cfr_sections
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13 rows where part_number = 352 and title_number = 21 sorted by section_id
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| section_id ▼ | title_number | title_name | chapter | subchapter | part_number | part_name | subpart | subpart_name | section_number | section_heading | agency | authority | source_citation | amendment_citations | full_text |
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| 21:21:5.0.1.1.27.1.1.1 | 21 | Food and Drugs | I | D | 352 | PART 352—SUNSCREEN DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE [STAYED INDEFINITELY] | A | Subpart A—General Provisions | § 352.1 Scope. | FDA | (a) An over-the-counter sunscreen drug product in a form suitable for topical administration is generally recognized as safe and effective and is not misbranded if it meets each condition in this part and each general condition established in § 330.1 of this chapter. (b) References in this part to regulatory sections of the Code of Federal Regulations are to Chapter I of Title 21 unless otherwise noted. | ||||
| 21:21:5.0.1.1.27.1.1.2 | 21 | Food and Drugs | I | D | 352 | PART 352—SUNSCREEN DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE [STAYED INDEFINITELY] | A | Subpart A—General Provisions | § 352.3 Definitions. | FDA | As used in this part: (a) Minimal erythema dose (MED). The quantity of erythema-effective energy (expressed as Joules per square meter) required to produce the first perceptible, redness reaction with clearly defined borders. (b) Product category designation (PCD). A labeling designation for sunscreen drug products to aid in selecting the type of product best suited to an individual's complexion (pigmentation) and desired response to ultraviolet (UV) radiation. (1) Minimal sun protection product. A sunscreen product that provides a sun protection factor (SPF) value of 2 to under 12. (2) Moderate sun protection product. A sunscreen product that provides an SPF value of 12 to under 30. (3) High sun protection product. A sunscreen product that provides an SPF value of 30 or above. (c) Sunscreen active ingredient. An active ingredient listed in § 352.10 that absorbs, reflects, or scatters radiation in the UV range at wavelengths from 290 to 400 nanometers. (d) Sun protection factor (SPF) value. The UV energy required to produce an MED on protected skin divided by the UV energy required to produce an MED on unprotected skin, which may also be defined by the following ratio: SPF value = MED (protected skin (PS))/MED (unprotected skin (US)), where MED (PS) is the minimal erythema dose for protected skin after application of 2 milligrams per square centimeter of the final formulation of the sunscreen product, and MED (US) is the minimal erythema dose for unprotected skin, i.e. , skin to which no sunscreen product has been applied. In effect, the SPF value is the reciprocal of the effective transmission of the product viewed as a UV radiation filter. | ||||
| 21:21:5.0.1.1.27.2.1.1 | 21 | Food and Drugs | I | D | 352 | PART 352—SUNSCREEN DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE [STAYED INDEFINITELY] | B | Subpart B—Active Ingredients | § 352.10 Sunscreen active ingredients. | FDA | [64 FR 27687, May 21, 1999] | The active ingredient of the product consists of any of the following, within the concentration specified for each ingredient, and the finished product provides a minimum SPF value of not less than 2 as measured by the testing procedures established in subpart D of this part: (a) Aminobenzoic acid (PABA) up to 15 percent. (b) Avobenzone up to 3 percent. (c) Cinoxate up to 3 percent. (d) [Reserved] (e) Dioxybenzone up to 3 percent. (f) Homosalate up to 15 percent. (g) [Reserved] (h) Menthyl anthranilate up to 5 percent. (i) Octocrylene up to 10 percent. (j) Octyl methoxycinnamate up to 7.5 percent. (k) Octyl salicylate up to 5 percent. (l) Oxybenzone up to 6 percent. (m) Padimate O up to 8 percent. (n) Phenylbenzimidazole sulfonic acid up to 4 percent. (o) Sulisobenzone up to 10 percent. (p) Titanium dioxide up to 25 percent. (q) Trolamine salicylate up to 12 percent. (r) Zinc oxide up to 25 percent. (f) Ensulizole up to 4 percent. (g) Homosalate up to 15 percent. (h) [Reserved] (i) Meradimate up to 5 percent. (j) Octinoxate up to 7.5 percent. (k) Octisalate up to 5 percent. (l) Octocrylene up to 10 percent. (m) Oxybenzone up to 6 percent. (n) Padimate O up to 8 percent. | |||
