Cosmetics as quasi and OTC drugs MCQs With Answer

Cosmetics as quasi and OTC drugs MCQs With Answer

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Cosmetics as Quasi and OTC Drugs — Introduction
Cosmetics, quasi‑drugs and OTC drugs occupy overlapping spaces in pharmaceutical practice, requiring B.Pharm students to understand regulatory definitions, active ingredients, labeling, quality control, stability, preservative efficacy and pharmacovigilance. This topic covers distinctions between cosmetic claims and therapeutic claims, examples like sunscreens and medicated shampoos, GMP and ISO 22716, INCI labeling, microbial limits, safety assessment and reporting adverse effects. Grasping how formulation, concentration and claims change regulatory status is essential for formulation, quality assurance and regulatory affairs. Keywords: cosmetics, quasi drugs, OTC drugs, INCI, GMP, safety assessment, pharmacovigilance, labeling. Now let’s test your knowledge with 30 MCQs on this topic.

Q1. Which statement best defines a cosmetic under typical regulatory frameworks?

  • A product intended to diagnose, cure, mitigate, treat or prevent disease
  • A product intended to be applied to human body for cleansing, beautifying or promoting attractiveness
  • A product that always contains active pharmaceutical ingredients at therapeutic doses
  • A product requiring prescription for sale

Correct Answer: A product intended to be applied to human body for cleansing, beautifying or promoting attractiveness

Q2. What characterizes a quasi‑drug (medicated cosmetic) compared with a cosmetic?

  • It is identical to a cosmetic but sold only by prescription
  • It has mild pharmacological or therapeutic activity and lies between cosmetics and drugs
  • It is always an OTC systemic drug
  • It contains no active ingredients

Correct Answer: It has mild pharmacological or therapeutic activity and lies between cosmetics and drugs

Q3. Which of the following best describes an OTC drug?

  • A drug that must be administered by a physician
  • A drug safe and effective for use without a prescription when used as directed
  • A cosmetic claiming therapeutic benefit
  • A product that cannot list active ingredients on the label

Correct Answer: A drug safe and effective for use without a prescription when used as directed

Q4. In the United States regulatory system, sunscreens are classified as:

  • Pure cosmetics with no drug oversight
  • OTC drugs when making SPF claims
  • Food additives
  • Quasi‑drugs identical to cosmetics

Correct Answer: OTC drugs when making SPF claims

Q5. Which labeling convention is commonly required for cosmetic ingredient declaration?

  • Proprietary trade names only
  • INCI (International Nomenclature of Cosmetic Ingredients) names listed in descending order
  • Only active pharmaceutical ingredients must be listed
  • No ingredient listing is required

Correct Answer: INCI (International Nomenclature of Cosmetic Ingredients) names listed in descending order

Q6. A face wash that claims “treats acne” will most likely be regulated as:

  • A cosmetic
  • A medical device
  • A drug because it claims to treat a condition
  • An excipient

Correct Answer: A drug because it claims to treat a condition

Q7. Compared to prescription drugs, stability testing for cosmetics is generally:

  • Not required at all
  • More stringent and identical to biopharmaceuticals
  • Required but can be less stringent in scope and regulatory expectation
  • Only required for oral cosmetics

Correct Answer: Required but can be less stringent in scope and regulatory expectation

Q8. Which guideline is widely used for cosmetic good manufacturing practices?

  • ICH Q7
  • ISO 22716
  • ICH Q1A
  • Pharmacopoeial monograph for tablets

Correct Answer: ISO 22716

Q9. Pharmacovigilance or adverse reaction reporting for cosmetics requires:

  • No monitoring because cosmetics are harmless
  • Active monitoring and reporting of serious or unexpected adverse effects to competent authorities
  • Reporting only if a cosmetic contains a drug ingredient
  • Reporting only for prescription medications

Correct Answer: Active monitoring and reporting of serious or unexpected adverse effects to competent authorities

Q10. Which factor most often shifts a product from cosmetic to drug classification?

  • Use of natural botanical extracts only
  • Making a therapeutic claim or affecting body functions
  • Packaging in a pharmacy‑style bottle
  • Marketing to men versus women

Correct Answer: Making a therapeutic claim or affecting body functions

Q11. Mandatory labeling elements for OTC topical drugs typically include:

  • Only brand name and color
  • Active ingredients, indications, directions, warnings and expiry information
  • Ingredients listed in proprietary codes only
  • Only manufacturer contact details

Correct Answer: Active ingredients, indications, directions, warnings and expiry information

Q12. Which of the following is a common example of a quasi‑drug in some regulatory systems?

  • Plain water
  • Medicated toothpaste containing fluoride marketed for anti‑caries effect
  • Perfume with no active agents
  • Disposable cotton pads

Correct Answer: Medicated toothpaste containing fluoride marketed for anti‑caries effect

Q13. pH adjusters in cosmetic formulations are typically classified as:

  • Active pharmaceutical ingredients requiring a prescription
  • Excipients or cosmetic ingredients without intrinsic therapeutic claims
  • Biologic drugs
  • Regulated as food

Correct Answer: Excipients or cosmetic ingredients without intrinsic therapeutic claims

Q14. Which marketing claim is acceptable for a cosmetic product?

