BRAND NAME

Bio‑Oil®


PRODUCT NAME AND SIZES

Skincare Oil 25ml
Skincare Oil 60ml
Skincare Oil 125ml
Skincare Oil 200ml


INDICATIONS

Scars Helps improve the appearance of new and old scars. Stretch marks Helps improve the appearance of stretch marks. Also helps improve skin elasticity, thereby reducing the possibility of stretch marks forming. Uneven skin tone Helps improve the appearance of uneven skin tone. Ageing skin Helps improve the appearance of ageing skin on the face and body. Dehydrated skin Helps reduce moisture loss and improve the appearance of dehydrated skin.


PRESENTATION

Orange / pink oil.


FORMULATION

Specialist oil mixture with vitamins and plant extracts.


INGREDIENTS

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


ALLERGENS

There are 11 allergens in Bio‑Oil® Skincare Oil. 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.


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.


SCAR 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 scars. Sample Subjects: 36 female participants of various Fitzpatrick skin types. Scar ages: newly formed to 3 years old. Scar 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 scars or a scar large enough to allow a half-half scar 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 scar parameters as defined in the Patient and Observer Scar Assessment Scale (POSAS) were evaluated. Result Bio‑Oil® Skincare Oil is efficacious in improving the appearance of scars. 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.


ACNE SCAR STUDY

Trial centre Dept. of Dermatology, Peking University First Hospital, Beijing, China. Objective An exploratory study to assess the efficacy of Bio‑Oil® Skincare Oil in improving the appearance of facial acne scars on Chinese subjects. Sample Subjects: 44 Chinese subjects with newly formed acne scars on the face (<1 year old). Bio‑Oil® Skincare Oil treatment cell included 32 subjects and the untreated cell included 12 subjects. Age of participants: 14–30. Methodology Randomised, controlled, efficacy grader-blinded study. Subjects participated in an initial screening evaluation followed by a 1-week washout period. Product applied twice daily for 10 weeks. Application performed under supervision at regular intervals. Assessments conducted at 0, 4, 8 and 10 weeks included the following: Global scarring score (GSS) assessment by the investigator, measurement of acne scar colour / redness using a chromameter, measurement of sebum levels using a sebumeter, documentation of number of comedones and inflammatory lesions by a dermatologist. Subjects also completed self-assessment questionnaires at each visit. Result The best result of the clinical grading was in Bio‑Oil® Skincare Oil’s ability to reduce the erythema or redness of macular (flat) acne scars, with the overall skin becoming brighter. Results of the self-assessment questionnaire showed that more than 84% of subjects experienced an improvement in the overall condition of their acne scars and more than 90% experienced an improvement in scar colour. Acne count and sebum measurement results showed that using Bio‑Oil® Skincare Oil does not cause or aggravate acne or increase sebum secretion.


STRETCH 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 stretch marks. Sample Subjects: 38 female participants of various Fitzpatrick skin types. Stretch mark causes: various (post pregnancy, weight gain or adolescent growth spurt). Stretch mark locations: abdomen, thighs and hips. Age of participants: 18–65. Methodology Double-blind, randomised and placebo-controlled study. Subjects had matching stretch marks or stretch marks large enough to allow a half-half stretch mark application and intra-subject comparison. Product was 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 scar parameters as defined in the Patient and Observer Scar Assessment Scale (POSAS) were evaluated. Result Bio‑Oil® Skincare Oil is efficacious in improving the appearance of stretch marks. A statistically significant result was achieved after only 2 weeks (day 15), evident in 95% of the subjects. After 8 weeks (day 57), 100% of subjects showed an improvement, with the extent of the improvement more than double that at 2 weeks. A continuous improvement of POSAS over the duration of the study.


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 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 baseline visit. Clinical evaluations conducted at 0, 2, 4, 8 and 12 weeks. Subjects were clinically graded separately on the face and neck for uneven skin tone and mottled pigmentation. 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.


AGEING SKIN 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 (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 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 (ageing) 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 (ageing) 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 treatment cell included 35 subjects and the untreated cell 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 (ageing) 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) barrier function and hydration. Sample Subjects: 40 female participants of various Fitzpatrick skin types. Test site: test products applied to the volar forearm of all subjects. 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 Caucasian participants. Test site: test products applied to the outer, lower leg of all subjects. 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.


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 lactic acid stinging test. 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 (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 No subjects experienced any adverse reactions to the test product, with a visual score of 0 (zero) recorded for all subjects at all timepoints. 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. 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. 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. It is safe to use on a scar as soon as the skin on the surface has fully healed. Results will vary from individual to individual. 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. 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 Pregnancy stretch marks can appear anywhere on the body, but are most likely to appear on the abdomen, thighs, hips, lower back, buttocks and breasts. To help prevent the formation of pregnancy stretch marks it is recommended that Bio‑Oil® Skincare Oil be applied to these areas twice a day, from the start of the first trimester until after birth. Regularly applied Bio‑Oil® Skincare Oil will also provide active relief to itchy and dehydrated skin, associated with pruritis gravidarum. It can also be used for uneven skin tone that results from hormonal fluctuations that occur 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 Although Bio‑Oil® Skincare Oil does not contain any ingredients that can absorb radiation 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. In an acne scar study conducted on 44 subjects aged 14–30 with newly formed acne scars on the face; acne count and sebum measurement results showed that using Bio‑Oil® Skincare Oil does not cause or aggravate acne or increase sebum secretion. It is however advisable for people suffering from acne to seek the advice of a medical practitioner before using Bio‑Oil® Skincare Oil.


