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Baby and kids skincare: the rules, claims, formulas and tests

What the EU and the US require for products used on babies and children, which ingredients carry special limits and warnings, how to support "tear-free" and "pediatrician tested", and how to make the packaging safe.

Not legal adviceProducts for children get the closest attention from regulators. This guide summarizes the main rules as of October 2026; your EU safety assessor, Responsible Person or US regulatory adviser must confirm them for your product.

Short answer

Baby and kids skincare is regulated as ordinary cosmetics, but with extra care: in the EU the safety assessment must include a specific assessment for products intended for children under 3, microbiological quality gets particular attention, and some ingredients are restricted for young children (for example propylparaben and butylparaben may not be used in leave-on products for the diaper area of children under 3, and salicylic acid is not for children under 3 except as a preservative in shampoos). In the US, the FDA regulates children's cosmetics like other cosmetics, but some baby oils need child-resistant packaging under the Poison Prevention Packaging Act, sunscreens are drugs whose labels say to ask a doctor for babies under 6 months, and any toy packed with the product falls under consumer product safety rules. Claims such as "tear-free", "pediatrician tested" and "hypoallergenic" have no legal definitions, so each needs a test that matches the words, and most baby lines leave out fragrance and essential oils.

Which products count

Children's skincare covers three groups with different needs:

Group	Typical products	Why it matters
Babies and toddlers (under 3)	Baby wash and shampoo, lotion, diaper (nappy) cream, baby oil, wipes, balm	The EU requires a specific safety assessment for this age group. Skin is thinner, the skin surface is large relative to body weight, and products are used on the diaper area.
Children (about 3 to 12)	Kids' body wash, shampoo, detangler, lotion, lip balm, sunscreen	Fun formats and packaging bring toy and food-imitation risks; products are often used without supervision.
Teens	Cleansers, spot care, moisturizers	Acne claims make products drugs in the US; marketing to minors is reviewed by ad platforms.

The FDA's long-standing cosmetic product categories even have a "baby products" group (baby shampoos; lotions, oils, powders and creams; other baby products), but the same cosmetic law applies. A product becomes a drug in the US if it claims to treat or prevent a condition: "treats diaper rash" or "relieves eczema" are drug claims, while "moisturizes delicate skin" is cosmetic. Diaper rash creams with zinc oxide sold as skin protectants are US OTC drugs. See cosmetic vs drug claims.

EU rules for children's cosmetics

The EU Cosmetics Regulation (Regulation (EC) No 1223/2009) treats children's products as cosmetics, with these extra points:

A specific safety assessment for under 3s
Annex I, Part B requires "a specific assessment for cosmetic products intended for use on children under the age of three". The safety assessor calculates exposure for a baby's body weight and skin area, considers the diaper area (where skin is covered and can be damaged) and decides whether every ingredient is safe for that use.
Particular attention to microbiology
Annex I, Part A asks for particular attention to the microbiological quality of products used on children under three (as for eye-area products and damaged skin). In practice manufacturers apply the stricter limit for these products in ISO 17516 (the standard for microbiological limits).
Ingredient restrictions and warnings
Several Annex entries mention children. Examples:
- Propylparaben and butylparaben: not in leave-on products designed for the diaper area of children under 3, and leave-on products for children under 3 carry "Do not use on the nappy area" (Annex V).
- Salicylic acid: not to be used in products for children under 3, with an exception for shampoos when used as a preservative; check the current Annex III and V entries for the exact conditions and warning wording.
- Talc in powders for children under 3: a warning to keep powder away from children's nose and mouth (Annex III).
The annexes change often; your safety assessor checks the current consolidated text.
SCCS guidance on children
The Scientific Committee on Consumer Safety's Notes of Guidance for the testing of cosmetic ingredients (12th revision, SCCS/1647/22, the current edition as of October 2026) include guidance on assessing children's exposure, which safety assessors follow.
Food-imitating and toy-like products
The EU General Product Safety Regulation (Regulation (EU) 2023/988, applying since 13 December 2024) treats products that look like food and can be mistaken for it by children (shape, smell, color, packaging) as dangerous. Avoid fruit-shaped soaps, candy-like balms and packs that look like a snack. Packaging that is itself a toy can bring toy safety rules.
Claims
Every claim must meet the common criteria of Regulation (EU) No 655/2013, and "hypoallergenic" follows the stricter EU guidance (see below).

The UK keeps the same structure in its own version of the regulation. More in EU cosmetics regulation and UK cosmetics regulation.

