Pharmaceutical sciences
Cosmetics
Baby Care Products
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Development Team
Principal Investigator
Dr. Vijaya Khader
Former Dean, Acharya N G Ranga Agricultural University Prof. Farhan J Ahmad
Jamia Hamdard, New Delhi
Paper Coordinator Dr. Javed Ali
Jamia Hamdard, New Delhi
Content Writer Sana Khan
Jamia Hamdard, New Delhi
Content Reviewer Dr. Mohd. Aqil
Jamia Hamdard, New Delhi
Pharmaceutical sciences
Cosmetics
Baby Care Products
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CONTENT
1. Introduction
2. Anatomical differences between baby skin and adult skin 3. Classification of Baby Care Products
4. Desirable features of quality baby care products 5. Potential negative effects of baby care products 6. Formulation of Baby Care Products
7. Cleansing Products for Babies
8. Moisturizing and Protecting Products for Babies 9. Packaging of Baby Care Products
10. Chemicals to be avoided in baby cosmetics formulations 11. Evaluation and Safety assessment of Baby Care Products
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1. Introduction
Baby care products characterize a very distinctclass of products specially developed for gentle baby skin. Baby care products are primarily functional products,rather than decorative products, including baby skin care and hair care cleansingformulations as well as skin protecting products.
Due to the sensitivity and vulnerabilityof the baby skin, special considerations have to be taken into account.There are marked anatomical and physiological differences betweenbaby skin and adult skin.
Baby products are products intended to be used on infants and children under the age of three.
Baby products are specifically formulated to be mild and non-irritating and use ingredients that are selected for these properties as newborn skin care is a sensitive matter. In the current scenario,restriction of exposure of babies to harmful chemicals is the utmost matter of consideration as this can adversely affect the health of baby.
The newborn needs dye-free, fragrance-free baby skin care products. Babies, are being consistently exposed to different harmful chemicals which are present in baby care products such as baby creams, ointments, oils, shampoos and soaps. When these products are applied to baby skin, they get easily absorbed into the systemic circulation and can cause serious adverse effects to baby’s health. It is seen that a baby is ten times more susceptible to the harmful effect of chemicals as compared to adults.
Baby products include baby shampoos and baby lotions, oils, powders and creams. These products are used to moisturize, clean and soften the skin of infants and children. Adults that have sensitive skin or that are very sensitive to ordinary products may also use Baby lotions, Oils, Powders and Creams. Manufacturers conduct extensive safety tests to ensure that these products are safe for use on young children.
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2. Anatomical differences between baby skin and adult skin
Skin:In general theskin consists of the epidermis, which is the outer layer, the dermis beneath the epidermis, and the subcutaneous fat. The outermost layer of the epidermis is the stratumcorneum, which primarily acts as a barrier function. Epidermal lipids play an important role in maintaining skin barrier function and integrity.The skin of new born baby is very delicate, thin and fragile.The skin of premature newborn is functionally not very effective as barrier owing its thinness and weak cohesion between epidermis and dermis. This leads to greater transepidermal loss of water and higher percutaneous absorption of chemicals resulting in enormous susceptibility to infections, toxicity and complications in fluid homeostasis.
Figure 1:Difference between baby and adult skin
Source: http://mypositiveparenting.org/2016/03/22/your-babys-skin-the-power-of-touch/
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Baby stratum corneum is approximately 30% thinner than that of adult, and the entire epidermis in baby skin is about 20–30% thinner than in adult skin.However, the lipid content of the skin of infants is lesseras a result of the low activity of the sebaceous glands. The nonglandular epidermal lipids is present in place of the hydrolipid film in infant which are supposed to be less capable of defending the skin.In addition to this, the stratum corneum regulates the normal functioning of the skin by striking a balance among moisture and intercellular lipids. In contrast to adult skin, baby skin has much less moisture, and fewer intercellular lipids, making it more vulnerable to dryness.
In adults, the acidic pH of skin surface provides a protective environment against external microorganisms. Whilst in newborns, particularly in premature ones, pH of skinis neutral, which is why the skin of a premature baby is not capable ofproviding any protection against excessive microbial growth and preventing transepidermal water loss.
