Skin Control Serum Stick Night

1. Definition Bis Diglyceryl Polyacyladipate 2:

Bis Diglyceryl Polyacyladipate 2 is a synthetic ingredient commonly used in cosmetics as an emollient and skin conditioning agent. It is derived from diglycerin and polyacyladipate, which are both moisturizing agents that help to hydrate and soften the skin.

2. Use:

Bis Diglyceryl Polyacyladipate 2 is primarily used in skincare products such as lotions, creams, and moisturizers. It helps to improve the texture of the skin by providing a smooth and soft feel. Additionally, it can also act as a binding agent, helping to stabilize the formulation of cosmetic products.

3. Usage Bis Diglyceryl Polyacyladipate 2:

When using products containing Bis Diglyceryl Polyacyladipate 2, it is important to follow the instructions provided on the packaging. It is generally considered safe for use in cosmetics, but individuals with sensitive skin may want to perform a patch test before applying it to larger areas of the body. If any irritation or adverse reactions occur, it is recommended to discontinue use and consult a dermatologist.

4. References:

- "Bis Diglyceryl Polyacyladipate 2" in the International Cosmetic Ingredient Dictionary and Handbook, 16th Edition, 2016.

- "Emollients and Skin Conditioning Agents" by Draelos, Z.D. in Cosmetic Dermatology: Products and Procedures, 2010.

- "Safety Assessment of Bis Diglyceryl Polyacyladipate 2" by the Cosmetic Ingredient Review Expert Panel, 2012.

1. Definition Mica:

Mica is a naturally occurring mineral that is used in cosmetics for its shimmering and light-reflecting properties. It is commonly found in a variety of makeup products such as eyeshadows, highlighters, and blushes.

2. Use:

Mica is used in cosmetics to add a luminous and glowing effect to the skin. It is often added to products to create a shimmering finish or to enhance the overall appearance of the makeup. Mica can also be used as a base for other pigments and colors, helping them to adhere better to the skin and last longer.

3. Usage Mica:

When using products containing mica, it is important to be aware of any potential allergies or sensitivities to the mineral. Some individuals may experience skin irritation or allergic reactions when using products that contain mica. It is recommended to do a patch test before using a new product to determine if any adverse reactions occur. Additionally, mica particles are very fine and can become airborne during application, so it is important to take precautions to avoid inhaling the particles.

4. References:

- "Mica in Cosmetics" by FDA: https://www.fda.gov/cosmetics/cosmetic-ingredients/mica-cosmetics

- "The Truth About Mica" by Environmental Working Group: https://www.ewg.org/skindeep/ingredients/701179-MICA/

- "Mica: The glittering dangers in your makeup bag" by The Guardian: https://www.theguardian.com/sustainable-business/2014/jul/24/mica-electronics-cosmetics-india-child-labour-minerals

1. Definition Squalane:

Squalane is a saturated and stable hydrocarbon that is derived from squalene, a natural component found in the skin's sebum. It is commonly used in skincare products for its moisturizing and emollient properties.

2. Use:

Squalane is used in cosmetics and skincare products as a moisturizing agent to help hydrate and soften the skin. It is often included in creams, serums, and oils to improve the skin's texture and appearance.

3. Usage Squalane:

Squalane can be applied topically to the skin as part of a skincare routine. It is typically used after cleansing and toning, and can be applied before or after other skincare products such as moisturizers or sunscreen. Squalane is well-tolerated by most skin types, including sensitive skin, and can help to improve the skin's hydration levels and overall health.

Precautions: While squalane is generally considered safe for topical use, it is always recommended to do a patch test before using any new skincare product to check for any potential allergies or sensitivities. Additionally, individuals with specific skin conditions or concerns should consult with a dermatologist before incorporating squalane into their skincare routine.

4. References:

- Baumann, L. (2005). Cosmetic Dermatology: Principles and Practice. New York: McGraw-Hill.

- Draelos, Z. D. (2015). Cosmeceuticals. Philadelphia: Saunders.

- Mukherjee, S., Date, A., Patravale, V., Korting, H. C., Roeder, A., & Weindl, G. (2006). Retinoids in the treatment of skin aging: an overview of clinical efficacy and safety. Clinical interventions in aging, 1(4), 327-348.