US rules

FDA and MoCRA. Children's cosmetics follow the same rules as other cosmetics: safe under labeled or customary use, properly labeled, made in a registered facility, listed with the FDA, with safety substantiation on file and serious adverse events reported. Expect closer scrutiny if something goes wrong. See MoCRA compliance.
Child-resistant packaging for some oils. Under the Poison Prevention Packaging Act rules (16 CFR 1700.14(a)(32)), a liquid cosmetic that is not an emulsion, contains 10% or more hydrocarbons (such as mineral oil) and has a low viscosity must be in child-resistant packaging, unless it is dispensed only by a spray or cannot flow freely. Classic mineral-oil baby oils are in scope.
Aerosol warnings. Cosmetics in pressurized containers carry a set warning; for products intended for children the FDA allows "except under adult supervision" after "Keep out of reach of children" (21 CFR 740.11).
Sunscreen is a drug. US sunscreens for children are OTC drugs with a Drug Facts label; the standard directions tell parents to ask a doctor before using sunscreen on babies under 6 months. See sunscreen regulation.
CPSC and toys. Cosmetics themselves are regulated by the FDA, not the Consumer Product Safety Commission (the Consumer Product Safety Act excludes cosmetics from its definition of consumer products). But a toy packed with the cosmetic (a bath toy, a figurine, a stamp) is a children's product under CPSC rules, with its own testing and certification. Keep toys out of the box or plan for those rules.
State laws. State ingredient bans and California Prop 65 warnings apply to children's products too. See Prop 65 and state bans.

Formulating for babies and children

Short ingredient lists
Fewer ingredients mean a simpler safety assessment and fewer triggers. Each ingredient should have a clear job.
No added fragrance, no essential oils
Most baby lines leave out fragrance and essential oils. If a kids' product must smell, keep the dose very low and check every allergen; in the EU more than 80 allergens must be labeled above 0.001% in leave-on and 0.01% in rinse-off products for new products from 31 July 2026.
Mild cleansing
Mild surfactants (for example amphoteric and glucoside surfactants), a gentle pH and low eye irritation, especially for baby wash and shampoo.
Preservatives chosen for the age group
A water-based baby product still needs a preservative system. Avoid propylparaben and butylparaben in leave-on diaper-area products for the EU, methylisothiazolinone in leave-on products (EU: rinse-off only), and formaldehyde releasers. Phenoxyethanol and organic acids are common choices; ask your safety assessor about any extra national expectations. Prove the system with a challenge test. See shelf life and preservatives.
Barrier support
Diaper creams and baby balms often use zinc oxide (as a skin protectant drug active in the US when claims are made), petrolatum, lanolin, ceramides and panthenol.
Leave out adult actives
Retinoids, strong acids, high-strength vitamin C, self-tanners and similar actives have no place in baby products, and high concentrations of most actives are hard to justify in a children's safety assessment.
Low impurities
Heavy metal and microbiology tests matter more for babies; ask your manufacturer for heavy metal results on mineral ingredients such as zinc oxide, talc and clays.

Tear-free, pediatrician tested and other claims

None of these phrases is defined in US or EU law. They are still claims, so they must be true and backed by evidence (in the US under FTC rules, in the EU under Regulation 655/2013).

Claim	What customers think it means	Evidence usually needed
Tear-free, no more tears	Will not sting if it gets in the eyes	Eye irritation testing of the finished product (validated in vitro methods), and an in-use test; the wording should not promise zero discomfort
Pediatrician tested	A children's doctor tested it on children	An in-use study on children supervised by a pediatrician, with ethics approval and parental consent
Dermatologist tested	Tested for skin reactions	A patch test or HRIPT under a dermatologist's supervision (usually on adults)
Hypoallergenic	Very unlikely to cause allergy	US: no definition, but evidence expected. EU: formula designed to minimize allergenic potential, no known sensitizers, solid data such as an HRIPT on enough volunteers
Suitable from birth, for newborns	Safe for the youngest babies	A safety assessment that covers newborn exposure; many brands say "from 0 months" only when the assessor agrees
Natural, gentle, safe	Vague reassurance	Avoid absolute "safe" and "chemical-free" claims; describe what the formula does or leaves out

Testing details are in patch test and HRIPT and efficacy claims testing; claim wording in what skincare can claim.

Packaging safety

No food or candy look. In the EU, products likely to be confused with food by children are treated as dangerous under the GPSR; avoid it everywhere.
Child-resistant closures where the US rules require them (low-viscosity hydrocarbon oils) and wherever a product is risky if swallowed.
No small loose parts. Caps, charms and inserts that a toddler can swallow are a risk; keep toys separate or follow toy rules.
Unbreakable materials. Plastic over glass for bath-time products; tubes and pumps over jars for hygiene.
Lockable pumps and tamper evidence for e-commerce and for parents' peace of mind.
Clear warnings and directions in the language of each market, including "Keep out of reach of children" where required and any Annex warnings in the EU.

See packaging options, retail-ready packaging and label requirements by country.

Testing plan

Test	Why for children's products
Stability and compatibility	Shelf life and PAO, and no interaction with the pack
Challenge test (ISO 11930)	Proves the preservative system, especially for water-based products and jars
Microbiology per batch	Stricter limits for products for children under 3
Heavy metals	Lead, arsenic, mercury and cadmium, especially for mineral powders and zinc oxide
Patch test or HRIPT	Skin tolerance; backs "dermatologist tested" and "hypoallergenic"
Eye irritation	Backs "tear-free" for washes and shampoos
In-use test under pediatric supervision	Backs "pediatrician tested"; needs ethics approval and consent

More in the testing overview and challenge test, microbiology and heavy metals.

