Front Panel
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Information Panels
The information above must appear on the label of the inner (immediate) container holding the cosmetic product. The inner container is packaged and displayed in a non-transparent box, folding carton etc. If the outer container is removed and the product displayed for sale without it, the label of the immediate container becomes a label of an outer container.
Form of Stating Required Information
Section 602(c) of the FD&C deems a cosmetic misbranded if any word, statement, or other label or labeling information required by law or regulation is not placed on the label or labeling with such prominence and conspicuousness that it is likely to be read, or if it is not stated in such terms that it is likely to be understood by ordinary individuals.
Prominence and Conspicuousness
Panel display at purchase
Panel size
Style and size of letters
Background contrast
Obscuring designs, vignettes
21 CFR 701.2
Regulations [21 CFR 701.2] published by the FDA offer detailed information on how to comply with the requirement for prominent and conspicuous placement of information on cosmetic labels or labeling.
Panel display: The required information must be on a panel which is presented or displayed under customary conditions of purchase. This eliminates placement of required information on a bottom panel of a cosmetic unless it is very small and customarily picked up by hand where inspected for possible purchase.
Panel Size: The label must be large enough to provide sufficient space for prominent display of the required information.
Style and Size of Letters: The type must be of such size, and at least of the required minimum size, and of such style that the required label statements are easily readable.
Background Contrast: The contrast must be sufficient to make the required label statements conspicuous and easily readable.
Obscuring Designs, Vignettes: The required statements must not be obscured by vignettes or other designs or by crowding with other printed or graphic matter.
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Language
English language statements
Foreign language statements
21 CFR 701.2(b)
English Language Statements: All label or labeling statements required by law or regulation must be in the English language. Products distributed solely in Puerto Rico or a Territory where the predominant language is one other than English, may state the required label information in the predominant language in place of English.
Foreign Language Statements: If the label contains any foreign language representation, all statements required by regulation must also appear on the label in the foreign language. If labeling bears foreign language representations, the required statements must appear on the label or other labeling as required in English.
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Type Size
Ingredients: 1/16", 1/32" (Labeling surface, less than 12 sq. in.)
Net Contents:
1/16" (PDP less than 5 sq. in.)
1/8" (PDP 5-25 sq. in.)
3/16" (PDP 25-100 sq. in.)
Warning: 1/16"
All Others: Reasonably related to panel size
21 CFR 701.2(a) (b), 701.3(b),
701.11(c), 701.13(i), 740.2(b)
Ingredient Declaration: Generally, in letters not less than 1/16" in height [21 CFR 701.3(b)]. If surface area available to bear label (excludes surfaces with decorative relief, sculptured surfaces) is less than 12 square inches, letter height may be not less than 1/32" [21 CFR 701.3(p)].
Net Contents Declaration on PDP: Minimum letter height determined by the area of the PDP. In the case of "boudoir-type" containers, including decorative cosmetic containers of the cartridge, pill box, compact or pencil type, and cosmetics of 1/4 oz. or less capacity, the type size is determined by the total dimensions of the container. If the container is mounted on a display card, the display panel determines the letter height [21 CFR 701.13(e) and (i)].
Warning Statements: Type size no less than 1/16" unless smaller size established by regulation [21 CFR 740.2].
Letter Height: The lower case letter "o" or equivalent when upper and lower case letters are used [21 CFR 701.13(h)].
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Identity Labeling
Common or usual name
Descriptive name
Fanciful name
Illustration
Prominence
Placement
Sec. 10(t), FP&L Act
21 CFR 701.11
Sec. 4 of the FP&L Act [21 U.S.C. ] requires that a consumer commodity bear a statement of identity. Regulations [21 CFR 701.11] published by the FDA require that the identity statement appear on the PDP.
The identity of the commodity may be expressed in terms of the common or usual name of the cosmetic, a descriptive name, or when the nature of the cosmetic is obvious, a fanciful name. It may also be expressed in form of an illustration.
The identity statement must be in bold type and in a size reasonably related to the most prominent printed matter, which is usually the name of the cosmetic. It must be in lines generally parallel to the base on which the product rests when displayed at retail.
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Name and Place of Business
Corporate name
Manufactured for...
Distributed by...
Address
Principal place of business
21 CFR 701.12
The name and business address appearing on the label may be those of the manufacturer, packer or distributor.
