Aloe Up Coco-Mango Broad Spectrum SPF 50 Sunscreen Lotion

Aloe Up by

Drug Labeling and Warnings

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

Drug Details [pdf]

ALOE UP BROAD SPECTRUM SPF 50 SUNSCREEN- octisalate, avobenzone, homosalate, octocrylene lotion 
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 Coco-Mango Broad Spectrum SPF 50 Sunscreen Lotion

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 ine 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 protecion measures including:
• limit time in the sun, especially from 10am-2pm
• wear long sleeve shirts, pants, hats, and sunglasses
• children under 6 months: 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, Fragrance, 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 excesive heat and direct sun

Questions or Comments?

Call Toll free 1-855-950-2563

Aloe Up Coco-Mango SPF 50 Broad Spectrum Sunscreen Lotion

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58443-0560
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	148.95 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	99.4 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	29.79 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	49.65 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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)
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)
CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 809Y72KV36)
FRAGRANCE 13576 (UNII: 5EM498GW35)

Product Characteristics
Color	white (Off white)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58443-0560-3	118 mL in 1 TUBE; Type 0: Not a Combination Product	06/01/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	M020	06/01/2022

Labeler - Prime Enterprises Inc. (101946028)

Registrant - Prime Enterprises Inc. (101946028)

Establishment
Name	Address	ID/FEI	Business Operations
Prime Enterprises Inc.		101946028	pack(58443-0560) , manufacture(58443-0560) , label(58443-0560) , analysis(58443-0560)

Revised: 8/2022

Document Id: e699354b-76d2-53dd-e053-2995a90a8876

34390-5

Set id: e6993bd6-ced4-66e1-e053-2995a90adb1e

Version: 1

Effective Time: 20220819