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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Active Ingredients       Purpose

Avobenzone 2.5%

Ensulizole 3.0%

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.

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

Inactive ingredients
aloe barbadensis leaf juice (stabilized* aloe vera gel), butyloctyl salicylate, caprylic/capric triglyceride, cetearyl olivate, ceteth-20, cetyl alcohol, cetyl dimethicone, cetyl PEG/PPG-10/1 dimethicone, fragrance (parfum), glycerin, glyceryl stearate, hexyl laurate, methylisothiazolinone, PEG-75 stearate, phenoxyethanol, polyglyceryl-4 isostearate, sodium chloride, sorbitan olivate, steareth-20, tocopheryl acetate, triethanolamine, water (aqua), xanthan gum

Other information

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

image of tube

ALOE SUNSCREEN 
homosalate, octisalate, avobenzone, ensulizole and octocrylene lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11697-199
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE10.0 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5.0 g  in 100 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE2.5 g  in 100 mL
ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42) ENSULIZOLE3.0 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE2.79 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X) 29.4 g  in 100 mL
WATER (UNII: 059QF0KO0R) 29.2 g  in 100 mL
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) 3.0 g  in 100 mL
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) 3.0 g  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX) 2.0 g  in 100 mL
CETEARYL OLIVATE (UNII: 58B69Q84JO) 1.7 g  in 100 mL
SORBITAN OLIVATE (UNII: MDL271E3GR) 1.4 g  in 100 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 1.0 g  in 100 mL
CETYL ALCOHOL (UNII: 936JST6JCN) 0.7 g  in 100 mL
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) 0.7 g  in 100 mL
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7) 0.7 g  in 100 mL
HEXYL LAURATE (UNII: 4CG9F9W01Q) 0.7 g  in 100 mL
PHENOXYETHANOL (UNII: HIE492ZZ3T) 0.3 g  in 100 mL
PEG-75 STEARATE (UNII: OT38R0N74H) 0.3 g  in 100 mL
TRIETHYLAMINE (UNII: VOU728O6AY) 0.3 g  in 100 mL
XANTHAN GUM (UNII: TTV12P4NEE) 0.2 g  in 100 mL
CETETH-20 (UNII: I835H2IHHX) 0.2 g  in 100 mL
STEARETH-20 (UNII: L0Q8IK9E08) 0.1 g  in 100 mL
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) 0.1 g  in 100 mL
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) 0.01 g  in 100 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11697-199-05118.000 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35204/06/2011
Labeler - Aloe Vera of America, Inc. (049049463)
Registrant - Aloe Vera of America, Inc. (049049463)
Establishment
NameAddressID/FEIBusiness Operations
Aloe Vera of America, Inc.049049463manufacture(11697-199)

Revised: 1/2015
Document Id: 6f7c5e65-6ad1-431f-a801-7aa79fd40926
Set id: 611798eb-4004-40e8-b7ff-345136253975
Version: 8
Effective Time: 20150121
 
Aloe Vera of America, Inc.