Hair:The hair of newborns is well-built; nonetheless, it is only slightly pigmented. Their body is predominantly covered with vellus hair, which is much lighter in color and thinner than adult hair. The number of hair follicles per square centimeter is higher than that in adult skin, which increases the risk of deeper penetration of topical substances applied to the skin. Due to the reduced activity of the sebaceous glands, there is not much oil on the hair shafts’ surface.
Therefore, strong surfactants are not needed to clean the hair.
Eyes:In line with the differences between baby and adult skin, babies have a greater vulnerability to ocular exposure as well. Babies have neither a fully developed blink reflex nor a behavioral blink response in expectation of accidental exposure, such as during bathing.
Therefore, it is chieflyimperativethat products for babies be extra mild with a minimum number and an extremely low amount of irritating ingredients.
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3. Classification of Baby Care Products
Baby care products can be classified as cleansing products and protecting products on account of their function. Baby care products, as per cosmetic functions, provide suitablecleansing, skin conditioning, as well as protection against water loss. Baby care products are essential in preserving the skin’s barrier function and preventing the entry of bacteria, allergens, particulates, pollution, and other exogenous substances into the body.Therefore, most products may fallunder the category of cosmetics. Nevertheless, sunscreens, which protect the skin from ultraviolet (UV) radiation,and diaper rash creams, which treat topical skinirritation and inflammation, fall under the category of drugs.
◾Cleansing products: Cleansing productsfor babies are intended to clean the baby skin and hair and remove saliva, sweat, bacteria, residues of milk, and other dirt and irritants. In general, baby cleansing products are comparable to adult cleansing products; nonetheless, the surfactants used in these products are much milder. Further, many baby products are aroma-free or contain only a low level of such components. Cleansing products may include baby bath products, shampoos, and cleansing wipes.
◾Protecting products: As their name suggests, protecting products are designed to protect the baby skin, help maintain its hydration, and, accordingly, prevent drying. These products are analogous to the moisturizing products for adults. Most moisturizing products for babies are oil in water emulsions. Sunscreens and formulations for the diaper zone, however, are principally water in oil emulsions, which provide awaterproofing effect. Protecting products consists of moisturizing lotions, creams, diaper rash creams, sunscreens, and baby powders.
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4. Desirable features of quality baby care products
Good skin hygiene is essential to the overall health of babies.A quality baby care product should possess thecharacteristics that can make the baby and child's skin capable of having a proper protective function, less vulnerable to sun radiation and external aggressions and reduced tendency to dehydrate easily:
Table 1: Ideal features of quality baby care products Ideal characteristics of a quality baby care products Cleansing products Hydrate the skin
Good foamabilty
Do not alter the skin structure
Non-irritant for the eyes
Pleasant feeling during and after application
Contains non-toxic and non-sensitizing materials
Does not change the surface pH
Slightly fragranced or not fragranced
Appropriate texture
Mild
Diaper rash products Provide protection against diaper rash
Non-irritant for the skin
Easy to spread
Easy to remove
Appropriate rheological properties
Proven efficacy
Sun protection products Provide efficient protection against UVB and UVAradiations
Proven efficacy
Dermatological safety
Long-term stability
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5. Potential negative effects of baby care products
The most common potential negative effects of baby care products are summarized as follows:
Baby skin is more vulnerable to develop irritant/allergic contact dermatitis. Fragrances, certain preservatives, and some ingredients used in moisturizer products are known irritants for adult skin. Therefore, they can certainly irritate delicate skin of a baby, and their use should be minimized in baby care products.
Skin care products with an inappropriate pH and/or ingredients can harm the skin.
Alkaline soaps are effective skin cleansers; however, they can damage the skin surface pH, decrease the thickness of subcutaneous layer, alter the skin lipids, and lead to dryness and irritation. Water, in addition to not being an effective cleanser, may also have a drying effect on theskin of a baby. Further, cleansing products including antimicrobial ingredients are not recommended for use in babies because of their harshness and potentially negative effect on skin colonization.
