Suntone
FDA Label NDC 58443-0098

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Prime Enterprises, Inc. for the product Suntone (NDC 58443-0098). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding principal display panel - 236 ml  bottle label, active ingredients, uses, warnings, otc - when using, otc - stop use, otc - keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Principal Display Panel - 236 Ml  Bottle Label

Principal Display Panel (236 mL Bottle Label)

Principal Display Panel (236 mL Bottle Label)

Suntone

Fit for the Sun

DARK TANNING

Sunscreen Spray Oil

SPF 4

Water Resistant

(80 Minutes)

4

Contains Aloe Vera

8 FL. OZ./236mL

Active Ingredients

Octinoxate 2 %

Uses

  • helps prevent sunburn

Warnings

Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn, not skin cancer or early skin aging.

Otc - When Using

When using this product keep out of eyes. Rinse with water to remove.

Otc - Stop Use

Stop use and ask a doctor if rash occurs.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • apply liberally 15 minutes before sun exposure.
  • do not spray directly into face. Spray on hands then apply to face
  • reapply:
    • after 80 minutes of swimming or sweating
    • immediately after towel drying
    • at least every 2 hour
    • children under 6 months: ask a doctor.

Inactive Ingredients

Aloe Barbadensis Extract, Cocos Nucifera (Coconut) Oil, Fragrance (Parfum), Mineral Oil (Paraffinum Liquidum), Propylparaben, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Simmondsia Chinensis (Jojoba) Seed Oil, Tocopheryl Acetate

Other Information

  • protect this product from excesive heat and direct sun.
  • avoid spraying on fabrics - could cause discoloration

* Please review the disclaimer below.