ALOE UP KIDS BROAD SPECTRUM SPF 50 SUNSCREEN- octisalate, avobenzone, homosalate, octocrylene, octinoxate gel 
Prime Enterprises 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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ALOE UP KIDS SPORT PERFORMANCE SUNSCREEN Spectrum SPF 50

INACTIVE INGREDIENTS

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

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. Keep away from face to avoid breathing it.

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.

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.

Purpose

Sunscreen

Uses

Active Ingredients

Avobenzone 3.0%

Octocrylene 10%

Homosalate 5.0%

Octisalate 5.0%

Octinoxate 6.0%

Directions

Other Information

Questions or Comments?

Call Toll free 1-855-950-2563

ALOE UP KIDS SPORT PERFORMANCE SUNSCREEN Broad spectrum SPF 50

Principal Display Label

ALOE UP  KIDS BROAD SPECTRUM SPF 50 SUNSCREEN
octisalate, avobenzone, homosalate, octocrylene, octinoxate gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58443-0301
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE49.7 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE99.4 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE29.82 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE49.7 mg  in 1 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE59.64 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
ISOPROPYLPHTHALIMIDE (UNII: 1J1MM83329)  
SORBITOL (UNII: 506T60A25R)  
PROPANEDIOL (UNII: 5965N8W85T)  
TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
COCOA BUTTER (UNII: 512OYT1CRR)  
ISODECYL NEOPENTANOATE (UNII: W60VYE24XC)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
ALLANTOIN (UNII: 344S277G0Z)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
WATER (UNII: 059QF0KO0R)  
TROLAMINE (UNII: 9O3K93S3TK)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
N-BUTYLPHTHALIMIDE (UNII: 5TH1DKT35E)  
CAMELLIA SINENSIS FLOWER (UNII: 9I2BJY2J17)  
Product Characteristics
Colorwhite (Off white) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58443-0301-4177 mL in 1 BOTTLE; Type 0: Not a Combination Product07/03/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35207/03/2018
Labeler - Prime Enterprises Inc. (101946028)
Registrant - Prime Enterprises Inc. (101946028)
Establishment
NameAddressID/FEIBusiness Operations
Prime Enterprises Inc.101946028pack(58443-0301) , manufacture(58443-0301) , label(58443-0301) , analysis(58443-0301)

Revised: 5/2020
Document Id: a4d730ef-44af-586f-e053-2995a90a46e9
Set id: a4d73025-9c5b-7455-e053-2995a90ab746
Version: 1
Effective Time: 20200504
 
Prime Enterprises Inc.