On a sunlit beige stone countertop sit an unlabelled white tube with its cap beside it, a glass dish holding cream, a water glass beaded with condensation, and folded linen cloth, with window-frame shadows falling across the surface

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The short answer: SPF is not a number you choose, it is a number measured on people and then written down lower

A sunscreen brief almost always opens with a number. "Please hit SPF 50+ PA++++" sits on the first line.

That number is not set while the formula is being built. It is measured in a test on human subjects, and then reduced by a prescribed method before it may be printed. The sun protection factor is a ratio of minimal erythema doses obtained on human skin, and the UVA protection grade is converted from an index produced by a separate test. Raising the number is partly a formulation problem, but before that it is a testing and documentation problem.

A second question sits on top of it. A product that protects the skin from ultraviolet radiation is a functional cosmetic, so it may only be sold after each item has either passed a review or had a report submitted. Which of those two routes applies changes the evidence you have to assemble, and that difference drives most of the development schedule.

This article reads that process directly from the provisions. How Korean law splits ultraviolet products, how a project lands on review or on report, what evidence attaches to sunscreen alone, how SPF, PA and water resistance are each measured and each displayed, what conditions open the reduced-submission route, and what follows onto the label and into advertising.

The scope is the law of the Republic of Korea, and every provision cited here was read in the original on the Korean Law Information Center on 11 October 2026. This is not legal advice on any specific matter, and it makes no claim about EVAS commercial terms, facilities, or testing record.

Key takeaways

1. Korean law splits ultraviolet products in two

Article 2, subparagraph 2 of the Cosmetics Act defines functional cosmetics and places in item (c) a "product that helps the skin tan evenly or helps protect the skin from ultraviolet radiation". Two different things sit inside one item.

Article 2 of the Enforcement Rule separates them. Subparagraph 4 is a cosmetic with the function of blocking strong sunlight so that the skin tans evenly, and subparagraph 5 is a cosmetic with the function of blocking or scattering ultraviolet radiation to protect the skin from it. Sun creams, sun lotions and sun sticks, whose purpose is to block ultraviolet radiation, fall under subparagraph 5.

This split is not a filing formality. The report-route concessions and the submission exemptions examined below repeatedly address "cosmetics under subparagraphs 4 and 5 of Article 2" as a pair, so it is worth knowing where the two subparagraphs are treated alike and where they are not.

2. As a functional cosmetic it must clear a review or a report first

Article 4(1) of the Cosmetics Act provides that a cosmetics manufacturer, a cosmetics responsible distributor, or a university or research institute prescribed by Ordinance of the Prime Minister that intends to sell a product recognised as a functional cosmetic shall, for each item, undergo a review by the Minister of Food and Drug Safety or submit a report to the Minister of Food and Drug Safety as to safety and efficacy. The same applies when a submitted report or a reviewed matter is changed.

Article 4(2) adds a boundary: the efficacy review is conducted only within the efficacy and effects specified in each item of Article 2, subparagraph 2 of the Act. For an ultraviolet product, what is reviewed is the function of protecting the skin from ultraviolet radiation, not whatever else a brand would like to add.

The Act names the Minister, but the office that actually receives the filing appears in the Enforcement Rule. Article 9(1) directs the review to the President of the National Institute of Food and Drug Safety Evaluation, and Article 10(2) directs the report to the same office.

Review and report are also not a menu the brand picks from. Article 9(1) states in a parenthesis that its scope excludes functional cosmetics for which a report must be submitted under Article 10. You first ask whether the item is a report target, and go to review only when it is not.

3. One piece of evidence attaches to sunscreen alone

Article 9(1) of the Enforcement Rule lists the documents attached to the review request in five subparagraphs: subparagraph 1, origin and development history; subparagraph 2, safety data; subparagraph 3, efficacy or function data; subparagraph 4, the evidence supporting the sun protection factor and the UVA protection grade; and subparagraph 5, standards and test methods.

Subparagraph 4 is the one that attaches to ultraviolet products. It reads "evidence supporting the sun protection factor and the UVA protection grade", limited in a parenthesis to "cosmetics having the function of blocking or scattering ultraviolet radiation to protect the skin from it".

The notification states it slightly more broadly. Item (d) of subparagraph 1 of Article 4 of the Regulation on the Review of Functional Cosmetics reads "evidence supporting the sun protection factor (SPF), the water-resistant sun protection factor (SPF, water resistant or very water resistant) and the UVA protection grade (PA)", and limits it to cosmetics under subparagraphs 4 and 5 of Article 2 of the Enforcement Rule. Evidence for a water resistance claim therefore enters through this same item.