  • “Cures eczema in two days”
  • “Reduces visible facial oiliness and cleanses skin”
  • “Prevents bacterial infections systemically”
  • “Lowers blood pressure”

Correct Answer: “Reduces visible facial oiliness and cleanses skin”

Q15. Microbial quality control for cosmetics requires:

  • No testing since cosmetics are non‑sterile by definition
  • Testing to meet specified microbial limits and preservative efficacy where applicable
  • Sterilization of all products before release
  • Only visual inspection for contamination

Correct Answer: Testing to meet specified microbial limits and preservative efficacy where applicable

Q16. The Sun Protection Factor (SPF) primarily measures protection against which type of radiation?

  • UVA only
  • UVB (sunburn‑causing) radiation
  • Visible light
  • Infrared radiation

Correct Answer: UVB (sunburn‑causing) radiation

Q17. Preservative efficacy testing (challenge test) in cosmetic development is performed to:

  • Demonstrate color stability over time
  • Evaluate product resistance to microbial contamination during use and shelf life
  • Test for heavy metals
  • Determine viscosity

Correct Answer: Evaluate product resistance to microbial contamination during use and shelf life

Q18. The OTC monograph system (e.g., for sunscreens or analgesics) allows marketing of products that:

  • Have no regulatory oversight
  • Conform to established active ingredients, doses, and labeling without individual premarket approval
  • Require a full new drug application
  • Can advertise therapeutic cures without evidence

Correct Answer: Conform to established active ingredients, doses, and labeling without individual premarket approval

Q19. Parabens in cosmetic formulations are primarily used as:

  • Fragrances
  • Preservatives with permitted concentration limits
  • Colorants
  • Active analgesics

Correct Answer: Preservatives with permitted concentration limits

Q20. Which statement best describes the boundary between cosmetic and drug classification?

  • It is determined solely by product cost
  • It depends on ingredient, concentration and claims made by the manufacturer
  • All topical products are automatically cosmetics
  • All products sold in pharmacies are drugs

Correct Answer: It depends on ingredient, concentration and claims made by the manufacturer

Q21. What is commonly required on cosmetic packaging regarding shelf life?

  • No date information ever allowed
  • Manufacturing and expiry dates or a Period‑After‑Opening (PAO) symbol where applicable
  • Only the country of origin is required
  • Only batch number with no date information

Correct Answer: Manufacturing and expiry dates or a Period‑After‑Opening (PAO) symbol where applicable

Q22. A soap labeled “antibacterial” may be regulated differently because the claim suggests:

  • Purely cosmetic moisturizing benefit
  • An antimicrobial therapeutic claim that could classify it as an OTC antiseptic
  • It is safe for ingestion
  • It is exempt from labeling

Correct Answer: An antimicrobial therapeutic claim that could classify it as an OTC antiseptic

Q23. If a consumer experiences an allergic reaction to a cosmetic, the appropriate immediate action is to:

  • Ignore symptoms and continue use
  • Stop using the product, seek medical care if needed and report the event to manufacturer or regulator
  • Increase product dose to build tolerance
  • Assume all cosmetics cause the reaction

Correct Answer: Stop using the product, seek medical care if needed and report the event to manufacturer or regulator

Q24. Which topical ingredient is commonly classed as an OTC topical analgesic rather than a cosmetic?

  • Glycerin
  • Methyl salicylate
  • Fragrance oil
  • Colorant lake

Correct Answer: Methyl salicylate

Q25. Prior to marketing in the EU, safety of a cosmetic product must be established by:

  • No documentation required
  • A qualified safety assessor producing a Cosmetic Product Safety Report (CPSR)
  • Only animal testing reports
  • Consumer testimonials alone

Correct Answer: A qualified safety assessor producing a Cosmetic Product Safety Report (CPSR)

Q26. Color additives used in cosmetics typically:

  • Require compliance with permitted lists and purity specifications
  • Can be any industrial dye without limits
  • Never need to be declared on the label
  • Are identical worldwide with no regulatory differences

Correct Answer: Require compliance with permitted lists and purity specifications

Q27. Which statement about ingredient listing is correct?

  • Only active drug ingredients must be listed; excipients can be omitted
  • All ingredients must be declared by INCI name on cosmetic labels
  • Manufacturers may hide ingredients as corporate secrets
  • Labels should list chemical structures rather than names

Correct Answer: All ingredients must be declared by INCI name on cosmetic labels

Q28. Permanent hair dyes containing para‑phenylenediamine (PPD) are regulated as:

  • Foods
  • Cosmetics with specific restrictions and mandatory warnings due to sensitization risk
  • Always OTC drugs
  • Medical devices

Correct Answer: Cosmetics with specific restrictions and mandatory warnings due to sensitization risk

Q29. Which sunscreen active is commonly listed in OTC monographs and regulated as a drug ingredient in some jurisdictions?

  • Avobenzone
  • Sodium chloride
  • Citric acid
  • Isopropyl myristate

Correct Answer: Avobenzone

Q30. In India, the primary regulatory body responsible for drug and cosmetic regulation at the central level is:

  • Food Safety and Standards Authority of India (FSSAI)
  • Central Drugs Standard Control Organization (CDSCO)
  • Reserve Bank of India (RBI)
  • Ministry of Agriculture

Correct Answer: Central Drugs Standard Control Organization (CDSCO)

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