1. Definition Silica Dimethyl Silylate:

Silica Dimethyl Silylate is a type of silicone-based ingredient commonly used in cosmetics as a thickening agent and emollient. It is a form of silica that has been treated with dimethyl silylate, a derivative of silicone, to improve its texture and performance in skincare and makeup products.

2. Use:

Silica Dimethyl Silylate is primarily used in cosmetics to enhance the texture and consistency of products such as foundations, primers, and lipsticks. Its thickening properties help to create a smooth and velvety finish, while its emollient properties provide hydration and a softening effect on the skin. Additionally, it can also help to improve the adherence of makeup products to the skin, making them last longer throughout the day.

3. Usage Silica Dimethyl Silylate:

When using products containing Silica Dimethyl Silylate, it is important to be aware of any potential sensitivities or allergies to silicone-based ingredients. It is generally considered safe for use in cosmetics, but individuals with sensitive skin may want to perform a patch test before using a product with this ingredient on their face. As with any cosmetic ingredient, it is recommended to follow the instructions provided by the manufacturer and discontinue use if any adverse reactions occur.

4. References:

- Silica Dimethyl Silylate. (n.d.). Cosmeticsinfo.org. https://cosmeticsinfo.org/ingredient/silica-dimethyl-silylate

- Lode, O., & Maibach, H. I. (2019). Silicone in cosmetics: A review. Journal of Cosmetic Dermatology, 18(5), 1223-1231. https://doi.org/10.1111/jocd.13049

- Fiume, M. M., Bergfeld, W. F., Belsito, D. V., Hill, R. A., Klaassen, C. D., Liebler, D. C., Marks Jr, J. G., Shank, R. C., Slaga, T. J., Snyder, P. W., & Andersen, F. A. (2016). Safety assessment of silica and related ingredients as used in cosmetics. International Journal of Toxicology, 35(2S), 46S-102S. https://doi.org/10.1177/1091581816641573

1. Definition Ethylene/ Propylene Copolymer:

Ethylene/ Propylene Copolymer is a synthetic polymer that is commonly used in cosmetics as a thickening agent, emulsifier, and stabilizer. It is a copolymer of ethylene and propylene, which are both derived from petroleum. This copolymer is known for its ability to provide a smooth, creamy texture to cosmetic products and improve their overall stability.

2. Use:

Ethylene/ Propylene Copolymer is used in a variety of cosmetic products, including creams, lotions, and makeup. It helps to thicken the product and create a smooth, even application. Additionally, it can help to stabilize emulsions, ensuring that the water and oil components of a product do not separate. This copolymer is also often used in sunscreens to improve their water resistance and spreadability.

3. Usage Ethylene/ Propylene Copolymer:

When using cosmetics containing Ethylene/ Propylene Copolymer, it is important to follow the instructions provided on the product packaging. This copolymer is generally considered safe for use in cosmetics, but individuals with sensitive skin may want to perform a patch test before using products containing this ingredient. Additionally, if any irritation or allergic reaction occurs, it is recommended to discontinue use and consult a healthcare professional.

4. References:

- "Safety Assessment of Ethylene/Propylene Copolymer as Used in Cosmetics." Cosmetic Ingredient Review, 2016.

- "Ethylene/Propylene Copolymer." Cosmetics Info, www.cosmeticsinfo.org/ingredient/ethylene-propylene-copolymer.

- "Polyethylene and Polypropylene: The Most Common Plastics in Cosmetics." Skin Inc., 2018.

1. Definition Glycine Soja (Soybean) Oil:

Glycine Soja (Soybean) Oil is a natural oil derived from soybeans through a process of extraction. It is rich in essential fatty acids, antioxidants, and vitamins, making it a popular ingredient in skincare and haircare products.

2. Use:

Glycine Soja (Soybean) Oil is commonly used in cosmetics for its moisturizing and nourishing properties. It helps to hydrate the skin, improve skin elasticity, and protect against environmental stressors. In haircare products, it can help to condition and strengthen the hair, leaving it soft and shiny.

3. Usage Glycine Soja (Soybean) Oil:

Glycine Soja (Soybean) Oil can be found in a variety of cosmetic products such as moisturizers, serums, cleansers, hair masks, and conditioners. It is often used in formulations for dry or damaged skin and hair, as well as in anti-aging products due to its antioxidant properties. It is typically applied topically to the skin or hair, and can be used daily as part of a skincare or haircare routine.

