International reference: 6 US FDA recalls for this ingredient

CGMP Deviations (octinoxate)

GMP Deviations: manufacturing of API material did not meet GMP and quality requirements. (octinoxate)

cGMP Deviations (avobenzone)

Subpotent Drug: Avobenzone 3%, one of the active sunscreen ingredients may be subpotent and sunscreen effectiveness may be less than labeled (avobenzone)

cGMP Deviations (avobenzone)

Subpotent Drug: low out of specification assay results for the octocrylene and avobenzone ingredients. (avobenzone)

US-market enforcement records (OpenFDA), shown for reference - not specific to this product in Kenya.

Registered Kenya · PPB

ULTRAGUARD

OCTINOXATE USP 7.5% W/V, OXYBEZONE USP 3% W/V, OCTOCRYLENE USP 3% W/V, AVOBENZONE USP 2% W/V, ZINC OXIDE BP 2% W/V, LOTION BASE QS.

H2005/598 100ML GENERIC/BIOSIMILARS INN generic

What it does

Avobenzone is a sunscreen ingredient that helps protect the skin from harmful UV rays.

Commonly used for: sunburn prevention, skin protection from UV radiation

Read more in plain English ↓

Plain-language summary for general understanding - not medical advice. Always follow your pharmacist/doctor.

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Registration & product details

Registration no.
H2005/598
Registration date
-
Expiry date
-
Status
Registered
Active ingredient
OCTINOXATE USP 7.5% W/V, OXYBEZONE USP 3% W/V, OCTOCRYLENE USP 3% W/V, AVOBENZONE USP 2% W/V, ZINC OXIDE BP 2% W/V, LOTION BASE QS.
Dosage form
100ML
Strength
-
Pack size
100ML
Therapeutic class
GENERIC/BIOSIMILARS
RxNorm RxCUI
45045
Manufacturer / MAH
Biopharma
Applicant / LTR
BIOPHARMA LIMITED
Country of origin
LOCAL
Manufacturer location
Building No. 01, Road 01 Dhaka Housing Main Rd, Dhaka 1207, Bangladesh

Source: Pharmacy and Poisons Board · fetched 2026-01-28 20:06:45 · updated 2026-08-03 04:07:00

Disclaimer: This information is sourced from Pharmacy and Poisons Board (Kenya). Always consult a qualified healthcare professional before using any medication.

About avobenzone

Avobenzone is a sunscreen ingredient that helps protect the skin from harmful UV rays.

What it treats

  • sunburn prevention
  • skin protection from UV radiation

How it works

Avobenzone absorbs UV light, preventing it from penetrating the skin and causing damage.

Who it's for

It is suitable for anyone looking to protect their skin from sun exposure.

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

About octinoxate

Octinoxate is a chemical often used in sunscreens to help protect the skin from harmful UV rays.

What it treats

  • sunburn prevention
  • skin protection from UV radiation

How it works

Octinoxate works by absorbing UV radiation, preventing it from penetrating the skin.

Who it's for

It is suitable for anyone looking to protect their skin from sun damage, including children and adults.

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

About octocrylene

Octocrylene is a sunscreen ingredient used to protect the skin from harmful UV rays.

What it treats

  • sunburn prevention
  • skin protection from UV radiation

How it works

It absorbs UV light and helps prevent skin damage caused by the sun.

Who it's for

It is suitable for anyone looking to protect their skin from sun exposure.

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

About oxide

Oxide is a type of compound often used in various treatments. It is important to understand its uses and any precautions necessary when taking it.

What it treats

  • treatment of certain skin conditions
  • used in some respiratory therapies

How it works

Oxide works by interacting with the body in a way that helps improve certain health conditions.

Who it's for

Oxide may be suitable for individuals suffering from specific health issues as determined by their healthcare provider.

Cautions

  • • Always follow the healthcare provider's instructions when using this compound.
  • • Inform your doctor about any other medications you are taking.