What kind of evidence it is appears in item (d) of subparagraph 1 of Article 5 of the notification. All three sets must be data under item (c)(2) of the same subparagraph, that is human application test data, produced by one of the listed measurement methods. Alongside Attached Table 3 of the notification, the lists name foreign and international standards, and the international standard numbers are given as ISO 24444 for the sun protection factor, ISO 16217 for the water-resistant sun protection factor, and ISO 24442 for UVA protection. The three lists do not name exactly the same foreign standards, so if you plan to rely on a certificate issued abroad, check the list attached to that particular item.

4. How SPF is measured

Attached Table 3 of the notification, Measurement Methods and Standards for Ultraviolet Protection Effect, is the backbone of the measurement. It defines its terms first. Ultraviolet radiation is divided into UVC at 200 to 290 nanometres, UVB at 290 to 320 nanometres, and UVA at 320 to 400 nanometres.

The sun protection factor is the index expressing a product's blocking effect against UVB, obtained by dividing the minimal erythema dose with the product applied by the minimal erythema dose without it. The minimal erythema dose is the smallest dose of UVB that can produce erythema across the entire irradiated area within 16 to 24 hours after irradiation of human skin.

The test conditions are specific.

The calculation takes each subject's index and averages them. One condition then governs whether the test stands at all. The 95 per cent confidence interval of the sun protection factor must lie within plus or minus 20 per cent of that factor. If it does not, the sample size is increased or the test conditions are reset and the test is repeated.

In a development schedule that single line causes more trouble than any other. When the results scatter, the number does not come out low; the test has to be run again.

5. The measured value and the displayed value are different

Two figures of 20 per cent now sit side by side, and they come from different provisions and mean different things. The plus or minus 20 per cent above is the confidence-interval condition that decides whether a test stands. The minus 20 per cent below is the range of numbers you are allowed to print.

Article 13(2), subparagraph 1 of the notification provides that the sun protection factor is displayed, on the basis of the measurement result, as an integer within the range down to minus 20 per cent from the mean value with the decimals discarded, and that an SPF of 50 or above is displayed as "SPF50+". The example written into the provision is clear: where the mean SPF value is 23, the displayed value is an integer between 19 and 23.

Read the other way round, that becomes a development target. If there is a number you want on the label, the measured mean has to come in at or above it. And at 50 and above, however high the measurement goes, the label converges on the single expression "SPF50+". A measured 60 and a measured 80 are not distinguishable on the package.

Attached Table 3 states the display method once more: the sun protection factor obtained by the calculation method is displayed as an integer with the decimals discarded, and the example given is SPF30.

6. The PA grade comes from a separate test

The UVA side uses different indicators. The minimal persistent pigment darkening dose is the smallest dose of UVA that produces a faint darkening recognisable across the entire irradiated area within 2 to 24 hours after irradiation of human skin, and the UVA protection factor is that dose with the product applied divided by the dose without it. It is abbreviated PFA.

Again at least ten subjects per product are required, but the selection criteria differ. Supplementary Table 5 follows the criteria in Supplementary Table 1 except that subjects are selected whose Fitzpatrick skin type is II, III or IV. The skin-type ranges of the two tests do not coincide, so the subject groups do not simply overlap.

The display method is in Chapter 4 of Attached Table 3. The PFA value is displayed as an integer with the decimals discarded, and once that value reaches 2 the grade is displayed according to the table below. It may be displayed alongside the sun protection factor, and the example in the provision is SPF30, PA+.

Printing PA++++ requires a PFA of 16 or more. A formulation change that lifts SPF does not lift PFA in the same proportion, so the two numbers have to be set as separate targets.

7. Water resistant and very water resistant differ in immersion time

A product meant to go into water picks up one more item. Chapter 3 of Attached Table 3 sets the measurement method for the water-resistant sun protection factor, and it starts by constraining the environment. The water must meet the quality standards of the Water Supply and Waterworks Installation Act and be between 23 and 32 degrees Celsius, and shear force must be applied through water circulation or air jets. The sun protection factor and the water-resistant sun protection factor must be measured in the same laboratory, on the same subjects, with the same equipment, under the same test conditions.

After the product is applied and dried, the immersion procedure branches in two.

During the rest intervals the subject must be left to dry naturally, and using a towel on the application site is prohibited. Drying after application lasts as long as the product states, and where no time is stated, at least 15 minutes in natural conditions.

