PRODUCT NAME AND SIZES

Body Lotion 175ml

Body Lotion 250ml

DESCRIPTION

A body lotion with 42% oil for daily moisturising.

INDICATION

Significantly increases skin moisturisation.

PRESENTATION

White fluid.

INGREDIENTS

Aqua, Dimethicone, Isopropyl Palmitate, Ethylhexyl Cocoate, Isododecane, Isopropyl Myristate, Urea, Polyglyceryl-2 Dipolyhydroxystearate, Glycerin, Pentylene Glycol, Dicaprylyl Carbonate, Polyglyceryl-3 Diisostearate, Sodium Lactate, Dipentaerythrityl Hexacaprylate/Hexacaprate, Gluconolactone, Rosa Canina Fruit Oil, Simmondsia Chinensis Seed Oil, Calendula Officinalis Extract, Butyrospermum Parkii Oil, Helianthus Annuus Seed Oil, Glycine Soja Oil, Isostearyl Isostearate, Bisabolol, Octyldodecyl PCA, Retinyl Palmitate, Tocopheryl Acetate, Linoleic Acid, Linolenic Acid, Tocopherol, Sodium PCA, Sodium Hyaluronate, Lactic Acid, Stearalkonium Hectorite, Propylene Carbonate.

DRY SKIN CLINICAL TRIAL

Trial centre

Complife Italia S.r.l, Italy.

Objective

A clinical evaluation to test the efficacy of Bio‑Oil® Body Lotion in improving skin moisturisation.

Sample

Subjects: 30 healthy female participants with Fitzpatrick skin types II-V and clinically showing dry / very dry skin at the level of the outer lower legs. Test site: test product applied to an outer, lower leg of all subjects. Age of participants: 25–65.

Methodology

Split body, evaluator-blinded, randomised and controlled clinical-instrumental study. Participants washed their legs with soap to induce dry skin over a 7-day period. Baseline clinical and instrumental evaluations were taken. Bio‑Oil® Body Lotion was applied twice daily for 28 days to the assigned lower lateral leg, the opposite leg remained untreated. Clinical assessments and instrumental evaluations were conducted on days 1, 3, 6, 8, 10, 14, 21 and 28. The control untreated site was also evaluated at all time points. Subjects 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. Additionally, a self-assessment questionnaire was completed on days 8 and 14.

Result

Compared to the untreated area, treatment with Bio‑Oil® Body Lotion resulted in a statistically significant improvement in clinical grading of dryness, Tewameter and Corneometer measurements, from as early as day 1, and at all time points. For clinical grading of dryness, statistically significant improvements were evident in 96.7% of participants from day 14 onwards, almost double the improvement noted at day 1. After 28 days of use, 100% of participants showed a significant increase in skin moisturisation, with the extent of the improvement almost 4 times that at day 1. Similarly, after 28 days of use 100% of participants showed a significant decrease in TEWL, with the extent of the improvement more than double that at day 1. These findings are supported by the results of the self-assessment questionnaire. (Note: The product has been registered for moisturising effects.)

DRY SKIN USER TRIAL

Trial centre

Ayton Global Research, United Kingdom.

Objective

To assess the performance of Bio‑Oil® Body Lotion as a body moisturiser.

Sample

Subjects: 117 female participants in good health. Age of participants: 18 and over.

Methodology

A 2-week, single-placement, in-home user trial. Participants were instructed to apply product twice daily, morning and evening. Massage into skin until fully absorbed. Three short questionnaires were completed: the first after initial application, the second after 12 hours, and the third after 2 weeks of using the product.