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

About oxybezone

Oxybenzone is a chemical commonly used in sunscreen products to help protect the skin from harmful UV rays.

What it treats

  • sunburn prevention
  • skin protection from UV radiation

How it works

Oxybenzone absorbs UV light, preventing it from penetrating the skin and causing damage.

Who it's for

This product is suitable for anyone looking to protect their skin from sun exposure.

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

Clinical monograph: avobenzone

BNF-referenced

Avobenzone is a chemical compound primarily used in topical sunscreen formulations. It is recognized for its ability to absorb ultraviolet (UV) radiation, specifically UVA wavelengths, thereby providing protection against sun-induced skin damage such as sunburn and photoaging. Avobenzone is noted for its broad-spectrum efficacy, making it a key ingredient in effective sun protection products.

Indications

  • Sun protection
  • Prevention of sunburn
  • Prevention of skin aging due to UV exposure

Dosage

Children: For children under 6 months, consult a doctor. For children 6 months and older, apply liberally to all exposed skin 15 minutes before sun exposure. Reapply at least every 2 hours, or after swimming, sweating, or towel drying.

Adults: Apply liberally to all exposed skin 15 minutes before sun exposure. Reapply at least every 2 hours, or after swimming, sweating, or towel drying.

Mechanism of action

Avobenzone blocks UVA I (340-400 nm) and UVA II (320-340 nm) wavelengths by absorbing UV radiation within these specific ranges. This action limits the penetration of ultraviolet light through the epidermis, thus protecting the skin from potential damage caused by UV exposure.

Pharmacodynamics

The pharmacodynamics of avobenzone are characterized by its ability to absorb UV light, which reduces the harmful effects of UV radiation on the skin. Its efficacy is influenced by its molecular structure, which determines the specific wavelengths of UV radiation that it can absorb. Avobenzone is particularly effective in the UVA range, making it a vital component for broad-spectrum sunscreen formulations.

Pharmacokinetics

The pharmacokinetics of avobenzone, when applied topically, involves minimal systemic absorption, as it primarily acts locally on the skin's surface. Its absorption profile is influenced by the formulation in which it is incorporated, as well as the condition of the skin. The duration of action can vary based on the formulation and application frequency, necessitating reapplication for sustained protection.

Pregnancy

Avobenzone is generally considered safe for use in pregnancy, but exposure to sunscreens should be minimized. Consultation with a healthcare provider is recommended.

Breast-feeding

Avobenzone is considered safe for use during breastfeeding. However, it is advisable to use it sparingly and consult a healthcare professional.

Storage

Store in a cool, dry place away from direct sunlight.

Formulations

  • Topical cream
  • Topical lotion
  • Topical spray

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.

Clinical monograph: octinoxate

BNF-referenced

Octinoxate is a chemical compound primarily used as an active ingredient in sunscreen formulations. It functions as a photoprotective agent by absorbing ultraviolet (UV) radiation, specifically UV-B and to some extent UV-A rays. By accumulating in the outermost layer of the epidermis, it helps prevent skin damage associated with UV exposure, such as DNA damage and skin cancer. Its efficacy in absorbing UV radiation makes it a common choice in topical sun protection products.

Indications

  • Sun protection
  • Prevention of sunburn
  • Protection against skin damage from UV radiation

Dosage

Children: Refer to the BNF for Children for appropriate pediatric dosing guidelines.

Adults: Apply liberally to the skin before sun exposure, reapply as directed, especially after swimming or sweating.

Mechanism of action

Octinoxate absorbs UV-B (predominantly) and UV-A rays, preventing cellular damage by reducing p53 protein expression following UV exposure. It diminishes the penetration of UV light through the epidermis by absorbing UV radiation within specific wavelength ranges. The molecular structure of octinoxate allows it to effectively absorb UV radiation, raising the electron energy level and protecting skin cells from harmful effects.

