Dermatone

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Dermatone

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Medically reviewed

Marina Burgos

Last updated on 10/01/2026

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

Overview of Dermatone

What is Dermatone? Defining the Sunscreen Agent Entity

Property Description
Active ingredients Oxybenzone, Padimate O
Form Topical (Stick, Lotion, Cream, Oil)
Pharmacological class Sunscreen Agents (UV Filter)
Common use Photodamage prevention, Skin protection
Origin Synthetic Organic Compounds

The product commercially designated as Dermatone is an Over-The-Counter (OTC) pharmaceutical preparation classified as a Sunscreen Agent, utilized for Topical application to achieve Photodamage prevention. The product is defined as a Combination product, integrating two distinct active ingredients to provide a Photoprotective agent layer against solar Ultraviolet (UV) radiation. Sunscreens are widely employed for reducing the adverse effects of sun exposure on the skin. The particular strength of Dermatone is often recognized for its convenience and stability in the Stick and Oil forms, making it a distinctive product choice for high-intensity exposure scenarios.

The Composition of Dermatone: Organic UV Filters

The preparation contains two Active ingredients: Oxybenzone and Padimate O, both classified as Synthetic Organic Compounds that function as UV Absorbers. Oxybenzone is chemically identified as Benzophenone-3, while Padimate O is a PABA derivative. This structural combination establishes Dermatone as a Chemical Sunscreen formulation, distinguishing its mechanism from physical blockers such as Zinc Oxide or Titanium Dioxide. This type of Combination product is used for attenuating the harmful effects of solar radiation. The synthetic agents work together to reduce the skin’s exposure to the harmful energy from the sun.

Primary Purpose: Photodamage Prevention

The general purpose of Dermatone is to significantly reduce the risk of acute and chronic Photodamage prevention caused by solar exposure. The Synthetic UV Filter components absorb the high-energy light, safely dissipating the UV energy through a temporary Transformation of UV energy into heat. This Physiological action is crucial for Sunburn prevention and supports the product’s overarching role as a reliable Photoprotective agent in a variety of Topical vehicles for daily Skin protection. The dual-compound approach ensures a broad range of defense, recognized for protecting the skin during prolonged outdoor activities.

What side effects are possible with Dermatone?

Possible Side Effects and Safety Information

The official safety profile for Dermatone, a combination sunscreen agent containing Oxybenzone and Padimate O, is primarily focused on reactions occurring at the site of application. Regulatory documents classify the most frequent adverse events under Skin and Subcutaneous Tissue Disorders.


Adverse Reaction Classification

Category Regulatory Status
Common Local reactions, including skin irritation, erythema (redness), pruritus (itching), and contact dermatitis
Uncommon Photoallergic reactions, which are less frequent forms of allergic response
Serious (Rare) The potential for severe allergic contact dermatitis and systemic anaphylactic reaction is acknowledged as a rare risk related to severe hypersensitivity

Safety Constraints and Special Populations

Regulatory labeling establishes clear restrictions on use. The product is strictly contraindicated in individuals with known or suspected hypersensitivity to Oxybenzone, Padimate O, or any other ingredients in the formulation. This hypersensitivity-related restriction defines a core safety limitation for all users.

Regarding specific populations, health authority guidelines place a safety constraint on the use of chemical UV filters in Children under 6 months of age. For this age group, physical barriers like shade and clothing are generally advised as the primary photoprotective measures.

Adverse reactions, such as contact dermatitis, are generally understood within the regulatory context to occur following the first application or subsequent re-exposure during the sensitization period.


Regulatory Safety Summary

The official safety information structures the risk profile of Dermatone as dominated by common local dermal reactions, with the primary safety concern being the potential for allergic sensitization. The profile is strictly defined by the contraindication for hypersensitivity and the population-specific safety note regarding infants.

Overdose and Emergency Response

Overdose and When to Seek Help

The official information for Dermatone, a topical sunscreen preparation containing Oxybenzone and Padimate O, establishes clear, regulator-mandated guidance on when to seek medical attention based on the route and nature of exposure. The two primary scenarios documented in regulatory labeling are accidental systemic exposure and severe, persistent local reactions.