The verdict is a ratio. For each subject the water-resistant sun protection factor is divided by the sun protection factor to give a water resistance ratio, and the one-sided 95 per cent confidence interval of the mean of those ratios is calculated. Attached Table 3 provides that water resistance may be claimed when the confidence interval of the water resistance ratio is 50 per cent or more, and Article 13(2), subparagraph 2 of the notification sets the same threshold for displaying "water resistant" or "very water resistant".

Those two are the expressions the provisions contemplate. The text records the display method for the water-resistant sun protection factor as "water resistant, very water resistant".

8. The report route carries concessions that exist only for ultraviolet products

Article 10(1) of the Enforcement Rule lists in three subparagraphs the items that submit a report instead of undergoing a review.

Subparagraph 1 covers a functional cosmetic whose type and content of the efficacy-producing ingredient, efficacy and effects, directions and dosage, and standards and test methods are the same as an item published by the Minister of Food and Drug Safety. All four have to match the published item.

Subparagraph 2 covers an item in which five matters are all the same as a functional cosmetic already reviewed. A party condition attaches: the cosmetics manufacturer must be the same, or the cosmetics responsible distributor must be the same, or the reviewed research institute must be the same, and on the manufacturer side only where the manufacturer designed, developed and produced the product.

Three points inside it matter for ultraviolet products.

Subparagraph 3 deals with combinations. It covers only items that mix the efficacy-producing ingredients and contents of an already-reviewed functional cosmetic under subparagraphs 4 and 5 of Article 2 with those of a published functional cosmetic under subparagraphs 1 to 3. This is the route used by the so-called multi-functional products that add brightening or wrinkle improvement to ultraviolet protection. The same minus 20 per cent deeming in item (b) applies here too.

The report itself is filed per item on Form 10, the report on items excluded from functional cosmetics review, to the President of the National Institute of Food and Drug Safety Evaluation. After confirming the requirements, that office records the report number and date, the trade name and address, the product name, and the efficacy and effects in the report register. What changes when you work from a stock formula rather than a new one is set out separately in base formula versus custom formulation.

9. The reduced-submission route, and its conditions

Even on the review route you do not build every file from scratch. Article 6 of the notification collects the exemptions, and four of them bear on ultraviolet products.

Items whose ingredient and content are published. Article 6(3) exempts submission of the data in items (a) to (c) of subparagraph 1 of Article 4 for items whose ingredient and content are published in Attached Table 4, Types of Functional Cosmetics Exempt from Data Submission. Paragraph 1 of Attached Table 4 is the ingredient and maximum concentration table for ultraviolet products, listing drometrizole at 1 per cent, ethylhexyl methoxycinnamate at 7.5 per cent, octocrylene at 10 per cent, homosalate at 10 per cent, zinc oxide at 25 per cent and titanium dioxide at 25 per cent, among others.

A scope limit is attached in a parenthesis, however. It restricts the table to products falling, within paragraph 1 of Attached Table 1 of the Regulation on Precautions for Use of Cosmetics and Labelling of Allergenic Substances, under the infant product category for ages 3 and under (lotions, creams and oils), the colour cosmetics category, and the basic skincare category. Where the product type sits outside that, the reduced submission does not apply at all.

And here is the point most often misread. The exemption in Article 6(3) runs from item (a) to item (c), and item (d), the evidence supporting the sun protection factor, is not inside that range. The proviso to Article 9(1) of the Enforcement Rule does open the possibility of omitting the data in subparagraphs 1 to 4 for items whose ingredient and content are published. The detailed scope of that omission, however, is delegated to the notification under Article 9(6) of the same Article. The scope the notification actually sets stops at item (c). Using a listed ingredient within its listed concentration does not by itself remove the measurement on human subjects.

Products at SPF 10 or less. Article 6(5) exempts submission of the data in item (d) of subparagraph 1 of Article 4 for products with a sun protection factor of 10 or less. For a product claiming a low index the testing burden genuinely falls.

Items identical to one already reviewed. For ultraviolet products, Article 6(6) exempts submission of the data in subparagraph 1 of Article 4 where the type, specification and quantity of the efficacy-producing raw material, the directions and dosage, and the dosage form are identical to a functional cosmetic already reviewed. That is the whole of subparagraph 1, item (d) included. The party condition is limited to cases where the responsible distributor is the same, or the manufacturer that designed, developed and produced the product is the same. The proviso narrows it further: for a water-resistant product the exemption applies only where the type, specification and quantity of every raw material other than fragrance and preservative, together with the directions and dosage and the dosage form, are identical.