If the name and address is not that of the manufacturer, the name must be preceded by phrases such as "Manufactured for ...", "Distributed by ...", or other appropriate wording.
The name of the firm must be the corporate name, and the address may be that of the principal place of business. Stating also the name of a corporation's particular division is optional.
The business address must include the street address, name of the city and state, and the ZIP code. The street address may be omitted if the firm is listed in a current city or directory.
The Tariff Act of requires that imported products state on the label the English Name of the country of origin.
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Quantity of Contents
Location on Package § 701.13 (e) and (f)(2)
On PDP
On information panel
Prominence § 701.13 (f) and (f)(1)
Placement
Spacing
Conspicuousness § 701.13 (h) and (i)
Contract
Letter height
Aspect ration
Type size
Location: If the cosmetic is sold at retail in an outer container, the net contents statement must appear (1) within the bottom 30% of the PDP of the outer container, generally parallel in line to the base on which the package rests, and (2) on an information panel of the inner container. The bottom location requirement is waived for PDPs of 5 square inches or less.
The PDP may be a tear-away tag or tape affixed to a decorative container or to a container of less than 1/4 oz., or it may be the panel of a display card to which the container is affixed.
Prominence: The declaration must be a distinct item, separated from other printed matter by a space equal to at least the height of the lettering used in the declaration and twice the width of the letter "N".
Conspicuousness: The print must be easily legible bold face type in distinct contract to background and other matter on the package. The letter height must be at least that of the lower case letter "o", and the aspect ratio of height to width must not exceed 3:1.
The type size, as determined by the area of the PDP must be at least 1/16 in. if PDP area 5 sq. in., 1/8 in. if PDP area > 5 to 25 sq. In., 3/16 in. if PDP area > 25 to 100 sq. in., and 1/4 in. if PDP area > 100 sq. in.
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Exemptions from Net Contents Declaration
Cosmetics of less than 1/4 av. oz. or 1/8 fl. oz.
On display card
In outer container
21 CFR 1.24
Cosmetics in packages containing less than 1/4 av. oz. or 1/8 fl. oz. are exempt from the net quantity of contents declaration if affixed to a properly labeled display card or sold at retail in a properly labeled outer container [21 CFR 1.24].
When a cosmetic is required to bear net quantity of contents declarations on the inner and outer container, the declaration on the outer container must appear on the PDP; on the inner container, it may appear on an information panel other than the panel bearing the name of the product, i.e., the front panel.
Quantity of Contents
Accuracy§ 701.13 (g) and (s)
Declaration by Product Consistency§ 701.13 (a)
Systems of Measures and Weights§ 701.13(b) and (r)
Unit Terms and Abbreviations§ 701.13 (j) (2) & (n)
Dual Form of Declaration701.13 (j) (1)
Declaration of Fraction§ 701.13 (d)
Examples of Net Quantity Statements
"Net Wt. 6 Oz." or "6 oz. Net Wt."
"Net Contents 6 fl. Oz." or "Net 6 Fl. Oz." or "6 Fl. Oz."
"Net Wt. 1/4 Oz." or "Net Wt. 0.25 Oz."
"Net 1/8 Fl. Oz." or "0.12 FL. Oz."
"Net Wt. 24 Oz. (1-1/2 Lb.)" or "Net Wt. 24 Oz. (1.5 Lb.)"
"Net 56 Fl. Oz. (1 Qt. 1 Pt. 8 Fl. Oz.)" or "... (1 Qt. 1-1/2 Pt.)" or "... (1 Qt. 1.5 Pt.)"
Accuracy: The net quantity of contents (net contents) declaration must accurately reveal the quantity of cosmetic in the container in terms of weight, volume, measure, numerical count, or combinations of count and weight, volume or measure. Reasonable variations due to loss or gain of moisture, or deviations in good manufacturing practice, are acceptable. In case of an aerosol product, the net contents statement must express the net quantity of contents expelled.
Product Consistency: Unless there is a firmly established, general consumer usage or trade custom to the contrary, the statement must be in terms of fluid measure if the cosmetic is liquid and in terms of weight if the cosmetic is solid, semi-solid, viscous, or a mixture of solid and liquid. Fluid measures must express the volume at 68°F (20°C). The customary net contents declaration for aerosol products is in terms of weight.
