PRODUCT NAME AND SIZES

Skincare Oil (Natural) 25 ml

Skincare Oil (Natural) 60 ml

Skincare Oil (Natural) 125 ml

Skincare Oil (Natural) 200 ml

DESCRIPTION

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

INDICATIONS

Helps improve dry and uneven skin; moisturises for healthy, smooth, and brighter 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.

UNEVEN SKIN TONE CLINICAL TRIAL

Trial centre

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

Objective

To evaluate the efficacy of Bio‑Oil® Skincare Oil (Natural) in improving the appearance of uneven skin tone and mottled pigmentation when used by women with mild to moderate photodamaged (ageing) skin on the face and neck.

Sample

Subjects: 57 female participants of various Fitzpatrick skin types with clinically determined mild to moderate photodamage on the face and neck. Bio‑Oil® Skincare Oil (Natural) treatment cell included 28 subjects and the untreated cell included 29 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 performed under supervision at the baseline visit. Clinical evaluations were conducted at 0, 2, 4, 8 and 16 weeks. Subjects were clinically graded on the face and neck for uneven skin tone and mottled pigmentation. Digital images were also taken of each subject’s face and neck, photo grading was performed after study completion.

Result

Bio‑Oil® Skincare Oil (Natural) is efficacious in improving the appearance of uneven skin tone and mottled pigmentation on photodamaged (ageing) skin. After 16 weeks, a statistically significant result was achieved for both parameters on the face and neck, according to clinical and photo grading. After 16 weeks, 61% of subjects showed a statistically significant improvement in uneven skin tone, and 57% in mottled pigmentation.

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: 57 female participants of various Fitzpatrick skin types with clinically determined mild to moderate photodamage on the face and neck. Bio‑Oil® Skincare Oil (Natural) treatment cell included 28 subjects and the untreated cell included 29 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, 8 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, mottled pigmentation, uneven skin tone, 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, mottled pigmentation, uneven skin tone, 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) treatment group significantly outperformed the untreated control group for all clinically and photo graded efficacy parameters. This was clinically observed from 4 weeks, except for mottled pigmentation. After 16 weeks, 54% of subjects in the Bio‑Oil® Skincare Oil (Natural) treatment cell showed a statistically significant improvement in overall appearance of the face and neck.

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: 57 female participants of various Fitzpatrick skin types with clinically determined mild to moderate photodamage on the face and neck. Bio‑Oil® Skincare Oil (Natural) treatment cell included 28 subjects and the untreated cell included 29 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, 8 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) treatment group significantly outperformed the untreated control group for all clinically graded efficacy parameters. After 16 weeks, 82% of subjects in the Bio‑Oil® Skincare Oil (Natural) treatment cell 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.

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. A control untreated site was also measured at all time points.

Result

Bio‑Oil® Skincare Oil (Natural) treatment resulted in a significant improvement of skin moisturisation and a significant decrease of transepidermal water loss (TEWL), an index of improvement in skin barrier condition, at each experimental monitored check, compared to dehydrated skin.

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. A control untreated site was also evaluated at all time points.

Result

Bio‑Oil® Skincare Oil (Natural) treatment resulted in a significant improvement of skin moisturisation and a significant decrease of TEWL, an index of improvement in skin barrier condition, at each experimental monitored check, compared to dehydrated skin. 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 treated 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 skin capacitance in both studies.

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 lactic acid stinging test. 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 (with 0 being no erythema, oedema, or other types of skin irritation, and 4 being serious erythema and oedema, indicating dark red appearance and extended swelling beyond the application area).

Result

The skin tolerability of Bio‑Oil® Skincare Oil (Natural) was deemed ‘non-irritating’.

NON-COMEDOGENIC TEST

Trial centre

Complife Italia S.r.l, Italy.

Objective

To test whether Bio‑Oil® Skincare Oil (Natural) is likely to cause acne and comedones (pimples).

Sample

Subjects: 20 participants; 14 female and 6 male of various Fitzpatrick skin types with acne prone skin. Age of participants: 18–65.

Methodology

Controlled study. The product was applied on a disk of filter paper to the upper back region of participants. Patches were left in place for 48 to 72 hours, removed and applied again. A total of 12 patches were applied for 4 consecutive weeks. Three areas were evaluated by comparing a negative control (demineralised water), the test product (Bio‑Oil® Skincare Oil (Natural)) and a positive control (lanolin alcohol, a known comedogenic product). Skin reactions were clinically evaluated under the supervision of a dermatologist 15 minutes after the removal of each patch to compare the presence of comedones before and after each product application.

Result

Bio‑Oil® Skincare Oil (Natural) was found to be non-comedogenic. The area to which Bio‑Oil® Skincare Oil (Natural) was applied showed no significant difference to the negative control area. The positive control induced acne.

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 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.

Use in conjunction with a skincare routine

For maximum absorption, Bio‑Oil® Skincare Oil (Natural) should be applied to cleansed skin. Mixing Bio‑Oil® Skincare Oil (Natural) with other products to ‘make it go further’ may negatively affect its efficacy. 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 during pregnancy

Bio‑Oil® Skincare Oil (Natural) is safe to use during pregnancy.

Vitamin A and pregnancy

Women are usually recommended to limit vitamin A nutritional supplements during pregnancy and therefore may have concerns around using skincare products with vitamin A. Any substance applied to the skin is only harmful if it is present at levels above its toxicological threshold. Because the skin provides a significant barrier to penetration, only a fraction of topically applied vitamin A enters the body. The European Commission’s Scientific Committee on Consumer Safety (SCCS) has evaluated vitamin A and its esters, when used as cosmetic ingredients. The SCCS opinion is that the use of vitamin A in body lotions, up to the maximum concentration of 0.05% of retinol equivalent, is safe. The vitamin A present in the Bio‑Oil® Skincare Oil (Natural) formulation, by virtue of its presence in rosehip oil, is at a level well below this maximum allowable concentration for a body lotion. Bio‑Oil® Skincare Oil (Natural) can be used safely throughout pregnancy. By including vitamin A at a low level, Bio‑Oil® Skincare Oil (Natural) provides pregnant women with the benefits of vitamin A without any safety risk.

