PRODUCT NAME AND SIZES

Dry Skin Gel 50ml

Dry Skin Gel 100ml

Dry Skin Gel 200ml

DESCRIPTION

A gel with 83% oil for very dry skin.

INDICATION

Significantly increases skin moisturisation.

PRESENTATION

Orange / pink gel.

INGREDIENTS

Paraffinum Liquidum, Isopropyl Palmitate, Triisononanoin, Glycerin, Cetearyl Ethylhexanoate, Isopropyl Myristate, Aqua, Caprylic/Capric Triglyceride, Isostearyl Isostearate, C26-28 Alkyl Dimethicone, Butyrospermum Parkii Butter, Sodium Lactate, Urea, Gluconolactone, Sodium PCA, Sodium Hyaluronate, Octyldodecyl PCA, Sucrose Laurate, Sucrose Stearate, Lactic Acid, Lanolin, Butylene Glycol, Dimethicone/Vinyl Dimethicone Crosspolymer, Bisabolol, Helianthus Annuus Seed Oil, Silica, Glycine Soja Oil, Retinyl Palmitate, Tocopheryl Acetate, Niacinamide, Linoleic Acid, Linolenic Acid, Tocopherol, Anthemis Nobilis Flower Oil, Calendula Officinalis Extract, Rosmarinus Officinalis Leaf Oil, Lavandula Angustifolia Oil, Parfum, CI 17200.

DRY SKIN CLINICAL TRIAL

Trial centre

Complife Italia S.r.l, Italy.

Objective

A clinical evaluation to test the efficacy of Bio‑Oil® Dry Skin Gel in improving skin moisturisation.

Sample

Subjects: 40 healthy females with Fitzpatrick skin types II-V and clinically showing dry / very dry skin (grade II-IV) at the level of the outer lower legs, and Corneometer values of less than 40 at enrolment. Test site: test product applied to one entire lower leg of all subjects. Age of participants: 40–65.

Methodology

Split-body, evaluator-blinded, randomised and controlled clinical-instrumental study. Subjects participated in an initial screening evaluation followed by a 7-day dry down period, a 28-day conditioning period and a 3-day follow up period (regression). During the dry down period, and throughout the study, subjects washed their legs twice daily with soap. Bio‑Oil® Dry Skin Gel was then applied twice daily to the assigned lower leg, the opposite leg remained unconditioned. Clinical assessments and instrumental evaluations were conducted at screening, baseline and on days 1, 3, 6, 8, 10, 14, 21, 28, 29, 30 and 31. The control unconditioned site was also evaluated at all time points. The assessment was as follows: participants were clinically graded for dryness (on a scale from 0–5) by a trained visual evaluator. Quantitative measurement of skin hydration was by Corneometer. Quantitative measurement of transepidermal water loss (TEWL), as an indicator of barrier function, was by Tewameter.

Result

Bio‑Oil® Dry Skin Gel significantly improved skin moisturisation, barrier function and the appearance of dry skin (clinical grading of dryness) at each experimental monitored check, both compared to baseline values and to the unconditioned (control) area. (Note: This product has been registered for moisturising efficacy.)

SENSITIVE SKIN TEST

Trial centre

Complife Italia S.r.l, Italy.

Objective

To assess the potential of Bio‑Oil® Dry Skin Gel to cause skin irritation.

Sample

Subjects: 30 participants; 28 female and 2 male, all with sensitive skin according to a lactic acid stinging test (note: a testing method). Age of participants: 18–70.

Methodology

Controlled study. Two areas were evaluated: an area to which a negative control was applied (demineralised water) and an area to which Bio‑Oil® Dry Skin Gel was applied. Test products were applied to participants’ back region for a period of 48 hours using a Finn Chamber®. Skin reactions were evaluated under the supervision of a dermatologist, to assess primary skin irritation at 15 minutes, 1 hour and 24 hours after patch removal. Skin reactions were rated on a scale from 0–4 (0 indicates no skin irritation, and 4 indicates severe irritation).

Result

The skin tolerability of Bio‑Oil® Dry Skin Gel was deemed ‘non-irritating’. (Note: This product is registered as non-irritating.)

OCCLUSIVITY STUDY

Trial centre

Rigano Laboratories, Milan, Italy.

Objective

To experimentally determine the occlusivity of Bio‑Oil® Dry Skin Gel and thereby its ability to help the skin to retain moisture by reducing TEWL.

Methodology

Known quantities of water were placed in beakers covered with a semi-permeable membrane called Vitro-Skin™, which mimics the surface properties of human skin. Product was applied to the membrane and the rate of water loss from the beakers was measured over time. This was compared with the rate of water loss from control beakers, without any product on the membrane.

Result

The water vapour transmission rate (WVTR) test methodology is a standard test for measuring the occlusivity of products. A reduction in the WVTR value indicates that a particular formulation is occlusive. Bio‑Oil® Dry Skin Gel was shown to reduce the WVTR values statistically compared to the unconditioned control when applied to the Vitro-Skin™ membrane. This in vitro result suggests that Bio‑Oil® Dry Skin Gel will help the skin to retain moisture in vivo and thereby help relieve the signs and conditions of dry skin. (Note: This product has been registered for moisturising effects.)