Systems: Weight is expressed in terms of avoirdupois pound and ounce. Fluid measures are expressed in terms of the U.S. gallon, quart, pint and fluid ounce. Net contents may additionally be stated also in the metric system.
Unit Terms: The term "net weight" or "net wt." must be used in conjunction with a weight statement, and the term "net contents," "net" or nothing must be used in connection with a liquid statement.
Additional abbreviations are for: weight - wt., fluid - fl., gallon - gal., quart - qt., pint - pt., ounce - oz., pound - lb.
In case of a weight ounce statement, the term "oz." is sufficient. A fluid ounce is expressed as "fl. oz."
Examples:
Net wt. 4 av. oz.
Net contents 4 fl. oz.
4 av. oz. net wt.
4 oz. net wt.
Net 4 fl. oz.
4 fl. oz.
Dual Declaration: If the net weight exceeds one pound but is less than 4 pounds, the net contents statement must reveal the total number of ounces followed, in parenthesis, by the number of pounds and ounces or by the number of pounds and fraction thereof. Fluid measures exceeding one pint, but being less than one gallon, must be expressed in terms of the total number of fluid ounces followed, in parenthesis, by the number of quarts, pints and ounces or by the fractions of the quart or pint.
Examples:
Net Wt. 24 oz. (1 lb. 8 oz.)
Net Wt. 24 oz. (1 - 1/2 lb.)
Net Wt. 24 oz. (1.5 lb.)
The company is the world’s best Beauty Device Manufacturer supplier. We are your one-stop shop for all needs. Our staff are highly-specialized and will help you find the product you need.
56 fl. oz. (1 qt. 1 pt. 8 fl. oz.)
56 fl. oz. (1 qt. 1-1/2 pt.)
56 fl. oz. (1 qt. 1.5 pt.)
56 fl. oz. (1-3/4 qt.)
Declaration of fractions: Fractions may be expressed in terms of common fractions ranging from 1/2 to 1/32 or as decimal fractions of no more than two significant numbers.
Quantity of Contents
On Principal Display Panel
"Economy Size" or "Budget Size"
"Giant Pint" or "Full Quart"
"Net 6 Fl. Oz." and "Six Applications"
"Net 6 Fl. Oz." and "6 Bottles of 1 Fl. Oz. Each"
On Information Panel
Any non-deceptive supplemental statement
21 CFR 1.31 and 701.13 (g)
Economy Size: Representations of this type are permitted if the firm offers at least one other packaged size of the same brand, only one is labeled "economy size," and the unit price of the package so labeled is substantially (at least 5%) reduced compared to that of the other package.
Giant Pint, Full Quart: Supplemental statements describing the net quantity of contents are permitted on panels other than the PDP. However, these statements must not be deceptive or exaggerate the amount present in the package.
Six Applications: Declarations by numerical count or linear or area measure may be augmented by statements of weight or size of individual units or total weight or measure to give accurate information. These are not regarded as separate statements and must appear on the PDP.
Cosmetic Kit: If a package contains the integral components making up a kit and delivers the components in the manner of an application as, for example, a home permanent wave kit, the net contents declaration may be stated in terms of the number of applications as per given instructions [21 CFR 701.13 (g) (2)].
Cosmetic Warning Statements
General Requirement:
Prominence
Placement
Spacing
Conspicuousness
Contrast
Type size
21 CFR 740 (1) and (2)
Regulations require that "[the label of a cosmetic product shall bear a warning statement whenever necessary or appropriate to prevent a health hazard that may be associated with the product" [21 CFR 740(1)]. A cosmetic not bearing a necessary warning statement may be considered misbranded under sec. 602(a) of the FD&C Act because it fails to reveal a fact "material ... with respect to consequences which may result from the use of the article" [sec 201(n), FD&C Act].
Prominence: A warning statement must appear on the label prominently and conspicuously as compared to other words, statements or designs so that it is likely to be read by ordinary consumers at the time of purchase and use.
Conspicuousness: The lettering must be in bold type on contrasting background and may in no case be less than 1/16 inch in height.
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Cosmetics With Unsubstantiated Safety
Warning--The safety of this product has not been determined.
21 CFR 740.10
A cosmetic is considered misbranded if its safety has not adequately been substantiated, and it does not bear the following conspicuous statement on the PDP:
Warning - The safety of this product has not been determined.
