NDC 11697-199 Aloe Sunscreen

Product Information

What is NDC 11697-199?

The NDC code 11697-199 is assigned by the FDA to the product Aloe Sunscreen which is product labeled by Aloe Vera Of America, Inc.. The product's dosage form is and is administered via form. The product is distributed in a single package with assigned NDC code 11697-199-05 118 ml in 1 tube . This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information, RxNorm crosswalk and the complete product label.

NDC Product Code11697-199
Proprietary Name What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Aloe Sunscreen
Product Labeler Information What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.
Aloe Vera Of America, Inc.
Labeler Code11697
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
04-06-2011
Listing Expiration Date What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.
12-31-2017
Exclude Flag What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".
I
NDC Code Structure

What are the uses for Aloe Sunscreen?


Product Packages

NDC Code 11697-199-05

Package Description: 118 mL in 1 TUBE

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Product Details

Aloe Sunscreen Active Ingredients UNII Codes

Aloe Sunscreen Inactive Ingredients UNII Codes

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

* Please review the disclaimer below.

Aloe Sunscreen Product Label

FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Label Table of Contents



Otc - Active Ingredient



Active Ingredients       Purpose

Avobenzone 2.5%

Ensulizole 3.0%

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.


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

  • apply liberally 15 minutes before sun exposure
  • rapply:
  •   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 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
aloe barbadensis leaf juice (stabilized* aloe vera gel), butyloctyl salicylate, caprylic/capric triglyceride, cetearyl olivate, ceteth-20, cetyl alcohol, cetyl dimethicone, cetyl PEG/PPG-10/1 dimethicone, fragrance (parfum), glycerin, glyceryl stearate, hexyl laurate, methylisothiazolinone, PEG-75 stearate, phenoxyethanol, polyglyceryl-4 isostearate, sodium chloride, sorbitan olivate, steareth-20, tocopheryl acetate, triethanolamine, water (aqua), xanthan gum


Indications & Usage



Other information

  • protect this product from excessive heat and direct sun
  • tube sealed for your protection

Otc - Questions



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


* Please review the disclaimer below.