It is also known that Atopic dermatitisoccurs in 15–20% of children, typically early in life: 49–70% of childhoodatopic dermatitis appears before 6 months of age and 80–90%
of babies suffer from atopic dermatitis before 5 years of age. Compromised skin barrier function is believed to becrucial to the development and severity of atopic dermatitis, which is often accompanied by dry, scaly skin and itching. Special care and the use of adequately formulated,mild cleansers, and skin moisturizers are particularly important for thesechildren.
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6. Formulation of Baby Care Products
The baby care market consists of limited variety of products, usually focused on cleaningand moisturizing. There are some major factors that should be taken into considerationwhen formulating any type of product for babies. In general, formulators should only use ingredients that have an establishedsafety profileand are deemed to be safe on baby skin.
Figure 2: Widely used Himalaya baby care products including baby powder, baby soap and baby cream (source: http://www.himalayababycare.com/)
◾ Ingredients known to be irritants, sensitizing agents, and allergens shouldbe avoided when formulating products for highly sensitive and immature babyskin. Examples include sodium lauryl sulfate, ethanol, strong or large amount of preservatives, and fragrances.
◾As most formulations for babies are water based, the use ofpreservativesis essential in these products. Preservative-free formulations are more dangerousto baby skin due to the potential risk of microbiological contamination thanformulations with preservatives. The level of
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preservativesshould be kept as low as possible in formulations. A good way is to applya combination of preservatives. This way they may have a broader spectrum,their overall efficacy can be increased, and the concentration of the individualingredients can be kept low.
◾Special care should also be taken when using “natural” preservatives since they may have not been tested on baby skin; therefore, thereis no safety information about their use.
◾ Formulations should be keptmild and their pH should be close to the skin’s naturalpH in order not to disturb the natural skin flora.
◾ Ingredients known to be penetration enhancers, for example urea or propyleneglycol, should not be included in formulations. The reason behind it isthat penetration through baby skin is already easier for many ingredients than through adult skin. Enhancing the penetration could easily enhance irritation and may lead to inflammation.
◾Emollientsshould be cautiously selected for baby formulations in order not tocause allergic reactions, irritation, or other types of problems.
◾ Formulations should have ingredients that do not lead toeye irritationinbabies. Cleansing products can often run into the eyes during rinsing. As blinking, which serves as a protective mechanism for the eyes, continues with the eyes maturing duringthe first year, the babies’ eyes are more sensitive to irritants.
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7. Cleansing Products for Babies
Cleansing products for babies are usually surfactant-based systems formulated as shampoos, bath products, andwipes. The majority of ingredients are similar to adultcleansing products;
Baby Bath Products:Baby bath products do not require havinghigh cleansing activity, as the extent of soiling of a baby’s skin is generally low in contrast with adult skin. For the same reason, adult skin cleansershould not be applied on baby skin. Also, strong and effective anionicsurfactants can take away components of subcutaneous lipids, and can even insert themselves into the skin. All these factors can lead to disruption of theskin barrier and development of symptoms, such as irritation, dryness, and itching. Mainnecessities of a baby bath are that it should be effective, mild on the skin, and should not cause dryness.Therefore, baby bath formulations generally consist of the following secondary surfactants in low concentration:
Amphoteric surfactants (e.g. cocamidopropyl betaine)
Nonionic surfactants (e.g. polyethylene glycol (PEG)-80 sorbitan laurate).
Mild anionic surfactants (e.g., disodium laurethsulfosuccinate, and e.g., sodium cocoyl isethionate)
The micelles forming above the criticalmicelle concentration (CMC) are generally larger with a lower micellar chargewhencombination of such surfactants is used.This causesbetter toleranceand condensed aggressiveness of the surfactant system to the skin and. Viscosity is anotheressential factor to consider as it can preventrunning of the formulation into the eyes. In general, hydrophilic thickeners, for example cellulose derivatives, gums, or acrylate polymers are incorporated. Humectants and emollients mayalso be included in the formulations to minimize any drying effect and increase thesoftness of the skin.Other ingredientsincludes solvents, usually water; preservatives; antioxidants; and chelating agents. Formulation of baby bath productsstarts with dispersion and hydration of the thickeners, while surfactants are added
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inthe final step with tender mixing to evade excessive foam formation.They canalter the skin’s normal pH to the alkaline range, which can damage the skin barrierand lead to irritation and dryness.
