OTC Medication Information: Aloe Sunscreen

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.

Active Ingredients Purpose

Avobenzone 2.7%

Ensulizole 4.0%

Homosalate 10.0%

Octisalate 5.0%

Octocrylene 2.79% Sunscreen

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

For external use only

Do not use on damaged or broken skin

When using this product keep out of eyes. Rinse with water to remove. Keep away from face to avoid breathing product.

Stop use and ask doctor if rash occurs

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

Shake well before use.

  • hold container 4 to 6 inches from the skin and spray generously and spread evenly by hand 15 minutes before sun exposure
  • do not spray directly into face. Spray on hands then apply to face.
  • rapply:
  • after 80 minutes of swimming or sweating
  • immediately after towel drying
  • at least every 2 hours
  • do not apply in windy conditions
  • use in well-ventilated area
  • 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 ingredients
acrylates/C12-22 alkyl methacrylate copolymer, acrylates copolymer, aloe barbadensis leaf juice (stabilized* aloe vera gel), butyloctyl salicylate, ceteareth-25, diethylhexyl carbonate, disodium ethylene dicocamide PEG-15 disulfate, disodium EDTA, fragrance (parfum), methylisothiazolinone, neopentyl glycol diheptanoate, panthenol, pentylene glycol, phenoxyethanol, polyester-7, propanediol, styrene/acrylates copolymer, tocopheryl acetate, triethanolamine, water (aqua)

Other information

  • protect this product from excessive heat and direct sun

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

image of bottle
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ALOE SUNSCREEN
homosalate, octisalate, avobenzone, ensulizole anf octocrylene 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 10.0 g in 100 mL
OCTISALATE (OCTISALATE) OCTISALATE 5.0 g in 100 mL
ENSULIZOLE (ENSULIZOLE) ENSULIZOLE 4.0 g in 100 mL
AVOBENZONE (AVOBENZONE) AVOBENZONE 3.0 g in 100 mL
OCTOCRYLENE (OCTOCRYLENE) OCTOCRYLENE 2.79 g in 100 mL
Inactive Ingredients
Ingredient Name Strength
ALOE VERA LEAF 29.3 g in 100 mL
WATER 27.3 g in 100 mL
PROPANEDIOL 3.0 g in 100 mL
DIETHYLHEXYL CARBONATE 3.0 g in 100 mL
BUTYLOCTYL SALICYLATE 3.0 g in 100 mL
POLYESTER-7 2.4 g in 100 mL
STYRENE/ACRYLAMIDE COPOLYMER (MW 500000) 1.9 g in 100 mL
NEOPENTYL GLYCOL DIHEPTANOATE 1.6 g in 100 mL
CETEARETH-25 0.7 g in 100 mL
PHENOXYETHANOL 0.3 g in 100 mL
DISODIUM ETHYLENE DICOCAMIDE PEG-15 DISULFATE 0.3 g in 100 mL
PENTYLENE GLYCOL 0.1 g in 100 mL
PANTHENOL 0.1 g in 100 mL
.ALPHA.-TOCOPHEROL ACETATE 0.01 g in 100 mL
METHYLISOTHIAZOLINONE 0.01 g in 100 mL
EDETATE DISODIUM 0.1 g in 100 mL
TROLAMINE 0.3 g in 100 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:11697-319-07 178.000 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)
Registrant — Aloe Vera of America, Inc. (049049463)
Establishment
Name Address ID/FEI Operations
Aloe Vera of America, Inc. 049049463 manufacture (11697-319)

Revised: 01/2015 Aloe Vera of America, Inc.

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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