Bio-Oil

BRAND NAME

Bio‑Oil®

PRODUCT NAME AND SIZES

Skincare Oil 25 ml

Skincare Oil 60 ml

Skincare Oil 125 ml

Skincare Oil 200 ml

DESCRIPTION

A 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

Orange / pink oil.

INGREDIENTS

Paraffinum Liquidum, Triisononanoin, Cetearyl Ethylhexanoate, Isopropyl Myristate, Tocopheryl Acetate, Bisabolol, Parfum, Retinyl Palmitate, Helianthus Annuus Seed Oil, Tocopherol, Anthemis Nobilis Flower Oil, Lavandula Angustifolia Oil, Rosmarinus Officinalis Leaf Oil, Calendula Officinalis Extract, Glycine Soja Oil, CI 26100, Alpha-Isomethyl Ionone, Amyl Cinnamal, Benzyl Salicylate, Citronellol, Coumarin, Eugenol, Farnesol, Geraniol, Hydroxycitronellal, Limonene, Linalool.

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 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: 67 female participants of various Fitzpatrick skin types with clinically determined mild to moderate photodamage on the face and neck. Bio‑Oil® Skincare Oil treatment cell included 35 subjects and the untreated cell included 32 subjects. Age of participants: 30–70.

Methodology

Result

Bio‑Oil® Skincare Oil is efficacious in improving the appearance of uneven skin tone and mottled pigmentation in photodamaged (ageing) skin. After 4 weeks a statistically significant result was achieved for both parameters on the face and neck. After 12 weeks, 86% of subjects in the Bio‑Oil® Skincare Oil treatment cell showed a statistically significant improvement in uneven skin tone on the face, 71% of subjects in mottled pigmentation on the face, 69% in uneven skin tone on the neck and 60% in mottled pigmentation on the neck.

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

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, mottled pigmentation, uneven skin tone, 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 treatment cell 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.

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

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

Result

After immediate application, both oils reduced transepidermal water loss (TEWL) compared to the untreated control. 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.

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 untreated 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 untreated control. Bio‑Oil® Skincare Oil was statistically superior on day 3. Significant improvements in visual appearance of skin sites treated 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 treated 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 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 to cause skin irritation.

Sample

Subjects: 25 participants; 19 female and 6 male, all with sensitive skin according to lactic acid stinging test. Age of participants: 18–70.

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 (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 was deemed ‘non-irritating’.

NON-COMEDOGENIC TEST

Trial centre

Complife Italia S.r.l, Italy.

Objective

To test whether Bio‑Oil® Skincare Oil 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

Randomised and 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) 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 was found to be non-comedogenic. The area to which Bio‑Oil® Skincare Oil 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.

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.

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.

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.

How long to use

Bio‑Oil® Skincare Oil’s various clinical trials 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.

Use in conjunction with a skincare routine

For maximum absorption, Bio‑Oil® Skincare Oil should be applied to cleansed skin. Mixing Bio‑Oil® Skincare Oil 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 has been completely absorbed into the skin. For all over body use, apply Bio‑Oil® Skincare Oil after showering or bathing.

Use during pregnancy

Bio‑Oil® Skincare Oil 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. Bio‑Oil® Skincare Oil includes vitamin A in its formulation at well below this maximum allowable concentration for a body lotion and can be used safely throughout pregnancy. By including vitamin A at a low level, Bio‑Oil® Skincare Oil 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 is very low and therefore safe to use during pregnancy.

Use while breastfeeding

Bio‑Oil® Skincare Oil 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, even in very small amounts.

Use on babies and children

The safety of using Bio‑Oil® Skincare Oil 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 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 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 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 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.

Use on oily skin

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

Use on acne-prone skin

Bio‑Oil® Skincare Oil 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 was found to be non-comedogenic.

SAFETY ASSESSMENT

Bio‑Oil® Skincare Oil 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 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 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, 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.

ALLERGENS

As with most allergens, these are present in the plant oils and the fragrance. They are: Alpha-Isomethyl Ionone, Amyl Cinnamal, Benzyl Salicylate, Citronellol, Coumarin, Eugenol, Farnesol, Geraniol, Hydroxycitronellal, Limonene, and Linalool.

ACCIDENTAL INGESTION

In the event of the accidental ingestion of Bio‑Oil® Skincare Oil, it is unlikely that any adverse effects beyond feelings of nausea and diarrhoea will be experienced because Bio‑Oil® Skincare Oil 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 has a PAO of 36 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 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 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 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.

NOT TESTED ON ANIMALS

Bio‑Oil® Skincare Oil and its constituent raw materials are manufactured in compliance with EU regulations pertaining to animal testing for cosmetic purposes. Neither Bio‑Oil® Skincare Oil, 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 does not contain any animal-derived ingredients.

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