| 21:21:5.0.1.1.27.2.1.3 | 21 | Food and Drugs | I | D | 352 | PART 352—SUNSCREEN DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE [STAYED INDEFINITELY] | B | Subpart B—Active Ingredients | § 352.20 Permitted combinations of active ingredients. | FDA | [64 FR 27687, May 21, 1999, as amended at 68 FR 33380, June 4, 2003] | The SPF of any combination product is measured by the testing procedures established in subpart D of this part. (a) Combinations of sunscreen active ingredients. (1) Two or more sunscreen active ingredients identified in § 352.10(a), (c), (e), (f), and (h) through (r) may be combined with each other in a single product when used in the concentrations established for each ingredient in § 352.10. The concentration of each active ingredient must be sufficient to contribute a minimum SPF of not less than 2 to the finished product. The finished product must have a minimum SPF of not less than the number of sunscreen active ingredients used in the combination multiplied by 2. (2) Two or more sunscreen active ingredients identified in § 352.10(b), (c), (e), (f), (i) through (l), (o), and (q) may be combined with each other in a single product when used in the concentrations established for each ingredient in § 352.10. The concentration of each active ingredient must be sufficient to contribute a minimum SPF of not less than 2 to the finished product. The finished product must have a minimum SPF of not less than the number of sunscreen active ingredients used in the combination multiplied by 2. (b) Combinations of sunscreen and skin protectant active ingredients. Any single sunscreen active ingredient or any permitted combination of sunscreen active ingredients when used in the concentrations established for each ingredient in § 352.10 may be combined with one or more skin protectant active ingredients identified in § 347.10(a), (d), (e), (g), (h), (i), (k), (l), (m), and (r) of this chapter. The concentration of each sunscreen active ingredient must be sufficient to contribute a minimum SPF of not less that 2 to the finished product. The finished product must have a minimum SPF of not less than the number of sunscreen active ingredients used in the combination multiplied by 2, and the product must be labeled according to § 352.60. (c) [Reserved] (a) Combinations of sunscreen active ingredients. (1) Two or mor… | |||
| 21:21:5.0.1.1.27.3.1.1 | 21 | Food and Drugs | I | D | 352 | PART 352—SUNSCREEN DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE [STAYED INDEFINITELY] | C | Subpart C—Labeling | § 352.50 Principal display panel of all sunscreen drug products. | FDA | In addition to the statement of identity required in § 352.52, the following labeling statements shall be prominently placed on the principal display panel: (a) For products that do not satisfy the water resistant or very water resistant sunscreen product testing procedures in § 352.76 —(1) For products with SPF values up to 30. “SPF (insert tested SPF value of the product up to 30).” (2) For products with SPF values over 30. “SPF 30” (select one of the following: “plus” or “ + ”). Any statement accompanying the marketed product that states a specific SPF value above 30 or similar language indicating a person can stay in the sun more than 30 times longer than without sunscreen will cause the product to be misbranded under section 502 of the Federal Food, Drug, and Cosmetic Act (the act). (b) For products that satisfy the water resistant sunscreen product testing procedures in § 352.76. (1) (Select one of the following: “Water,” “Water/Sweat,” or “Water/Perspiration”) “Resistant.” (2) “SPF (insert SPF value of the product, as stated in paragraph (a)(1) or (a)(2) of this section, after it has been tested using the water resistant sunscreen product testing procedures in § 352.76).” (c) For products that satisfy the very water resistant sunscreen product testing procedures in § 352.76. (1) “Very” (select one of the following: “Water,” “Water/Sweat,” or “Water/Perspiration”) “Resistant.” (2) “SPF (insert SPF value of the product, as stated in paragraph (a)(1) or (a)(2) of this section, after it has been tested using the very water resistant sunscreen product testing procedures in § 352.76).” | ||||
| 21:21:5.0.1.1.27.3.1.2 | 21 | Food and Drugs | I | D | 352 | PART 352—SUNSCREEN DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE [STAYED INDEFINITELY] | C | Subpart C—Labeling | § 352.52 Labeling of sunscreen drug products. | FDA | [64 FR 27687, May 21, 1999, as amended at 68 FR 33380, June 4, 2003] | (a) Statement of identity. The labeling of the product contains the established name of the drug, if any, and identifies the product as a “sunscreen.” (b) Indications. The labeling of the product states, under the heading “Uses,” all of the phrases listed in paragraph (b)(1) of this section that are applicable to the product and may contain any of the additional phrases listed in paragraph (b)(2) of this section, as appropriate. Other truthful and nonmisleading statements, describing only the uses that have been established and listed in this paragraph (b), may also be used, as provided in § 330.1(c)(2) of this chapter, subject to the provisions of section 502 of the act relating to misbranding and the prohibition in section 301(d) of the act against the introduction or delivery for introduction into interstate commerce of unapproved new drugs in violation of section 505(a) of the act. (1) For products containing any ingredient in § 352.10. (i) “[bullet] 1 helps prevent sunburn [bullet] higher SPF gives more sunburn protection”. 