PRODUCT NAME AND SIZES
Body Lotion 175ml
Body Lotion 250ml
Significantly increases skin moisturisation.
Lotion with 42% occlusive ingredients and 14% humectants.
Aqua, Dimethicone, Isopropyl Palmitate, Ethylhexyl Cocoate, Isododecane, Isopropyl Myristate, Urea, Polyglyceryl-2 Dipolyhydroxystearate, Glycerin, Pentylene Glycol, Dicaprylyl Carbonate, Polyglyceryl-3 Diisostearate, Sodium Lactate, Dipentaerythrityl Hexacaprylate / Hexacaprate, Gluconolactone, Rosa Canina Fruit Oil, Simmondsia Chinensis Seed Oil, Calendula Officinalis Extract, Butyrospermum Parkii Oil, Helianthus Annuus Seed Oil, Glycine Soja Oil, Isostearyl Isostearate, Bisabolol, Octyldodecyl PCA, Retinyl Palmitate, Tocopheryl Acetate, Linoleic Acid, Linolenic Acid, Tocopherol, Sodium PCA, Sodium Hyaluronate, Lactic Acid, Stearalkonium Hectorite, Propylene Carbonate.
Bio‑Oil® Body Lotion 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.
DRY SKIN CLINICAL TRIAL
Trial centre Complife Italia S.r.l, Italy. Objective A clinical evaluation to test the efficacy of Bio‑Oil® Body Lotion in improving skin moisturisation. Sample Subjects: 30 healthy female participants with Fitzpatrick skin types II-V and clinically showing dry / very dry skin at the level of the outer lower legs. Test site: test product applied to an outer, lower leg of all subjects. Age of participants: 25–65. Methodology Split body, evaluator-blinded, randomised and controlled clinical-instrumental study. Participants washed their legs with soap to induce dry skin over a 7-day period. Baseline clinical and instrumental evaluations were taken. Bio‑Oil® Body Lotion was applied twice daily for 28 days to the assigned lower lateral leg, the opposite leg remained untreated. Clinical assessments and instrumental evaluations were conducted on days 1, 3, 6, 8, 10, 14, 21 and 28. The control untreated site was also evaluated at all time points. Subjects were clinically graded for dryness (on a scale from 0–5) by a trained visual evaluator. Quantitative measurement of skin hydration was by Corneometer. Quantitative measurement of transepidermal water loss (TEWL) as an indicator of barrier function, was by Tewameter. Additionally, a self-assessment questionnaire was completed on days 8 and 14. Result Compared to the untreated area, treatment with Bio‑Oil® Body Lotion resulted in a statistically significant improvement in clinical grading of dryness, Tewameter and Corneometer measurements, from as early as day 1, and at all time points. For clinical grading of dryness, statistically significant improvements were evident in 96.7% of participants from day 14 onwards, almost double the improvement noted at day 1. After 28 days of use, 100% of participants showed a significant increase in skin moisturisation, with the extent of the improvement almost 4 times that at day 1. Similarly, after 28 days of use 100% of participants showed a significant decrease in TEWL, with the extent of the improvement more than double that at day 1. These findings are supported by the results of the self-assessment questionnaire.
DRY SKIN USER TRIAL
Trial centre Ayton Global Research, United Kingdom. Objective To assess the performance of Bio‑Oil® Body Lotion as a body moisturiser. Sample Subjects: 119 female participants in good health. Age of participants: 25–65. Methodology A 2-week, single-placement, in-home user trial. Participants were instructed to apply product twice daily, morning and evening. Massage into skin until fully absorbed. Three short questionnaires were completed: the first after initial application, the second after 12 hours, and the third after 2 weeks of using the product. Result Application: 95% of participants agreed that ‘the product is lighter than any moisturiser they have used before’. 93% of participants agreed that ‘the product spreads more easily than any moisturiser they have used before’. Absorption: 82% of participants agreed that ‘the product absorbs more easily than any moisturiser they have used before’. 75% of participants agreed that ‘the product absorbs quicker than any moisturiser they have used before’. 74% of participants agreed that ‘the product leaves no greasy residue after application’. 86% of participants agreed that ‘after applying the product they were able to get dressed immediately’. Hydration: 93% of participants agreed that ‘the product leaves skin feeling immediately moisturised’. 92% of the participants agreed that ‘after applying the product their skin feels smooth and silky’. 90% of participants agreed that ‘their skin felt moisturised the entire day’ and 91% agreed that ‘their skin feels smooth and silky the entire day’. 92% of participants agreed that ‘their skin looks better than it did at the beginning of the 2-week period’. Overall: 73% of participants agreed that ‘the product is better than any moisturiser they have used before’.