Baby Shampoos:Babies have few lipids on their hair and are easy to clean. Akin to babybath products, baby shampoos generally consists of mild secondary surfactants, suchasnonionics (e.g., PEG-80 sorbitan laurate) and amphoterics (e.g., cocamidopropylhydroxysultaine). These surfactants are mild to the eyes. Irritation can be furtherreduced by increasing the product’s viscosity since it can prevent the product fromrunning into the eyes. These surfactants as well as anionic surfactants do not foam;therefore, baby shampoos may be considered low-performing products by some parents.However, as discussed previously, foaming is not related to the cleansing efficacyof shampoos; a low-foaming formulation can be an effective cleanser just as ahighly foaming formulation.The formulation procedure of baby shampoos is similar to that of adult shampoosas well as baby bath products.
Baby Wipes:Disposable baby wipes represent one of the fastest growing sectors ofthe baby products market. Nowadays they are very commonly used as an alternative to liquid cleansingproducts, specifically for the diaper area. Baby wipes are generally made ofa nonwovendisposable cloth immersed in an aqueous surfactant solution or an O/W emulsionenriched with emollients. As the purpose of wipes is to wipe off the baby skin without rinsing it afterwards, they are generally non-lathering formulations. Classic cleansing ingredientsused in such formulation are
Surfactants: Mild nonionic surfactants, such as coco glucoside and lauryl glycoside, as well as amphoteric surfactants, such as disodiumcocamphodiacetate are generally incorporated in baby wipes formulations.
Humectants: It can also be added into the solutions oremulsions, which provide moisturizing benefits for the products.
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Thickeners: In generalhydrophilic thickners, such as xanthan gum, are usedin baby wipes to provide optimal viscosity for the soaking solution or emulsion.
Preservatives:Due to the watercontent of the emulsions, preservatives must be used toprevent contamination. On the other hand,preservatives and fragrances, can cause irritation also.
Anti-inflammatory agents: Soothing and anti-inflammatory ingredients can also be added in the solutions to reduce the signs of any irritation. Examples for such ingredientsincludeallantoin, and plant extracts, such as chamomile extract, pot marigold extract,and aloe extract.
Baby wipes are usually shown to be mild and well-tolerated bybaby skin, even when used on sensitive skin or dermatitis skin.Essential factorsthat should be noted for preparing baby wipes are as follow:
- pH of wipes,
- Fragrance selection, and
- Typesand amount of surfactants
It has been observed that use of irritants, such as alcohol, fragrances nottested for their allergic potential and pH significantly different from that of the skin damage the baby skin or worsen diaper rash.Wipe clothsare soaked in the cleansing solution and packaged either individually into sachets ortogether into plastic bags or other types of containers.
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8. Moisturizing and Protecting Products for Babies
Protecting products forbabies generally comprise of emulsions formulated as moisturizers, powders, sunscreens and diaper rash products. As baby skin is prone to drying, moisturizing products containing humectants andemollients can be used to prevent this. Diaper dermatitis and other irritation reactions in thediaper zone can be managed by formulations that can make the skin more waterproof.
Figure 3. Johnson’s Baby powder, baby oil, baby soap, baby lotion, baby cream and baby toothbrush (source: http://www.prosisupermarket.com/product_sub.php?product=Cosmetics) Baby Lotions and Creams:Moisturizing lotions and creams for babies consist ofemulsions, usually, light O/W formulations that have goodspread ability and are quicklyabsorbed. The formulation steps for baby lotions and creamsfollow the general emulsification process.The oil
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phase generally consists of various emollients and also occlusiveingredients, In general, mineral oil and vegetable oils, such as sweetalmond oil, sunflower oil, and palm oil, are used.A common issue with many vegetable oils is their sensitivity to oxidation, whichresults in rancidity. Mineral oil is a stable andocclusive ingredient that forms a protective waterproof layer over the skin, reducingwater loss. It may also function as an emollient. Mineral oilhas a long record of safe use.