1 See § 201.66(b)(4) of this chapter. (ii) For products that satisfy the water resistant testing procedures identified in § 352.76. “[bullet] retains SPF after 40 minutes of” (select one or more of the following: “activity in the water,” “sweating,” or “perspiring”). (iii) For products that satisfy the very water resistant testing procedures identified in § 352.76. “[bullet] retains SPF after 80 minutes of” (select one or more of the following: “activity in the water,” “sweating,” or “perspiring”). (2) Additional indications. In addition to the indications provided in paragraph (b)(1) of this section, the following may be used for products containing any ingredient in § 352.10: (i) For products that provide an SPF of 2 to under 12. Select one or both of the following: [“[bullet]” (select one of the following: “provides minimal,” “provides minimum,” “minimal,” or “minimum”) “protection against” (select one of the following: “sunburn” or “sunburn and tanning”)], … | |||
| 21:21:5.0.1.1.27.3.1.3 | 21 | Food and Drugs | I | D | 352 | PART 352—SUNSCREEN DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE [STAYED INDEFINITELY] | C | Subpart C—Labeling | § 352.60 Labeling of permitted combinations of active ingredients. | FDA | [64 FR 27687, May 21, 1999, as amended at 68 FR 33380, June 4, 2003] | Statements of identity, indications, warnings, and directions for use, respectively, applicable to each ingredient in the product may be combined to eliminate duplicative words or phrases so that the resulting information is clear and understandable. (a) Statement of identity. For a combination drug product that has an established name, the labeling of the product states the established name of the combination drug product, followed by the statement of identity for each ingredient in the combination, as established in the statement of identity sections of the applicable OTC drug monographs. For a combination drug product that does not have an established name, the labeling of the product states the statement of identity for each ingredient in the combination, as established in the statement of identity sections of the applicable OTC drug monographs. (b) Indications. The labeling of the product states, under the heading “Uses,” the indication(s) for each ingredient in the combination as established in the indications sections of the applicable OTC drug monographs, unless otherwise stated in this paragraph. Other truthful and nonmisleading statements, describing only the indications for use that have been established in the applicable OTC drug monographs or listed in this paragraph (b), may also be used, as provided by § 330.1(c)(2) of this chapter, subject to the provisions of section 502 of the Federal Food, Drug, and Cosmetic Act (the act) relating to misbranding and the prohibition in section 301(d) of the act against the introduction or delivery for introduction into interstate commerce of unapproved new drugs in violation of section 505(a) of the act. (1) In addition, the labeling of the product may contain any of the “other allowable statements” that are identified in the applicable monographs. (2) For permitted combinations containing a sunscreen and a skin protectant identified in § 352.20(b), any or all of the applicable indications for sunscreens in § 352.52(b) and the indication for skin protect… | |||
| 21:21:5.0.1.1.27.4.1.1 | 21 | Food and Drugs | I | D | 352 | PART 352—SUNSCREEN DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE [STAYED INDEFINITELY] | D | Subpart D—Testing Procedures | § 352.70 Standard sunscreen. | FDA | (a) Laboratory validation. A standard sunscreen shall be used concomitantly in the testing procedures for determining the SPF value of a sunscreen drug product to ensure the uniform evaluation of sunscreen drug products. The standard sunscreen shall be an 8-percent homosalate preparation with a mean SPF value of 4.47 (standard deviation = 1.279). In order for the SPF determination of a test product to be considered valid, the SPF of the standard sunscreen must fall within the standard deviation range of the expected SPF ( i.e. , 4.47 ±1.279) and the 95-percent confidence interval for the mean SPF must contain the value 4. (b) Preparation of the standard homosalate sunscreen. (1) The standard homosalate sunscreen is prepared from two different preparations (preparation A and preparation B) with the following compositions: Composition of Preparation A and Preparation B of the Standard Sunscreen (2) Preparation A and preparation B are heated separately to 77 to 82 °C, with constant stirring, until the contents of each part are solubilized. Add preparation A slowly to preparation B while stirring. Continue stirring until the emulsion formed is cooled to room temperature (15 to 30 °C). Add sufficient purified water to obtain 100 grams of standard sunscreen preparation. (c) Assay of the standard homosalate sunscreen. Assay the standard homosalate sunscreen preparation by the following method to ensure proper concentration: (1) Preparation of the assay solvent. The solvent consists of 1 percent glacial acetic acid (V/V) in denatured ethanol. The denatured ethanol should not contain a UV radiation absorbing denaturant. (2) Preparation of a 1-percent solution of the standard homosalate sunscreen preparation. Accurately weigh 1 gram of the standard homosalate sunscreen preparation into a 100-milliliter volumetric flask. Add 50 milliliters of the assay solvent. Heat on a steam bath and mix well. Cool the solution to room temperature (15 to 30 °C). Then dilute the solution to volume with the assay solvent an… | ||||