Pharmacodynamics

Octinoxate acts as a photoprotective agent, mitigating the damaging effects of UV rays on the skin. It prevents DNA damage, cell cycle arrest, immunological depression, apoptosis, and transcriptional changes that can result from UV irradiation. The protective mechanism is primarily due to its ability to absorb UV radiation and reduce its penetration into the skin.

Pharmacokinetics

Octinoxate is applied topically and primarily accumulates in the outer layers of the skin. Its absorption and distribution are influenced by the formulation and the presence of other ingredients in sunscreen products. The compound mainly provides localized effects rather than systemic absorption, minimizing potential systemic toxicity. The duration of action is contingent upon factors such as the formulation's water resistance, the frequency of application, and environmental conditions.

Pregnancy

Octinoxate is generally considered safe for use in pregnancy when applied topically, but it is advisable to consult a healthcare professional before use.

Breast-feeding

Octinoxate is considered safe during breastfeeding when used topically. However, it is recommended to consult a healthcare professional.

Storage

Store in a cool, dry place away from direct sunlight. Keep out of reach of children.

Formulations

  • Cream
  • Lotion
  • Gel

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.

Clinical monograph: octocrylene

BNF-referenced

Octocrylene is an oil-soluble liquid UV-B filter widely used in sunscreens and cosmetic formulations. It is known for its excellent photostability and ability to dissolve crystalline UV filters, enhancing the overall efficacy of sun protection products. The compound serves as both a UV filter and a photostabilizer, ensuring prolonged protection against harmful ultraviolet radiation.

Indications

  • Photoprotection
  • Sunburn prevention
  • Skin cancer prevention
  • Cosmetic formulations

Dosage

Children: Refer to specific product guidelines for application frequency and amount in children, as dosing can vary based on formulation and intended use.

Adults: Refer to specific product guidelines for application frequency and amount, as dosing can vary based on formulation and intended use.

Mechanism of action

Octocrylene absorbs UVB and short-wave UVA rays with wavelengths ranging from 280-320 nm, thereby protecting the skin from direct DNA damage. Its conjugated acrylate portion is responsible for UV absorption, while the ethylhexanol portion acts as an emollient due to its hydrophobic properties.

Pharmacodynamics

As a UV filter, octocrylene works by absorbing ultraviolet radiation, preventing it from penetrating the skin and causing damage. The emollient properties of the ethylhexanol component contribute to skin hydration and smoothness, enhancing the user experience of formulations containing octocrylene.

Pharmacokinetics

The pharmacokinetics of octocrylene in humans is not extensively characterized. However, it is known to be absorbed through the skin when applied topically. The degree of absorption can vary based on product formulation and individual skin characteristics. Octocrylene is generally considered safe for topical use in cosmetic products.

Pregnancy

There are no adequate and well-controlled studies in pregnant women. Use only if clearly needed.

Breast-feeding

Octocrylene is considered safe for use during breastfeeding when applied topically.

Storage

Store in a cool, dry place, away from direct sunlight.

Formulations

  • Topical creams
  • Lotions
  • Gels

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.

Clinical monograph: oxide

BNF-referenced

Oxide refers to a chemical compound that contains at least one oxygen atom and one other element. Oxides can be formed from a variety of elements, and their properties can vary significantly depending on the specific elements involved. Common oxides include metal oxides, such as iron oxide (rust), and non-metal oxides, such as carbon dioxide. In a pharmaceutical context, oxides may play roles as inactive ingredients or act as preservatives or stabilizers in drug formulations.

Mechanism of action

Oxides do not have a single mechanism of action as they are a broad category of compounds. However, in general, metal oxides can exhibit catalytic properties, while non-metal oxides may participate in biochemical reactions by forming acids or bases upon dissolution in water.

Pharmacodynamics

The pharmacodynamics of oxides depend on the specific type of oxide and its interaction with biological systems. For instance, metal oxides may have antimicrobial properties, while certain non-metal oxides can influence metabolic pathways through their acid-base chemistry. The effects vary widely, necessitating specific studies for each oxide's role in therapeutic contexts.

