PRODUCT NAME AND SIZES
Dry Skin Gel 50ml
Dry Skin Gel 100ml
Dry Skin Gel 200ml
Significantly increases skin moisturisation.
Orange / pink gel.
Gel with 84% occlusive ingredients, 13% humectants and 3% water.
Paraffinum Liquidum, Isopropyl Palmitate, Triisononanoin, Glycerin, Cetearyl Ethylhexanoate, Isopropyl Myristate, Aqua, Caprylic / Capric Triglyceride, Isostearyl Isostearate, C26-28 Alkyl Dimethicone, Butyrospermum Parkii Butter, Sodium Lactate, Urea, Gluconolactone, Sodium PCA, Sodium Hyaluronate, Octyldodecyl PCA, Sucrose Laurate, Sucrose Stearate, Lactic Acid, Lanolin, Butylene Glycol, Dimethicone / Vinyl Dimethicone Crosspolymer, Bisabolol, Helianthus Annuus Seed Oil, Silica, Glycine Soja Oil, Retinyl Palmitate, Tocopheryl Acetate, Niacinamide, Linoleic Acid, Linolenic Acid, Tocopherol, Anthemis Nobilis Flower Oil, Calendula Officinalis Extract, Rosmarinus Officinalis Leaf Oil, Lavandula Angustifolia Oil, Parfum, Farnesol, Limonene, Linalool, CI 17200.
There are three allergens in Bio‑Oil® Dry Skin Gel. As with most allergens, these are present in the plant oils and the fragrance. They are: Farnesol, Limonene, and Linalool.
Bio‑Oil® Dry Skin Gel 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® Dry Skin Gel in improving skin moisturisation. Sample Subjects: 40 healthy females with Fitzpatrick skin types II-V and clinically showing dry / very dry skin (grade II-IV) at the level of the outer lower legs, and Corneometer values of less than 40 at enrolment. Test site: test product applied to one entire lower leg of all subjects. Age of participants: 40–65. Methodology Split-body, evaluator-blinded, randomised and controlled clinical-instrumental study. Subjects participated in an initial screening evaluation followed by a 7-day dry down period, a 28-day treatment period and a 3-day follow up period (regression). During the dry down period, and throughout the study, subjects washed their legs twice daily with Dove Beauty Bar. Bio‑Oil® Dry Skin Gel was then applied twice daily to the assigned lower leg, the opposite leg remained untreated. Clinical assessments and instrumental evaluations were conducted at screening, baseline and on days 1, 3, 6, 8, 10, 14, 21, 28, 29, 30 and 31. The control untreated site was also evaluated at all time points. The assessment was as follows: participants 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. Result Bio‑Oil® Dry Skin Gel determined a statistically significant improvement in skin moisturisation, barrier function and the appearance of dry skin (clinical grading of dryness) at each experimental monitored check, both compared to baseline values and to the untreated (control) area. For clinical grading of dryness, statistically significant improvements were evident in 62% of participants from day 1, and greater than 85% of participants from day 3 onwards. From day 21, 100% of participants showed an improvement. At day 28 participants showed over 3.5 times the improvement in clinical grading score 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 more than double that at day 1. Similarly, after 28 days of use 82% of participants showed a significant decrease in TEWL, with the extent of the improvement more than 5.5 times that of day 1. The effectiveness of Bio‑Oil® Dry Skin Gel in improving skin moisturisation, barrier function and the appearance of dry skin was also confirmed in the 3 days of follow-up, when product use had been discontinued.
SENSITIVE SKIN TEST
Trial centre Complife Italia S.r.l, Italy. Objective To assess the potential of Bio‑Oil® Dry Skin Gel to cause skin irritation. Sample Subjects: 30 participants; 28 female and 2 male, all with sensitive skin according to the lactic acid stinging test. Age of participants: 18–70. Methodology Controlled study. Two areas were evaluated: an area to which a negative control was applied (demineralised water) and an area to which Bio‑Oil® Dry Skin Gel was applied. Test products were applied to participants’ back region 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® Dry Skin Gel was deemed ‘non-irritating’.
Trial centre Complife Italia S.r.l, Italy. Objective To assess the comedogenic potential of Bio‑Oil® Dry Skin Gel. Sample Subjects: 20 participants; 18 female and 2 male, 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® Dry Skin Gel) 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® Dry Skin Gel was found to be non-comedogenic. The area to which Bio‑Oil® Dry Skin Gel was applied showed no significant difference to the negative control area. The positive control induced acne.
Trial centre Rigano Laboratories, Milan, Italy. Objective To experimentally determine the occlusivity of Bio‑Oil® Dry Skin Gel and thereby its ability to help the skin to retain moisture by reducing TEWL. 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. Product was applied to the membrane and the rate of water loss from the beakers was measured over time. This was compared with the rate of water loss from control beakers, without any product on the membrane. Result The water vapour transmission rate (WVTR) test methodology is a standard test for measuring the occlusivity of products. A reduction in the WVTR value indicates that a particular formulation is occlusive. Bio‑Oil® Dry Skin Gel was shown to reduce the WVTR values statistically compared to the untreated control when applied to the Vitro-Skin™ membrane. This in vitro result suggests that Bio‑Oil® Dry Skin Gel will help the skin to retain moisture in vivo and thereby help relieve the signs and symptoms of dry skin.