APPLICATION

How to apply

Apply a small amount of Bio‑Oil® Dry Skin Gel to dry skin as required. In the case of persistent dry skin, it is recommended that it be applied twice daily, morning and evening. The product was specifically formulated for the body, however it may also be used on the face. Bio‑Oil® Dry Skin Gel is intended for topical cosmetic application only. It should not be applied to an open wound or broken skin. Avoid contact with eyes. If product gets into eyes, rinse thoroughly with water. Keep out of reach of children. Contains Vitamin A (as Retinyl Palmitate). Consider your daily usage before use.

How long to use

Bio‑Oil® Dry Skin Gel’s clinical trial (Note: Moisturising) has been performed over a four-week period, allowing the performance of the product to be assessed over time. Statistical analysis shows a significant improvement in the appearance of the skin after as little as 24 hours and that this improvement is maintained for the duration of the trial. Bio‑Oil® Dry Skin Gel may however be used on an ongoing basis for its moisturising and skin-nourishing properties, making it a part of a daily skincare routine. (Note: Results may vary depending on individual skin condition and frequency of use.)

Use in conjunction with a skincare routine

For maximum absorption, Bio‑Oil® Dry Skin Gel should be applied to cleansed skin. If applying a sun protection lotion or other cream only do so once Bio‑Oil® Dry Skin Gel has been completely absorbed into the skin. For all over body use, apply Bio‑Oil® Dry Skin Gel after showering or bathing.

Use in conjunction with pharmaceutical products

Bio‑Oil® Dry Skin Gel is a cosmetic product. For advice regarding use of the product in conjunction with the simultaneous use of pharmaceutical products, it is best to seek the advice of a medical practitioner.

Use on sensitive skin

Bio‑Oil® Dry Skin Gel can be used on sensitive skin. In a skin irritation study conducted on 30 participants aged 18–70 with sensitive skin, no subjects experienced any adverse reactions to Bio‑Oil® Dry Skin Gel. (Note: This product is registered as non-irritating. If you are concerned about allergic reactions, it is recommended to perform a simple allergy test first. The method is to apply a small amount of the product to the inside of the forearm and wait 24 hours to see if any adverse reaction occurs. Data is from the above-mentioned "Sensitive Skin Test" experiment.)

CONDITIONS AND CAUSES OF DRY SKIN

Conditions

Conditions of dry skin include dull and flaky skin, fine lines, grey or ashy coloured skin and the feeling of roughness and tightness.

Causes

Dry skin is caused by both external and internal factors. External factors: Dry climates cause moisture to be drawn from inside the skin, through the lipid bilayer and into the dry outside air. Air conditioners and heaters draw moisture out of the air, creating an artificially dry climate that draws moisture out of the skin. Everyday washing and exposure to harsh detergents cause the skin’s lipid bilayer to be stripped, making it easier for moisture to escape from the skin. Internal factors: As the body ages, the skin produces fewer lipids causing the lipid bilayer to thin and making it easier for moisture to escape. Genetics can play a role in the development of dry skin due to naturally occurring lower levels of ceramides in the lipid bilayer. This results in reduced occlusivity of the skin barrier, contributing to above normal levels of moisture loss. The pH of the skin influences the barrier function. A higher pH level in the skin impairs the healthy functioning of the lipid bilayer.

ADVERSE REACTIONS

If any adverse reactions occur, please discontinue use immediately and seek medical attention.

ACCIDENTAL INGESTION

Bio‑Oil® Dry Skin Gel is for external use only and should not be ingested. Accidental ingestion may cause mild side affects such as nausea and diarrhoea. It is recommended to seek medical attention immediately.

PERIOD AFTER OPENING (PAO)

Bio‑Oil® Dry Skin Gel has a shelf life of 12 months after opening. It is recommended to use it as soon as possible after opening.

MANUFACTURE

The manufacture of Bio‑Oil® Dry Skin Gel conforms to the Good Manufacturing Practice (GMP) requirements of ISO 22716:2007 for cosmetic products. No raw materials or packaging materials are released to production until quality control tests have been passed. Every Bio‑Oil® Dry Skin Gel batch mixed is allocated a unique batch number. A sample from the batch is tested by the laboratory for appearance, colour, odour, identification by spectrophotometry, density, viscosity and microbiology. The sample is retained for four years. Filling and packing of Bio‑Oil® Dry Skin Gel takes place in a temperature and humidity-controlled facility. The air passes through a high efficiency particulate air (HEPA) filtering system to prevent dust contamination. Employees working on the production lines wear hats, face masks, face shields, gloves, coats and shoe covers. Samples are taken off the line at regular intervals and are inspected by the Quality Control department as a precaution against extraordinary defect. A batch number is printed on the tub, carton and shipper, and a retention sample from each manufactured batch is kept for four years.

STORAGE INSTRUCTIONS

Bio‑Oil® Dry Skin Gel should be stored in a cool place, out of direct sunlight.

RECYCLING

All Bio‑Oil® Dry Skin Gel packaging (tub, lid, label and carton) is recyclable.

CERTIFICATIONS

Bio‑Oil® Dry Skin Gel is certified Halaal and Kosher.

CHANGE IN APPEARANCE

There are two conditions under which the appearance of Bio‑Oil® Dry Skin Gel may change. The first condition occurs when the gel is exposed to extreme high or low temperatures for extended periods; extreme elevated temperatures dehydrate the surface of the gel, this is exaggerated when the container is left open. In contrast, extreme low temperatures can cause freezing. Both events may give the gel a white appearance. The second condition occurs when water, or another liquid, is introduced into the jar during use. The liquid will interact with the emulsifier in the formulation and initiate the emulsifying process, causing the gel to turn white and the consistency to change.

PACKAGING