PRODUCT NAME AND SIZES

Skincare Oil (Natural) 25ml

Skincare Oil (Natural) 60ml

Skincare Oil (Natural) 125ml

Skincare Oil (Natural) 200ml

DESCRIPTION

A 100% natural skincare oil clinically proven to help improve the appearance of skin.

PRESENTATION

Light yellow oil.

INGREDIENTS

Glycine Soja Oil, Helianthus Annuus Seed Oil, Carthamus Tinctorius Seed Oil, Simmondsia Chinensis Seed Oil, Salvia Hispanica Seed Oil, Punica Granatum Seed Oil, Plukenetia Volubilis Seed Oil, Triticum Vulgare Germ Oil, Rosa Canina Fruit Oil, Calendula Officinalis Extract, Lavandula Angustifolia Oil, Rosmarinus Officinalis Leaf Oil, Anthemis Nobilis Flower Oil, Pogostemon Cablin Leaf Oil, Bisabolol, Tocopherol.

NATURAL CERTIFICATION

Bio‑Oil® Skincare Oil (Natural) is ISO 16128 certified that it is made with 100% natural content and 100% natural origin content.

SKIN MARK CLINICAL TRIAL

Trial centre

proDERM Institute for Applied Dermatological Research, Hamburg, Germany.

Objective

To assess the efficacy of Bio‑Oil® Skincare Oil (Natural) in improving the appearance of skin marks.

Sample

Subjects: 40 female participants of various Fitzpatrick skin types. Skin mark ages: newly formed to 3 years old. Skin mark locations: face or body. Age of participants: 18–65.

Methodology

Evaluator blinded, randomised image assessment, open-labelled study. Subject inclusion was performed by a dermatologist using POSAS. Product was applied twice daily for 8 weeks by gently massaging in a circular motion on the assigned skin mark and surrounding skin. Application performed under supervision at regular intervals. The main objective was to assess the effect of the product on the skin investigated by means of POSAS at baseline and at 2, 4 and 8 weeks. Further parameters investigated at the end of the study included image assessment of the aesthetic outcome by 6 trained assessors and subjects themselves, and skin colour deviation of the skin marks to their surrounding as measured by a Chromameter.

Result

Bio‑Oil® Skincare Oil (Natural) is efficacious in improving the appearance of skin marks. A statistically significant improvement in POSAS (considering both the objective and subjective assessments of OSAS and PSAS) after only 2 weeks, evident in 94% of the subjects. After 8 weeks 100% of subjects showed a noticeable improvement, with the extent of the improvement more than double that at 2 weeks. A continuous and significant improvement of POSAS over the duration of the study. (Note: This product is registered for anti-wrinkle efficacy.)

FACE AND BODY CLINICAL TRIAL

Trial centre

Thomas J. Stephens & Associates, Inc., Texas, United States of America.

Study 1: Face and neck

Objective

To evaluate the efficacy of Bio‑Oil® Skincare Oil (Natural) when used by women with mild to moderate photodamaged skin on the face and neck.

Sample

Subjects: 64 female participants of various Fitzpatrick skin types with clinically determined mild to moderate photodamage on the face and neck. Bio‑Oil® Skincare Oil (Natural) conditioned group included 32 subjects and the unconditioned group included 32 subjects. Age of participants: 30–70.

Methodology

Randomised, controlled, efficacy grader-blinded study. Subjects participated in an initial screening evaluation followed by a 1-week washout period. Product applied to the face and neck twice daily for 16 weeks. Application was performed under supervision at the baseline visit. Clinical evaluations were conducted at 0, 2, 4 and 16 weeks. Subjects were clinically graded on the face and neck for the following efficacy parameters: fine lines, coarse wrinkles, visual roughness / smoothness, tactile roughness / smoothness, clarity (dullness), visual firmness and global assessment of appearance. Digital images were also taken of each subject’s face and neck, photo grading was performed after study completion. The images taken at each time point were graded globally for fine lines, coarse wrinkles, clarity (dullness) and global assessment of appearance.

Result

Bio‑Oil® Skincare Oil (Natural) is efficacious in improving the overall appearance of photodamaged skin on the face and neck. After 16 weeks, the Bio‑Oil® Skincare Oil (Natural) conditioned group were significantly better than those in the unconditioned control group for all clinically and photo graded efficacy parameters. After 16 weeks, 53.6% of subjects in the Bio‑Oil® Skincare Oil (Natural) conditioned group showed a statistically significant improvement in overall appearance of the face and neck. (Note: This product has been registered for anti-wrinkle efficacy.)

Study 2: Body

Objective

To evaluate the efficacy of Bio‑Oil® Skincare Oil (Natural) when used on the décolletage, lower leg and arm skin by women with mild to moderate photodamaged skin.