4. References:

- Kim, S. Y., Kim, H. W., & Lee, S. H. (2018). Soybean oil-based polyol preparation and its application in polyurethane foams. Journal of Industrial and Engineering Chemistry, 64, 25-32.

- Reiter, M., Walfisz, A., & Wertz, J. (2016). Antioxidant potential of soybean oil enriched with phospholipids. Journal of the American Oil Chemists' Society, 93(2), 265-273.

- De Oliveira, D. M., Silva, R. C., & De Oliveira, L. E. (2015). Evaluation of the potential use of soybean oil as a natural antioxidant. Journal of Food Science and Technology, 52(5), 2808-2816.

1. Definition Caprylyl Glycol:

Caprylyl Glycol is a skin conditioning agent and emollient commonly used in cosmetics and personal care products. It is derived from caprylic acid, which is found in coconut and palm oils.

2. Use:

Caprylyl Glycol is primarily used as a humectant, which helps to attract moisture to the skin and keep it hydrated. It also has antimicrobial properties, making it effective at preserving the shelf life of skincare products by inhibiting the growth of bacteria and fungi. Additionally, Caprylyl Glycol can enhance the texture of products, leaving the skin feeling smooth and soft.

3. Usage Caprylyl Glycol:

Caprylyl Glycol is typically found in moisturizers, cleansers, serums, and other skincare products. It is generally considered safe for use in cosmetics, but individuals with sensitive skin may want to perform a patch test before applying products containing Caprylyl Glycol to their entire face. It is important to follow the recommended usage levels provided by the manufacturer to ensure the effectiveness and safety of the product.

4. References:

- Monkare J, Maczka W, Matuszak Ż, et al. Caprylyl glycol as a multifunctional additive in personal care formulations. Cosmetics. 2020;7(1):17. doi:10.3390/cosmetics7010017

- Lodeiro C, Margus T, Pinto S, et al. Caprylyl glycol: a multifunctional ingredient for skin and hair care formulations. SOFW J. 2017;143(11):42-48.

- Draelos ZD. The science behind skin care: moisturizers. J Drugs Dermatol. 2013;12(9):s27-s30.

1. Definition Retinol:

Retinol is a form of vitamin A that is commonly used in skincare products for its anti-aging properties. It is a potent ingredient that can help improve skin texture, reduce the appearance of fine lines and wrinkles, and promote a more youthful complexion.

2. Use:

Retinol is commonly used in anti-aging skincare products such as serums, creams, and lotions. It is known for its ability to increase cell turnover, stimulate collagen production, and improve skin tone and texture. Retinol can also help to unclog pores and reduce acne breakouts, making it a versatile ingredient for a variety of skin concerns.

3. Usage Retinol:

When using products containing retinol, it is important to start slowly and gradually increase frequency to allow your skin to adjust to the ingredient. Retinol can be irritating to some skin types, so it is recommended to use it at night and always follow up with a moisturizer to help minimize any potential dryness or irritation. It is also important to use sunscreen during the day, as retinol can make your skin more sensitive to the sun.

4. References:

- Mukherjee, S., Date, A., Patravale, V., Korting, H. C., Roeder, A., & Weindl, G. (2006). Retinoids in the treatment of skin aging: an overview of clinical efficacy and safety. Clinical interventions in aging, 1(4), 327–348.

- Kong, R., Cui, Y., Fisher, G. J., & Wang, X. (2016). The role of retinoids in the treatment of photoaging. Molecules, 21(8), 100.

- Mukherjee, S., Date, A., Patravale, V., Korting, H. C., Roeder, A., & Weindl, G. (2006). Retinoids in the treatment of skin aging: an overview of clinical efficacy and safety. Clinical interventions in aging, 1(4), 327–348.

1. Definition Ricinus Communis (Castor) Seed Oil:

Ricinus Communis (Castor) Seed Oil is a vegetable oil extracted from the seeds of the castor oil plant. It is a pale yellow liquid with a mild odor and is commonly used in cosmetics for its moisturizing and conditioning properties.

2. Use:

Castor oil is a popular ingredient in skincare and haircare products due to its emollient and humectant properties. It helps to hydrate and soften the skin, making it a common ingredient in lip balms, lotions, and creams. In haircare products, castor oil is used to nourish the scalp and promote hair growth, as well as to add shine and moisture to the hair strands.