| 21:21:5.0.1.1.27.4.1.2 | 21 | Food and Drugs | I | D | 352 | PART 352—SUNSCREEN DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE [STAYED INDEFINITELY] | D | Subpart D—Testing Procedures | § 352.71 Light source (solar simulator). | FDA | A solar simulator used for determining the SPF of a sunscreen drug product should be filtered so that it provides a continuous emission spectrum from 290 to 400 nanometers similar to sunlight at sea level from the sun at a zenith angle of 10° it has less than 1 percent of its total energy output contributed by nonsolar wavelengths shorter than 290 nanometers; and it has not more than 5 percent of its total energy output contributed by wavelengths longer than 400 nanometers. In addition, a solar simulator should have no significant time-related fluctuations in radiation emissions after an appropriate warmup time, and it should have good beam uniformity (within 10 percent) in the exposure plane. To ensure that the solar simulator delivers the appropriate spectrum of UV radiation, it must be measured periodically with an accurately-calibrated spectroradiometer system or equivalent instrument. | ||||
| 21:21:5.0.1.1.27.4.1.3 | 21 | Food and Drugs | I | D | 352 | PART 352—SUNSCREEN DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE [STAYED INDEFINITELY] | D | Subpart D—Testing Procedures | § 352.72 General testing procedures. | FDA | (a) Selection of test subjects (male and female). (1) Only fair-skin subjects with skin types I, II, and III using the following guidelines shall be selected: Selection of Fair-skin Subjects Skin Type and Sunburn and Tanning History (Based on first 30 to 45 minutes sun exposure after a winter season of no sun exposure.) I—Always burns easily; never tans (sensitive). II—Always burns easily; tans minimally (sensitive). III—Burns moderately; tans gradually (light brown) (normal). IV—Burns minimally; always tans well (moderate brown) (normal). V—Rarely burns; tans profusely (dark brown) (insensitive). VI—Never burns; deeply pigmented (insensitive). Selection of Fair-skin Subjects Skin Type and Sunburn and Tanning History (Based on first 30 to 45 minutes sun exposure after a winter season of no sun exposure.) I—Always burns easily; never tans (sensitive). II—Always burns easily; tans minimally (sensitive). III—Burns moderately; tans gradually (light brown) (normal). IV—Burns minimally; always tans well (moderate brown) (normal). V—Rarely burns; tans profusely (dark brown) (insensitive). VI—Never burns; deeply pigmented (insensitive). (2) A medical history shall be obtained from all subjects with emphasis on the effects of sunlight on their skin. Ascertain the general health of the individual, the individual's skin type (I, II, or III), whether the individual is taking medication (topical or systemic) that is known to produce abnormal sunlight responses, and whether the individual is subject to any abnormal responses to sunlight, such as a phototoxic or photoallergic response. (b) Test site inspection. The physical examination shall determine the presence of sunburn, suntan, scars, active dermal lesions, and uneven skin tones on the areas of the back to be tested. The presence of nevi, blemishes, or moles will be acceptable if in the physician's judgment they will not interfere with the study results. Excess hair on the back is acceptable if the hair is clipped or shaved. (c) Inf… | ||||
| 21:21:5.0.1.1.27.4.1.4 | 21 | Food and Drugs | I | D | 352 | PART 352—SUNSCREEN DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE [STAYED INDEFINITELY] | D | Subpart D—Testing Procedures | § 352.73 Determination of SPF value. | FDA | (a)(1) The following erythema action spectrum shall be used to calculate the erythema effective exposure of a solar simulator: V i (λ) = 1.0 (250 <λ <298 nm) V i (λ) = 1.0 0.094 (298 - l ) (298 <λ <328 nanometers) V i (λ) = 1.0 0.015 (139 - l ) (328 <λ <400 nanometers) (2) The data contained in this action spectrum are to be used as spectral weighting factors to calculate the erythema effective exposure of a solar simulator as follows: (b) Determination of MED of the unprotected skin. A series of UV radiation exposures expressed as Joules per square meter (adjusted to the erythema action spectrum calculated according to § 352.73(a)) is administered to the subsite areas on each subject with an accurately calibrated solar simulator. A series of five