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Medical Disclaimer: This information is for educational purposes only and is not a substitute for professional medical advice.
Brand Name
Active
Generic Name
Broad Spectrum
Active Ingredient
OctisalateCategory
Non-Standardized Chemical Allergen [EPC]
Variants
1
Different strengths and dosage forms
| Strength | Form | Route | NDC |
|---|---|---|---|
| 5 g/100g | LOTION | TOPICAL | 68726-264 |
Detailed information about Active
This page is for informational purposes only and does not replace medical advice. Before using any prescription or over-the-counter medication for Active, you must consult a qualified healthcare professional.
Octisalate is a salicylate-based compound primarily used as a UV filter in topical formulations. It is pharmacologically classified as a non-standardized chemical allergen and exhibits properties of an adenosine receptor agonist and calcium chelating agent.
Because systemic absorption is minimal with topical use, dosage adjustments are typically not required. However, patients with severe renal failure should use large-surface-area applications with caution due to the potential for salicylate accumulation.
No specific adjustments are documented for topical use. Systemic metabolism depends on liver esterases, but the low levels of absorption make toxicity unlikely in standard use.
No specific dosage adjustments are required. However, elderly patients with thinner skin may experience slightly higher systemic absorption.
Octisalate is for external use only. It should not be ingested or applied to broken or infected skin. When using sprays, avoid inhaling the mist and do not spray directly onto the face; spray into hands first and then apply to the face, avoiding the eyes and mouth. Store products containing Octisalate at room temperature (15°C to 30°C) and protect them from excessive heat and direct sun.
For UV protection, if you forget to apply Octisalate, apply it as soon as you remember before going outdoors. If you are already outdoors, seek shade until the product can be applied. For diagnostic testing, if a patch falls off, contact your allergist or dermatologist immediately.
Signs of systemic salicylate overdose (salicylism) include tinnitus (ringing in the ears), nausea, vomiting, and dizziness. If Octisalate is accidentally ingested, contact a Poison Control Center or seek emergency medical attention immediately.
> Important: Follow your healthcare provider's dosing instructions. Do not adjust your dose without medical guidance.
Most users do not experience significant side effects from Octisalate. However, some may notice:
> Warning: Stop taking Octisalate and call your doctor immediately if you experience any of these.
Prolonged use of Octisalate in sunscreen is generally considered safe. However, chronic use in individuals with undiagnosed salicylate sensitivity may lead to persistent low-grade skin irritation or localized eczema. There is no evidence currently suggesting that long-term topical use leads to systemic organ toxicity in healthy individuals.
No FDA black box warnings have been issued for Octisalate. It is recognized as GRASE (Generally Recognized as Safe and Effective) for its intended use in sunscreens by the FDA.
Report any unusual symptoms to your healthcare provider.
Octisalate is intended for topical use only. Avoid contact with eyes, as it can cause significant irritation. If contact occurs, rinse thoroughly with water. Octisalate should not be applied to deep puncture wounds, animal bites, or serious burns without medical consultation.
No FDA black box warnings for Octisalate.
No routine lab tests (such as blood counts or liver function tests) are required for standard topical use of Octisalate. However, if used as part of a clinical trial for calculi dissolution, monitoring of serum calcium and renal function may be necessary.
Topical application of Octisalate does not typically affect the ability to drive or operate heavy machinery.
There are no known direct interactions between topical Octisalate and alcohol consumption. However, alcohol can increase skin blood flow, which might theoretically increase the absorption of topically applied chemicals.
Octisalate can be discontinued at any time without a tapering schedule. If being used for UV protection, discontinuation will immediately remove the photoprotective benefits, increasing the risk of sunburn.
> Important: Discuss all your medical conditions with your healthcare provider before starting Octisalate.
There are no documented contraindications for the topical use of Octisalate with other medications. However, it should not be used simultaneously with other topical products that contain high concentrations of salicylates to avoid cumulative skin irritation.
There are no known food interactions with topically applied Octisalate. It does not interact with grapefruit, dairy, or caffeine.
Octisalate may interfere with certain urine tests for salicylates if absorbed in significant quantities, leading to false-positive results.
> Important: Tell your doctor about ALL medications, supplements, and herbal products you are taking.
Octisalate may show cross-reactivity with other salicylate UV filters, such as Homosalate and Trolamine Salicylate. Individuals who have reacted to these ingredients in other sunscreens should avoid Octisalate.
> Important: Your healthcare provider will evaluate your complete medical history before prescribing Octisalate.
Octisalate is generally considered safe for use during pregnancy when applied topically as directed. According to the FDA, there is no evidence that the small amount of Octisalate absorbed through the skin poses a risk to the developing fetus. However, pregnant women should avoid applying it to large areas of the body for prolonged periods to minimize any potential systemic exposure.
It is unknown if topically applied Octisalate passes into breast milk in significant quantities. It is considered low risk for nursing infants. To prevent accidental ingestion by the infant, breastfeeding mothers should avoid applying Octisalate directly to the nipple or areola area.
Octisalate is approved for use in children aged 6 months and older. In children, the surface-area-to-body-weight ratio is higher than in adults, which could theoretically increase systemic absorption. Parents should monitor for any signs of skin rash or irritation.
There are no specific restrictions for geriatric use. Elderly patients should be mindful of skin integrity, as application to thinned or damaged skin may increase absorption. No significant polypharmacy concerns exist for the topical form.
In patients with severe renal impairment, the clearance of any absorbed salicylates may be reduced. While topical use is generally safe, such patients should avoid excessive use over large body surfaces.
No specific adjustments are required. The low systemic levels of Octisalate are unlikely to tax hepatic function or lead to toxicity in patients with liver disease.
