FD&C Red No. 4

Create vibrant red coloration in topical formulations using FD&C Red 4 Powder (CI 14700) — a high-purity FDA-certified azo dye designed specifically for externally applied drugs and cosmetics.

Also known as Ponceau SX, this dye produces a bright red to pink-red shade and dissolves rapidly in water-based systems. Its fine powder form enables precise dosing and fast integration into cosmetic and pharmaceutical formulations.

FD&C Red 4 offers:

✔ Rapid dissolution in water
✔ Strong tint strength
✔ Uniform color dispersion
✔ Excellent clarity in aqueous systems
✔ FDA-certified regulatory compliance

Regulatory Compliance – External Use Only

FD&C Red 4 is:

• Listed under 21 CFR Part 74
• Subject to FDA batch certification
• Permitted in externally applied drugs
• Permitted in cosmetics
• Not approved for food use

Each batch must be certified by the FDA prior to distribution.

Why Choose FD&C Red 4?

This dye is ideal when developing:

• Topical lotions and creams
• Cosmetic gels and serums
• External pharmaceutical preparations
• Mouthwash and rinse-off products

Because it dissolves fully in water, it ensures uniform coloration in aqueous cosmetic systems.

Typical Applications

• Facial creams and lotions
• Cosmetic gels
• Topical pharmaceutical products
• Rinse-off cosmetic products

Imagine formulating a red-tinted cosmetic gel with consistent shade clarity — FD&C Red 4 ensures even dispersion and strong visual impact.

Technical Characteristics

• Highly water soluble
• Bright red shade
• Strong tint strength
• Compatible with neutral to mildly acidic systems
• Good light stability

Avoid highly alkaline environments.

Handling & Storage

• Avoid inhalation of powder dust
• Use PPE during handling
• Store sealed and moisture-protected
• Shelf life: 24–36 months

Category: Cosmetic Colors -> D&C Dyes. FDA Certified Colors

Tags: FD&C Red 4, CI 14700, Ponceau SX, FDA Cosmetic Dye, External Use Dye, Water Soluble Dye, Cosmetic Colorant

Attributes / Specifications

Product Name: FD&C Red No. 4
CI Number: 14700
CAS Number: 4548-53-2
Chemical Class: Azo Dye
Form: Fine Powder
Color: Bright Red
Solubility: Highly soluble in water
Grade: FDA Certified (Batch Certification Required)
Use Restriction: External Use Only
Food Use: Not permitted
Shelf Life: 24–36 months

FAQs

Q1: Is FD&C Red 4 approved for food use?
No. It is only approved for externally applied drugs and cosmetics.

Q2: Is FD&C Red 4 water soluble?
Yes. It dissolves completely in water-based formulations.

Q3: What is Ponceau SX?
Ponceau SX is the common name for FD&C Red 4.

Q4: Does this dye require FDA certification?
Yes. Each batch must be FDA batch-certified before distribution.

Q5: Where is FD&C Red 4 commonly used?
It is used in topical pharmaceuticals, creams, gels, and rinse-off cosmetics.

Q6: Can it be used in beverages or foods?
No. It is not approved for food use in the United States.

Authoritative references consulted:

1. U.S. Electronic Code of Federal Regulations – 21 CFR Part 74
   https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-74
2. FDA Color Additive Status List
   https://www.fda.gov/industry/color-additives/color-additives-status-list
3. PubChem – CAS 4548-53-2
   https://pubchem.ncbi.nlm.nih.gov/compound/4548-53-2
4. FDA Cosmetics Guidance
   https://www.fda.gov/cosmetics

Conclusion: FD&C Red 4 is an FDA-certified color additive for externally applied drugs and cosmetics only, requiring batch certification.