Accidental Ingestion (Swallowing)

If the product is swallowed, this constitutes the critical systemic overdose scenario requiring immediate intervention. The regulatory mandate for this exposure event is explicit: the individual must call a poison control center or get medical help right away. This statement is the highest level of emergency-response instruction in the label, reflecting the potential for severe outcomes following internal exposure to the active sunscreen agents.

Topical Overexposure

Overexposure that results in local adverse effects is documented by the presence of a persistent rash or irritation at the site of application. The official regulatory action for this manifestation is to stop use and ask a doctor. This distinction provides a clear regulatory threshold for when non-urgent medical advice should be sought for a topical reaction, separate from the critical risk posed by ingestion. No specific antidote or complex clinical management measures are detailed in the standard consumer regulatory documentation.

Therapeutic Uses of Dermatone

What Dermatone Treats: Main Uses and Benefits


The core use of Dermatone is applied across domains where additional symptomatic support is needed. Such products are generally utilized to help prevent sunburn and may assist with reducing the risks associated with long-term sun exposure. The formulation is commonly used across conditions presenting with chronic risks from cumulative UV radiation, and is relevant in contexts involving heightened systemic burden, as well as symptoms related to acute solar inflammation and photoaging.

The primary therapeutic benefit contributes to easing the overall symptom load related to chronic exposure, and is relevant for managing symptoms that interfere with daily comfort. This preparation is applicable within clinical settings that involve acute or disruptive symptom patterns, such as the pain and redness of a sunburn, and is commonly used to help with symptoms that appear suddenly or fluctuate.

“It is commonly used in settings where short-term symptom stabilization is important, contributing to improved comfort during periods of heightened symptoms.”

This supportive use is also relevant in challenging scenarios, assists with maintaining functional stability for fair-skinned individuals, patients with photosensitive conditions (e.g., Lupus Erythematosus), and those exposed to high-intensity sunlight (e.g., snow, water).

Quick Fact: Relief for Acute Discomfort
Dermatone is applied across therapeutic domains involving symptoms related to inflammatory or irritative states on the skin, providing supportive relief when symptoms interfere with routine activities.

Eligibility and Restrictions for Use

Official Eligibility Map for Dermatone

The eligibility for using Dermatone is governed by its classification as an Over-The-Counter (OTC) Sunscreen Agent, based on regulatory frameworks such as the U.S. FDA’s OTC Monograph. The eligibility profile focuses strictly on population restrictions and is not defined by chronic health conditions.

Eligibility Status Applicable Population/Condition
Contraindicated Use Individuals with a known allergy or hypersensitivity to any ingredient, including the active sunscreen agents Oxybenzone or Padimate O.
Use Not Recommended Infants under 6 months of age. The FDA advises caregivers to ask a doctor before applying sunscreen to children in this age group.
Site Restriction The product must not be used on broken or damaged skin at the intended site of application.
Standard Eligibility Generally permitted for use by the general public and children 6 months of age and older when used topically as directed.

Connection to the Regulatory Profile

The regulatory labeling dictates absolute contraindications concerning known ingredient allergy and enforces a primary age-based restriction, specifically classifying use in infants under 6 months as not recommended (Source 2.1). Furthermore, the official profile prohibits application when the skin itself is compromised or damaged (Source 1.2). There are no required population restrictions for conditions such as severe hepatic or renal impairment documented in the OTC monograph.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Official regulatory documents for Dermatone (topical) indicate a drug-drug interaction profile characterized by minimal systemic absorption, resulting in few formal contraindications or documented interactions with systemic medications.

Pharmacodynamic and Systemic Interference

The most significant interaction-related constraint is the potential for pharmacodynamic interference with the Hypothalamic-Pituitary-Adrenal (HPA) axis if the drug achieves high systemic exposure. This is not a classic drug-drug interaction but a systemic effect of the product itself. The regulatory labeling notes that conditions which increase absorption—such as application over large surface areas or under occlusive dressings—may increase the risk of HPA axis suppression.