It is unlikely to go rancid even in extreme climates.Silicone oils have also gained more attention nowadays because of their beneficial effectson the skin. Alike cleansing wipes, soothing and anti-inflammatory ingredients,such as allantoin, and natural extracts, such as calendula extract, canalso be incorporatedinto the products. The water phase may contain humectants; such as, glycerin for its beneficial moisturizing effect. Antioxidants, such astocopherol, and chelating agents, such as tetrasodium glutamate diacetate, areusually also added to prevent deterioration accelerated bymetal ions and free radicals.
Baby Powder: Baby powderis among the earliest formulation of all baby care products.The mainfunction of a baby powder is to soak up the residual moisture onthe skin, lubricates the skin, and prevents irritation. Themain lubricants used in baby powders are talc and starch. Other absorbents, such as kaolin; fragrances;and antioxidants can also be included in the formulation.
Zinc oxide may alsobe used because of its mild antibacterial properties.Nowadays, corn starch–
based baby powders are preferred due to safety issues,which were seen in the past for talc-based products.
Diaper Rash Creams and Ointments:Diaper rash, better known as diaper dermatitis, constitutes as one of the most common dermatologic conditions seen in babies while usingdiapers. Factors responsible for its developmentinclude skin wetness due to incontinence in babies along with infrequentdiaper changes, which increases contact time between the skin and potentialskin irritants. Moisture also makes the skin more fragile and enhances its susceptibilityto frictional damage caused by the diaper, pressure, and chafing.
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Diaper rashis a result of amain reaction to irritants in urine and feces, as well as moistureand friction. It irritates the skin and causes degradation of the skin proteinsand lipids and adisrupted barrier function. Further, alteration of the skin pHleads to the growth of microorganisms, including Candida, Staphylococcus, andStreptococcus species.
Figure 4: Causes and symptoms of diaper rash
(Source: https://theabsoluteparent.com/how-to-get-rid-of-diaper-rash/)
Erythema and mild scaling occur as a symptom of diaper rash. If not treated in the earlier stages, papules and edema can occur, or, insevere cases, ulcerated lesions may develop.More repeated diaper change shouldbe done with proper cleansing to prevent the worsening of diaper rash. It decreases the timethe skin is exposed to urine and feces.Further, formulations for treatingdiaper rash should be applied on the skin surface.Products predominantly formulated for the diaper zone are generally W/O emulsionsor they can be anhydrous pastes, which are thicker, longer-lasting, and more waterproof thanwater-based formulations. TheOTC monograph has released a list of ingredients for skin protection and their concentrationthat, if used in the concentration stated, are considered drugs. Below this concentration, the same ingredients in the productsare considered
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cosmetics. Following are the examples for suchingredients commonly used in diaper rash treatment products with their concentrationas listed in the OTC monograph:
◾Allantoin: 0.5–2%
◾ Cocoa Butter: 50–100%
◾Dimethicone: 1–30%
◾ Glycerin: 20–45%
◾ Kaolin: 4–20%
◾ Lanolin: 12.5–50%
◾ Petrolatum: 30–100%
◾ Zinc Oxide: 1–25%.
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9. Packaging of Baby Care Products
The most commonly used packaging materials for baby care products involve thefollowing:
◾Plastic Bottles:The large amount of cleansing and protective products as well asbaby sunscreens are supplied in plastic bottles, usually with a flip-top cap, screwhead, tilted head, or pump head.
◾Soft Tubes and Jars:Some protective products and baby sunscreens are packedinto soft tubesor they can also be packaged into jars.
◾Baby wipes packaging: Packing of baby wipes is required to be durable and disposable.The majority of babycleansing wipes are folded together and packaged either into sachets or plastic containers(tubs and canisters) with a resealable label or flip-flop lid. These containers aredesigned to easily dispense single sheets while keeping the wipes moist until ready for use.
Figure 5:Packaging of baby wipes
◾Aerosol Cans Sunscreens may also be available in aerosol containers, similarto adult products.
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10. Chemicals to be avoided in baby cosmetics formulations
As the skin of the newborn is delicate and vulnerable, cosmetic formulationsdesired for their protection need special consideration in the selection of their ingredients. Ingredients that may be potentially harmful to the skin should be avoided.
