ALOE UP BROAD SPECTRUM SPF 50 SUNSCREEN- octisalate, avobenzone, homosalate, octocrylene lotion 
Prime Enterprises Inc.

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Aloe Up Broad Spectrum SPF 50 Sport Performance Sunscreen Lotion

Active Ingredients

Avobenzone 3%

Homosalate 15%

Octisalate 5%

Octocrylene 10%

Purpose

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 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.

Directions

INACTIVE INGREDIENTS

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Allantoin, Aloe Barbadensis Leaf Juice, Aluminum Starch Octenylsuccinate, Butyloctyl Salicylate, C12-15 Alkyl Benzoate, Camellia Sinensis (Green Tea) Leaf Extract, Carbomer, Ethylhexylglycerin, Isodecyl Neopentanoate, Phenoxyethanol, Polyethylene, Polysorbate 20, Propanediol, Sodium Hydroxide, Sorbitol, Theobroma Cacao (Cocoa) Seed Butter, Tocopheryl Acetate, Trisodium Ethylenediamine Disuccinate, Water

Other Information

Questions or Comments?

Call Toll free 1-855-950-2563

Aloe Up Sport SPF 50 Broad Spectrum Performance Sunscreen Lotion

Principal Display Label

ALOE UP  BROAD SPECTRUM SPF 50 SUNSCREEN
octisalate, avobenzone, homosalate, octocrylene lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58443-0559
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE148.95 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE99.4 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE29.79 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE49.65 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
COCOA BUTTER (UNII: 512OYT1CRR)  
ISODECYL NEOPENTANOATE (UNII: W60VYE24XC)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
SORBITOL (UNII: 506T60A25R)  
ALLANTOIN (UNII: 344S277G0Z)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
PROPANEDIOL (UNII: 5965N8W85T)  
CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
WATER (UNII: 059QF0KO0R)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
CAMELLIA SINENSIS FLOWER (UNII: 9I2BJY2J17)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
Product Characteristics
Colorwhite (Off white) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58443-0559-4177 mL in 1 TUBE; Type 0: Not a Combination Product11/03/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02011/03/2020
Labeler - Prime Enterprises Inc. (101946028)
Registrant - Prime Enterprises Inc. (101946028)
Establishment
NameAddressID/FEIBusiness Operations
Prime Enterprises Inc.101946028pack(58443-0559) , manufacture(58443-0559) , label(58443-0559) , analysis(58443-0559)

Revised: 5/2024
Document Id: 178ebb36-0339-8623-e063-6294a90a0c22
Set id: 178ebb2b-8175-4e09-e063-6394a90a5b8f
Version: 1
Effective Time: 20240503
 
Prime Enterprises Inc.