> Important: Special populations require individualized medical assessment.
Octisalate acts as a chemical UV filter by absorbing UVB radiation (wavelengths 280–320 nm). The chemical structure, an ester of salicylic acid, contains a conjugated pi-electron system that allows it to absorb high-energy photons. In its role as an Adenosine Receptor Agonist, it may bind to and activate adenosine receptors, potentially modulating inflammatory pathways. Its Calcium Chelating Activity involves the formation of complexes with divalent cations, which can disrupt the structure of mineralized calculi.
The onset of photoprotection is immediate upon application, though it is recommended to wait 15 minutes for the product to form a uniform film on the skin. The duration of effect is typically 2 hours, after which the chemical may be degraded by UV light or removed by physical activity (sweating/swimming).
| Parameter | Value |
|---|---|
| Bioavailability | <1% (Topical) |
| Protein Binding | >90% (if systemic) |
| Half-life | Not established (systemic) |
| Tmax | 2-4 hours (post-topical application) |
| Metabolism | Skin/Liver Esterases |
| Excretion | Renal (as salicylic acid) |
Octisalate is classified as a Non-Standardized Chemical Allergen and a Salicylate UV Filter. It is related to other salicylates like Homosalate and Methyl Salicylate.
Common questions about Active
Octisalate is primarily used as an active ingredient in sunscreens to protect the skin from UVB radiation, which causes sunburn and contributes to skin cancer. It works by absorbing ultraviolet light and converting it into heat, which is then released from the skin. Additionally, it is used in medical diagnostics as a chemical allergen to test for contact sensitivities. In specialized clinical settings, it may be categorized for its potential to help dissolve mineralized stones or calculi. It also serves as an emollient, helping to soften the skin and improve the texture of cosmetic products.
The most common side effects of Octisalate are localized skin reactions, such as mild redness, itching, or a tingling sensation at the site of application. These symptoms are usually temporary and resolve on their own once the product is washed off. Some individuals may develop contact dermatitis, which is a more persistent red, itchy rash. Serious side effects are extremely rare because very little of the drug reaches the bloodstream. If you experience severe blistering or signs of an allergic reaction like swelling, you should stop use and consult a doctor.
There are no known contraindications for consuming alcohol while using topical Octisalate. Because Octisalate is applied to the skin and very little is absorbed into the body, it does not interact with alcohol in the way oral medications might. However, alcohol can cause vasodilation (widening of blood vessels), which might slightly increase the rate at which topical chemicals are absorbed. It is always best to use Octisalate as directed on the product label. If you have concerns about systemic absorption, discuss them with your healthcare provider.
Octisalate is generally considered safe for use during pregnancy when applied topically for sun protection. Current medical consensus and FDA guidelines suggest that the minimal systemic absorption of Octisalate does not pose a significant risk to a developing fetus. Pregnant women are encouraged to use sunscreen to prevent melasma (the 'mask of pregnancy'), which is triggered by UV exposure. However, it is advisable to avoid applying it to very large areas of the body or on broken skin. Always consult your obstetrician before starting any new skin care regimen during pregnancy.
Octisalate begins absorbing UV radiation as soon as it is applied to the skin. However, most dermatologists and manufacturers recommend applying the product at least 15 to 30 minutes before sun exposure. This delay allows the product to dry and form a protective, uniform film on the skin surface, ensuring maximum efficacy. If you go into the water or sweat immediately after application, the product may be washed away before it can provide protection. For best results, follow the specific 'Directions' section on your product's packaging.
Yes, you can stop using Octisalate-containing products at any time without any withdrawal effects or physical dependence. Octisalate is not a systemic medication that requires a tapering dose. However, once you stop applying it, your skin will no longer be protected from UVB radiation. This means your risk of sunburn and long-term skin damage will increase immediately upon sun exposure. If you are using it as part of a diagnostic test, do not remove the patches until instructed by your doctor.
If you miss an application of Octisalate before going into the sun, apply it as soon as you realize the omission. If you are already outdoors, try to stay in the shade or wear protective clothing until the sunscreen has been applied and had time to set. For the best protection, it is important to reapply Octisalate every two hours while outdoors. Missing a dose increases your immediate risk of skin damage from UV rays. There is no need to 'double up' on the amount used; simply resume regular application.
There is no clinical evidence to suggest that Octisalate causes weight gain. Octisalate is applied topically and does not interfere with the metabolic or endocrine processes that regulate body weight. Even the tiny amounts that might be absorbed into the bloodstream are quickly metabolized and excreted by the body. Weight gain is not listed as a side effect in any FDA or clinical database for this ingredient. If you experience unexplained weight gain, you should consult your doctor to identify other potential causes.
Octisalate is generally safe to use alongside most oral and topical medications. Because it is applied to the skin, it has a very low potential for drug-drug interactions. However, you should be cautious when using it with other topical products that contain salicylates, such as certain acne treatments or muscle rubs, as this could increase skin irritation. If you are taking blood thinners like warfarin, consult your doctor before applying Octisalate to large areas of the body. Always inform your healthcare provider about all the products you use on your skin.
Octisalate is the name of the active ingredient itself and is found in hundreds of different brand-name and generic sunscreen and cosmetic products. It is not a prescription drug, so the concept of 'generic' vs. 'brand name' applies more to the final product (like a store-brand sunscreen vs. a major brand) rather than the ingredient. All products containing Octisalate must meet the same FDA standards for safety and efficacy. You can check the 'Active Ingredients' section of a sunscreen label to see if Octisalate is included. It is widely available in over-the-counter formulations.
Other drugs with the same active ingredient (Octisalate)