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


Drug Facts for Aloe Sunscreen

ALOE SUNSCREEN   - homosalate, octisalate, avobenzone, ensulizole and octocrylene lotion 
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 Aloe Sunscreen

Active ingredients                                      Purpose

Homosalate 10.0%, Octisalate 5.0%

Avobenzone 3.0%, Ensulizole 3.0%,

Octocrylene 2.79%.......................................Sunscreens


Uses

                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

Warnings  For external use only

                When using this product

  • Keep out of eyes, Rinse with water to remove.

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

Directions

  • Apply generously and evenly 15-30 minutes before sun exposure and as needed.
  • Children under 6 months of age: ask a doctor.

Other Information

Other information

  • High sun protection product.
Sun Alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risk of skin aging, skin cancer, and other harmful effects of the sun.

Inactive ingredients

Aloe Barbadensis Leaf Juice (Stabilized* Aloe Vera Gel), Water (Aqua), Butyloctyl Salicylate, Caprylic/Capric Triglyceride, Glycerin, Cetearyl Olivate, Sorbitan Olivate, Sodium Chloride, Cetyl Alcohol, Glyceryl Stearate, Polyglyceryl-4 Isostearate, Cetyl PEG/PPG-10/1 Dimethicone, Hexyl Laurate, Cetyl Dimethicone, Phenoxyethanol, PEG-75 Stearate, Triethanolamine, Xanthan Gum, Ceteth-20, Steareth-20, Tocopheryl Acetate, Fragrance (Parfum), Methylisothiazolinone.

Questions:

Call 1-888-440-2563, Monday-Friday.

Package Label Principal Display Panel


Copy of Label


ALOE SUNSCREEN  
homosalate lotion
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:11697-199
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HOMOSALATE (HOMOSALATE) HOMOSALATE 1.18 mL  in 118 mL
OCTISALATE (OCTISALATE) OCTISALATE 5.9 mL  in 118 mL
AVOBENZONE (AVOBENZONE) AVOBENZONE 3.54 mL  in 118 mL
ENSULIZOLE (ENSULIZOLE) ENSULIZOLE 3.54 mL  in 118 mL
OCTOCRYLENE (OCTOCRYLENE) OCTOCRYLENE 3.922 mL  in 118 mL
Inactive Ingredients
Ingredient Name Strength
ALOE VERA LEAF 34.7097 mL  in 118 mL
WATER 34.51264  mL  in 118 mL
BUTYLOCTYL SALICYLATE 3.54 mL  in 118 mL
MEDIUM-CHAIN TRIGLYCERIDES 3.54 mL  in 118 mL
GLYCERIN 2.36 mL  in 118 mL
CETEARYL OLIVATE 1.947 mL  in 118 mL
SORBITAN OLIVATE 1.593 mL  in 118 mL
SODIUM CHLORIDE 1.18 mL  in 118 mL
CETYL ALCOHOL .08496 mL  in 118 mL
GLYCERYL MONOSTEARATE .08024 mL  in 118 mL
POLYGLYCERYL-4 ISOSTEARATE .08024 mL  in 118 mL
HEXYL LAURATE .07788 mL  in 118 mL
PHENOXYETHANOL .4012 mL  in 118 mL
PEG-75 Stearate .354 mL  in 118 mL
TROLAMINE .354 mL  in 118 mL
XANTHAN GUM .236 mL  in 118 mL
CETETH-20 .1888 mL  in 118 mL
STEARETH-20 .1652 mL  in 118 mL
ALPHA-TOCOPHEROL ACETATE .118 mL  in 118 mL
METHYLISOTHIAZOLINONE .00826 mL  in 118 mL
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:11697-199-04 118 mL in 1 TUBE None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 04/06/2011

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

Revised: 05/2011 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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