SCAR FORMATION

A scar is the growth of collagen which forms as a natural part of the healing process following injury to the skin. Collagen is made up of naturally occurring proteins which form the main component of the body’s connective tissue. When an injury to the skin occurs, the body acts as quickly as possible to repair the affected area, with a focus on survival rather than perfect healing. The rapid overproduction of collagen in response to the injury is what creates scars. While a scar will go through numerous changes as it matures, it will never attain the normal strength of the surrounding skin. Hair follicles and sweat glands at the scar site will not grow back. Scar formation has the following four phases: Haemostatic phase This begins immediately after an injury occurs and lasts for a few hours, as the wounded area attempts to restore its normal state by constricting blood vessels to control bleeding. The injured cells simultaneously release certain proteins to activate clotting, thereby sealing off damaged vessels and reducing blood loss. Inflammatory phase The redness and swelling that appears for a period of three or four days after the initial trauma is a visible indicator of the immune response. White blood cells release chemicals that cleanse the wound of debris and bacteria. Proliferative phase This begins around day three and continues for about three weeks. Three different processes occur simultaneously in this phase to close and bind the wound: Granulation: fibroblasts (cells responsible for synthesising collagen) over proliferate at the site of the wound in order to quickly create collagen to fill the wound. Ephithelialisation: a layer of skin is created to cover the wound. Wound contraction: the wound is pulled together in an attempt to minimise the defect. Maturation phase This ‘remodelling’ phase begins after approximately three weeks and may continue for up to two years depending on the size and depth of the wound. During this time, collagen continues to build as the fibres are rearranged according to the stresses placed on the injury area, determining the final nature of the scar. While the scar covers and protects the site of the wound, it can easily be disrupted. Scar tissue generally exhibits 70% of the tensile strength of normal skin.


TYPES OF SCARS

Because individuals heal differently, the final appearance of a scar will vary from person to person. Factors like skin type, scar location, type of injury, age of the person and even nutritional status will play a role in determining what a scar will look like. Scar types can be divided into the following categories: Common scars These scars appear inflamed and dark in the beginning but become flatter and less noticeable over time resulting in a fine line scar. Atrophic scars These scars cause depressions or indentations below the surface of the skin. Examples are scars from acne or chickenpox. Hypertrophic scars These scars are raised above the surface of the skin. They are characterised by excessive amounts of collagen, but always remain within the boundaries of the original wound. Keloid scars Keloids should not be confused with hypertrophic scars. Although they are also raised scars, keloids are characterised by the fact that they spread beyond the boundaries of the original wound. They may continue to grow over time and usually recur after excision. Scar contractures A contracture scar occurs when the skin tightens permanently. They often develop when scars cross joints, or skin creases, at right angles. The scar tissue is resistant to stretching and can inhibit normal movement. Scar contractures often occur following burn injuries. Stretch marks (Striae) Stretch marks occur during periods of rapid changes in weight (e.g. teenage growth spurts, pregnancy) when the body expands faster than the skin covering it, causing internal tears in the skin tissue. When these tears repair themselves they form scars that are known as stretch marks.


STRETCH MARK FORMATION

In medical terms stretch marks, or striae, are simply another form of scarring, however, most people view them differently to scars. Striae are lines on the skin that develop in periods of rapid expansion of the skin, for example in pregnant women, body builders, and adolescents during their growth spurt. They are caused by exactly what their name suggests, stretching. Lighter-skinned people tend to develop pinkish stretch marks, whereas darker-skinned people tend to have stretch marks that are lighter than the surrounding skin. The skin is naturally elastic. This elasticity is provided by the collagen and elastin in the dermis, which underlies the skin tissue. Collagen is made up of a group of naturally occurring proteins and is a key component of the body’s connective tissue. Elastin, which is also made up of naturally occurring proteins, is also found in connective tissue and provides its elastic properties. This connective tissue enables the dermis to adapt to continuous movement of the body by expanding and contracting, but during periods of rapid weight gain it may have insufficient time to adjust, causing internal tears in the skin tissue. When these tears repair themselves they form the scars that we know as stretch marks. A useful analogy is that of a spring being stretched. If you stretch a spring within a certain range, known as its natural elastic limit, it contracts back to its original size time and again. However, if you overstretch the spring beyond its natural elastic limit, it becomes permanently stretched and will not spring back to its original size. Although stretch marks do not represent a significant medical problem, they can cause emotional distress to those who develop them. The likelihood of developing them varies according to skin type, age, heredity, diet and the hydration of the skin. The stages of stretch mark formation are as follows: Stage one Early stretch marks appear pale in colour and may also be itchy. The skin immediately around the stretch marks may also look ‘flattened’ and ‘thin’. Stage two Gradually the stretch marks will enlarge in length and width becoming darker and more pronounced. Stage three Once the stretch marks have matured and when the skin is no longer under tension they will start to fade and become paler. They may also appear slightly depressed and irregular in shape or length.


PREGNANCY STRETCH MARK FORMATION

It is estimated that between 50% and 90% of pregnant women are prone to stretch marks. Stretch marks can develop on the abdomen, thighs, hips, lower back, buttocks and breasts – areas where there is the greatest stretching of the skin as the body changes during pregnancy. While they can appear anywhere on the body, they are most likely to appear in places where large amounts of fat are stored. While stretch marks generally become visible during the later trimesters of pregnancy (around the sixth or seventh month) some women start to see stretch marks forming in the first trimester. Pregnancy stretch marks may also result from the priming of the skin for childbirth by increased levels of hormones. These hormones attract more water into the skin, which relaxes the bonds between collagen fibres. This makes it easier for the skin to tear when it is stretched and for stretch marks to form. The likelihood of developing stretch marks varies according to skin type, age, heredity, diet and hydration of the skin.


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. No harmful emissions, hazardous waste or wastewater is generated in the production of Bio‑Oil® Skincare Oil.


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.


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.


CERTIFICATIONS

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


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.


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.


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.


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.


DATE LAST UPDATED

22 August 2023