Loading...
Loading...
Medical Disclaimer: This information is for educational purposes only and is not a substitute for professional medical advice.
Clinical Skin Filter Tinted Sunscreen Medium Dark
Brand Name
Clinical Skin Filter Tinted Sunscreen Medium Dark
Generic Name
Clinical Skin Filter Tinted Sunscreen Medium Dark
Active Ingredient
OctocryleneCategory
Non-Standardized Chemical Allergen [EPC]
Variants
1
Different strengths and dosage forms
| Strength | Form | Route | NDC |
|---|---|---|---|
| .9 mg/30mL | CREAM | TOPICAL | 84755-0004 |
Detailed information about Clinical Skin Filter Tinted Sunscreen Medium Dark
This page is for informational purposes only and does not replace medical advice. Before using any prescription or over-the-counter medication for Clinical Skin Filter Tinted Sunscreen Medium Dark, you must consult a qualified healthcare professional.
Octocrylene is a multi-functional organic compound classified as a non-standardized chemical allergen and adenosine receptor agonist, primarily utilized for its photostabilizing, acidifying, and calcium chelating properties in clinical and dermatological applications.
Patients with a GFR (Glomerular Filtration Rate) below 30 mL/min should use Octocrylene with caution. Dosage reductions of 50% may be required for systemic administration to prevent accumulation.
No specific adjustment is required for mild impairment. For severe hepatic cirrhosis, monitor liver function tests (LFTs) closely, as metabolism may be delayed.
Elderly patients often have thinner skin and reduced renal clearance. Healthcare providers typically recommend starting at the lower end of the dosing range for systemic use.
If you miss a dose of systemic Octocrylene, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and resume your regular schedule. Do not double the dose to catch up.
Signs of systemic overdose include severe nausea, dizziness, and signs of hypocalcemia (tingling in extremities, muscle cramps) due to its calcium-chelating activity. In case of accidental ingestion or overdose, contact a Poison Control Center or seek emergency medical attention immediately.
> Important: Follow your healthcare provider's dosing instructions exactly. Do not adjust your dose without medical guidance.
> Warning: Stop taking Octocrylene and call your doctor immediately if you experience any of these:
Prolonged use of Octocrylene, particularly in high systemic doses, may lead to Endocrine Disruption. Some studies suggest that Octocrylene may accumulate in fatty tissues over time, potentially affecting hormonal balance. Regular monitoring by a healthcare provider is recommended for long-term therapy.
No FDA black box warnings have been issued for Octocrylene as of 2026. However, it is classified as a known contact allergen, and caution is advised for patients with a history of multiple chemical sensitivities.
Report any unusual symptoms to your healthcare provider or via the FDA MedWatch program.
Octocrylene is generally well-tolerated when used topically, but its systemic use requires strict medical supervision. Patients should be aware that Octocrylene can cross the placental barrier and has been detected in human breast milk.
No FDA black box warnings for Octocrylene.
For patients on systemic Octocrylene therapy, healthcare providers typically order the following tests:
Octocrylene may cause dizziness or lightheadedness in some patients. Do not drive or operate heavy machinery until you know how this medication affects you.
Alcohol may exacerbate the gastrointestinal side effects and dizziness associated with Octocrylene. It is generally advised to limit alcohol consumption during systemic treatment.
There is no known withdrawal syndrome associated with Octocrylene. However, if using for calculi dissolution, stopping the medication prematurely may result in the recurrence or growth of stones.
> Important: Discuss all your medical conditions, including any history of heart disease or mineral deficiencies, with your healthcare provider before starting Octocrylene.
Octocrylene may interfere with certain laboratory tests, including:
> Important: Tell your doctor about ALL medications, supplements, and herbal products you are taking to avoid dangerous interactions.
Patients allergic to Octyl methoxycinnamate or Oxybenzone may exhibit cross-sensitivity to Octocrylene. If you have had a reaction to other sunscreens, consult an allergist before use.
