ALOE ICE WHITE SPF 20- avobenzone, homosalate, octisalate and octocrylene lotion 
Aloe Care International, LLC

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:

AVOBENZONE 2.0%

HOMOSALATE 4.0%

OCTISALATE 5.0%

OCTOCRYLENE 3.0%

PURPOSE:

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

Directions
• apply liberally 15 minutes before sun exposure
• reapply:
• after 40 minutes of swimming or sweating
• immediately after towel drying
• at least every 2 hours
• 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

Other information
• protect this product from excessive heat and direct sun

Questions or comments?
Call toll free 1-800-950-2563 • www.aloeiceco.com

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

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 a doctor if rash occurs

Inactive ingredients

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Allantoin, Aloe Barbadensis Leaf Juice, Aluminum Starch Octenylsuccinate, Butylphthalimide, C12-15 Alkyl Benzoate, Camellia Sinensis Leaf Extract, Carbomer, Fragrance, Iodopropynyl Butylcarbamate, Isodecyl Neopentanoate, Isopropylphthalimide, Methylisothiazolinone, PEG-8, Phenoxyethanol, Polyethylene, Polysorbate 20, Propanediol, Sorbitol, Theobroma Cacao (Cocoa) Seed Butter, Tocopheryl Acetate, Triethanolamine, Trisodium Ethylenediamine Disuccinate, Water

Aloe Ice-White SPF 20 Lotion

ALOE ICE WHITE  SPF 20
avobenzone, homosalate, octisalate, octocrylene lotion
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:61477-201
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (AVOBENZONE) AVOBENZONE2 g  in 100 mL
HOMOSALATE (HOMOSALATE) HOMOSALATE4 g  in 100 mL
OCTISALATE (OCTISALATE) OCTISALATE5 g  in 100 mL
OCTOCRYLENE (OCTOCRYLENE) OCTOCRYLENE3 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
CARBOMER INTERPOLYMER TYPE A (55000 CPS) 
ALLANTOIN 
ALOE VERA LEAF 
ALUMINUM STARCH OCTENYLSUCCINATE 
3-BUTYLPHTHALIDE 
C12-15 ALKYL BENZOATE 
CAMELLIA SINENSIS WHOLE 
CARBOMER 940 
ISODECYL NEOPENTANOATE 
ISOPROPYLPHTHALIMIDE 
METHYLISOTHIAZOLINONE 
POLYETHYLENE GLYCOL 400 
PHENOXYETHANOL 
HIGH DENSITY POLYETHYLENE 
POLYSORBATE 20 
PROPANEDIOL 
SORBITOL 
COCOA BUTTER 
.ALPHA.-TOCOPHEROL ACETATE 
TROLAMINE 
TRISODIUM ETHYLENEDIAMINE DISUCCINATE 
WATER 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61477-201-14177 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35202/24/2014
Labeler - Aloe Care International, LLC (938242187)
Registrant - Aloe Care International, LLC (938242187)

Revised: 2/2014
 
Aloe Care International, LLC