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Name:Aloe Sunscreen
Manufacturer:Aloe Vera Of America, Inc.
Category:Over-the-counter (OTC) Marketed Drugs


Drug Facts for OTC drug listing SPL for Aloe Sunscreen Spray

ALOE SUNSCREEN  - homosalate, octisalate, ensulizole, avobenzone and octocrylene spray 
Aloe Vera of America, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts for OTC drug listing SPL for Aloe Sunscreen Spray

Active Ingredients

                                                                                                 Purpose
Homosalate 10%, Octisalate 5.0%, Ensulizole 4.0%,
Avobenzone 3.0%, Octocrylene 2.79%...........................Sunscreens

Uses

  • Helps prevent sunburn.
  • Higher SPF gives more sunburn protection.
  • Retains SPF after 80 minutes of activity in the water.
  • Provides high protection against sunburn.

Warnings

  • For external use only
  • do not spray directly into face

When using this product

  • avoid spraying into eyes. if contact occurs, rinse thoroughly with water.

Stop use and ask doctor if

  • rash or irritation develops and lasts.

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • apply generously and evenly 15-30 minutes before sun exposure and as needed.
  • spray on hands to apply to face
  • reapply at frequent intervals and after swimming or towel drying.
  • ask doctor before use on children under 6 months of age.

Other information

  • high sun protection product.

Sun alert:  Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risks of skin aging, skin cancer, and other harmful effects of the sun.

Inactive Ingredients

Aloe Barbadensis Leaf Juice (Stabilized Aloe Vera Gel), Water (Aqua),Propanediol,Diethylhexyl Carbonate,Butyloctyl Salicylate,Polyester-7,Styrene/Acrylates Copolymer,Neopentyl Glycol Diheptanoate,Acrylates/C12-22 Alkyl Methacrylate Copolymer,Ceteareth-25,Acrylates Copolymer,Phenoxyethanol,Disodium EthyleneDicocamide PEG-15 Disulfate,Trithanolamine,Pentylene Glycol,Disodium EDTA,Panthenol,Fragrance (Parfum),Tocopheryl Acetate,Methylisothiazolinone.

Package Label Principal Display Panel

../images_otc/aloe_sunscre_Aloe_spray_Sunscreen_US.jpg

Image of carton label

ALOE SUNSCREEN 
homosalate spray
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:11697-319
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Homosalate (Homosalate) Homosalate 17.8 mL  in 178 mL
Octisalate (Octisalate) Octisalate 8.9 mL  in 178 mL
Ensulizole (Ensulizole) Ensulizole 7.12 mL  in 178 mL
Avobenzone (Avobenzone) Avobenzone 5.34 mL  in 178 mL
Octocrylene (Octocrylene) Octocrylene 4.9662 mL  in 178 mL
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:11697-319-06 178 mL in 1 BOTTLE, SPRAY None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 08/16/2010

Labeler - Aloe Vera of America, Inc. (049049463)

Revised: 09/2010 Aloe Vera of America, Inc.



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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