Result

Application: 95% of participants agreed that ‘the product is lighter than any moisturiser they have used before’. 93% of participants agreed that ‘the product spreads more easily than any moisturiser they have used before’. Absorption: 82% of participants agreed that ‘the product absorbs more easily than any moisturiser they have used before’. 75% of participants agreed that ‘the product absorbs quicker than any moisturiser they have used before’. 74% of participants agreed that ‘the product leaves no greasy residue after application’. 86% of participants agreed that ‘after applying the product they were able to get dressed immediately’. Hydration: 93% of participants agreed that ‘the product leaves skin feeling immediately moisturised’. 92% of the participants agreed that ‘after applying the product their skin feels smooth and silky’. 90% of participants agreed that ‘their skin felt moisturised the entire day’ and 91% agreed that ‘their skin feels smooth and silky the entire day’. 92% of participants agreed that ‘their skin looks better than it did at the beginning of the 2-week period’. Overall: 73% of participants agreed that ‘the product is better than any moisturiser they have used before’. (Note: The product has been registered for moisturising effects.)

SENSITIVE SKIN TEST

Trial centre

Complife Italia S.r.l, Italy.

Objective

To assess the potential of Bio‑Oil® Body Lotion to cause skin irritation.

Sample

Subjects: 25 participants; 22 female and 3 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: area to which a negative control was applied (demineralised water) and an area to which Bio‑Oil® Body Lotion was applied. Test products were applied to the back region of participants, in contact with the skin surface, 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® Body Lotion was deemed ‘non-irritating’. (Note: This product is registered as non-irritating.)

VISCOSITY STUDY

Trial centre

Union Swiss, South Africa.

Objective

An internal study to assess the dynamic viscosity of Bio‑Oil® Body Lotion compared to similar moisturising products.

Sample

Comparison of Bio‑Oil® Body Lotion to 13 moisturising products manufactured by 10 global brands with an established history in moisturisation.

Methodology

Dynamic viscosity was read using an Anton Paar RheoLab QC rheometer, using spindle CC 39, speed: 200 rpm at 20˚C, shear rate: 155.

Result

Bio‑Oil® Body Lotion was found to have a 7.5 times lower dynamic viscosity than the average of the competitor products (94 mPa.s vs. 707 mPa.s respectively), indicating a thinner, lighter fluid that’s more easily and rapidly absorbed.

APPLICATION

How to apply

Bio‑Oil® Body Lotion should be massaged in a circular motion on the body until fully absorbed. It is recommended that Bio‑Oil® Body Lotion be applied twice daily, morning and evening. Bio‑Oil® Body Lotion should not be applied to an open wound or broken skin. It is intended for topical cosmetic application only. 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.

Shake before use

Bio‑Oil® Body Lotion is an emulsion in which the water and oil are very lightly bound together. So lightly, that when left standing some of the oils rise to the surface of the product forming a thin layer. By gently shaking the product before use, the oil layer disperses back into the lotion. Layer formation can take anywhere from three days to three weeks and is dependent on factors such as temperature, how vigorously and how frequently the bottle has been shaken. The mere act of using the product daily, turning the bottle upside down when dispensing, is more than sufficient to ensure that this oil layer does not form. If an oil layer has formed and the product is dispensed without shaking, a clear oil mixture may flow from the bottle.

How long to use

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

Use in conjunction with pharmaceutical products

Bio‑Oil® Body Lotion 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® Body Lotion can be used on sensitive skin. In a skin irritation study conducted on 25 participants aged 18–70 years old with sensitive skin, no subjects experienced any adverse reactions to the formulation. (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® Body Lotion 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® Body Lotion 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® Body Lotion 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® Body Lotion 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. The filling and packing of Bio‑Oil® Body Lotion is 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 bottle, carton and shipper, and a retention sample from each manufactured batch is kept for four years.

STORAGE INSTRUCTIONS

Bio‑Oil® Body Lotion should be stored in a cool place, out of direct sunlight.

RECYCLING

All Bio‑Oil® Body Lotion packaging (bottle, cap and carton) is recyclable.

CERTIFICATIONS

Bio‑Oil® Body Lotion is certified Halaal and Kosher.

CHANGE IN APPEARANCE

Bio‑Oil® Body Lotion contains calendula extract and essential oils, as well as vitamin A palmitate, all of which are light sensitive. Exposure to sunlight may cause a change in colour over time. Bio‑Oil® Body Lotion should be stored out of direct sunlight.

PACKAGING