PRODUCT NAME AND SIZES

Skincare Oil 25ml

Skincare Oil 60ml

Skincare Oil 125ml

Skincare Oil 200ml

DESCRIPTION

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

PRESENTATION

Orange / pink oil.

INGREDIENTS

Paraffinum Liquidum, Triisononanoin, Cetearyl Ethylhexanoate, Isopropyl Myristate, Helianthus Annuus Seed Oil, Bisabolol, Tocopheryl Acetate, Anthemis Nobilis Flower Oil, Lavandula Angustifolia Oil, Rosmarinus Officinalis Leaf Oil, Calendula Officinalis Extract, Glycine Soja Oil, Simmondsia Chinensis Seed Oil, Lithospermum Erythrorhizon Root Extract, Retinyl Palmitate, Tocopherol, Parfum, Beta Carotene (CI 40800).

SKIN MARK CLINICAL TRIAL

Trial centre

proDERM Institute for Applied Dermatological Research, Hamburg, Germany.

Objective

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

Sample

Subjects: 36 female participants of various Fitzpatrick skin types. Skin mark ages: newly formed to 3 years old. Skin mark locations: abdomen, leg, arm, neck, knee, trunk, upper body. Age of participants: 18–65.

Methodology

Double-blind, randomised and placebo-controlled study. Subjects had matching skin marks or a skin mark large enough to allow a half-half skin mark application and intra-subject comparison. Product applied twice daily for 8 weeks; no additional massaging performed on the target area. Application performed under supervision at regular intervals. Assessments conducted at 0, 2, 4 and 8 weeks. Different parameters as defined in POSAS were evaluated.

Result

Bio‑Oil® Skincare Oil is efficacious in improving the appearance of skin marks. A statistically significant result was achieved after only 2 weeks (day 15), evident in 66% of the subjects. After 8 weeks (day 57) 92% of subjects showed an improvement, with the extent of the improvement almost triple that at 2 weeks. A continuous 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 when used by women with mild to moderate photodamaged skin on the face and neck.

Sample

Subjects: 67 female participants of various Fitzpatrick skin types with clinically determined mild to moderate photodamage on the face and neck. Bio‑Oil® Skincare Oil conditioned group included 35 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 12 weeks. Application performed under supervision at the baseline visit. Clinical evaluations were conducted at 0, 2, 4, 8 and 12 weeks. Subjects were clinically graded separately on the face and neck for the following efficacy parameters: overall appearance, fine lines, coarse wrinkles, visual roughness / smoothness, tactile roughness / smoothness, firm appearance, and clarity (dullness).

Result

Bio‑Oil® Skincare Oil is efficacious in improving the overall appearance of photodamaged skin on the face and neck. After 8 weeks a statistically significant result was achieved for all clinically graded efficacy parameters. After 12 weeks 94% of subjects in the Bio‑Oil® Skincare Oil conditioned group showed a statistically significant improvement in overall appearance on the face and 80% of subjects showed a statistically significant improvement in overall appearance on the neck. (Note: The product has been registered for anti-wrinkle efficacy.)

Study 2: Body

Objective

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

Sample

Subjects: 67 female participants of various Fitzpatrick skin types with clinically determined mild to moderate photodamage on the face and neck. Bio‑Oil® Skincare Oil conditioned group included 35 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 12 weeks. Application was performed under supervision at the baseline visit. Clinical evaluations were conducted at 0, 2, 4, 8 and 12 weeks. Subjects were clinically graded separately on the décolletage, lower legs and arms for the following efficacy parameters: overall appearance, crêpey texture, dryness / scaling, visual roughness / smoothness, and tactile roughness / smoothness.

Result

Bio‑Oil® Skincare Oil is efficacious in improving the overall appearance of photodamaged skin on the body. After 4 weeks a statistically significant result was achieved for all clinically graded efficacy parameters. After 12 weeks 89% of subjects in the Bio‑Oil® Skincare Oil conditioned group showed a statistically significant improvement in overall appearance of the décolletage, lower legs and arms.

DEHYDRATED SKIN CLINICAL TRIAL

Trial centre

Photobiology Laboratory of the Medical University of South Africa.

Study 1: Stratum corneum hydration and barrier function

Objective

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

Sample

Subjects: 40 female participants of various Fitzpatrick skin types. Test site: test products applied to the volar forearm of all subjects. Age of participants: 25–65.

Methodology

Assessment of skin hydration with a Corneometer as the primary measure, assessment of barrier function with a Vapometer as a secondary measure. 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 and a reference oil were then applied to separate sites on the volar forearm of all subjects. Measurements were taken again immediately after product application as well as 2 hours later, before and after wiping the products off. An unconditioned control site was also measured at all time points.

