Titanium dioxide + Butyl methoxydibenzoyl methane + Padimate + Oxybenzone

Uses

This Lotion is used for the treatment, control, prevention, & improvement of the following diseases, conditions and symptoms:

• Sunburn
• Premature aging
• Risk of skin cancer
• Uv rays protection
• Dryness and chapping of the lips
• Cold sores
• Sun and fever blisters

Titanium dioxide + Butyl methoxydibenzoyl methane + Padimate + Oxybenzone is also used to associated treatment for these conditions: SunburnBlisters, Dermatitis, Eczematous, Sunburn, Wounds, Abrasions, Dry, cracked skin, UV protection therapy

How Titanium dioxide + Butyl methoxydibenzoyl methane + Padimate + Oxybenzone works

Oxybenzone absorbs UV-A ultraviolet rays, preventing them from reaching the 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.

Dosage

Titanium dioxide + Butyl methoxydibenzoyl methane + Padimate + Oxybenzone dosage

Apply on the area exposed to sunlight (such as face, neck & body) at least 30 min before exposure and whenever necessary. Massage on to skin until absorbed.

To ensure maximum protection, we recommend repeating the application every two hours after continuous exposure to the sun and after swimming, physical exercise (sweat or dry with towel).

Side Effects

The following is a list of possible side-effects that may occur from all constituting ingredients of this lotion. This is not a comprehensive list. These side-effects are possible, but do not always occur. Some of the side-effects may be rare but serious. Consult your doctor if you observe any of the following side-effects, especially if they do not go away.

• Rash
• Itching
• Severe dizziness
• Trouble breathing
• Skin irritation
• Skin redness
• Acne
• Burning or itching of the skin
• Dark red spots on the skin
• Painful, red and pus-filled blisters in hair follicles

Toxicity

Rat - LD50 Intratracheal (>100ug/kg ) Effects: Structural or functional changes in bronchi and trachea. There is inadequate evidence in humans for the carcinogenicity of titanium dioxide. Cancer in experimental animals: There is sufficient evidence in experimental animals for the carcinogenicity of titanium dioxide. Overall evaluation: Titanium dioxide is possibly carcinogenic to humans (Group 2B).

Precaution

Before using this lotion, inform your doctor about your current list of medications, over the counter products (e.g. vitamins, herbal supplements, etc.), allergies, pre-existing diseases, and current health conditions (e.g. pregnancy, upcoming surgery, etc.). Some health conditions may make you more susceptible to the side-effects of the drug. Take as directed by your doctor or follow the direction printed on the product insert. Dosage is based on your condition. Tell your doctor if your condition persists or worsens. Important counseling points are listed below.

• Apply it 30 minutes before going in the sun exposure
• Breastfeeding
• Herpes infection
• Infants
• Planning to have baby
• Pregnancy
• Pregnant, planning to become pregnant or breastfeeding
• Pregnant, planning to get pregnant or breastfeeding
• Skin disease
• Do not take by mouth. Consult with your doctor before using this medicine on open wounds, dry, chapped, irritated, or sun-burned skin.
• Wash your hands before and after applying this lotion. Clean and dry the skin area to be treated.
• Do not wash the treated area after immediately applying this lotion. Also avoid the use of other products on the treated area unless directed by your doctor.
• Applying an excessive amount may result in pilling. Use a thinner layer or lesser quantity of medicine to avoid pilling.
• Avoid getting this medication in your eyes or nose or mouth.

Interaction

There are no known drug interactions and none well documented.

Volume of Distribution

Six hours after titanium dioxide was administered to rats through IV injection at 250 mg/kg body weight, the highest concentration appeared in the liver; after 24 hours, the highest concentration was detected in the celiac lymph nodes, which filter the lymph from the liver.

Elimination Route

When male and female rats were fed a diet containing titanium dioxide (100 g/kg) for a period of about 32 days, a significant retention of titanium of 0.06 and 0.11 mg/kg wet weight was found only in the muscles; no retention was observed in the liver, spleen, kidney, bone, plasma, or erythrocytes

Half Life

The kinetics of TiO2 elimination in the rat lung following its deposition after 7 hr exposure at 10 and 50 mg/cu m were determined for periods up to 140 days...The retention half-time was 14 days for the first clearance phase and 88 days thereafter.

Clearance

The clearance of titanium dioxide from the lungs was studied in rats after inhalation of 15 or 100 mg/cu m. The average median aerodynamic diameter of the titanium dioxide particles was 1.48 um. After a single exposure, about 40-45% of the deposited particles were cleared from the lung in 25 days. At 15 mg/cu m, 0.7% was found in the hilar lymph nodes indicating penetration of titanium dioxide particles from alveoli into the lymphatic system and partial clearance by the lymphatic route. The clearance rate was similar after intra-tracheal administration of titanium dioxide. At an exposure of 100 mg/cu m, the clearance rate decreased drastically. /Other researchers/ demonstrated the presence of titanium dioxide in the lymphatic systems of 3 workers employed in processing titanium dioxide pigments.

Elimination Route

In vivo studies show oxybenzone is abosorbed transdermally (through the skin) and is excreted in the urine.

The kinetics of TiO2 elimination in the rat lung following its deposition after 7 hr exposure at 10 and 50 mg/cu m were determined for periods up to 140 days.The retention half-time was 14 days for the first clearance phase and 88 days thereafter.

Pregnancy & Breastfeeding use

Pregnancy Category C. Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks

Contraindication

Hypersensitivity to Spectraban this lotion is a contraindication. In addition, Spectraban Ultra 28 Lotion should not be used if you have the following conditions:

• Allergic reaction
• Allergic reactions
• Contact with eyes
• Hypersensitivity

Storage Condition

Store medicines at room temperature, away from heat and direct light. Do not freeze medicines unless required by package insert. Keep medicines away from children and pets.

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