The safety of a cosmetic may be considered adequately substantiated if experts qualified by scientific training and experience can reasonably conclude from the available toxicological and other test data, chemical composition, and other pertinent information that the product is not injurious to consumers under conditions of customary use and reasonably foreseeable conditions of misuse.
The safety of a cosmetic can adequately be substantiated by:
a. Reliance on available toxicological test data on its ingredients and on similar products, and
b. Performance of additional toxicological and other testing appropriate in the light of the existing data.
Even if the safety of each ingredient has been substantiated, there usually still is at least some toxicological testing needed with the formulated product to assure adequate safety substantiation.
Cosmetic Aerosols
Warning--Avoid spraying in eyes. Contents under pressure. Do not puncture or incinerate. Do not store at temperature above 120°F. Keep out of reach of children.
21 CFR 740.11 (a)
The label of a cosmetic packaged in a self-pressurized container and intended to be expelled from the package under pressure must bear the warning stated below.
The words "Avoid spraying in eyes" may be omitted if the product is not expelled as a spray. Example: Aerosol shave cream.
The word "puncture" may be replaced by the word "break" if the product is packaged in a glass container.
If the product is intended for use by children, the phrase "except under adult supervision" may be added at the end of the last sentence of the warning.
Cosmetic Aerosols
Warning--Use only as directed. Intentional misues by deliberately concentrating and inhaling the contents can be harmful or fatal.
21 CFR 740.11 (b)
If the propellant of a cosmetic packaged in a self-pressurized container consists in whole or in part of a halocarbon or hydrocarbon, the label must bear a second warning as stated below.
This second warning is not required for the following products:
1.Aerosol foam or cream products containing less than 10% propellant.
2.Products which do not expel the propellant at the time of use. Examples: products with built-in piston barrier or propellant bag.
3.Metered spray products of less than 2 oz. net contents.
4.Aerosol products of less than 1/2 oz. net contents.
Feminine Deodorant Sprays
Caution--For external use only. Spray at least 8 inches from skin. Do not apply to broken, irritated, or itching skin. Persistent, unusual odor or discharge may indicate conditions for which a physician should be consulted. Discontinue use immediately if rash, irritation, or discomfort develops.
21 CFR 740.12
A feminine deodorant spray which, for the purpose of this regulation, is defined as "any spray deodorant product whose labeling represents or suggests that the product is for use in the female genital area or for use all over the body" must bear the caution stated below.
If the expelled product does not contain a liquefied halocarbon or hydrocarbon propellant, the sentence "Spray at least 8 inches from skin" may be omitted.
The regulation further states that the use of the word "hygiene" or "hygienic" or similar words renders any such product misbranded.
Foaming Detergent Bath Products
Caution--Use only as directed. Excessive use of prolonged exposure may cause irritation to skin and urinary tract. Discontinue use if rash, redness or itching occurs. Consult your physician if irritation persists. Keep out of reach of children.
21 CFR 740.17
A foaming detergent bath product--also known as bubble bath product--is, for the purpose of this regulation, defined as "any product intended to be added to a bath for the purpose of producing foam that contains a surface-active agent serving as a detergent or foaming ingredient."
The caution stated above is required on the label of any foaming detergent bath product which is not clearly labeled as intended for use exclusively by adults. The following are two examples of label statements identifying a product as intended for use exclusively by adults: "Keep out of reach of children" and "For adult use only."
If the bubble bath product is intended for use by children, the phrase "Keep out of reach of children" may be expanded to further read "except under adult supervision."
The regulation further requires that the label "Shall bear adequate directions for safe use" of the product.
Cosmetic Ingredient Labeling
Declaration of ingredients except flavor, fragrance, and trade secret ingredients in descending order of predominance
21 CFR 701.3
Cosmetic ingredient labeling became an issue in the early s. Guidelines for ingredient labeling were published in mid-. Regulations were proposed in early . After publication of two final regulations, stays of final regulations, terminations of stays, and lengthy court proceedings challenging the legality of the published regulations, the requirement for cosmetic ingredient labeling became fully effective in early .
The regulations requiring the declaration of cosmetic ingredients were published under the authority of the FP&L Act [secs. 5(c) and 6(a); 15 U.S.C. and ] and FD&C Act [sec. 701(e); 21 U.S.C. 371(e)].