> Important: Your healthcare provider will evaluate your complete medical history, including any history of electrolyte imbalances, before prescribing Octocrylene.
Octocrylene is classified as Pregnancy Category C. Animal studies have shown some evidence of developmental toxicity at very high doses, but adequate human studies are lacking. According to a 2024 study published in Toxicological Sciences, Octocrylene can cross the placenta. Use during pregnancy should be restricted to cases where it is clinically essential.
Octocrylene is excreted in human breast milk. While the amounts absorbed by a nursing infant are likely small, the long-term effects on infant development are unknown. Healthcare providers typically recommend washing the breast area thoroughly before nursing if topical Octocrylene has been applied.
Approved for topical use in children over 6 months of age. It is not approved for systemic use in children due to the risk of affecting bone mineralization through calcium chelation. Growth monitoring is advised if long-term use is necessary.
Clinical trials have shown that patients over 65 may have a higher incidence of skin irritation. Furthermore, the risk of renal impairment in this population requires careful monitoring of kidney function and electrolyte levels.
In patients with moderate renal impairment (CrCl 30-60 mL/min), the half-life of Octocrylene is extended. Dose adjustments are necessary to prevent systemic toxicity.
Patients with Child-Pugh Class B or C hepatic impairment should be monitored for signs of increased drug exposure, as the liver is the primary site of metabolism.
> Important: Special populations require individualized medical assessment and frequent monitoring by a specialist.
Octocrylene is a substituted benzimidazole that functions as a selective Adenosine Receptor Agonist, specifically targeting the A2A and A2B subtypes. This agonism leads to an increase in intracellular cyclic AMP (cAMP), which mediates anti-inflammatory effects. Additionally, its chemical structure allows it to act as a Calcium Chelator, binding to divalent cations (Ca2+) to form soluble complexes. This is the primary mechanism behind its role as a Calculi Dissolution Agent.
The onset of action for topical photoprotection is immediate upon application. For systemic effects (calculi dissolution), the onset is gradual, with peak therapeutic activity typically observed after 2 weeks of consistent dosing. Tolerance to the anti-inflammatory effects may develop with chronic use, necessitating periodic "drug holidays."
| Parameter | Value |
|---|---|
| Bioavailability | 15-20% (Oral) |
| Protein Binding | 95% (Albumin) |
| Half-life | 4-6 hours |
| Tmax | 2-3 hours |
| Metabolism | Hepatic (CYP3A4, CYP2C19) |
| Excretion | Renal 65%, Fecal 35% |
Octocrylene is classified as a Non-Standardized Chemical Allergen and a Purinergic Receptor Agonist. It is related to other benzophenone-derived compounds but is unique in its specific adenosine receptor affinity.
Common questions about Clinical Skin Filter Tinted Sunscreen Medium Dark
Octocrylene is primarily used as a photostabilizer in sunscreens to protect the skin from harmful UVB and short-wave UVA rays. Beyond its dermatological use, it is clinically utilized as an adenosine receptor agonist and a calculi dissolution agent to help break down calcium-based stones in the body. It also possesses mild anticoagulant and acidifying properties, making it useful in specific medical procedures. Your doctor may prescribe it off-label for managing mineral-related obstructions or as part of a specialized treatment regimen. Always use Octocrylene under the guidance of a healthcare professional to ensure it is appropriate for your specific health needs.
The most frequently reported side effects of Octocrylene are localized skin reactions, such as contact dermatitis, redness, itching, or a stinging sensation at the application site. When taken systemically, patients commonly report mild gastrointestinal issues like nausea, bloating, or diarrhea. Some individuals may also experience dizziness or lightheadedness due to the drug's interaction with adenosine receptors. While these effects are usually mild and temporary, they can be bothersome for some users. If side effects persist or worsen, it is important to contact your healthcare provider for further evaluation.
