ALOE SUNSCREEN- homosalate, octisalate, avobenzone, ensulizole anf 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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Active Ingredients         Purpose

Avobenzone 2.7%

Ensulizole 4.0%

Homosalate 10.0%

Octisalate 5.0%

Octocrylene 2.79%          Sunscreen

Uses

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.

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

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

image of bottle

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
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 10.0 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5.0 g  in 100 mL
ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42) ENSULIZOLE 4.0 g  in 100 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 3.0 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 2.79 g  in 100 mL
Inactive Ingredients
Ingredient Name Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X) 29.3 g  in 100 mL
WATER (UNII: 059QF0KO0R) 27.3 g  in 100 mL
PROPANEDIOL (UNII: 5965N8W85T) 3.0 g  in 100 mL
DIETHYLHEXYL CARBONATE (UNII: YCD50O0Z6L) 3.0 g  in 100 mL
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) 3.0 g  in 100 mL
POLYESTER-7 (UNII: 0841698D2F) 2.4 g  in 100 mL
STYRENE/ACRYLAMIDE COPOLYMER (MW 500000) (UNII: 5Z4DPO246A) 1.9 g  in 100 mL
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X) 1.6 g  in 100 mL
CETEARETH-25 (UNII: 8FA93U5T67) 0.7 g  in 100 mL
PHENOXYETHANOL (UNII: HIE492ZZ3T) 0.3 g  in 100 mL
DISODIUM ETHYLENE DICOCAMIDE PEG-15 DISULFATE (UNII: QI9A6U005W) 0.3 g  in 100 mL
PENTYLENE GLYCOL (UNII: 50C1307PZG) 0.1 g  in 100 mL
PANTHENOL (UNII: WV9CM0O67Z) 0.1 g  in 100 mL
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) 0.01 g  in 100 mL
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) 0.01 g  in 100 mL
EDETATE DISODIUM (UNII: 7FLD91C86K) 0.1 g  in 100 mL
TROLAMINE (UNII: 9O3K93S3TK) 0.3 g  in 100 mL
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:11697-319-07 178.000 mL in 1 BOTTLE, SPRAY
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 Business Operations
Aloe Vera of America, Inc. 049049463 manufacture(11697-319)

Revised: 1/2015
Document Id: 50c98089-b653-428f-bb12-5cd65b50b9a8
Set id: d1fc6718-8611-44b5-b312-8cf4866cb46b
Version: 13
Effective Time: 20150122
 
Aloe Vera of America, Inc.