Aloe Sunscreen
FDA Label NDC 11697-319

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Aloe Vera Of America, Inc. for the product Aloe Sunscreen (NDC 11697-319). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, warnings, otc - do not use, otc - when using, otc - stop use, otc - keep out of reach of children, instructions for use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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

Image Of Bottle (Sunscreenbottle)

Image Of Bottle (Sunscreenbottle)

* Please review the disclaimer below.