exposures shall be administered to the untreated, unprotected skin to determine the subject's inherent MED. The doses selected shall be a geometric series represented by (1.25 n ), wherein each exposure time interval is 25 percent greater than the previous time to maintain the same relative uncertainty (expressed as a constant percentage), independent of the subject's sensitivity to UV radiation, regardless of whether the subject has a high or low MED. Usually, the MED of a person's unprotected skin is determined the day prior to testing a product. This MED(US) shall be used in the determination of the series of UV radiation exposures to be administered to the protected site in subsequent testing. The MED(US) should be determined again on the same day as the standard and test sunscreens and this MED(US) should be used in calculating the SPF. (c) Determination of individual SPF values. A series of UV radiation exposures expressed as Joules per square meter (adjusted to the erythema action spectrum calculated according to § 352.73(a)) is administered to the subsite areas on each subject with an accurately-calibrated solar simulator. A series of seven exposures shall be administered to the protected test sites to determine the MED of the protected skin … | ||||
| 21:21:5.0.1.1.27.4.1.5 | 21 | Food and Drugs | I | D | 352 | PART 352—SUNSCREEN DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE [STAYED INDEFINITELY] | D | Subpart D—Testing Procedures | § 352.76 Determination if a product is water resistant or very water resistant. | FDA | The general testing procedures in § 352.72 shall be used as part of the following tests, except where modified in this section. An indoor fresh water pool, whirlpool, and/or jacuzzi maintained at 23 to 32 °C shall be used in these testing procedures. Fresh water is clean drinking water that meets the standards in 40 CFR part 141. The pool and air temperature and the relative humidity shall be recorded. (a) Procedure for testing the water resistance of a sunscreen product. For sunscreen products making the claim of “water resistant,” the label SPF shall be the label SPF value determined after 40 minutes of water immersion using the following procedure for the water resistance test: (1) Apply sunscreen product (followed by the waiting period after application of the sunscreen product indicated on the product labeling). (2) 20 minutes moderate activity in water. (3) 20-minute rest period (do not towel test sites). (4) 20 minutes moderate activity in water. (5) Conclude water test (air dry test sites without toweling). (6) Begin solar simulator exposure to test site areas as described in § 352.73. (b) Procedure for testing a very water resistant sunscreen product. For sunscreen products making the claim of “very water resistant,” the label SPF shall be the label SPF value determined after 80 minutes of water immersion using the following procedure for the very water resistant test: (1) Apply sunscreen product (followed by the waiting period after application of the sunscreen product indicated on the product labeling). (2) 20 minutes moderate activity in water. (3) 20-minute rest period (do not towel test sites). (4) 20 minutes moderate activity in water. (5) 20-minute rest period (do not towel test sites). (6) 20 minutes moderate activity in water. (7) 20-minute rest period (do not towel test sites). (8) 20 minutes moderate activity in water. (9) Conclude water test (air dry test sites without toweling). (10) Begin solar simulator exposure to test site areas as described in § 352.73. | ||||
| 21:21:5.0.1.1.27.4.1.6 | 21 | Food and Drugs | I | D | 352 | PART 352—SUNSCREEN DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE [STAYED INDEFINITELY] | D | Subpart D—Testing Procedures | § 352.77 Test modifications. | FDA | The formulation or mode of administration of certain products may require modification of the testing procedures in this subpart. In addition, alternative methods (including automated or in vitro procedures) employing the same basic procedures as those described in this subpart may be used. Any proposed modification or alternative procedure shall be submitted as a petition in accord with § 10.30 of this chapter. The petition should contain data to support the modification or data demonstrating that an alternative procedure provides results of equivalent accuracy. All information submitted will be subject to the disclosure rules in part 20 of this chapter. |
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CREATE TABLE cfr_sections (
section_id TEXT PRIMARY KEY,
title_number INTEGER,
title_name TEXT,
chapter TEXT,
subchapter TEXT,
part_number TEXT,
part_name TEXT,
subpart TEXT,
subpart_name TEXT,
section_number TEXT,
section_heading TEXT,
agency TEXT,
authority TEXT,
source_citation TEXT,
amendment_citations TEXT,
full_text TEXT
);
CREATE INDEX idx_cfr_title ON cfr_sections(title_number);
CREATE INDEX idx_cfr_part ON cfr_sections(part_number);
CREATE INDEX idx_cfr_agency ON cfr_sections(agency);