1. Home
  2. Labeler Index
  3. Prime Enterprises, Inc.
  4. 58443-0100
  5. Label Information: Suntone Broad Spectrum Spf 4

FDA Label for Suntone Broad Spectrum Spf 4

View Indications, Usage & Precautions

Table of Contents

    1. PRINCIPAL DISPLAY PANEL - 177 ML  CAN LABEL
    2. ACTIVE INGREDIENTS
    3. USES
    4. WARNINGS
    5. OTC - WHEN USING
    6. OTC - STOP USE
    7. OTC - KEEP OUT OF REACH OF CHILDREN
    8. DIRECTIONS
    9. INACTIVE INGREDIENTS
    10. OTHER INFORMATION

Suntone Broad Spectrum Spf 4 Product Label

The following document was submitted to the FDA by the labeler of this product Prime Enterprises, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Principal Display Panel - 177 Ml  Can Label



PRINCIPAL DISPLAY PANEL - 177 mL Can Label - 58443 0100 4

PRINCIPAL DISPLAY PANEL - 177 mL Can Label - 58443 0100 4

Suntone

Fit for the sun

Sunscreen Lotion

Broad Spectrum SPF 4

Water Resistant (80 minutes)

Non-Greasy Formula

4

6 FL. OZ /177mL


Active Ingredients



Avobenzone 1 %, Octocrylene 0.85 %


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
  • 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



Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf Juice, Butylphthalimide, C12-15 Alkyl Benzoate, Carbomer, Disodium EDTA, Fragrance (Parfum), Hydroxypropyl Methylcellulose, Isopropylphthalimide, Methylisothiazolinone, Methylparaben, Polyethylene, Polysorbate 20, Propylene Glycol, Propylparaben, Sorbitan Oleate, Theobroma Cacao (Cocoa) Seed Butter, Tocopheryl Acetate, Triethanolamine, Water (Aqua)


Other Information



  • protect this product from excesive heat and direct sun


* Please review the disclaimer below.