Pharmacokinetics

The pharmacokinetics of oxides are also variable. Many metal oxides are poorly soluble and thus have limited absorption when ingested. Non-metal oxides, such as carbon dioxide, can be readily absorbed and utilized in metabolic processes. The distribution, metabolism, and excretion of oxides depend on their chemical form and the biological system in which they are involved.

Pregnancy

Not applicable as oxide is not a drug but a class of chemical compounds.

Breast-feeding

Not applicable as oxide is not a drug but a class of chemical compounds.

Storage

Store in a cool, dry place away from direct sunlight.

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.

Clinical monograph: oxybezone

Oxybenzone is an organic compound that is commonly used as a chemical sunscreen agent. It absorbs ultraviolet (UV) light, specifically UVB and some UVA rays, protecting the skin from harmful effects of sun exposure. Oxybenzone is incorporated into various cosmetic and topical formulations to provide photoprotection and prevent sunburn.

Indications

  • Sunburn prevention
  • Photodermatosis
  • Photoprotection in cosmetics

Dosage

Children: For children, apply according to the same guidelines as adults, ensuring to use formulations appropriate for sensitive skin.

Adults: Apply liberally to all exposed skin areas before sun exposure, reapply every 2 hours, or after swimming, sweating, or towel drying.

Mechanism of action

Oxybenzone functions primarily as a UV filter. Upon application to the skin, it absorbs UV radiation and converts it into heat, which is then released from the skin. This mechanism helps to protect skin cells from UV-induced damage, including DNA damage that can lead to skin cancer.

Pharmacodynamics

Oxybenzone exhibits a broad-spectrum UV filter property, providing effective protection against both UVA and UVB rays. Its efficacy is dose-dependent, with higher concentrations offering greater protection. Oxybenzone may also have some potential endocrine-disrupting effects, although this is still a subject of investigation.

Pharmacokinetics

Oxybenzone is readily absorbed through the skin upon topical application. It has a relatively high bioavailability compared to other sunscreen agents, leading to systemic exposure. The compound is metabolized in the liver and excreted primarily via urine. Its half-life in the body can vary based on individual metabolism and the formulation used.

Adverse effects

  • Skin irritation
  • Allergic reactions
  • Photosensitivity
  • Hormonal disruption (potential)

Precautions

  • Use with caution in patients with known allergies to benzophenones
  • Consider potential hormonal effects in sensitive populations

Pregnancy

Safety during pregnancy has not been established. Use only if clearly needed.

Breast-feeding

Minimal risk is expected, but consult a healthcare provider before use.

Storage

Store at room temperature, away from direct sunlight and moisture.

Formulations

  • Creams
  • Lotions
  • Gels
  • Sprays

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.

Molecular reference: avobenzone

PubChem CID 51040

Molecular formula: C20H22O3

Mechanism of action

It blocks UVA I, UVA II, and UVB wavelengths, thereby limiting the impact of UV rays on skin. Diminish the penetration of ultraviolet (UV) light through the epidermis by absorbing UV radiation within a specific wavelength range. The amount and wavelength of UV radiation absorbed are affected by the molecular structure of the sunscreen agent. Diminish the penetration of ultraviolet (UV) light through the epidermis by absorbing UV radiation within a specific wavelength range. The amount and wavelength of UV radiation absorbed are affected by the molecular structure of the sunscreen agent. /Sunscreen agents, topical/ A 2025 review by authors in the U.S. and U.K. noted that avobenzone is one of the most effective absorbers in the UVA range, blocking both UVA-I (340-400 nm) and UVA-II (320-340 nm) wavelengths. Also, they noted that avobenzone is currently the only dedicated UVA absorber listed in the U.S. FDA Over-the-Counter (OTC) Sunscreen Drug Monograph, and thus it is an essential UV filter for the formulation of effective, broad-spectrum sunscreen products.

