Aloe Up by Prime Enterprises

Aloe Up by

Drug Labeling and Warnings

Aloe Up by is a Otc medication manufactured, distributed, or labeled by Prime Enterprises. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

----------

Active Ingredients

Avobenzone 3%

Homosalate 15%

Octisalate 5%

Octocrylene 10%

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

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

• apply liberally 15 minutes before sun exposure
• reapply:
• after 80 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 value of 15 or higher and other sun protection measures including:
• limit time in the sun, especially from 10 am - 2 pm
• wear long-sleeve shirts, pants, hats, and sunglasses
• children under 6 months of age: Ask a doctor

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

protect this container from excessive heat and direct sun

Questions or Comments?

Call toll free 1-800-950-2563

Aloe Up Kids Broad Spectrum SPF 50 Lotion

ALOE UP  BROAD SPECTRUM SPF 50
avobenzone, homosalate, octisalate, octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58443-0650
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	49.65 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	99.3 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	148.95 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	29.79 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
COCOA BUTTER (UNII: 512OYT1CRR)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER (60000 MPA.S) (UNII: 8Z5ZAL5H3V)
ALLANTOIN (UNII: 344S277G0Z)
ISODECYL NEOPENTANOATE (UNII: W60VYE24XC)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
SORBITOL (UNII: 506T60A25R)
TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q)
WATER (UNII: 059QF0KO0R)
LOW DENSITY POLYETHYLENE (UNII: J245LN42AI)
PROPANEDIOL (UNII: 5965N8W85T)
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
PHENOXYETHANOL (UNII: HIE492ZZ3T)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58443-0650-4	177 mL in 1 TUBE; Type 0: Not a Combination Product	05/02/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	05/02/2024

Labeler - Prime Enterprises (101946028)

Registrant - Prime Enterprises (101946028)

Establishment
Name	Address	ID/FEI	Business Operations
Prime Enterprises		101946028	analysis(58443-0650) , label(58443-0650) , manufacture(58443-0650) , pack(58443-0650)

Revised: 5/2024

Document Id: 177fb42b-cdef-3db2-e063-6294a90a77fe

34390-5

Set id: 177fb42b-cdee-3db2-e063-6294a90a77fe

Version: 1

Effective Time: 20240502