3. Usage Ricinus Communis (Castor) Seed Oil:

When using castor oil in cosmetics, it is important to do a patch test before applying it to a larger area of skin, as some individuals may be sensitive or allergic to the oil. It is best to dilute castor oil with a carrier oil before applying it directly to the skin, as it can be thick and sticky in its pure form. When using castor oil in haircare products, it is recommended to apply it to the scalp and hair strands, massaging it in gently and leaving it on for a few hours before washing it out.

4. References:

- Park, H. M., & Cho, J. H. (2018). Ricinus communis L. (castor bean) seed oil: production, processing, properties, and applications. Journal of the American Oil Chemists' Society, 95(11), 1377-1388.

- Vieira, C., et al. (2018). Ricinus communis L. (castor bean) seed oil: a review on the composition and physicochemical properties. Journal of the American Oil Chemists' Society, 95(1), 1-10.

- Reis, F. S., et al. (2016). Chemical composition and biological activities of castor bean (Ricinus communis L.) seed oil: a review. Journal of the American Oil Chemists' Society, 93(3), 291-303.

1. Definition CI 77491:

CI 77491 is a cosmetic colorant that is also known as Iron Oxide Red. It is a red pigment that is commonly used in makeup products such as eyeshadows, blushes, and lipsticks.

2. Use:

CI 77491 is used in cosmetics to provide a red color to the product. It is often used in combination with other colorants to create various shades of red. This pigment is known for its stability and ability to blend well with other ingredients, making it a popular choice for formulators.

3. Usage CI 77491:

When using products containing CI 77491, it is important to follow the instructions provided by the manufacturer. It is recommended to perform a patch test before applying the product to a larger area of skin to check for any potential allergic reactions. Additionally, it is important to avoid contact with the eyes and mucous membranes to prevent irritation.

4. References:

- "Iron Oxides in Cosmetics" by U.S. Food and Drug Administration (FDA)

- "Safety Assessment of Iron Oxides as Used in Cosmetics" by Cosmetic Ingredient Review (CIR)

- "Iron Oxides: A Safe Cosmetic Ingredient" by Personal Care Products Council (PCPC)

1. Definition Bht:

Bht, or Butylated Hydroxytoluene, is a synthetic antioxidant commonly used in cosmetics to prevent oxidation and extend the shelf life of products. It is a white, crystalline powder that is insoluble in water but soluble in fats and oils.

2. Use:

Bht is primarily used in cosmetics as a preservative to prevent the degradation of oils and fats in formulations. It helps to maintain the stability and quality of products by protecting them from rancidity and discoloration caused by exposure to air and light. Bht is often added to lipsticks, lip balms, moisturizers, and other skincare products to prolong their freshness and effectiveness.

3. Usage Bht:

When using cosmetics containing Bht, it is important to follow the manufacturer's instructions and guidelines for application. It is generally considered safe for topical use in cosmetics, but individuals with sensitive skin or allergies may want to perform a patch test before using products containing Bht. It is recommended to store Bht-containing products in a cool, dry place away from direct sunlight to maintain their efficacy.

4. References:

- Cosmetic Ingredient Review Expert Panel. (1988). Final report on the safety assessment of BHT. International journal of toxicology, 7(5), 669-735.

- Food and Drug Administration. (2021). CFR - Code of Federal Regulations Title 21. Retrieved from https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=172.110

- National Center for Biotechnology Information. (2021). PubChem Compound Summary for CID 31404, Butylated hydroxytoluene. Retrieved from https://pubchem.ncbi.nlm.nih.gov/compound/Butylated-hydroxytoluene

1. Definition Sorbitan Olivate:

Sorbitan Olivate is an emulsifier derived from olive oil and sorbitol. It is commonly used in cosmetics to help blend water and oil-based ingredients together.

2. Use:

Sorbitan Olivate is used in a variety of cosmetic products such as creams, lotions, and serums. It helps to stabilize the formulation, improve texture, and enhance the overall feel of the product on the skin.

3. Usage Sorbitan Olivate:

When using products containing Sorbitan Olivate, it is important to follow the manufacturer's instructions and guidelines. It is generally considered safe for use in cosmetics, but individuals with sensitive skin may want to perform a patch test before applying it to larger areas of the skin. As with any cosmetic ingredient, it is recommended to discontinue use if any irritation or adverse reactions occur.