The percutaneous absorption of drugs is determined by the physical and chemical properties of the drug. Immature systems of drug metabolism and underdeveloped epidermal barrier in newborn babiesalso influence the absorption phenomenon. Perhaps the drugs having labelssuch as “dermatologically tested” or “natural or organic ingredients” do not ensure the safe use of such ingredients.
The following chemicals have potentially harmful effects on the babies’ skin hence should be avoided:
Table 2: Chemicals to be avoided in Baby CareFormulations
S.No. Chemical Potential Harmful Effect
1 Alcohol Topical applicaion: hemorrhagic necrosis in premature babies
Cleansing solution: skin burns in newborns having low birthweight
2 Iodine Solution: serious and transient hypothyroidism
levels of thyroid hormones should be checked in premature babies who undergo the exposure of iodine 3 Prilocaine Overdose causes methemoglobinemia
4 Propylene glycol At concentration greater than 5%: .burning and skin irritation
Oral use: central nervous system toxicity in premature
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S.No. Chemical Potential Harmful Effect newborn
Parentral use: risk of hyperosmolality and seizures 5 Sodium lauryl sulfate potent skin irritant that disrupts the lipid barrier,
resulting inflammation of the skin layers 6 Methylisothiazolinone neurological defects
7 Parabens contact dermatitis and skin rash
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11. Evaluation and Safety assessment of Baby Care Products
The usual quality-related problems of baby care products consists ofless foaming of cleansing products, separation of emulsions,microbiological contamination, clumping, rancidification and valve clogging for aerosol sunscreens. Parameters commonly tested to evaluatethe quality of baby care products include the following
o spray characteristics; aerosol can leakage and pressure test, actuation force for aerosol products;
o spreadability, texture, and firmness, color; preservative efficacy; viscosity; and pH.of lotions, creams, gels, and ointments;
o foam stability, foam density, foam viscosity, and foam structure for cleansing products;
Following are the parameters which indicate the performance of baby moisturizing products:
protective effect of diaper rash products,
hydrating effect
protective effect of sunscreens and moisturizers.
Safety is the prime concern for cosmetics usage and should include all consumer groups unless the user group is specifically indicated through special product presentations. User groups may include geriatrics, expecting mothers, lactating women, children and adolescents. A good example may include skin/hair cleansers and skincare products which are used by all groups discussed above. As an outcome there are two types of safety assessments; first one is the normal safety assessment for all end users and second one is a distinctive safety assessment for any special/novel active component present in the product.
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Figure 6: Johnson baby products
An example of harmful chemical ingredient is Formaldehyde a carcinogen which is associated with respiratory, eye and skin irritation and also linked to leukemia in some studies. This ingredient has been detected in Johnson and Johnson products. A probable reason could be presence of quaternium which release formaldehyde.
The only key to avoid such hazards is a sound safety assessment. This could include special assessments e.gEuropean cosmetics legislation (also known as EC Cosmetics Directive)suggests the need of special evaluation for pediatric population below three years of age. The evaluation should also consider the latest guidelines and scientific findings relevant for pediatric safety should be a mandate for the product development. The compatibility assessment is also an important pillar for development of this kind of formulations. Another important aspect is the selection of excipients compliance to legal regulations. As per EU standards evaluations by the SCCNFP (Scientific Committee on Cosmetic Products and Non-Food Products (the scientific advisory committee of the European Commission), is a mandatory requirement. Important selection criteria are
toxicologicalprofile
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skin and mucous membrane irritation potential
microbiological quality
purity of raw materials.
testing for heavy metals
testing for presence of pesticide residues.
These harmful substances must be avoided but if present, the level should on based ALARP (As Low As Reasonably Possible) principle. The control strategies are based on continuous and detailed analytical methods specific for the presence of contaminant in question as safety of finished product is governed by the safety and toxicological evaluation of excipients. The aforementioned assessment is supplemental to estimation of physico-chemical properties like pH, viscosity, rheological properties etc. Lastly, due consideration should be given to intended use and route of administration. The overall exposure level estimation is essential in case the user is exposed to same ingredient through foods, preservatives etc. and overall exposure should be accounted for to avoid health and safety hazards.