SENSITIVE SKIN TEST
Trial centre Complife Italia S.r.l, Italy. Objective To assess the potential of Bio‑Oil® Body Lotion to cause skin irritation. Sample Subjects: 25 participants; 3 male and 22 female, 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® Body Lotion was applied. Test products were applied to the back region of participants, in contact with the skin surface, 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® Body Lotion was deemed ‘non-irritating’.
Trial centre Complife Italia S.r.l, Italy. Objective To assess the comedogenic potential of Bio‑Oil® Body Lotion. Sample Subjects: 20 participants; 14 female and 6 male of varying ethnicities 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® Body Lotion) 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® Body Lotion was found to be non-comedogenic. The area to which Bio‑Oil® Body Lotion was applied showed no significant difference to the negative control area. The positive control induced acne.
Trial centre Union Swiss, South Africa. Objective An internal study to assess the dynamic viscosity of Bio‑Oil® Body Lotion compared to similar moisturising products. Sample Comparison of Bio‑Oil® Body Lotion to 13 moisturising products manufactured by 10 global brands with an established history in moisturisation. Methodology Dynamic viscosity was read using an Anton Paar RheoLab QC rheometer, using spindle CC 39, speed: 200 rpm at 20˚C, shear rate: 155. Result Bio‑Oil® Body Lotion was found to have a 7.5 times lower dynamic viscosity than the average of the competitor products (94 mPa.s vs. 707 mPa.s respectively), indicating a thinner, lighter fluid that’s more easily and rapidly absorbed.
How to apply Bio‑Oil® Body Lotion should be massaged in a circular motion on the body until fully absorbed. It is recommended that Bio‑Oil® Body Lotion be applied twice daily, morning and evening. Bio‑Oil® Body Lotion should not be applied to an open wound or broken skin. It is intended for topical cosmetic application only. Shake before use Bio‑Oil® Body Lotion is an emulsion in which the water and oil are very lightly bound together. So lightly, that when left standing some of the oils rise to the surface of the product forming a thin layer. By gently shaking the product before use, the oil layer disperses back into the lotion. Layer formation can take anywhere from three days to three weeks and is dependent on factors such as temperature, how vigorously and how frequently the bottle has been shaken. The mere act of using the product daily, turning the bottle upside down when dispensing, is more than sufficient to ensure that this oil layer does not form. If an oil layer has formed and the product is dispensed without shaking, a clear oil mixture may flow from the bottle. This is not a consumer safety risk. How long to use Bio‑Oil® Body Lotion’s clinical trial has been performed over a four-week period, 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 24 hours and that this improvement is maintained for the duration of the trial. Bio‑Oil® Body Lotion may however be used on an ongoing basis for its moisturising and skin-nourishing properties, making it a part of a daily skincare routine. Use in conjunction with a skincare routine For maximum absorption, Bio‑Oil® Body Lotion should be applied to cleansed skin after showering or bathing. If applying a sun protection lotion or other cream only do so once Bio‑Oil® Body Lotion has been completely absorbed into the skin. Use during pregnancy Bio‑Oil® Body Lotion 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® Body Lotion formulation is at a level well below this maximum allowable concentration for a body lotion and can be used safely throughout pregnancy. Use while breastfeeding Bio‑Oil® Body Lotion 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® Body Lotion, even in very small amounts. Use on babies and children The safety of using Bio‑Oil® Body Lotion 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. Use in the sun Tests conducted on Bio‑Oil® Body Lotion 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® Body Lotion has been classified as safe for all uses, however its safety has not been tested for contact with mucosal membranes as this is not a reasonably foreseeable use of the product. Use in conjunction with radiotherapy or chemotherapy Although Bio‑Oil® Body Lotion 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® Body Lotion 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® Body Lotion can be used on sensitive skin. In a skin irritation study conducted on 25 participants aged 18–70 years old with sensitive skin, no subjects experienced any adverse reactions to the formulation. Use on oily skin Bio‑Oil® Body Lotion can be used on oily skin. In a trial conducted on 20 participants aged 18–65 years old with acne prone skin, Bio‑Oil® Body Lotion was found to be non-comedogenic. Use on acne-prone skin Bio‑Oil® Body Lotion can be used on acne-prone skin. In a trial conducted on 20 participants aged 18–65 with acne prone skin, Bio‑Oil® Body Lotion 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® Body Lotion.
