Aloe Sunscreen description, usages, side effects, indications, overdosage, supplying and lots more!

Aloe Sunscreen

Aloe Vera of America, Inc.

  • Description
  • Clinical Pharmacology
  • Indications & Usage
  • Contraindications
  • Warnings
  • Precautions
  • Side Effects
  • Overdosage
  • Dosage & Administration
  • How Supplied
  • Patient Counseling Information
  • Supplemental Patient Material
  • Boxed Warning
  • Patient Package Insert
Drug Facts for Aloe Sunscreen

FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient

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.

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


Package Label Principal Display Panel

Aloe Sunscreen

Homosalate LOTION

Product Information

Product Type Human otc drug label Item Code (Source) NDC:11697-199
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
HOMOSALATE Homosalate 1.18 mL
OCTISALATE OCTISALATE 5.9 mL
AVOBENZONE AVOBENZONE 3.54 mL
Ensulizole Ensulizole 3.54 mL
OCTOCRYLENE Octocrylene 3.922 mL

Inactive Ingredients

Ingredient Name Strength
Aloe Vera Leaf
water
BUTYLOCTYL SALICYLATE
MEDIUM-CHAIN TRIGLYCERIDES
GLYCERIN
CETEARYL OLIVATE
SORBITAN OLIVATE
SODIUM CHLORIDE
CETYL ALCOHOL
GLYCERYL MONOSTEARATE
POLYGLYCERYL-4 ISOSTEARATE
HEXYL LAURATE
PHENOXYETHANOL
peg-75 stearate
TROLAMINE
XANTHAN GUM
CETETH-20
Steareth-20
ALPHA-TOCOPHEROL ACETATE
METHYLISOTHIAZOLINONE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:11697-199-04 118 in 1 TUBE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part352 2011-04-06


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