NDC 11697-199 Aloe Sunscreen

NDC Product Code 11697-199

NDC CODE: 11697-199

Proprietary Name: Aloe Sunscreen 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.

NDC Code Structure

  • 11697 - Aloe Vera Of America, Inc.

NDC 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.

NDC Product Information

Aloe Sunscreen with NDC 11697-199 is a product labeled by Aloe Vera Of America, Inc.. The product's dosage form is and is administered via form.

Inactive Ingredient(s)

About the Inactive Ingredient(s)
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.

  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • WATER (UNII: 059QF0KO0R)
  • BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
  • MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • CETEARYL OLIVATE (UNII: 58B69Q84JO)
  • SORBITAN OLIVATE (UNII: MDL271E3GR)
  • SODIUM CHLORIDE (UNII: 451W47IQ8X)
  • CETYL ALCOHOL (UNII: 936JST6JCN)
  • GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
  • POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
  • HEXYL LAURATE (UNII: 4CG9F9W01Q)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • PEG-75 STEARATE (UNII: OT38R0N74H)
  • TRIETHYLAMINE (UNII: VOU728O6AY)
  • XANTHAN GUM (UNII: TTV12P4NEE)
  • CETETH-20 (UNII: I835H2IHHX)
  • STEARETH-20 (UNII: L0Q8IK9E08)
  • ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Aloe Vera Of America, Inc.
Labeler Code: 11697
Start Marketing Date: 04-06-2011 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2017 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.

Exclude Flag: I - INACTIVATED, the listing data was inactivated by the FDA. 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".

* Please review the disclaimer below.

Aloe Sunscreen Product Label Images

Aloe Sunscreen Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Otc - Active Ingredient

Active Ingredients       PurposeAvobenzone 2.5%Ensulizole 3.0%Homosalate 10.0%Octisalate 5.0%Octocrylene 2.79%         Sunscreen

Otc - Purpose

  • Useshelps prevent sunburnif 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

WarningsFor 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

  • Directionsapply liberally 15 minutes before sun exposurerapply:  after 80 minutes of swimming or sweating  immediately after towel drying  at least every 2 hoursSun 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 sunglasseschildren under 6 months: Ask a doctor

Inactive Ingredient

Inactive ingredientsaloe 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 informationprotect this product from excessive heat and direct suntube 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.