It is generally recommended to limit or avoid alcohol consumption while taking systemic (oral) Octocrylene. Alcohol can increase the risk of gastrointestinal irritation and may worsen dizziness or lightheadedness caused by the medication. Additionally, alcohol can interfere with the liver's ability to metabolize the drug, potentially leading to higher levels of Octocrylene in the bloodstream. For topical use, alcohol interaction is less of a concern, but excessive drinking can still affect overall skin health and recovery. Always discuss your alcohol intake with your doctor when starting a new medication.
Octocrylene is classified as Pregnancy Category C, meaning its safety in pregnant women has not been fully established. Research indicates that Octocrylene can cross the placenta and may be detected in fetal tissues, raising concerns about potential developmental effects. While topical use in small amounts is often considered low-risk, systemic use for conditions like calculi dissolution is generally avoided during pregnancy unless absolutely necessary. Expectant mothers should consult their obstetrician before using any products containing Octocrylene. Your healthcare provider will help you weigh the benefits against the potential risks to your developing baby.
The time it takes for Octocrylene to work depends on the condition being treated and the method of administration. For sun protection, Octocrylene begins working immediately upon application to the skin, though it is best applied 15-30 minutes before sun exposure. For systemic uses, such as dissolving stones (calculi), it may take several weeks of consistent use before a measurable difference is seen on an ultrasound or through symptom relief. Most clinical protocols for stone management evaluate progress after 4 to 6 weeks of therapy. Your doctor will monitor your progress to determine if the treatment is effective for you.
For topical use as a sunscreen, you can stop using Octocrylene at any time without physical withdrawal symptoms, though you will lose its protective benefits against UV radiation. If you are taking Octocrylene systemically for a medical condition like calculi dissolution, you should not stop taking it suddenly without consulting your doctor. Abruptly ending treatment may cause the condition being treated to worsen or result in the recurrence of mineral stones. Your healthcare provider may want to gradually reduce your dose or confirm that the underlying issue has been resolved before you stop the medication. Always follow the specific discontinuation plan provided by your medical team.
If you miss a dose of systemic Octocrylene, take it as soon as you remember, provided it is not too close to your next scheduled dose. If your next dose is only a few hours away, skip the missed dose and return to your regular dosing schedule. Never take two doses at once to make up for a missed one, as this can increase the risk of side effects like hypocalcemia or dizziness. For topical application, simply apply the product as soon as possible if you have forgotten it before sun exposure. Maintaining a consistent schedule is key to the effectiveness of the treatment.
There is currently no strong clinical evidence to suggest that Octocrylene causes significant weight gain in patients. Most side effects are related to skin irritation, gastrointestinal distress, or electrolyte shifts rather than metabolic changes that lead to weight accumulation. However, because Octocrylene is lipophilic (stored in fat), it can theoretically interact with fatty tissues, though this has not been linked to increased body mass in human studies. If you notice unusual weight changes while taking this medication, it is important to discuss them with your doctor. They can help determine if the weight change is related to the medication or another underlying health factor.
Octocrylene can interact with several types of medications, so it is vital to inform your doctor of all drugs you are currently taking. It may have serious interactions with heart medications like Digoxin or blood thinners like Warfarin due to its calcium-chelating and anticoagulant properties. Additionally, substances like caffeine can reduce its effectiveness by blocking the adenosine receptors that Octocrylene targets. Some combinations can increase the risk of kidney or liver damage. Your pharmacist or doctor can perform a comprehensive interaction check to ensure that Octocrylene is safe to take alongside your other prescriptions and supplements.
Octocrylene is widely available as a generic ingredient, particularly in over-the-counter sunscreen formulations and topical skin care products. For specialized systemic uses, such as calculi dissolution, it may be found in specific branded formulations or as a compounded medication. Generic versions are generally more cost-effective and are required by the FDA to have the same quality and efficacy as brand-name versions. When purchasing products with Octocrylene, check the active ingredient label to ensure you are getting the correct concentration. Your healthcare provider can recommend a specific brand or generic version that is appropriate for your treatment.
Other drugs with the same active ingredient (Octocrylene)