D&C Orange 4

Bring vibrant orange tones to your cosmetic and pharmaceutical formulations with D&C Orange 4 Powder (CI 15510) — a professional-grade, FDA-certified water-soluble dye designed for reliable performance in aqueous systems.

Unlike lake pigments or oil-soluble dyes, D&C Orange 4 dissolves fully in water, delivering bright, uniform orange shades in transparent and semi-transparent products. Its strong tinting strength allows precise shade control even at low usage levels.

If you are formulating products where color clarity and regulatory compliance are essential, D&C Orange 4 provides:

✔ Rapid water solubility
✔ Uniform dispersion
✔ High chromatic intensity
✔ Clear, bright orange hue
✔ FDA batch-certified compliance

Regulatory Compliance – FDA Certified Color

D&C Orange 4 is:

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

Each batch must be certified by the FDA prior to lawful commercial distribution for regulated applications in the United States.

Why Choose Water-Soluble D&C Orange 4?

Water-soluble dyes are preferred when:

• Creating transparent gels
• Formulating lotions and creams
• Developing liquid soaps and cleansers
• Producing pharmaceutical syrups or topical solutions
• Maintaining clarity in aqueous systems

Because it dissolves completely, it prevents sedimentation and ensures uniform coloring.

Typical Applications

• Lotions
• Facial cleansers
• Liquid soaps
• Shower gels
• Topical pharmaceutical gels
• Aqueous drug preparations (where permitted)

Imagine formulating a bright citrus-colored facial cleanser — D&C Orange 4 ensures clarity and consistent color throughout the product’s shelf life.

Technical Characteristics

• Highly water soluble
• Bright orange shade
• Stable under normal cosmetic processing conditions
• Good light stability
• Compatible with neutral to mildly acidic systems

Avoid prolonged exposure to highly alkaline environments.

Handling & Storage

• Avoid inhalation of powder dust
• Use gloves and protective eyewear
• Store in sealed, moisture-resistant packaging
• Protect from humidity
• Shelf life: 24–36 months

Category: Cosmetic Colors -> D&C Dyes, Food Colors -> Water Soluble Dyes,

Tags: D&C Orange 4, CI 15510, FDA Certified Dye, Water Soluble Color, Cosmetic Dye, Pharmaceutical Color, Orange Cosmetic Powder

Attributes / Specifications

Product Name: D&C Orange 4
CI Number: 15510
CAS Number: 633-96-5
Chemical Class: Azo Dye
Form: Fine Powder
Color: Bright Orange
Solubility: Highly soluble in water
Grade: FDA Certified (Batch Certification Required)
Intended Use: Drugs & Cosmetics
Food Use: Not approved
Shelf Life: 24–36 months
Packaging: Sealed moisture-resistant container

Q: Is D&C Orange 4 FDA approved?
A: Yes. It is listed under 21 CFR Part 74 and requires FDA batch certification for use in drugs and cosmetics.

Q: Is D&C Orange 4 water soluble?
A: Yes. It dissolves completely in water and is ideal for aqueous formulations.

Q: Can it be used in food?
A: No. D&C Orange 4 is not approved for food use in the United States.

Q: What products commonly use this dye?
A: It is commonly used in lotions, gels, liquid soaps, and pharmaceutical topical preparations.

Q: Does each batch require FDA certification?
A: Yes. FDA-certified colors must undergo batch certification before commercial distribution.

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 – Chemical Identity
   https://pubchem.ncbi.nlm.nih.gov/compound/D-C-Orange-No.-4
4. FDA Cosmetic Color Additive Guidance
   https://www.fda.gov/cosmetics

Conclusion: D&C Orange 4 (CI 15510) is an FDA-certified water-soluble color additive permitted in drugs and cosmetics when batch-certified.