Application directions Apply Bio‑Oil® Dry Skin Gel to dry skin as required. In the case of persistent dry skin, apply twice daily, morning and evening. For best results, the product should be applied to cleansed skin after showering or bathing. If applying other products, do so once Bio‑Oil® Dry Skin Gel has been completely absorbed into the skin. Bio‑Oil® Dry Skin Gel was specifically formulated for the body, it may however be used on the face. Application precautions Bio‑Oil® Dry Skin Gel is intended for topical cosmetic application only. The product should not be applied to an open wound or broken skin. Avoid contact with eyes. If product gets into eyes, rinse thoroughly with water. Keep out of reach of children. Application quantity When applying dry skin creams, lotions and butters, a large quantity needs to be applied as these products are predominantly water, which evaporates when coming into contact with skin. As Bio‑Oil® Dry Skin Gel is 84% oils, butters and waxes, substantially less product needs to be used to cover the same body area. Use during pregnancy Bio‑Oil® Dry Skin Gel is safe for 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® Dry Skin Gel formulation is at a level well below this maximum allowable concentration for a body lotion and can be used safely throughout pregnancy. 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® Dry Skin Gel is very low and therefore safe to use during pregnancy. Use while breastfeeding Bio‑Oil® Dry Skin Gel is safe for use 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® Dry Skin Gel. Use on babies and children The safety of using Bio‑Oil® Dry Skin Gel 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® Dry Skin Gel 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® Dry Skin Gel 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® Dry Skin Gel 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 with medical conditions Although Bio‑Oil® Dry Skin Gel can offer symptom relief from medical conditions, such as dermatitis, eczema, psoriasis and heat rash, it is advisable for people with these conditions to seek the advice of a medical practitioner before using the product. Use on sensitive skin Bio‑Oil® Dry Skin Gel can be used on sensitive skin. In a skin irritation study conducted on 30 participants aged 18 to 70 with sensitive skin, no subjects experienced any adverse reactions to Bio‑Oil® Dry Skin Gel. Use on oily skin Bio‑Oil® Dry Skin Gel can be used on oily skin. In a trial conducted on 20 participants aged 18–65 with acne-prone skin, Bio‑Oil® Dry Skin Gel was found to be non-comedogenic. Use on acne-prone skin Bio‑Oil® Dry Skin Gel can be used on acne-prone skin. In a trial conducted on 20 participants aged 18–65 with acne prone skin, Bio‑Oil® Dry Skin Gel 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® Dry Skin Gel.
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® Dry Skin Gel 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® Dry Skin Gel 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® Dry Skin Gel 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® Dry Skin Gel 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. No harmful emissions, hazardous waste or wastewater is generated in the production of Bio‑Oil® Dry Skin Gel.
Bio‑Oil® Dry Skin Gel should be stored in a cool place, out of direct sunlight.
All Bio‑Oil® Dry Skin Gel packaging (tub, lid, label and carton) is recyclable.
PERIOD AFTER OPENING (PAO)
Bio‑Oil® Dry Skin Gel 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® Dry Skin Gel is certified Halaal and Kosher.
While Bio‑Oil® Dry Skin Gel has a safe toxicological profile and meets international regulations in this respect, as with all cosmetic products, there exists a risk that Bio‑Oil® Dry Skin Gel 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® Dry Skin Gel, 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® Dry Skin Gel and its constituent raw materials are manufactured in compliance with EU regulations pertaining to animal testing for cosmetic purposes. Neither Bio‑Oil® Dry Skin Gel, nor any of its ingredients, are tested on animals by either Bio‑Oil or any of its raw material suppliers.
Bio‑Oil® Dry Skin Gel contains lanolin, which is a wax extracted from sheep’s wool. As such, Bio‑Oil® Dry Skin Gel is not vegan.
In the event of the accidental ingestion of Bio‑Oil® Dry Skin Gel, it is unlikely that any adverse effects beyond feelings of nausea and diarrhoea will be experienced because Bio‑Oil® Dry Skin Gel 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
There are two conditions under which the appearance of Bio‑Oil® Dry Skin Gel may change. The first condition occurs when the gel is exposed to extreme high or low temperatures for extended periods; extreme elevated temperatures dehydrate the surface of the gel, this is exaggerated when the container is left open. In contrast, extreme low temperatures can cause freezing. Both events may give the gel a white appearance. The second condition occurs when water, or another liquid, is introduced into the jar during use. The liquid will interact with the emulsifier in the formulation and initiate the emulsifying process, causing the gel to turn white and the consistency to change.
DATE LAST UPDATED
22 August 2023