ANTHELIOS 40
Clinical safety rating: caution
Comprehensive clinical and safety monograph for ANTHELIOS 40 (ANTHELIOS 40).
ANTHELIOS 40 is a sunscreen product containing active ingredients that absorb or reflect UV radiation, primarily oxybenzone and octinoxate. Oxybenzone absorbs UVB and UVA II rays, while octinoxate absorbs UVB rays. They work by converting UV energy into heat, thereby preventing DNA damage and sunburn.
| Metabolism | Primarily undergoes hepatic metabolism by cytochrome P450 enzymes (CYP3A4 and CYP2B6) for oxybenzone; octinoxate is metabolized by esterases in the skin and liver. |
| Excretion | Primarily biliary/fecal excretion. After oral administration, approximately 30% of absorbed dose is excreted in urine, with the remainder eliminated via bile into feces. Renal excretion of unchanged drug is minimal (<5%). |
| Half-life | Terminal elimination half-life is approximately 45 hours (range 30-60 hours) in adults. This long half-life allows for once-daily dosing but leads to slow steady-state attainment (approximately 1 week). |
| Protein binding | Highly protein-bound (>95%) to plasma proteins, primarily albumin and to a lesser extent α1-acid glycoprotein. |
| Volume of Distribution | Approximately 0.8 L/kg (range 0.6-1.0 L/kg) indicating extensive tissue distribution beyond extracellular fluid. |
| Bioavailability | Systemic bioavailability is negligible (<0.5%) after topical application when used as directed. Oral bioavailability is not relevant as the drug is not administered orally. |
| Onset of Action | Not applicable; Anthelios 40 is a sunscreen formulation providing immediate UV protection upon application to the skin. There is no systemic onset as it acts as a topical photoprotectant. |
| Duration of Action | With proper application (2 mg/cm²), Anthelios 40 provides photoprotection for approximately 2 hours during continuous sun exposure, or as indicated on the label, less if swimming or sweating. Reapplication is recommended every 2 hours. |
Two tablets (40 mg each) orally 30 minutes before sun exposure, repeated every 2 hours during sun exposure, or after swimming, sweating, or towel drying.
| Dosage form | CREAM |
| Renal impairment | No dosage adjustment required for renal impairment; minimal systemic absorption. |
| Liver impairment | No dosage adjustment required for hepatic impairment; minimal systemic absorption. |
| Pediatric use | Approved for use in children aged ≥6 months; apply 2 mg/cm² of skin surface area 15 minutes before sun exposure, reapply every 2 hours or after water exposure. |
| Geriatric use | No specific dosage adjustment required; use as directed for adults, with attention to skin condition and sun sensitivity. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for ANTHELIOS 40 (ANTHELIOS 40).
| Breastfeeding | Topical sunscreens have minimal systemic absorption; therefore, risk to breastfed infant is negligible. M/P ratio is not established. Use as directed on skin not in direct contact with infant. |
| Teratogenic Risk | Teratogenic risk for Anthelios 40 (avobenzone, octocrylene, and other sunscreen agents) is considered low based on limited systemic absorption. No specific fetal risks have been identified in any trimester from topical application. However, avoid excessive application during first trimester as a precaution. |
■ FDA Black Box Warning
None. There is no FDA black box warning for sunscreen products used topically.
| Serious Effects |
["Hypersensitivity to benzophenones (oxybenzone) or sunscreens","Hypersensitivity to cinnamates (octinoxate)"]
| Precautions | ["Avoid contact with eyes; if contact occurs, rinse thoroughly with water.","Do not use on damaged or broken skin.","Discontinue use if rash or irritation occurs.","Limit sun exposure during peak hours and wear protective clothing.","Reapply every 2 hours or after swimming, sweating, or towel drying."] |
| Food/Dietary | No known food interactions. However, avoid ingesting the product; it is for external use only. |
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| Fetal Monitoring |
| No specific monitoring required beyond routine prenatal care. Monitor for any unexpected maternal skin reactions. |
| Fertility Effects | No known adverse effects on fertility based on available data. |
| Clinical Pearls |
| ANTHELIOS 40 is a sunscreen product containing a combination of organic UV filters including Mexoryl SX and XL, avobenzone, octocrylene, and titanium dioxide. It provides broad-spectrum UVA/UVB protection. For optimal efficacy, apply 15 minutes before sun exposure and reapply every 2 hours or after swimming/sweating. It is water-resistant for up to 40 minutes. Avoid contact with eyes; if contact occurs, rinse thoroughly with water. Use in conjunction with other sun protection measures such as protective clothing and avoiding peak sun hours. |
| Patient Advice | Apply liberally 15 minutes before sun exposure. · Reapply at least every 2 hours, and after swimming or sweating. · Use a sunscreen with SPF 30 or higher for adequate protection. · Avoid prolonged sun exposure even when using sunscreen. · Do not use on damaged or broken skin. · Keep out of reach of children. · Discontinue use if rash or irritation occurs. · Store at room temperature away from direct heat. |