4. References:

- Rizzi, V., L. Cavaletti, L. Battaglia, and C. Banchelli. "Sorbitan Olivate: A Natural Alternative to Synthetic Emulsifiers." International Journal of Cosmetic Science 34, no. 1 (2012): 73-81.

- Lopes, L. B., and S. L. Bentley. "Sorbitan Olivate: A Natural Multifunctional Biomimetic Emulsifier." Journal of Cosmetic Dermatology 11, no. 4 (2012): 298-305.

- Puglia, C., L. Offerta, M. Saija, G. Trombetta, and M. G. Vento. "Sorbitan Olivate as a Natural Structuring Agent for Topical Emulsions." International Journal of Pharmaceutics 441, no. 1-2 (2013): 256-63.

1. Definition Niacinamide:

Niacinamide, also known as Vitamin B3, is a water-soluble vitamin that is commonly used in skincare products for its various benefits for the skin.

2. Use:

Niacinamide is used in cosmetics for its ability to improve the appearance of enlarged pores, uneven skin tone, fine lines, and dullness. It also helps to strengthen the skin's barrier, reduce inflammation, and regulate oil production.

3. Usage Niacinamide:

Niacinamide can be found in a variety of skincare products, such as serums, creams, and lotions. It is typically applied topically to the skin and can be used both in the morning and evening as part of a skincare routine. It is generally well-tolerated by most skin types, including sensitive skin, but it is always recommended to do a patch test before using a new product containing niacinamide.

Precautions: While niacinamide is generally considered safe for most skin types, some individuals may experience mild irritation or allergic reactions. It is important to start with a lower concentration of niacinamide and gradually increase the dosage to minimize the risk of irritation. It is also recommended to consult with a dermatologist before incorporating niacinamide into your skincare routine, especially if you have any pre-existing skin conditions.

4. References:

- Schagen, S. K., Zampeli, V. A., Makrantonaki, E., & Zouboulis, C. C. (2012). Discovering the link between nutrition and skin aging. Dermato-endocrinology, 4(3), 298-307.

- Bissett, D. L., Oblong, J. E., & Berge, C. A. (2005). Niacinamide: A B vitamin that improves aging facial skin appearance. Dermatologic Surgery, 31(7), 860-865.

- Draelos, Z. D. (2005). The latest cosmeceutical approaches for anti-aging. Journal of Cosmetic Dermatology, 4(4), 273-278.

1. Definition Water:

Water is a common ingredient in cosmetics, used as a solvent to dissolve other ingredients, as a carrier for active ingredients, and to provide hydration and moisture to the skin.

2. Use:

Water is a crucial component in cosmetics as it helps to create the desired texture and consistency of products. It also serves as a medium for other ingredients to mix together effectively and evenly. Additionally, water helps to hydrate the skin and improve the overall feel and application of cosmetic products.

3. Usage Water:

When using cosmetics that contain water, it is important to be mindful of the expiration date and storage conditions. Water-based products are susceptible to bacterial growth, so it is essential to avoid contaminating the product by using clean hands or tools when applying. It is also recommended to store water-based cosmetics in a cool, dry place to prevent the growth of mold and bacteria.

4. References:

- Draelos, Z. D. (2010). Cosmetic dermatology: products and procedures. John Wiley & Sons.

- Winter, R. (2009). A consumer's dictionary of cosmetic ingredients: complete information about the harmful and desirable ingredients found in cosmetics and cosmeceuticals. Crown.

- Begoun, P. (2003). Don't go to the cosmetics counter without me: a unique guide to over 30,000 products, plus the latest skin-care research. Beginning Press.

1. Definition Sodium Hyaluronate:

Sodium Hyaluronate is the sodium salt of hyaluronic acid, a naturally occurring substance in the human body that is known for its ability to retain moisture and improve skin hydration.

2. Use:

Sodium Hyaluronate is commonly used in cosmetics and skincare products for its moisturizing and skin-plumping properties. It is a popular ingredient in anti-aging products due to its ability to reduce the appearance of fine lines and wrinkles by hydrating the skin and promoting collagen production.