Rosemary oil and pregnancy

Rosemary oil in high concentrations has been found to be an emmenagogue, meaning it has the ability to provoke menstruation and possibly induce early labour. This is why aromatherapists and herbalists who use rosemary oil in high concentrations, recommend against using it during pregnancy. However, the concentration of rosemary oil in Bio‑Oil® Skincare Oil (Natural) is very low and therefore safe to use during pregnancy.

Use while breastfeeding

Bio‑Oil® Skincare Oil (Natural) is safe for use on the body while breastfeeding, but it is suggested to avoid application on the nipples. Although no harmful effects are likely, young babies are very sensitive and should not ingest Bio‑Oil® Skincare Oil (Natural), even in very small amounts.

Use on babies and children

The safety of using Bio‑Oil® Skincare Oil (Natural) on children under the age of three has not been assessed. In the first few years after birth, many changes take place in the human body, including the development of the immune system. It is therefore recommended that it is only used on children of three years of age or older. The product should be applied with care to children and should not be used near the eyes or mouth.

Use in the sun

Tests conducted on Bio‑Oil® Skincare Oil (Natural) show that the product does not potentiate or exacerbate sunburn. It is therefore safe to use in the sun, however the product offers no protection against the harmful effects of the sun’s UVA and UVB rays and it is therefore important to use the product in conjunction with a broad-spectrum sunscreen with a sun protection factor (SPF) of at least 30.

Use on or near mucosal membranes

Bio‑Oil® Skincare Oil (Natural) has been classified as safe for all uses, except for contact with mucosal membranes.

Use in conjunction with radiotherapy or chemotherapy

Bio‑Oil® Skincare Oil (Natural) is a cosmetic product. It is advisable for people undergoing radiotherapy or chemotherapy treatment to seek the advice of a medical practitioner before using the product.

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.

Use on oily skin

Bio‑Oil® Skincare Oil (Natural) can be used on oily skin. In a trial conducted on 20 participants aged 18–65 with acne prone skin, Bio‑Oil® Skincare Oil (Natural) was found to be non-comedogenic.

Use on acne-prone skin

Bio‑Oil® Skincare Oil (Natural) can be used on acne-prone skin. In a trial conducted on 20 participants aged 18–65 with acne prone skin, Bio‑Oil® Skincare Oil (Natural) was found to be non-comedogenic. It is advisable for people suffering from acne to seek the advice of a medical practitioner before using Bio‑Oil® Skincare Oil (Natural).

SAFETY ASSESSMENT

Bio‑Oil® Skincare Oil (Natural) has undergone a safety assessment by a qualified toxicologist and has been classified as safe for its intended use by adults, including pregnant and lactating women, and children over three years old.

ADVERSE REACTIONS

While Bio‑Oil® Skincare Oil (Natural) has a safe toxicological profile and meets international regulations in this respect, as with all cosmetic products, there exists a risk that Bio‑Oil® Skincare Oil (Natural) users may encounter an adverse reaction when using the product. If an adverse reaction occurs, use of the product should be discontinued immediately. Symptoms of an adverse skin reaction can include rashes, swelling and inflammation, which would typically occur in the area to which the product was applied. These reactions may be accompanied by itchiness and slight discomfort. In most cases, adverse reactions will subside within two to three days after use of the product has been discontinued. Until it has returned to its original condition, the skin may appear dry and flaky as the reaction subsides. If there is any concern regarding a potential allergic response to the application of Bio‑Oil® Skincare Oil (Natural), it is wise to carry out a simple allergy test to check this. This is done by applying a small amount of the product to the inner forearm and waiting for a period of 24 hours to see if any reaction occurs. A perceptible reddening of the skin (erythema) or slight swelling of the skin (oedema) may indicate the potential for an allergic response.

ACCIDENTAL INGESTION

In the event of the accidental ingestion of Bio‑Oil® Skincare Oil (Natural), it is unlikely that any adverse effects beyond feelings of nausea and diarrhoea will be experienced because Bio‑Oil® Skincare Oil (Natural) is not toxic. However, it is recommended to seek medical advice, especially in the case of accidental ingestion by an infant or child.

PERIOD AFTER OPENING (PAO)

Bio‑Oil® Skincare Oil (Natural) has a PAO of 12 months. This is the period of time after opening for which the product is safe and can be used without any harm to the consumer.

MANUFACTURE

The manufacture of Bio‑Oil® Skincare Oil (Natural) conforms to the Good Manufacturing Practice (GMP) requirements of ISO 22716:2007 for cosmetic products. All raw materials used in the manufacture of Bio‑Oil® Skincare Oil (Natural) are accompanied by a Certificate of Analysis (COA), and all packaging materials are accompanied by a Certificate of Conformance (COC). 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.

NOT TESTED ON ANIMALS

Bio‑Oil® Skincare Oil (Natural) and its constituent raw materials are manufactured in compliance with EU regulations pertaining to animal testing for cosmetic purposes. Neither Bio‑Oil® Skincare Oil (Natural), nor any of its ingredients, are tested on animals by either Bio‑Oil or any of its raw material suppliers.

VEGAN

Bio‑Oil® Skincare Oil (Natural) does not contain any animal-derived ingredients.

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