A baby wipe’s ingredient list follows FDA’s cosmetic labeling rule, 21 CFR 701.3, and that rule leaves three gaps a parent should know about. Fragrance can be listed as the single word “fragrance.” Anything at 1 percent or less can appear in any order after the larger ingredients. And an ingredient FDA has accepted as a trade secret can be replaced by the words “and other ingredients.” FDA’s own page on the word “hypoallergenic” adds a fourth: “there are no Federal standards or definitions that govern the use of the term.” This post reports what the regulation and FDA’s pages state and makes no claim about any wipe.
Why a wipe follows the cosmetic rules
FDA sorts products by what they are for. Its page Is It a Cosmetic, a Drug, or Both? quotes the law’s definition of a cosmetic: “articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body…for cleansing, beautifying, promoting attractiveness, or altering the appearance.” A wipe sold to clean a baby’s skin is sold for cleansing. The same page says intended use is set by “claims stated on the product labeling, in advertising, on the Internet, or in other promotional materials,” and that a claim to treat or prevent disease makes a product a drug. So a wipe that makes a drug claim answers to a different set of rules, with its active ingredient listed first.
What order are the ingredients in?
The regulation’s first sentence sets the order. “The label on each package of a cosmetic shall bear a declaration of the name of each ingredient in descending order of predominance.” The biggest ingredient comes first, which on most wipes is water. One wipe Runlow has a record for, Dyper’s Baby Wipes, lists “Water (99%)” at the top of its page’s ingredient list.
The rule also allows a second format, in paragraph (f). Ingredients above 1 percent come first, in descending order. Then come ingredients at “not more than 1 percent, without respect to order of predominance,” then color additives “without respect to order of predominance.” FDA’s cosmetics labeling guide works an example of both formats side by side. So past the first few entries, a list’s order can stop telling you which ingredient there is more of.
Why does a label just say “fragrance”?
The regulation allows it in so many words: “fragrance or flavor may be listed as fragrance or flavor.” FDA’s page on fragrances in cosmetics gives the reason. The ingredient list is required under the Fair Packaging and Labeling Act, which “is not allowed to be used to force a company to tell ‘trade secrets,’” and fragrance formulas “are the kinds of cosmetic components that are most likely to be ‘trade secrets.’” A company can still name the components. FDA’s labeling guide says they “may also be declared individually by their appropriate label names.”
Two more details from the same guide matter for a wipe sold as gentle. A masking agent, an ingredient “covering the undesirable off-odor of a product without adding a discernable odor to it,” can be declared by name or as “fragrance.” And if it is present “at an insignificant level,” the guide says it “need not be declared on the label.” That is the mechanism behind FDA’s line that “even some products labeled ‘unscented’ may contain fragrance ingredients,” which Fragrance-Free vs. Unscented covers in full.
What else can a list leave out?
Two things, both written into 701.3. An ingredient FDA has accepted as a trade secret under its own review procedure can be dropped from the list, and “the phrase ‘and other ingredients’ may be used at the end of the ingredient declaration.” And paragraph (l) says the rule does “not require the declaration of incidental ingredients that are present in a cosmetic at insignificant levels and that have no technical or functional effect.” Its examples include processing aids removed before packaging, and substances carried in as part of another ingredient.
What does “hypoallergenic” mean?
Nothing fixed, according to FDA. Its page on hypoallergenic cosmetics says “there are no Federal standards or definitions that govern the use of the term ‘hypoallergenic.’ The term means whatever a particular company wants it to mean.” It adds that manufacturers “are not required to submit substantiation of their hypoallergenicity claims to FDA.” The page reprints a 1978 FDA Consumer article explaining why. A federal appeals court had struck down FDA’s regulation defining the term, and the article says “there is no such thing as a ‘nonallergenic’ cosmetic.” Its summary points at the ingredient list instead, which “can help consumers determine if there is any significant difference between ‘hypoallergenic’ products and competing brands that don’t make this claim.”
Is fragrance allergen labeling coming?
FDA’s page on the Modernization of Cosmetics Regulation Act of 2022 lists “fragrance allergen labeling requirements” among the regulations the law requires FDA to establish. The page, read for this post, does not give a date for them. FDA’s fragrance page, dated 2022, says the agency “does not have the same legal authority to require allergen labeling for cosmetics as for food,” and suggests that a reader concerned about fragrance sensitivities “may want to choose products that are fragrance free, and check the ingredient list carefully.”
Where this comes from
Every statement above is quoted from 21 CFR 701.3 as published on eCFR and from four FDA pages: its cosmetics labeling guide, its pages on fragrances and on hypoallergenic cosmetics, its page on whether a product is a cosmetic or a drug, and its page on MoCRA. All were read on October 15, 2026. This post reports what the rules require of a label. It says nothing about whether any ingredient or any wipe is gentle on a baby’s skin, and Runlow has not tested any wipe.
Frequently asked questions
- What order are baby wipe ingredients listed in?
- For a product sold as a cosmetic, 21 CFR 701.3 requires each ingredient "in descending order of predominance." The same rule allows a second format. Ingredients above 1 percent come first in descending order, then ingredients at 1 percent or less "without respect to order of predominance," then color additives in any order.
- Why does a baby wipe label just say fragrance?
- FDA's rule says "fragrance or flavor may be listed as fragrance or flavor." FDA's page on fragrances explains that the ingredient list is required under the Fair Packaging and Labeling Act, which "is not allowed to be used to force a company to tell trade secrets," and that fragrance formulas are "the kinds of cosmetic components that are most likely to be trade secrets."
- What does hypoallergenic mean on baby wipes?
- Nothing fixed, by FDA's account. Its page on hypoallergenic cosmetics says "there are no Federal standards or definitions that govern the use of the term," that it "means whatever a particular company wants it to mean," and that manufacturers "are not required to submit substantiation" of the claim to FDA.
















