octinoxate
Regulatory sources consulted
Approved indications
- Helps prevent sunburn as a four-filter combination sunscreen product.
Contraindications
Absolute
- Do not use on damaged or broken skin.
Clinical warnings
- For external use only; avoid the eyes and rinse with water after contact. Stop and seek advice if a rash develops. — openFDA MediChoice Moisturizing Lip Balm SPF 15 set ID 00327815-28f0-4198-bca7-c8ae768ff416
Pregnancy and lactation
No specific recommendation is established for pregnancy or breastfeeding.
Recent literature (PubMed)
Human skin is the first line of photoprotection against UV radiation. However, despite having its defence mechanisms, the photoprotection that the skin exerts is not enough. To protect human skin, the inclusion of UV filters in the cosmetic industry has grown significantly as a photoprotection strategy. Octylmethoxycinnamate, also designated by octinoxate, or 2-ethylhexyl-4-methoxycinnamate (CAS number: 5466-77-3) is one of the most widely used UV-B filter in the cosmetic industry. The toxic effects of OMC have alarmed the public, but there is still no consensus in the scientific community about its use. This article aims to provide an overview of the UV filters' photoprotection, emphasizing the OMC and the possible negative effects it may have on the public health. Moreover, the current legislation will be addressed. In summary, the recommendations should be rethought to assess their risk-benefit, since the existing literature warns us to endocrine-disrupting effects of OMC. Further studies should be focus on the toxicity of OMC alone, in mixture and should consider its degradation products, to improve the knowledge of its risk assessment as EDC.
Polycystic ovary syndrome (PCOS) is a complex endocrine-metabolic disorder affecting 6-20% of women of reproductive age, manifesting through hyperandrogenism, ovulatory dysfunction, insulin resistance, and diverse metabolic derangements. Increasing evidence highlights the contribution of environmental factors, particularly endocrine-disrupting chemicals (EDCs), to PCOS susceptibility and severity. Sunscreen ultraviolet (UV) filters such as oxybenzone (benzophenone-3) and octinoxate (ethylhexyl methoxycinnamate) are widely used EDCs with established systemic absorption and biomonitoring evidence in human populations. Their endocrine-disrupting potential encompasses estrogenic and anti-androgenic activity, interference with steroidogenic enzymes, modulation of thyroid hormone, induction of oxidative stress, and epigenetic reprogramming, all of which are mechanistic pathways that overlap with PCOS pathophysiology. This evidence-based study critically appraises the evidence linking oxybenzone and octinoxate exposures to ovarian endocrinology, with a PCOS-specific focus. Human exposure patterns, pharmacokinetics, and regulatory perspectives are summarized alongside preclinical and in vitro data implicating these filters in ovarian dysfunction. Mechanistic intersections with PCOS include hyperandrogenism, disrupted folliculogenesis, oxidative stress-adipokine imbalance, and potential impairment of vitamin D signaling. Although epidemiological studies directly addressing PCOS outcomes remain sparse, the convergence of toxicological evidence with known endocrine vulnerabilities in PCOS underscores a need for targeted investigation. By mapping exposure pathways and mechanistic disruptions, this appraisal emphasizes the translational relevance of UV filter toxicity in the context of PCOS. It advocates for PCOS-specific biomonitoring cohorts, mechanistic studies, and regulatory consideration of reproductive endpoints while balancing the dermatological benefits of photoprotecti
Organic ultraviolet (UV) filters are used in a variety of cosmetic and personal care products (CPCPs), including sunscreens, due to their ability to absorb solar radiation. These UV filters can be washed down the drain through bathing, cleansing, or the laundering of clothing, therefore UV filters can enter the freshwater environment via wastewater treatment plant effluent, and so a freshwater risk assessment is necessary to establish the environmentally safe use of these important CPCP ingredients. In the present study, an environmental safety assessment for a UV filter of regulatory concern, octinoxate, was conducted. An established risk assessment framework designed specifically for CPCPs released to the freshwater environment in the United States was used for the assessment. A distribution of predicted environmental concentrations (PECs) representative of conditions across the region was calculated using the spatially resolved probabilistic exposure model iSTREEM. A review of available hazard data was conducted to derive a predicted no-effect concentration (PNEC). The safety assessment was conducted by comparing the PEC distribution to the PNEC. A substantial margin of safety was found between the 90th percentile PEC, which is representative of the reasonable worst-case environmental exposure, and the PNEC. Owing to this finding of negligible risk, further refinement of the risk assessment through the generation of experimental data or refinement of conservative assumptions is not prioritized. These results are critical for demonstrating the environmental safety of UV filters in the US freshwater environment and will help guide future work. Environ Toxicol Chem 2022;41:3116-3124. © 2022 The Authors. Environmental Toxicology and Chemistry published by Wiley Periodicals LLC on behalf of SETAC.
Availability of new UV filters in the United States lags behind the European Union (EU), partly due to differing approval processes. To review available human safety data of all US- and EU-approved UV filters. Data from Food and Drug Administration and EU regulatory guidelines, federal governmental documentation, databases, reviews, and opinions for approval and ongoing safety evaluation were analyzed. Currently, there are 17 US UV filters and 29 EU UV filters (18 EU-approved only filters). Almost all US filters possessed sensitization data (94%, 16/17) with the majority (76%, 13/17) showing minimal skin sensitization. The minority of EU-approved only filters (33%, 6/18) possessed sensitization data, all showing no sensitization. Some filters possessed dermal absorption data (US: 76%, 13/17; EU: 44%, 8/18). Oxybenzone, octinoxate, octisalate, homosalate, and octocrylene, approved in the US and EU, were shown to have plasma levels exceeding the Food and Drug Administration exposure threshold. Proprietary manufacturer human data were unavailable. Many new UV filters are available in the EU, but not yet in the United States. Rigorous US and EU guidelines ensure that UV filters provide adequate photoprotection assuming consumers follow American Academy of Dermatology SPF (sun protection factor) and broad-spectrum recommendations. Human data are limited, but known human risks of sunscreen appear minimal.