Sample

Subjects: 64 female participants of various Fitzpatrick skin types with clinically determined mild to moderate photodamage on the face and neck. Bio‑Oil® Skincare Oil (Natural) conditioned group included 32 subjects and the unconditioned group included 32 subjects. Age of participants: 30–70.

Methodology

Randomised, controlled, efficacy grader-blinded study. Subjects participated in an initial screening evaluation followed by a 1-week washout period. Product applied to the décolletage, lower legs and arms twice daily for 16 weeks. Application was performed under supervision at the baseline visit. Clinical evaluations were conducted at 0, 2, 4 and 16 weeks. Subjects were clinically graded separately on the décolletage, lower legs and arms for the following efficacy parameters: visual roughness / smoothness, tactile roughness / smoothness, dryness / scaling, visual crêpey texture and global assessment of appearance.

Result

Bio‑Oil® Skincare Oil (Natural) is efficacious in improving the overall appearance of photodamaged skin on the body. After 2 weeks, the Bio‑Oil® Skincare Oil (Natural) conditioned group were significantly better than those in the unconditioned control group for all clinically graded efficacy parameters. After 16 weeks, 82% of subjects in the Bio‑Oil® Skincare Oil (Natural) conditioned group showed a statistically significant improvement in overall appearance of the décolletage, 93% in overall appearance of the lower legs and 71% in overall appearance of the arms. (Note: This product has been registered for anti-wrinkle efficacy.)

DEHYDRATED SKIN CLINICAL TRIAL

Trial centre

Complife Italia S.r.l, Italy.

Study 1: Stratum corneum hydration and barrier function

Objective

To assess the efficacy of a single application of Bio‑Oil® Skincare Oil (Natural) to improve stratum corneum (SC) hydration and barrier function.

Sample

Subjects: 40 female participants of various Fitzpatrick skin types. Test site: test product applied to the volar forearm of all subjects. Age of participants: 18–65.

Methodology

Randomised, blinded and controlled study. Assessment of skin hydration with a Corneometer, assessment of barrier function with a Tewameter. Participants washed their forearms with soap 2 hours before measurements were taken to induce skin dryness. Baseline instrumental measurements were taken. Bio‑Oil® Skincare Oil (Natural) was then applied to a site on the volar forearm of all subjects. Measurements were taken again immediately after product application as well as 1 and 2 hours later, before and after wiping the product off. An unconditioned control site was also measured at all time points.

Result

Compared to dehydrated skin, Bio‑Oil® Skincare Oil (Natural) significantly improved skin hydration and significantly reduced transepidermal water loss (TEWL) in every monitoring test, demonstrating improved skin barrier function. (Note: The product is registered for moisturising and repairing effects.)

Study 2: Appearance of dry skin

Objective

To assess the efficacy of Bio‑Oil® Skincare Oil (Natural) in improving the appearance of dry skin.

Sample

Subjects: 25 female participants clinically showing dry / very dry desquamated skin at the level of the outer lower legs. Test site: test product applied to the outer, lower leg of all subjects. Age of participants: 25–65.

Methodology

Randomised, double-blinded and controlled clinical-instrumental study. Clinical evaluations of dry skin were performed by a trained visual evaluator, assessment of skin hydration with a Corneometer and assessment of barrier function with a Tewameter. Participants washed their legs with soap to induce dry skin over a 7-day period. Baseline instrumental measurements were taken. Bio‑Oil® Skincare Oil (Natural) was applied twice daily. Clinical assessments and instrumental evaluations were made on days 1 and 3. An unconditioned site was also evaluated at all time points.

Result

Compared to dehydrated skin, Bio‑Oil® Skincare Oil (Natural) significantly improved skin hydration and significantly reduced transepidermal water loss (TEWL) in every monitoring test, demonstrating improved skin barrier function. Instrumental results confirmed by the clinical analysis of skin dryness, carried out by the dermatologist.

Combined Study Result

The significant improvement in the visual appearance of dry skin conditioned with Bio‑Oil® Skincare Oil (Natural) in study 2 confirms its effectiveness in relieving dry and dehydrated skin. This is further supported with the improvements in stratum corneum barrier function and TEWL in both studies. (Note: The product is registered for moisturising and repairing effects.)

SENSITIVE SKIN TEST

Trial centre

Complife Italia S.r.l, Italy.

Objective

To assess the potential of Bio‑Oil® Skincare Oil (Natural) 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® Skincare Oil (Natural) was applied. Test products were applied to the backs of participants 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® Skincare Oil (Natural) was deemed ‘non-irritating’. (Note: This product is registered as non-irritating.)

ABSORPTION STUDY

Trial centre

proDERM Institute for Applied Dermatological Research, Hamburg, Germany.

Objective

To assess the rate of absorption of Bio‑Oil® Skincare Oil (Natural) after standardised application and rubbing in.

