FDA Label for Aloe Sunscreen

View Indications, Usage & Precautions

Aloe Sunscreen Product Label

The following document was submitted to the FDA by the labeler of this product Aloe Vera Of America, 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.

Otc - Active Ingredient



Active Ingredients         Purpose

Avobenzone 2.7%

Ensulizole 4.0%

Homosalate 10.0%

Octisalate 5.0%

Octocrylene 2.79%          Sunscreen


Otc - Purpose



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



Warnings

For external use only


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 product.


Otc - Stop Use



Stop use and ask 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.


Instructions For Use



Directions

Shake well before use.

  • hold container 4 to 6 inches from the skin and spray generously and spread evenly by hand 15 minutes before sun exposure
  • do not spray directly into face. Spray on hands then apply to face.
  • rapply:
  •   after 80 minutes of swimming or sweating
  •   immediately after towel drying
  •   at least every 2 hours
  • do not apply in windy conditions
  • use in well-ventilated area
  • 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 of 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 Ingredient



Inactive ingredients
acrylates/C12-22 alkyl methacrylate copolymer, acrylates copolymer, aloe barbadensis leaf juice (stabilized* aloe vera gel), butyloctyl salicylate, ceteareth-25, diethylhexyl carbonate, disodium ethylene dicocamide PEG-15 disulfate, disodium EDTA, fragrance (parfum), methylisothiazolinone, neopentyl glycol diheptanoate, panthenol, pentylene glycol, phenoxyethanol, polyester-7, propanediol, styrene/acrylates copolymer, tocopheryl acetate, triethanolamine, water (aqua)


Indications & Usage



Other information

  • protect this product from excessive heat and direct sun

Otc - Questions



Questions: Call 1-888-440-2563, Monday - Friday, 9:00 a.m. to 4:00 p.m. PT.


Package Label.Principal Display Panel




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