FDA Label for Reef Kids Spf 30 Oxybenzone Free

View Indications, Usage & Precautions

Reef Kids Spf 30 Oxybenzone Free Product Label

The following document was submitted to the FDA by the labeler of this product Tropical Seas, 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.

Other



Drug Facts


Active Ingredients



Octocrylene 5.0%

Octisalate 3.0%

Avobenzone 2.5%


Purpose



Sunscreen


Uses



  • helps prevent sunburn
  • 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

Flammable: Do not use near heat, flame, or while smoking


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.
  • Do not puncture or incinerate. Contents under pressure.
  • Do not store at temperatures above 120° F

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 on face - spray into hands and apply to face
  • hold approximately 4 - 6 inches from skin to spray
  • rub into skin evenly to ensure appropriate coverage
  • use in a well-ventilated area
  • avoid inhaling or exposing others to spray
  • do not apply in windy conditions
  • 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 a broad spectrum SPF 15 or higher and other sun protection measures including:
      • limit time in the sun, especially from 10 a.m. - 2 p.m.
      • wear long-sleeve shirts, pants, hats and sunglasses
      • children under 6 months: Ask a doctor

Inactive Ingredients



sd alcohol 40-b, deionized water, lauryl lactate, cyclopentasiloxane, c12-15 alcohols benzoate, acrylates octylacrylamide copolymer, octyldodecyl neopentanoate, octyl dodecyl citrate crosspolymer, phenethyl benzoate, and fragrance.


Other Information



  • protect this product from excessive cold, heat, and direct sun.
  • store at temp below 90° F and avoid long term storage
  • may stain fabrics or surfaces

Questions Or Comments?



Call toll free 1-800-368-7327


Principal Display Panel - Bottle Label



180ml NDC 52854-538-02


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