sale.

Frequently asked questions

Which emollients can carry an OTC skin-protectant claim in the US?

FDA’s OTC Monograph M016 lists mineral oil (50-100%) and lanolin (12.5-50%) among these emollients as over-the-counter (OTC) skin-protectant actives. It also lists petrolatum and white petrolatum at 30-100%.

M016 has been a final order since March 27, 2020, carrying over the monograph codified in 21 CFR 347.10. It also allows mineral oil at 30-35% with colloidal oatmeal and lanolin at 15.5% in diaper-rash combinations. Each range governs the active in a product labeled as a skin protectant; whether a lot is suitable as an OTC drug active is for your regulatory and quality team to decide, and a listing here does not make that claim.

What does CIR’s “safe when formulated to be non-irritating” mean for an ester purchase?

CIR’s Quick Reference Table (December 2025) marks many alkyl esters SQ, safe when formulated to be non-irritating, for example isononyl isononanoate, ethylhexyl isononanoate and isocetyl stearate. The qualifier attaches to the finished formula, not to a lot.

No line on a purchase order satisfies the qualifier: the lot CoA cannot show non-irritation in your finished formula. The table codes isopropyl myristate, isopropyl palmitate, ethylhexyl palmitate, cetyl palmitate and myristyl myristate S, but CIR’s 2013 alkyl esters report lists them under the same qualifier, so formulate as if it applies. When you qualify a new lot or grade of one of these esters, confirm the finished formula’s irritation result with it.

How much isopropyl myristate do formulators use?

Isopropyl myristate is used at up to 77.3% in leave-on products (other hair grooming aids), in 2012 survey data from CIR’s alkyl esters report. Ethylhexyl palmitate reached 78% in body and hand preparations and isopropyl palmitate 60%.

Those figures record what the survey found in products on the market; they are not a regulatory ceiling. The same report puts hexyl laurate at 3%, so a buyer sizing annual volume from a formula card should check which end of that spread the ester sits at.

Can mineral oil and petrolatum be used in food?

White mineral oil and petrolatum can be used in food under 21 CFR 172.878 and 172.880 (revised as of April 1, 2025), each under stated conditions. Section 172.880 requires petrolatum to meet the United States Pharmacopeia XX (1980) white petrolatum or National Formulary XV (1980) petrolatum specification and caps use by food category.

A listing here is not a statement that a lot meets either section. For food use, write the 21 CFR section and its specification onto the purchase order and check the lot’s Certificate of Analysis (CoA) against it before release.

How do I specify shea butter?

Shea butter’s reported iodine value is 45-77, saponification value 165-190, peroxide value 5.0 meq/kg maximum and melting point 32-46 °C (slip 28-42 °C). The ranges come from CIR’s plant-oils draft final report (CIR panel book, March 2011); use them as a reference for your own specification.

CIR collected the ranges from published data; it does not issue them as a purchase specification. Ask for each value on every lot’s CoA, and plan the melt: the butter is solid at room temperature.

Sources & methodology

Figures are RawSource sourcing data unless attributed to a named source. Regulatory citations are current as of publication. Chemical identities verified by CAS number against the RawSource catalog.

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Products mentioned: Argan Oil (Argania Spinosa Kernel Oil) Butyl Oleate Butyl Stearate C12-15 Alkyl Benzoate (C12-15 AB) Caprylic/Capric Triglyceride (MCT, Fractionated Coconut Oil) Cetearyl Ethylhexanoate (Cetearyl Octanoate) Cetearyl Isononanoate Cetyl Ethylhexanoate (Cetyl Octanoate) Cetyl Palmitate (Hexadecyl Palmitate) Coconut Oil (76 Degree, CNO) Decyl Oleate Dicaprylyl Carbonate (DCC) Diisopropyl Adipate Diisopropyl Sebacate Ethylhexyl Stearate (Octyl Stearate) Golden Jojoba Oil (Simmondsia Chinensis Seed Oil) Hexyl Laurate (Hexyl Dodecanoate) Hexyldecyl Stearate Hydrogenated Polyisobutene Isocetyl Stearate Isododecane Isononyl Isononanoate Isopropyl Isostearate Isopropyl Myristate (IPM, Isopropyl tetradecanoate) Isopropyl Palmitate (IPP) Lanolin (Wool Wax) Mango Butter Myreth-3 Myristate Myristyl Myristate Octyl Isononanoate (Ethylhexyl Isononanoate) Octyl Palmitate (Ethylhexyl Palmitate) Pentaerythrityl Tetracaprylate/Tetracaprate Pentaerythrityl Tetraisostearate Shea Butter (Butyrospermum Parkii, Vitellaria Paradoxa, Karite Butter) Squalane Sweet Almond Oil (Prunus Amygdalus Dulcis Oil) White Mineral Oil (Mineral Oil, White Oil)
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