ALOE UP SUNSCREEN  SPF 50- avobenzone, homosalate, octisalate, octocrylene, octinoxate 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.

----------

ALOE UP - SPF 50 LOTION - 61477-213

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 SUNSCREEN   SPF 50
avobenzone, homosalate, octisalate, octocrylene, octinoxate lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61477-213
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 100 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE5 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE6 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE10 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)  
ALLANTOIN (UNII: 344S277G0Z)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
CAMELLIA SINENSIS WHOLE (UNII: C5M4585ZBZ)  
CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED) (UNII: Z135WT9208)  
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
ISODECYL NEOPENTANOATE (UNII: W60VYE24XC)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
PROPANEDIOL (UNII: 5965N8W85T)  
SORBITOL (UNII: 506T60A25R)  
COCOA BUTTER (UNII: 512OYT1CRR)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
TROLAMINE (UNII: 9O3K93S3TK)  
TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61477-213-14118 mL in 1 TUBE; Type 0: Not a Combination Product02/24/2014
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: 4/2022
Document Id: dc949d17-dad2-8ac7-e053-2995a90ad4c5
Set id: 00e86762-db83-4c3a-9ce7-7b3f2ab0b3bd
Version: 5
Effective Time: 20220413
 
Aloe Care International, LLC