FDA.reportPublic FDA data

ALOE UP

Manufacturer
Prime Enterprises Inc.
Effective date
2020-05-04
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:09:37

Label at a glance#

ProductALOE UP Broad Spectrum SPF 50 Sunscreen
Active ingredientHOMOSALATE, OCTOCRYLENE, AVOBENZONE, OCTISALATE, OCTINOXATE
Label structure9 sections

Indications and 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

Dosage and administration

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 valvue of 15 or higher and other sun protecion measures including: limit tim ein the...

Label contents#

Full prescribing information#

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

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

WARNINGS SECTION

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.

OTC - DO NOT USE SECTION

Do not use on damaged or broken skin

OTC - WHEN USING SECTION

When using this product keep out of eyes. Rinse with water to remove.

OTC - ASK DOCTOR SECTION

Stop use and ask a doctor if rash occurs

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • 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

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 3.0%

Octocrylene 10%

Homosalate 5.0%

Octisalate 5.0%

Octinoxate 6.0%

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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 valvue of 15 or higher and other sun protecion measures including:
  • limit tim ein the sun, especially from 10am-2pm
  • wear long sleeve shirts, pants, hats, and sunglasses
  • children under 6 months: Ask a doctor

Other Information

OTHER SAFETY INFORMATION

  • protect this product from excesive heat and direct sun

Questions or Comments?

OTC - QUESTIONS SECTION

Call Toll free 1-855-950-2563

ALOE UP SPORT PERFORMANCE SUNSCREEN Broad spectrum SPF 50

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display LabelPrincipal Display Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58443-0302-42023-01-30C16284748780-1f386c64a-19b2-0266-e053-dadaa90a7c1aALOE UP SPORT PERFORMANCE SUNSCREEN Spectrum SPF 50

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58443-0302-4ALOE UPBroad Spectrum SPF 50 Sunscreen177 mL in 1 BOTTLESPRAY1771

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58443-0302ALOE UP BROAD SPECTRUM SPF 50 SUNSCREEN (OCTISALATE, AVOBENZONE, HOMOSALATE, OCTOCRYLENE,OCTINOXATE) SPRAY [PRIME ENTERPRISES INC.]1Legacy NDC, 1 package rows20200505_a4d7ac86-3329-8ad2-e053-2995a90a0671.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 29 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58443-030258443-0302-4

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 27 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALUMINUM STARCH OCTENYLSUCCINATEI9PJ0O6294IACT
ISOPROPYLPHTHALIMIDE1J1MM83329IACT
SORBITOL506T60A25RIACT
PROPANEDIOL5965N8W85TIACT
TRISODIUM ETHYLENEDIAMINE DISUCCINATEYA22H34H9QIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
IODOPROPYNYL BUTYLCARBAMATE603P14DHEBIACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
COCOA BUTTER512OYT1CRRIACT
ISODECYL NEOPENTANOATEW60VYE24XCIACT
HIGH DENSITY POLYETHYLENEUG00KM4WR7IACT
ALLANTOIN344S277G0ZIACT
PHENOXYETHANOLHIE492ZZ3TIACT
CARBOMER INTERPOLYMER TYPE A (55000 CPS)59TL3WG5COIACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
POLYSORBATE 207T1F30V5YHIACT
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
WATER059QF0KO0RIACT
TROLAMINE9O3K93S3TKIACT
ALOE VERA LEAFZY81Z83H0XIACT
N-BUTYLPHTHALIMIDE5TH1DKT35EIACT
CAMELLIA SINENSIS FLOWER9I2BJY2J17IACT
HOMOSALATEV06SV4M95SACTIB
OCTOCRYLENE5A68WGF6WMACTIB
AVOBENZONEG63QQF2NOXACTIB
OCTISALATE4X49Y0596WACTIB
OCTINOXATE4Y5P7MUD51ACTIB

Source Document#

Source XML · Source PDF

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
a4d7b69e-55d0-6d76-e053-2995a90add66a4d7ac86-3329-8ad2-e053-2995a90a06712020-05-04WarningsExact identifier
spl id: a4d7b69e-55d0-6d76-e053-2995a90add66
spl set id: a4d7ac86-3329-8ad2-e053-2995a90a0671

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.