FDA OTC Drug Monographs
Regulatory records
| Regulation | Status |
|---|---|
| Federal Register | authorized |
Record details
Federal Register
- product types
- sunscreen, sunscreen (oil, lotion, cream, gel, butter, paste, ointment, stick, spray)
Regulations of Bemotrizinol
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Identifiers
FormulaC38H49N3O5·CAS187393-00-6·EC425-950-7
Functions
HAIR ConditioningLight Stabilizer +2 more
How does the regulatory treatment of BEMOTRIZINOL differ by market or product category?
Regulatory treatment varies by market. In the EU, the substance is an active REACH registration and has ECHA C&L notifications, indicating it is a registered industrial chemical. In Australia, it is listed on the industrial chemicals inventory. In New Zealand, it lacks individual approval but may be used under an appropriate group standard. For cosmetics, it is listed as an active UV filter with a cosmetic restriction reference (VI/25), but no specific concentration limits are provided. This suggests market-specific compliance pathways differ, with the EU having a formal registration and NZ requiring group standard verification.
Which United States federal regulations apply to Bemotrizinol?
1 regulation
What EU regulatory requirements apply to Bemotrizinol?
1 regulation
REACH Registered Substance
Status: Active Update: 21-03-2023 https://echa.europa.eu/registration-dossier/-/registered-dossier/12265
What regulations apply to Bemotrizinol in China?
1 regulation
IECIC Listed Ingredients (List I)
- Published
- 24 Jun 2025
- Effective
- 24 Jun 2025
Regulatory records
| Entry | Regulation | Type | Status |
|---|---|---|---|
| 6251 | Inventory of Existing Cosmetic Ingredients in China (IECIC) I | List I | authorized |
Conditions
Use in accordance with the Safety and Technical Standards for Cosmetics (STSC)
Record details
Inventory of Existing Cosmetic Ingredients in China (IECIC) I
- professional use only
- No
What regulations apply to Bemotrizinol in Australia?
1 regulation
The Australian Inventory of Industrial Chemicals
Chemical: Phenol, 2,2'-[6-(4-methoxyphenyl)-1,3,5-triazine-2,4-diyl]bis[5-[(2-ethylhexyl)oxy]-
What regulations apply to Bemotrizinol in New Zealand?
1 regulation
New Zealand EPA Inventory of Chemical Status
Phenol, 2,2'-[6-(4-methoxyphenyl)-1,3,5-triazine-2,4-diyl]bis[5-[(2-ethylhexyl)oxy]-: Does not have an individual approval but may be used under an appropriate group standard
Which conditions, limits, and use contexts most affect a compliance assessment for BEMOTRIZINOL?
The most impactful conditions are the absence of explicit concentration limits and the presence of a cosmetic restriction reference (VI/25) for the UV filter function. The substance is also subject to EU REACH registration, which implies compliance with registration obligations. No GHS classifications or exposure limits are available, so hazard communication and occupational exposure assessments cannot rely on standardized data. The lack of specific conditions means formulators must verify compliance through other regulatory sources or seek clarification from authorities.
What should be in place before a product containing BEMOTRIZINOL is assessed for launch?
Before launch, a company should confirm the substance's regulatory status in each target market. For the EU, verify that the REACH registration is active and that any C&L notification obligations are met. For cosmetics, ensure compliance with the cosmetic restriction reference (VI/25) and confirm whether any specific conditions apply. In New Zealand, determine the applicable group standard. Since no concentration limits are provided, a full safety assessment and regulatory review are necessary to establish permissible use levels and documentation.
Where does the available regulatory position stop short of supporting a decision on BEMOTRIZINOL?
The available regulatory position is insufficient to support a final launch decision because it lacks specific concentration limits, conditions, and GHS classifications. The cosmetic restriction reference (VI/25) indicates a regulatory entry but does not detail the restriction's content. The REACH registration confirms active status but not the scope of uses or any risk management measures. Therefore, a compliance assessment cannot be completed without additional regulatory data or direct consultation with authorities.
Which recent regulatory changes or effective dates are material for BEMOTRIZINOL?
The only material regulatory update is the EU REACH registration status, which is active as of 21-03-2023. This indicates the substance is currently registered under REACH, but no changes or effective dates for restrictions are provided. The cosmetic restriction reference (VI/25) is listed without an effective date or amendment history. Therefore, no recent regulatory changes can be identified from the evidence, and companies should monitor official sources for updates.