Where human application test data is filed. Article 6(2) allows submission of the efficacy test data to be waived where human application test data is submitted among the efficacy or function data. A proviso follows: for an ingredient whose efficacy test data was waived, the efficacy and effects may not be stated on the label. The exemption is traded against what the label is then allowed to say.

10. The maximum concentrations in Attached Table 4 are not use limits

The maximum concentrations in paragraph 1 of Attached Table 4 are a condition for obtaining reduced submission, not in themselves the limit at which an ingredient may be used in a cosmetic. Use limits sit separately, in the ultraviolet filter section of Attached Table 2 of the Regulation on Safety Standards for Cosmetics, Raw Materials Subject to Restrictions on Use.

The two tables overlap substantially, but they are not the same table. TEA-salicylate, for example, appears in the ultraviolet filter section of Attached Table 2 of the safety standards notification with a use limit of 12 per cent, yet it is not in paragraph 1 of Attached Table 4 of the review regulation. A formula using that ingredient can sit inside the safety-standards limit and still fall outside the reduced-submission route.

So two separate questions have to be asked of an ingredient list. Whether this ingredient may be used at this concentration is answered by the safety standards notification; whether using it that way shortens the review file is answered by the review regulation. What else to check at the raw-material stage is collected in choosing ingredients.

11. What follows onto the label

Once the review or report is cleared, its outcome moves onto the package.

Article 10(1), subparagraph 8 of the Cosmetics Act requires a functional cosmetic to bear the words "functional cosmetic" or the design denoting a functional cosmetic as determined by the Minister of Food and Drug Safety. The shape of that design and the way it is applied are in paragraph 7, item (b) of Attached Table 4 of the Enforcement Rule. The design is scaled proportionally according to the use and the size of the packaging material, and must be shown legibly by printing, engraving or a similar method.

Item (a) of the same paragraph 7 does not reach ultraviolet products. The wording it governs is the phrase required by Article 19(4), subparagraph 7 of the Enforcement Rule, "not a medicine for the prevention or treatment of disease", and it applies to functional cosmetics under subparagraphs 8 to 11 of Article 2. Ultraviolet products fall under subparagraph 5 and are outside that requirement.

Article 19(4), subparagraph 2 of the Enforcement Rule, by contrast, applies to every functional cosmetic. The reviewed or reported efficacy and effects and the directions and dosage must be stated on the package. Label copy that diverges from what was reviewed or reported is a problem in itself.

Ultraviolet filters are also an exception to the shortening of ingredient lists. Article 19(2), subparagraph 3 of the Enforcement Rule allows some ingredients to be omitted from the labelling on packaging for a cosmetic with a content above 10 and up to 50 millilitres, or a weight above 10 and up to 50 grams. Cosmetics that the Minister of Food and Drug Safety publishes as requiring particular care in use are excluded from that allowance. And even where it applies, item (e) carves out the raw material producing a functional cosmetic's efficacy and effects, and item (f) carves out raw materials whose use limit the Minister has published. Even a small sun stick or a sample has to name its ultraviolet filters. For container decisions see packaging compatibility, and for finished-product testing see batch release testing.

12. The line to watch in advertising

Article 13(1), subparagraph 2 of the Cosmetics Act prohibits labelling or advertising likely to cause a cosmetic that is not a functional cosmetic to be mistaken for one, or that differs from the result of the review of a functional cosmetic's safety and efficacy. The second half catches sunscreen particularly often. Advertising a value higher than the one fixed by the review or report, or foregrounding a water-sports setting for a product that has no water resistance verdict, can reach it.

Article 22 of the Enforcement Rule passes the scope of labelling and advertising and the compliance matters to Attached Table 5. Three of its items bear closely on ultraviolet products. Item (b) prohibits labelling or advertising likely to cause a product that is not a functional cosmetic to be mistaken for one through its name, manufacturing method or efficacy and effects. Item (f) requires comparative advertising to state the subject and the basis clearly and to advertise only matters that can be objectively confirmed, and prohibits exclusive absolute expressions such as "best" or "finest". Item (h) prohibits advertising quality or efficacy that cannot be or has not been objectively confirmed.

Article 14(1) of the Act then requires a business operator or seller to be able to substantiate factual matters within its own labelling and advertising. Article 14(2) allows the Minister of Food and Drug Safety to request that material, specifying its content concretely, where the Minister finds substantiation necessary in order to judge whether the labelling or advertising falls under Article 13(1), subparagraph 4. Under Article 14(3) the party so requested must submit it within 15 days of the request, and that period may be extended where justifiable grounds are recognised. The requirements for substantiating material are in Article 23(2) of the Enforcement Rule. Test results must be human application test data, in vitro test data, or survey data of an equivalent or higher standard. The method of substantiation must be scientific and objective, being widely known academically or generally accepted in the relevant industry. What to prepare for a given expression is collected in substantiating claims.