DRY SKIN SYMPTOMS AND CAUSES
Symptoms Symptoms of dry skin include dull and flaky skin, fine lines, grey or ashy coloured skin and the feeling of roughness and tightness. Causes Dry skin is caused by both external and internal factors. External factors: Dry climates cause moisture to be drawn from inside the skin, through the lipid bilayer and into the dry outside air. Air conditioners and heaters draw moisture out of the air, creating an artificially dry climate that draws moisture out of the skin. Everyday washing and exposure to harsh detergents cause the skin’s lipid bilayer to be stripped, making it easier for moisture to escape from the skin. Internal factors: As the body ages, the skin produces fewer lipids causing the lipid bilayer to thin and making it easier for moisture to escape. Genetics can play a role in the development of dry skin due to naturally occurring lower levels of ceramides in the lipid bilayer. This results in reduced occlusivity of the skin barrier, contributing to above normal levels of moisture loss. The pH of the skin influences the barrier function. A higher pH level in the skin impairs the healthy functioning of the lipid bilayer.
The manufacture of Bio‑Oil® Body Lotion 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® Body Lotion 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® Body Lotion 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. The filling and packing of Bio‑Oil® Body Lotion is 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. No harmful emissions, hazardous waste or wastewater is generated in the production of Bio‑Oil® Body Lotion.
Bio‑Oil® Body Lotion should be stored in a cool place, out of direct sunlight.
All Bio‑Oil® Body Lotion packaging (bottle, cap and carton) is recyclable.
PERIOD AFTER OPENING (PAO)
Bio‑Oil® Body Lotion 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.
Bio‑Oil® Body Lotion is certified Halaal and Kosher.
While Bio‑Oil® Body Lotion has a safe toxicological profile and meets international regulations in this respect, as with all cosmetic products, there exists a risk that Bio‑Oil® Body Lotion 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® Body Lotion, it is wise to carry out a simple allergy test to check this. This is done by applying a small amount of Bio‑Oil® Body Lotion 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® Body Lotion and its constituent raw materials are manufactured in compliance with EU regulations pertaining to animal testing for cosmetic purposes. Neither Bio‑Oil® Body Lotion, nor any of its ingredients, are tested on animals by either Bio‑Oil or any of its raw material suppliers.
Bio‑Oil® Body Lotion does not contain any animal-derived ingredients.
In the event of the accidental ingestion of Bio‑Oil® Body Lotion, it is unlikely that any adverse effects beyond feelings of nausea and diarrhoea will be experienced because Bio‑Oil® Body Lotion 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® Body Lotion contains calendula extract and essential oils, as well as vitamin A palmitate, all of which are light sensitive. Exposure to sunlight may cause a change in colour over time. Bio‑Oil® Body Lotion should be stored out of direct sunlight.
DATE LAST UPDATED
22 August 2023