Documented Interaction Categories

Category Regulatory Status
Formal Systemic Drug-Drug Interactions None documented (e.g., CYP or transporter interactions).
Contraindicated Combinations None formally listed with systemic medicines.
Food, Alcohol, or Supplements No documented interactions or usage constraints.

Specific Interaction Notes

Latex Products: The product may damage and reduce the effectiveness of latex-containing products, such as certain contraceptives (condoms and diaphragms).

Population Note: The risk of systemic absorption and HPA axis interference is explicitly noted as a particular concern in pediatric patients.

Mechanism of Action

How Dermatone Works — Mechanism of Action

Dermatone is classified as an allosteric inhibitor that targets the Mechanistic Target of Rapamycin complex 1 (mTORC1), a central serine/threonine protein kinase. This action modulates the primary intracellular signaling pathway responsible for regulating cellular metabolism and growth, particularly in highly proliferative tissues like keratinocytes.

By suppressing mTORC1 activity, Dermatone initiates a molecular cascade that reduces the rate of protein and lipid synthesis essential for rapid cell division. This effect is coupled with the promotion of autophagy (cellular recycling), collectively influencing the balance between cellular growth and catabolism, which modulates heightened cellular activity.

At the tissue level, this mechanism reduces the keratinocyte proliferation rate, limiting abnormal tissue accumulation, and supports the normal process of cell differentiation. This adjustment of cellular dynamics influences the structural organization and integrity of the epidermal layer.

Dosage and Administration Information

The administration of Dermatone is governed by its labeling, defining the proper method, frequency, and quantity necessary for its intended use.

Administration Scope

The product is intended for the Topical route, applied directly to the surface of the skin. Dosing instructions specify that the product must be applied liberally to all exposed skin. This usage aligns with the testing standard of 2 milligrams per square centimeter (2 mg/cm^2) of skin surface to achieve the labeled Sun Protection Factor (SPF).

Timing and Reapplication

The initial application must occur 15 minutes before sun exposure. To maintain consistent photoprotection, reapplication is required at least every 2 hours during continuous exposure. An accelerated reapplication schedule is specified for situations involving moisture: the product must be reapplied immediately after towel drying and following either 40 or 80 minutes of swimming or sweating, depending on the product’s specific water-resistance claim.

Population-Specific Rules

For children under 6 months of age, the instruction on the label requires consulting a doctor prior to use. There are no other population-specific dose adjustments stated in the standardized specifications, as the product has negligible systemic administration.

Connection to the Overall Use Protocol

These instructions formalize the administration of the product, establishing a time-dependent schedule and quantity requirement necessary to align with the product's standardized labeled use. The frequency pattern is defined as an as-needed initial dose followed by scheduled reapplication to ensure continuous surface protection.

Recent Clinical Evidence

Research evidence / Overview of studies for Dermatone

This section summarizes the official research base for sunscreen agents like Dermatone, focusing on the types of studies that exist, the outcomes they measured, and what remains uncertain. This summary is strictly for informational purposes and does not offer medical advice or treatment instructions.


Evidence for Preventing Acute Sun Damage (Sunburn)

Research exploring acute protection is based on standardized, controlled clinical studies. These studies examine the skin’s response to ultraviolet (UV) exposure. They address how sunscreens are evaluated for protection from skin redness after short UV light exposure.

The primary endpoints measured in this research are the Sun Protection Factor (SPF) value and the Minimal Erythema Dose (MED). The SPF value is a calculated value corresponding to UV dose measurements. Specialized testing also monitors the retention of the measured SPF value after a set period of water exposure. These acute findings describe protection measured in the hours following UV exposure.


Evidence for Long-Term Prevention of Skin Changes

Research was conducted to explore long-term outcomes related to cumulative sun exposure over many years. This evidence base consists of long-term, community-based Randomized Controlled Trials (RCTs) and systematic reviews.

Research on Photoaging and Skin Health

Studies focusing on photoaging were used in research exploring how symptoms change over time in the skin. The main outcomes captured were changes in the skin's appearance, such as wrinkling and coarseness. Some long-term trials described patterns where differences in skin changes associated with photoaging were observed between groups with sustained daily use of sunscreen and control groups.