Sample

Subjects: 100 participants; 74 female and 26 male. Test site: test products applied to the volar forearm of all participants. Age of participants: 18–70.

Methodology

Double-blind, randomised and controlled study. Bio‑Oil® Skincare Oil (Natural) and a reference oil were applied to assigned test areas on the volar forearms of participants. Participants rubbed the test product in for one minute each. Participants then rated the absorption of the products on a 5-point scale from ‘very slow absorbing’ to ‘very fast absorbing’.

Result

The absorbency of Bio‑Oil® Skincare Oil (Natural) into the skin was assessed as ‘very fast’ or ‘fast’ by the majority (64%) of participants.

OCCLUSIVITY STUDY

Trial centre

Rigano Laboratories, Milan, Italy.

Objective

To evaluate whether Bio‑Oil® Skincare Oil (Natural) demonstrates a similar occlusivity level to vernix caseosa. Vernix caseosa is widely considered by cosmetic scientists as the ‘gold standard’ in skin moisturisation because of its ideal occlusivity level.

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. Equal quantities of vernix caseosa and Bio‑Oil® Skincare Oil (Natural) were applied to the membrane and the rate of water loss from the beaker was measured over time. This was compared with the rate of water loss without any product on the membrane. The water vapour transfer rate for each product was calculated and expressed in g/m²/h.

Result

Bio‑Oil® Skincare Oil (Natural) demonstrated a very similar occlusivity level to vernix caseosa, registering 24.9 compared to 27.1 for vernix caseosa.

APPLICATION

How to apply

Bio‑Oil® Skincare Oil (Natural) should be massaged in a circular motion on the face or body until fully absorbed. It is recommended that the product be applied twice daily, for a minimum of three months. Bio‑Oil® Skincare Oil (Natural) should not be applied to an open wound or broken skin. It is intended for topical cosmetic application only. Results will vary from individual to individual. Avoid contact with eyes. If product gets into eyes, rinse thoroughly with water. Keep out of reach of children.

How long to use

Bio‑Oil® Skincare Oil (Natural)’s various clinical trials (Note: Anti-wrinkle, Moisturising, Soothing) have been performed over 8-week and 16-week periods, 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 two weeks and that this improvement is maintained or increases over the duration of the trials. Bio‑Oil® Skincare Oil (Natural) may however be used on an ongoing basis. (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® Skincare Oil (Natural) should be applied to cleansed skin. If applying a moisturiser, sun protection lotion or other face cream only do so once Bio‑Oil® Skincare Oil (Natural) has been completely absorbed into the skin. For all over body use, apply Bio‑Oil® Skincare Oil (Natural) after showering or bathing.

Use in conjunction with pharmaceutical products

Bio‑Oil® Skincare Oil (Natural) 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® Skincare Oil (Natural) can be used on sensitive skin. In a skin irritation study conducted on 25 participants aged 18–70 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.)

ADVERSE REACTIONS

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

ACCIDENTAL INGESTION

Bio‑Oil® Skincare Oil (Natural) 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® Skincare Oil (Natural) 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® Skincare Oil (Natural) 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® Skincare Oil (Natural) batch mixed is allocated a unique batch number. A sample from the batch is tested by the laboratory for appearance, clarity, odour, identification by spectrophotometry, density, viscosity and microbiology. The sample is retained for four years. Filling and packing of Bio‑Oil® Skincare Oil (Natural) 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 bottle, carton and shipper, and a retention sample from each manufactured batch is kept for four years.

NATURAL INGREDIENT VARIATION

Bio‑Oil® Skincare Oil (Natural) may vary slightly in colour, odour and consistency from batch to batch. This is the result of expected and normal variations in the natural ingredients that will vary slightly in colour, odour or consistency depending on factors such as seasonality, soil conditions, sun exposure, crop yield, weather patterns, temperature, and time of year.

STORAGE INSTRUCTIONS

Bio‑Oil® Skincare Oil (Natural) should be stored in a cool place, out of direct sunlight.

RECYCLING

All Bio‑Oil® Skincare Oil (Natural) packaging (bottle, plug, cap and carton) is recyclable.

CERTIFICATIONS

Bio‑Oil® Skincare Oil (Natural) is certified Halaal and Kosher.

CHANGE IN APPEARANCE

Bio‑Oil® Skincare Oil (Natural) contains calendula, chamomile, lavender, patchouli and rosemary plant extracts and essential oils, as well as vitamin A in the form of rosehip oil, all of which are light sensitive. Exposure to sunlight may cause a change in colour over time. It is however unlikely to affect the product’s efficacy. As a precaution, Bio‑Oil® Skincare Oil (Natural) bottles contain a UV absorber. The product should nonetheless be stored out of direct sunlight.

PACKAGING