FDA Label for Fote Cabana Beach Club With Manuka Honey And Essential Oils Spf 8 Dry Tanning Sunscreen

View Indications, Usage & Precautions

Fote Cabana Beach Club With Manuka Honey And Essential Oils Spf 8 Dry Tanning Sunscreen Product Label

The following document was submitted to the FDA by the labeler of this product Fruit Of The Earth, 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.

Active Ingredients



Homosalate 7.0%, Octisalate 5.0%


Purpose



Sunscreen


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.


Flammable:



  • do not use near heat, flame or while smoking
  • avoid long term storage above 104°F (40°C)

Otc - Do Not Use



Do not use • on damaged or broken skin.


Otc - When Using



When using this product • keep out of eyes. Rinse with water to remove • keep away from face to avoid breathing it. • do not puncture or incinerate. Contents under pressure. • do not store at temperatures above 120°F.


Otc - Ask Doctor



Stop use and ask a doctor if • rash occurs.


Otc - Keep Out Of Reach Of Children



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


Directions



  • Spray liberally and spread evenly by hand 15 minutes before sun exposure
  • Hold can 4-6 inches away from the skin to apply
  • Do not spray directly into face. Spray into hands then apply to face
  • Do not apply in windy conditions
  • Use in a well-ventilated area.
  • Reapply:
  •    • after 80 minutes of swimming or sweating

       • immediately after towel drying

       • at least every 2 hours

    • Children under 6 months of age: ask a doctor

Other Information



  • protect this product from excessive heat and direct sun
  • may stain or damage some fabrics, materials or surfaces

Inactive Ingredients



alcohol denat., fragrance, acrylates/octylacrylamide copolymer, honey (manuka honey), bertholletia excelsa seed oil (brazil nut), vaccinium macrocarpon (cranberry) seed oil, tocopheryl acetate, mineral oil, tridecyl salicylate


Questions Or Comments?



Call toll free 1-800-527-7731


Package Label.Principal Display Panel



FRUIT OF THE EARTH CABANA BEACH CLUB WITH MANUKA HONEY & ESSENTIAL OILS SPF 8 DRY TANNING OIL SPRAY SUNSCREEN

5.5 OZ (156g)

NDC 62217-042-37

FRUIT OF THE EARTH CABANA BEACH CLUB WITH MANUKA HONEY & ESSENTIAL OILS SPF 8 DRY TANNING OIL SPRAY SUNSCREEN

2.7 OZ (76.5g)

NDC 62217-042-74


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