Source: PubChem (NCBI) · pathways from PathBank, Reactome, WikiPathways & PharmGKB.

Molecular reference: octinoxate

PubChem CID 5355130

Molecular formula: C18H26O3

Mechanism of action

Absorbs UV-B (predominantly) and UV-A rays while accumulating in the outermost layer of the epidermis. Like any other photoprotective agents, octinoxate prevents the damage to cells and deoxyribonucleic acid (DNA) by reducing the p53 protein expression following UV exposure and also increases the skin's tolerability to UV rays. Diminish the penetration of ultraviolet (UV) light through the epidermis by absorbing UV radiation within a specific wavelength range. The amount and wavelength of UV radiation absorbed are affected by the molecular structure of the sunscreen agent. /Sunscreen agents, topical/ Radiation is absorbed by chemical sunscreens when the electron energy level of the drug is raised from its ground state to a higher energy level or excited state. Chromophore groups (C=C, C=O, O-N=O) with loosely held electrons are easily excited by radiation. Compounds which have several chromophore groups in optimal positions have high absorbance over a broad range of wavelengths. Chemical sunscreens are usually agents that absorb not less than 85% of UVB radiation (thus preventing burning) but may permit transmission of UVA radiation (thus allowing tanning). Some sunscreens may absorb wavelengths over a range that is slightly wider or narrower than that of UVB. All PABA derivatives absorb wavelengths of approximately 290-320 nm, benzophenone derivatives absorb wavelengths of approximately 250-360 nm, cinnamic acid derivatives absorb wavelengths of 280-320 nm, and salicylate derivatives and other miscellaneous chemical sunscreens absorb wavelengths of about 270-320 nm. The wavelength to which the skin is maximally sensitive had been accepted for many years to be 296.7 nm; however, recent evidence suggests that the most erythemogenic UVB wavelength may be slightly lower (e.g., somewhere in the range of 292-295 nm). In addition, of the stronger burning wavelengths that reach the earth's surface, most are approximately 310 nm. Therefore, sunscreens that maximally absorb UVB radiation near either of these wavelengths are particularly effective at preventing sunburn. Maximum absorbance occurs at about 290 nm for PABA, at about 295 nm for glyceryl-p-aminobenzoate, and at about 310 nm for the remaining PABA derivatives. Maximum absorbance occurs at 280-290 nm for benzophenone derivatives, at 310 nm for cinnamic acid derivatives with the exception of diethanolamine-p-methoxycinnamate which has its maximum absorbance at 290 nm, and at 300-305 nm for salicylate derivatives and other miscellaneous sunscreens. /Sunscreens/

Pharmacodynamics

Acts as a photoprotective agent that protects the skin by preventing and minimizing the damaging effects of ultraviolet (UV) rays of natural light. The cellular effects of UV irradiation include DNA damage, cell cycle arrest, immunological depression, apoptosis, and transcriptional changes.

Source: PubChem (NCBI) · pathways from PathBank, Reactome, WikiPathways & PharmGKB.

Molecular reference: octocrylene

PubChem CID 22571

Molecular formula: C24H27NO2

Mechanism of action

Octocrylene is an effective oil soluble liquid UV‐B filter. It has excellent dissolving properties for crystalline UV filters. Due to its outstanding photostability it is used as photostabilizer. Conjugated acrylate portion absorbs UVB and short-wave UVA (ultraviolet) rays with wavelengths in the range of 280-320 nm which protects the skin from direct DNA damage. The ethylhexanol portion is a fatty alcohol, which functions as an emollient due to it's hydrophobicity.

Source: PubChem (NCBI) · pathways from PathBank, Reactome, WikiPathways & PharmGKB.

Molecular reference: oxide

PubChem CID 190217

Molecular formula: O-2

Source: PubChem (NCBI) · pathways from PathBank, Reactome, WikiPathways & PharmGKB.

This drug in other countries

The same active ingredient registered across other registries we cover - including different brands.