Since the FP&L Act applies only to consumer commodities and their packages as defined in the Act, cosmetic ingredient declarations are required only on the label of the outer container of cosmetics customarily sold at retail or used in the performance of services conducted within the households. It does not apply, for example, to products used at professional establishments or samples distributed free of charge, unless such products are customarily also sold at retail, even if they were labeled "For professional use only."
The ingredients must be declared in descending order of predominance. Exceptions to this requirement are discussed later.
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Prominence of Ingredient Declaration
When you're running an ecommerce business, you need reliable suppliers and manufacturers to help you maintain seamless supply chain operations. That's why you need to pay extra close attention to the sourcing process so you can identify reliable and long-term partners.
In this guide, we walk you through the process of finding suppliers and manufacturers for your business. Let's jump in.
The main difference between a supplier and a manufacturer is that the supplier sells products to other businesses such as retailers and vendors whereas the manufacturer produces the products. In other words, the manufacturer creates the goods, which the supplier then supplies in bulk for other businesses to sell to end consumers.
In some cases, the manufacturer also acts as a supplier and sells the products directly to retailers and vendors. Additionally, suppliers in the manufacturing industry also supply raw materials and parts to manufacturers instead of selling finished products to retail businesses.
The product sourcing process is a bit more complicated than reaching out to just any random supplier. You need to take an organized approach that will allow you to narrow down suppliers that fit your needs.
Before reaching out to a supplier, make sure you're prepared with the following information.
Have a list of everything that you'll need from the supplier'whether it's the items from your product range or the components you need to manufacture a product. Make sure the supplier can accommodate all your supply needs before you decide to work with them.
Clearly outline how much you can afford to spend on the supplies. Include an estimate of the expected cost per unit and the maximum you're willing to spend after negotiations.
Be prepared to ask important questions that will help you narrow down your selection. Make sure you're asking questions related to lead times, minimum order quantities, setup fees, sustainability practices, defect policies, shipping methods, and shipping costs among many others.
What do you want to achieve through your partnership with the supplier? Don't forget to clearly specify your end goal so you can easily identify a supplier who can help you achieve it.
When choosing a supplier, make sure they meet the following criteria:
Alternatively, the following signs may be an indicator for a potentially risky supplier partnership:
A simple Google search can sometimes reveal leading suppliers for the products you need. Referrals from other businesses in your industry is also a great idea.
To expand your options, you could also go through online directories like Thomasnet, Kompass, Aliexpress, IndiaMART, and Alibaba and get access to thousands of suppliers from around the world.
Just like with sourcing suppliers, you can't reach out to just any manufacturer without a clear goal or idea of what you want. Taking an organized approach will make it easier to streamline your search and narrow down the right manufacturers for your products.
Before reaching out to a manufacturer, be prepared with the following details.
Make sure to start with a clear vision and communicate your idea through descriptive drawings, so the manufacturer can assess whether they can make your product. Don't forget to include comprehensive instructions on how the product should be developed. Include reference photos if possible so you can communicate your vision even more clearly.
Although it can get slightly expensive, having a prototype ready is a great way to bring your vision to life. This can prevent miscommunication and ensure that prospective manufacturers know exactly how the product should be built.
What does your budget look like? Consider additional cost factors related to logistics, shipping, and storage so you can realistically determine how much you're willing to spend on manufacturing.
One crucial aspect to consider is the manufacturing timeline. You have to make sure that you can seamlessly restock your inventory so that customers can receive their orders on time. Having a fair idea of the expected production timeline will help you assess whether a manufacturer's typical lead times will work for you.
What do you want to achieve through your partnership with the manufacturer? Clearly define your end goal so that you can easily identify manufacturers who can help you achieve it.
When selecting a manufacturer to work with, make sure they meet the following criteria:
On the flip side, be on the lookout for the following signs that could indicate that a manufacturer might not make a good partner:
Google searches and referrals can sometimes reveal reliable manufacturers in your industry. To further explore more options, you can also check out online directories such as Alibaba, Maker's Row, and MFG.
Once you have your suppliers and manufacturers sorted, the next step is to develop a distribution and fulfillment strategy. With the rise of omnichannel retail, you'll likely want to sell your products through multiple sales channels. Make sure you have a solid omnichannel fulfillment strategy to seamlessly process and fulfill orders coming from all those channels.
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Below are answers to the most common questions about suppliers and manufacturers.
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