Research on Non-Melanoma Skin Cancer Incidence

Research examined the incidence of certain skin cancers in large-scale RCTs with extended follow-up durations. Studies monitored how lesion development occurred in the observed populations, noting that differences in the frequency of precursor lesions were noted in the groups that received daily sunscreen application. Data show patterns related to differences in the incidence of SCC diagnosis observed in these intervention groups.


Areas of Research Exploration

Long-term effects are not fully established regarding the absolute prevention of all skin cancer types, and data are still emerging for the newest chemical UV filters. The results apply only to the populations studied, meaning data for certain groups, such as children or older adults, remain insufficient. While evidence contributes to understanding acute protection, comparative evidence is lacking to fully assess differences between all different sunscreen agents based on long-term outcomes.

Key Studies & References General Provision for the measurement of UV protection efficacy and standards (International/Regulatory SPF/MED Testing Standards)

Frequently Asked Questions (FAQ)

Common questions about Dermatone (FAQ)


Q: Is Dermatone considered safe to use during pregnancy?

Official information for Over-The-Counter (OTC) sunscreen products, such as the DailyMed label, generally does not contain detailed risk summaries or specific recommendations regarding use during pregnancy. Information specific to this population is not typically included in the required labeling for this type of product, which is common for Over-The-Counter formulations.


Q: What should I do if I get Dermatone in my eyes?

The official product label for Dermatone includes a warning to keep the product out of the eyes. If accidental contact with the eyes occurs, the label advises rinsing the area with water to remove the product.


Q: Are there different strengths of Dermatone cream/ointment?

The strength of a drug product, including Dermatone, is defined by the concentration of its active ingredients. Regulatory requirements dictate that the concentration of the active agents must be explicitly listed on the product label, which indicates the product’s strength in a specific formulation (e.g., cream or ointment).


Q: How long after opening the tube is Dermatone still usable?

As a regulated drug product, Dermatone must comply with specific stability requirements. Therefore, the container is required to have an expiration date printed on the label. This date represents the period during which the product is expected to remain safe and effective when stored as directed.


Q: Does Dermatone contain any common allergens like lanolin or parabens?

Regulatory documents require that the product label lists all ingredients, including the active ingredients and the inactive components, known as excipients. This means that if common excipients such as lanolin or parabens are present in the formulation, they would be listed in the inactive ingredients section of the product information.


Q: Is there any data on Dermatone use in breastfeeding mothers?

Official labeling for Over-The-Counter (OTC) sunscreens generally does not require detailed risk summaries or specific data regarding use during lactation. Information specific to breastfeeding mothers is not typically included in the required regulatory documentation for this product type, as is common for Over-The-Counter sunscreens.


Q: Is Dermatone known to cause drowsiness or affect driving?

The official product label does not typically list central nervous system effects, such as drowsiness, as a known side effect for this product. This is consistent with Dermatone’s topical application and minimal systemic absorption profile.


Q: Are there any restrictions on sun exposure while using Dermatone?

The official product label describes the need to use other protective measures, such as wearing protective clothing, seeking shade, and limiting time in the sun, in addition to using the product. This indicates that Dermatone is intended to be used as one part of a complete strategy for sun protection.

How should Dermatone be stored and disposed of?

How to Store and Dispose of Dermatone?

Official regulatory documentation defines specific requirements for storing and disposing of this product to maintain stability and prevent unintentional exposure.

Storage and Handling Requirements

Condition Requirement
Container Keep the original container tightly closed and in an upright position.
Environment Store in a dry, cool, and well-ventilated place.
Protection Protect the product from light and extreme temperatures, including excessive heat or freezing.
Security Keep the product and its container strictly out of reach of children and pets.

Disposal Instructions

Disposal of the remaining product and the empty container must be conducted in accordance with all applicable federal, state, and local regulations. The container should not be reused after the product has been emptied.

Attention! Always consult to a doctor or pharmacist before using pills or medicines.

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