ALOE UP WHITE SUNSCREEN SPF 50- avobenzone, homosalate, octisalate, octinoxate 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 (3%)

HOMOSALATE (5%)

OCTINOXATE (6%)

OCTISALATE (5%)

OCTOCRYLENE (10%)

PURPOSE:

SUNSCREEN

INDICATIONS:

HELPS PREVENT SUNBURN.

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.

KEEP OUT OF REACH OF CHILDREN.

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. KEEP OUT OF REACH OF CHILDREN. IF PRODUCT IS SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

Other Ingredients:

ACRYLATES/C10-30 ALKYL ACRYLATES CROSSPOLYMER, ALLANTOIN, ALOE BARBADENSIS LEAF JUICE, ALUMINUM STARCH OCTENYLSUCCINATE, BUTYLOCTYL SALICYLATE, C12-15 ALKYL BENZOATE, CAMELLIA SINENSIS LEAF EXTRACT, CARBOMER, IODOPROPYNYL BUTYLCARBAMATE, ISODECYL NEOPENTANOATE, METHYLISOTHIAZOLINONE, PHENOXYETHANOL, POLYETHYLENE, POLYSORBATE 20, PROPANEDIOL, SORBITOL, THEOBROMA CACAO (COCOA) SEED BUTTER, TOCOPHERYL ACETATE, TRIETHANOLAMINE, TRISODIUM ETHYLENEDIAMINE DISUCCINATE, WATER

Aloe Up White 50 4 oz Lotion

ALOE UP WHITE SUNSCREEN  SPF 50
avobenzone, homosalate, octisalate, octocrylene, octinoxate lotion
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:61477-213
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (AVOBENZONE) AVOBENZONE3 g  in 100 mL
HOMOSALATE (HOMOSALATE) HOMOSALATE5 g  in 100 mL
OCTISALATE (OCTISALATE) OCTISALATE5 g  in 100 mL
OCTINOXATE (OCTINOXATE) OCTINOXATE6 g  in 100 mL
OCTOCRYLENE (OCTOCRYLENE) OCTOCRYLENE10   in 100 mL
Inactive Ingredients
Ingredient NameStrength
CARBOMER COPOLYMER TYPE A 
ALLANTOIN 
ALOE VERA LEAF 
ALUMINUM STARCH OCTENYLSUCCINATE 
BUTYLOCTYL SALICYLATE 
C12-15 ALKYL BENZOATE 
CAMELLIA SINENSIS WHOLE 
CARBOMER 934 
IODOPROPYNYL BUTYLCARBAMATE 
ISODECYL NEOPENTANOATE 
METHYLISOTHIAZOLINONE 
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:61477-213-14118 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