13. What to put in the development brief first

Instead of a single line of numbers, writing down the following makes quotes and schedules far more accurate.

  1. The target displayed value and its basis. Which SPF and which PA grade will go on the label, and the measured value you therefore need, given that the displayed value is an integer within the range down to minus 20 per cent of the measured mean.
  2. Whether water resistance will be claimed. Water resistant or very water resistant changes the immersion procedure and the testing time.
  3. The product type. Because the scope of paragraph 1 of Attached Table 4 is limited by product type, decide first whether the product is basic skincare, colour cosmetics, or an infant product for ages 3 and under.
  4. The relationship to an already-reviewed item. Whether the raw materials, directions and dosage and dosage form are identical to an existing reviewed item of the same responsible distributor or the same manufacturer changes the scope of the exemption.
  5. Whether the product is multi-functional. If brightening or wrinkle improvement will be claimed alongside, check the combination requirements in Article 10(1), subparagraph 3 of the Enforcement Rule first.
  6. The testing body and the origin of the certificate. Whether the test is domestic or a certificate issued abroad, and if abroad, under which measurement method, checked against the list in item (d) of subparagraph 1 of Article 5 of the notification.
  7. Initial volume and line-up. Testing and production schedules interlock, so small-batch planning and MOQ is worth reading alongside.
  8. Export plans. Products made solely for export have a different range of application, so see export-only products.

How to build a brief from the beginning is set out separately in writing a product brief.

14. Frequently asked questions

How high does the measurement have to be before I can print SPF 50+?

Article 13(2), subparagraph 1 of the notification provides that an SPF of 50 or above is displayed as "SPF50+". Because the displayed value is an integer within the range down to minus 20 per cent of the measured mean with the decimals discarded, displaying 50 requires a mean of 50 or above. Above that, whatever the measurement, the display converges on the single expression "SPF50+".

If I use an ingredient combination that already has an SPF certificate, can I skip the test?

Not on the strength of the combination alone. The exemption in Article 6(6) of the notification addresses a narrower case. The type, specification and quantity of the efficacy-producing raw material, the directions and dosage, and the dosage form must be identical to a functional cosmetic already reviewed. The responsible distributor must also be the same, or the manufacturer that designed, developed and produced the product must be the same. For a water-resistant product every raw material other than fragrance and preservative must be identical as well. Bringing in someone else's certificate is a different situation with different requirements.

If I stay within the ingredients and concentrations in Attached Table 4, does the whole review file disappear?

No. The range Article 6(3) exempts runs from item (a) to item (c) of subparagraph 1 of Article 4, and item (d), the evidence supporting the sun protection factor and the UVA protection grade, sits outside it. Unless the product has a sun protection factor of 10 or less, or meets the identical-item requirements in Article 6(6), the measurement on human subjects remains.

What do I need before I can write "waterproof"?

The display expressions the provisions contemplate are "water resistant" and "very water resistant". The condition for displaying either is that the water resistance test in Attached Table 3 returns a water resistance ratio confidence interval of 50 per cent or more. Without that result, an expression suggesting the product stands up to water can run into Article 13(1), subparagraph 2 of the Act and item (h) of paragraph 2 of Attached Table 5. For the lawfulness of a specific phrase, confirming with the competent regional office of the Ministry of Food and Drug Safety is the accurate course.

Is raising the PA grade the same work as raising SPF?

It is not. The sun protection factor is a ratio of minimal erythema doses measured against UVB, and the UVA protection factor is a ratio of minimal persistent pigment darkening doses measured against UVA. The indicators and the subject selection criteria both differ, so a rise on one side cannot be taken to carry the other with it. Setting the two as separate targets is the accurate approach.

15. Next steps

In sunscreen development the first thing to settle is not the formula but the display. Decide which number goes on the label, whether water resistance will be claimed, and which product type you are building, and the route follows: review or report. That route then fixes the evidence and the schedule.

If you have a project in progress, send the target displayed value, the product type, whether water resistance will be claimed, and the relationship to any existing reviewed item through our development enquiry. Once those conditions are confirmed, we can set out the available route and the items to prepare. How a functional claim reshapes a whole development is also visible in another category in functional claims.

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