FDA Label for Sunstation Sport Sunscreen Spf 30

View Indications, Usage & Precautions

Sunstation Sport Sunscreen Spf 30 Product Label

The following document was submitted to the FDA by the labeler of this product Impact Melanoma 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.

Drug Facts:




Active Ingredients



Octisalate 5%
Octocrylene 8%
Zinc Oxide 8%


Purpose



Sunscreen


Uses:



  • Helps prevent sunburn.
  • Higher SPF gives more sunburn protection
  • Retains SPF after 80 minutes of swimming or sweating
  • If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

Warnings:



For external use only.


Do Not Use



  • on damaged or broken skin.


When Using This Product



  • keep out of eyes. Rinse with water to remove.


Stop Use And Ask A Doctor If



  • Rash or irritation develops and lasts.

Keep Out Of Reach Of Children.



If swallowed, get medical help, or contact a Poison Control Center right away.


If Pregnant Or Breast-Feeding,



ask a health professional before use.


Directions:



  • Apply liberally 15 minutes before sun exposure & as needed.
  • For children under 6 months of age: ask a doctor.
  • REAPPLY::
  • after 80 minutes of swimming or sweating
  • immediately after towel drying
  • at least every 2 hours
  • Sun Protection Measures.Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with broad spectrum SPF of 15 or higher and other sun protection measures including:
  • Limit time in the sun, especially from 10 a.m. -2p.m.
  • Wear long-sleeved shirts, pants, hats, and sunglasses.

Inactive Ingredients:



Aloe Barbadensis Leaf Juice, Butyloctyl Salicylate, Calendula Officinalis Extract, Capryloyl Glycerin/Sebacic Acid Copolymer, Carbomer,
Ceteareth-20, Cetearyl Alcohol, Chamomilla Recutita (Matricaria) Flower Extract, Dimethicone, Ethylhexylglycerin, Glycerin, Glyceryl Stearate
SE, 1,2-Hexanediol, Isocetyl Stearate, Malva Sylvestris (Mallow) Flower Extract, Panax Ginseng Root Extract, Phenoxyethanol,
Polyhydroxystearic Acid, Polysorbate 20, Sorbitan Stearate, Sorbitol, Stearic Acid, Symphytum Officinale Extract, Tocopheryl Acetate,
Triethanolamine, Water (Aqua)


Other Information:



  • Protect the product in this container from excessive heat and direct sun.

Package Labeling:




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