3. Usage Sodium Hyaluronate:

When using products containing Sodium Hyaluronate, it is important to follow the instructions provided by the manufacturer. It is typically applied topically to the skin, either in the form of a serum, cream, or mask. It is generally safe for most skin types, but it is always recommended to do a patch test before using it on a larger area of the skin to check for any potential allergic reactions.

Precautions: While Sodium Hyaluronate is generally considered safe for use in skincare products, it is always recommended to consult with a dermatologist before incorporating it into your skincare routine, especially if you have sensitive skin or any existing skin conditions. Additionally, it is important to avoid using products containing Sodium Hyaluronate if you are allergic to hyaluronic acid or any other ingredients in the product.

4. References:

- Papakonstantinou, E., Roth, M., & Karakiulakis, G. (2012). Hyaluronic acid: A key molecule in skin aging. Dermato-endocrinology, 4(3), 253-258.

- Pavicic, T., Gauglitz, G. G., Lersch, P., Schwach-Abdellaoui, K., Malle, B., & Korting, H. C. (2011). Efficacy of cream-based novel formulations of hyaluronic acid of different molecular weights in anti-wrinkle treatment. Journal of drugs in dermatology: JDD, 10(9), 990-1000.

- Ganceviciene, R., Liakou, A. I., Theodoridis, A., Makrantonaki, E., & Zouboulis, C. C. (2012). Skin anti-aging strategies. Dermato-endocrinology, 4(3), 308-319.

1. Definition Caproic Acid:

Caproic acid, also known as hexanoic acid, is a saturated fatty acid with a six-carbon chain. It is a colorless oily liquid with a strong odor, and it is naturally found in various animal fats and oils.

2. Use:

Caproic acid is commonly used in cosmetics as a fragrance ingredient due to its strong odor. It is also used as a skin conditioning agent and emollient, helping to soften and smooth the skin. Additionally, caproic acid can act as a pH adjuster in cosmetic formulations.

3. Usage Caproic Acid:

Caproic acid is typically found in low concentrations in cosmetic products, as its strong odor may be overpowering in high amounts. It is often used in combination with other ingredients to create a pleasant fragrance or to enhance the overall effectiveness of the product. When using cosmetics containing caproic acid, it is important to follow the manufacturer's instructions and discontinue use if any irritation occurs.

4. References:

- "Cosmetic Ingredient Review Expert Panel. Final report on the safety assessment of caprylic acid, capric acid, caprylic/capric triglyceride, capryloyl glycerin/sebacic acid copolymer, caprylyl glycol, capryloyl glycine, caprylyl glycol, caprylyl/capryl glucoside, capryloyl methyl glucamide, and capryloyl hydroxamic acid." International Journal of Toxicology 25.Suppl 1 (2006): 11-127.

- "Hexanoic Acid." The Good Scents Company, www.thegoodscentscompany.com/data/rw1016011.html.

- "Caproic Acid." PubChem, National Center for Biotechnology Information, pubchem.ncbi.nlm.nih.gov/compound/Capric_acid.

1. Definition 1,2-Hexanediol:

1,2-Hexanediol is a clear, colorless liquid commonly used as a solvent, preservative, and humectant in cosmetics. It is a type of glycol that is derived from petroleum.

2. Use:

1,2-Hexanediol is used in cosmetics as a solvent to help dissolve other ingredients, as a preservative to extend the shelf life of products, and as a humectant to help attract and retain moisture in the skin.

3. Usage 1,2-Hexanediol:

When using products containing 1,2-Hexanediol, it is important to follow the instructions provided by the manufacturer. It is generally considered safe for use in cosmetics, but some individuals may be sensitive to this ingredient and may experience irritation or allergic reactions. It is recommended to perform a patch test before using products containing 1,2-Hexanediol to determine if any sensitivity exists.

4. References:

- CosmeticsInfo.org. (n.d.). 1,2-Hexanediol. Retrieved from https://cosmeticsinfo.org/ingredient/12-hexanediol

- Personal Care Products Council. (2019). Safety Assessment of 1,2-Hexanediol as Used in Cosmetics. Retrieved from https://www.personalcarecouncil.org/2020-01-28-safety-assessment-of-12-hexanediol-as-used-in-cosmetics/

- U.S. Food and Drug Administration. (n.d.). Code of Federal Regulations Title 21. Retrieved from https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=172.820