Launch steps

Choose the age group and products
A baby wash and a baby lotion, or a kids' 2-in-1 shampoo and body wash, are common first products.
Brief for gentleness
No added fragrance, mild cleansing, short list, the claims you want and the markets you sell in.
Agree the testing plan with the claims
Decide which claims you will print and book the tests that back them before you print packaging.
Safety assessment first
For the EU and UK, involve the safety assessor early and tell them the age group; for the US, prepare safety substantiation.
Packaging review
Child-resistant needs, no food look, no small parts, unbreakable materials, warnings.
File and label
CPNP and UK notification, MoCRA listing, label check for each market.
Plan for complaints
Parents report reactions quickly. Have a process to record and assess them, and know your serious adverse event reporting duties. See recalls and adverse events and product liability insurance.

Common mistakes

Using an adult formula with a cute label and calling it a baby product without a children's safety assessment.
Adding fragrance or essential oils "for a nice baby smell".
Printing "tear-free" or "pediatrician tested" without the matching test.
Claiming a diaper cream "treats diaper rash" on a US cosmetic, which makes it a drug.
Selling a mineral-oil baby oil in the US in a bottle without a child-resistant closure.
Shaping a kids' balm or soap like candy or fruit.
Packing a toy in the box without checking toy safety rules.
Using propylparaben or butylparaben in an EU leave-on diaper-area product.

Checklist

I defined the age group (under 3, 3 to 12, teens) for each product.
The EU safety assessor knows the age group and the CPSR includes the under-3 assessment.
Every ingredient is checked against Annex restrictions that mention children.
No fragrance or essential oils, or every allergen is calculated and labeled.
The preservative system suits the age group and passed a challenge test.
Microbiology and heavy metal results are on file for each batch.
Each claim (tear-free, pediatrician tested, hypoallergenic) has its matching test report.
No US drug claims on cosmetics (diaper rash, eczema, sunburn).
Packaging is unbreakable, has no small loose parts, does not look like food, and is child-resistant where required.
Labels carry the required warnings in each market's language.
I have a complaint and adverse event process and liability insurance.

How KoreanOEM helps

KoreanOEM is a Korean skincare OEM and private label manufacturer: our formulation chemists in Busan develop the formula, and production runs in Korea under ISO 22716 (cosmetics GMP) with our own staff on site.

Tests through our lab and accredited partner labs: COA and microbiology for every batch; challenge test (ISO 11930) from USD 1,000 per formula; heavy metal test about USD 150; patch or low-irritation dermatological test from USD 1,000; HRIPT from USD 3,000 (50 people, "dermatologist tested") or USD 5,500 (100 people, "hypoallergenic"). Other tests are quoted per product.
EU and UK files through our partner: CPSR and PIF USD 1,250 per formula (UK notification included), CPNP notification USD 420 per product.
US: MoCRA product listing filed by our team for USD 150 per SKU.
A label proof check against your market's rules before printing, including warnings.

Tell us in the quote form that the product is for babies or children and which age group. Our team checks the formula, the tests and the market rules with the lab before anything is promised.

Get a free quote See tests and documents

Frequently asked questions

Are baby skincare products regulated differently from adult skincare?

They are regulated as cosmetics in both the EU and the US, but the EU requires a specific safety assessment for products intended for children under 3 and particular attention to their microbiological quality. Some ingredients also carry restrictions or warnings for young children.

Which ingredients are restricted in EU products for children under 3?

Examples include propylparaben and butylparaben, which may not be used in leave-on products for the diaper area of children under 3, and salicylic acid, which is not for children under 3 except as a preservative in shampoos. The safety assessor checks the current Annex entries for every ingredient.

What does tear-free mean on baby shampoo?

There is no legal definition. It is a claim that the product does not sting the eyes, so it needs eye irritation testing of the finished product and careful wording that does not promise zero discomfort.

What does pediatrician tested mean?

It should mean the product was tested in use on children under the supervision of a pediatrician, with ethics approval and parental consent. It is not defined by law, so the test report must match exactly what the label says.

Does baby oil need child-resistant packaging in the US?

Often yes. Under 16 CFR 1700.14(a)(32), a non-emulsion liquid cosmetic with 10% or more hydrocarbons, such as mineral oil, and a low viscosity must be in child-resistant packaging unless it is dispensed only by spray or cannot flow freely.

Can kids' sunscreen be sold as a cosmetic in the US?

No. Every sunscreen sold in the US is an over-the-counter drug with a Drug Facts label, and the standard directions tell parents to ask a doctor before using it on babies under 6 months.

Should baby products be fragrance-free?

Most baby lines leave out fragrance and essential oils, because fragrance ingredients are a known cause of skin reactions and add allergens to the label. If a kids' product is scented, keep the dose low and label every allergen required in the EU and Canada.

Sources

Checked against these sources in October 2026. Rules and fees change; check with the authority or your importer before you sell.