Petrolatum
Also known as Petroleum Jelly, Vaseline, White Petrolatum, Yellow Petrolatum, Paraffinum Molle, Soft Paraffin
“EU CosIng says: restricted.”
Petrolatum (petroleum jelly, CAS 8009-03-8) is a purified semi-solid mixture of hydrocarbons derived from petroleum, used as an occlusive emollient and skin protectant. FDA classifies petrolatum as a safe and effective OTC skin protectant active ingredient at 30–100% under 21 CFR § 347.10(m), the most rigorous US regulatory determination for a cosmetic ingredient (OTC drug status). CIR formally deferred its own evaluation because FDA's assessment was already authoritative. A comprehensive 2024 JAAD review (Kamrani et al., PMID 37315800) confirmed petrolatum's favorable safety profile, addressing and dispelling misconceptions about allergenicity, comedogenicity, and flammability risk. Ghadially et al. (JAAD 1992, PMID 1564142) demonstrated that petrolatum penetrates the stratum corneum interstices and accelerates barrier recovery rather than acting as a simple surface occludent. Chuberre et al. (JEADV 2019, PMID 31588613) confirmed mineral oils/waxes including petrolatum are non-allergenic, do not penetrate systemically, and comply with EU PAH purity requirements when properly refined. Ghali et al. (Clin Pediatr 2025, PMID 40170321) reviewed petroleum-based emollients in pediatric atopic dermatitis and confirmed safety for pediatric use. The EU regulatory restriction (Annex II Entry 904) is a conditional prohibition based on PAH carcinogenicity concerns for unrefined petroleum: cosmetic-grade petrolatum with documented full refining history is permissible. The key safety variable is refining quality — USP/pharmaceutical-grade petrolatum has an established safety record; the primary concern applies only to inadequately refined grades.
Highly effective occlusive emollient — prevents transepidermal water loss (TEWL) and supports skin barrier function (Ghadially 1992; JAAD 2024 review)
FDA-approved OTC skin protectant active ingredient for minor cuts, scrapes, burns, chapped skin, and wound care (21 CFR Part 347)
Non-allergenic: highly stable, not susceptible to oxidation or rancidity; extremely low sensitization potential (Chuberre 2019; JAAD 2024)
Excellent tolerability in pediatric populations including atopic dermatitis (Ghali et al. 2025 review)
Does not penetrate systemic circulation — remains in stratum corneum interstices; no systemic bioavailability concern (Chuberre 2019)
Cost-effective, widely available, long-established safety and efficacy record in dermatology (JAAD 2024)
Useful as patch test vehicle, medicated ointment base, and wound care occlusive dressing (JAAD 2024)
- · PAH (polycyclic aromatic hydrocarbon) contamination in inadequately refined petrolatum — mitigated by pharmaceutical/cosmetic grade specifications and EU Annex II refining history requirement
- · EU Annex II Entry 904 conditional prohibition: petrolatum is listed as prohibited unless full refining history is documented and non-carcinogenicity of source material is demonstrated
- · Potential for product contamination during manufacturing if non-cosmetic-grade petrolatum is used
- · Possible occlusion of acne in acne-prone individuals at high concentrations, though JAAD 2024 review characterizes comedogenicity risk as overstated in consumer literature
CIR Ingredient Status: Petrolatum — CIR deferred evaluation to FDA per CIR Procedures (as reported on cosmeticsinfo.org, sourced from CIR…
“CIR deferred evaluation of Petrolatum because the safety has been assessed by FDA, in accordance with CIR Procedures.”— cosmeticsinfo.org/ingredient/petrolatum/ — ingredient safety section
21 CFR § 347.10 — Skin Protectant Active Ingredients: Petrolatum, 30 to 100 percent
“(m) Petrolatum, 30 to 100 percent.”— 21 CFR § 347.10(m)
EU Cosmetics Regulation 1223/2009, Annex II Entry 904: Petrolatum (CAS 8009-03-8) — prohibited except if full refining history is known a…
“Petrolatum, 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”— EU Regulation 1223/2009, Annex II, Entry 904 (CAS 8009-03-8, EC 232-373-2)