Result

After immediate application, both oils reduced transepidermal water loss (TEWL) compared to the unconditioned control group. Increased skin capacitance values at the 2 hour pre-wipe time point indicated increased skin hydration for both oils. Two hours later, after wiping the oils from the skin’s surface, Bio‑Oil® Skincare Oil showed further increased TEWL values compared to the reference oil, indicating increased moisture release and therefore increased skin hydration. (Note: The product is registered for moisturising and repairing effects.)

Study 2: Appearance of dry skin

Objective

To assess the effect of twice daily application of Bio‑Oil® Skincare Oil for moisturisation performance and relief 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

Soap was used to induce dry skin over a 7-day period. Bio‑Oil® Skincare Oil and a reference oil were applied twice daily. Skin assessments were made on days 1 and 3. Visual evaluations were performed by a trained visual evaluator using a 2x magnifying lamp. An unconditioned control site was also evaluated at all time points.

Result

Both Bio‑Oil® Skincare Oil and the reference oil improved skin dryness compared with the unconditioned control. Bio‑Oil® Skincare Oil was statistically superior on day 3. Significant improvements in visual appearance of skin sites conditioned with Bio‑Oil® Skincare Oil confirmed its effectiveness in relieving dry skin.

Combined Study Result

The significant improvement in the visual appearance of dry skin conditioned with Bio‑Oil® Skincare Oil 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 to cause skin irritation.

Sample

Subjects: 25 participants; 19 male and 6 female, all with sensitive skin according to a lactic acid stinging test (note: a testing method). Age of participants: 18–65.

Methodology

Randomised and controlled study. Two areas were evaluated: area to which a negative control was applied (demineralised water) and area to which Bio‑Oil® Skincare Oil was applied. Test products were applied to the back of the hands 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 was deemed ‘non-irritating’. (Note: This product is registered as non-irritating.)

ABSORPTION STUDY

Trial centre

proDERM Institute for Applied Dermatological Research, Hamburg, Germany.

Study 1: Trained raters

Objective

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

Sample

Subjects: 22 trained raters; 21 female and 1 male. Test site: test products applied to the volar forearm of all raters. Age of participants: 18–70.

Methodology

Double-blind, randomised and controlled study. Bio‑Oil® Skincare Oil and a reference oil were applied to assigned test areas on the volar forearms of raters. Raters performed 100 cyclic movements at a defined speed. Raters then rated the absorption of the products on a 5-point scale from ‘very slow absorbing’ to ‘very fast absorbing’. Sebumeter measurements, to assess the amount of oil on the skin, were taken at two time points; before application and 2 minutes after product application.

Result

The absorbency of Bio‑Oil® Skincare Oil into the skin was assessed as ‘very fast’ or ‘fast’ by the majority (77.3%) of trained raters. This was verified through instrumental measurement with sebumeter readings at the second time point showing that the amount of Bio‑Oil® Skincare Oil left on the skin was significantly lower than compared with the reference oil. (Note: Research results are subject to testing conditions; individual user experiences may vary, and results may differ from person to person.)

Study 2: Consumer panel

Objective

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

Sample

Subjects: 100 participants; 97 female and 3 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 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 into the skin was assessed as ‘very fast’ or ‘fast’ by the majority (72%) of participants. (Note: Research results are subject to testing conditions; individual user experiences may vary, and results may differ from person to person.)

OCCLUSIVITY STUDY

Trial centre

Trial conducted by Prof. Dr. J Wiechers at Rigano Laboratories, Milan, Italy.

Objective

To evaluate whether Bio‑Oil® Skincare Oil 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 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 demonstrated a very similar occlusivity level to vernix caseosa, registering 23.5 compared to 27.2 for vernix caseosa.

APPLICATION

How to apply

Bio‑Oil® Skincare Oil 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 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. Contains Vitamin A (as Retinyl Palmitate). Consider your daily usage before use.

How long to use

Bio‑Oil® Skincare Oil’s various clinical trials (Note: Nourishing, Repairing, Moisturising, Anti-wrinkle, Firming, Soothing) have been performed over 8-week and 12-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 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 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 has been completely absorbed into the skin. For all over body use, apply Bio‑Oil® Skincare Oil after showering or bathing.

Use in conjunction with pharmaceutical products

Bio‑Oil® Skincare Oil 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 can be used on sensitive skin. In a skin irritation study conducted on 25 participants aged 18–65 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 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 has a shelf life of 36 months after opening. It is recommended to use it as soon as possible after opening.

MANUFACTURE

The manufacture of Bio‑Oil® Skincare Oil 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 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 six years. Filling and packing of Bio‑Oil® Skincare Oil 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 six years.

STORAGE INSTRUCTIONS

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

RECYCLING

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

CERTIFICATIONS

Bio‑Oil® Skincare Oil is certified Halaal and Kosher.

CHANGE IN APPEARANCE

Bio‑Oil® Skincare Oil contains calendula, chamomile, lavender and rosemary plant extracts and essential oils, as well as vitamin A, 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 bottles contain a UV absorber. The product should nonetheless be stored out of direct sunlight.

PACKAGING