FDA.reportPublic FDA data

ALOE UP - SPORT SPF 50 LOTION (61477-218)

Manufacturer
Aloe Care International, LLC
Effective date
2026-01-28
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 01:35:24

Label at a glance#

ProductALOE UP SPORT SPF-50
Active ingredientAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE
Label structure10 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 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...

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

AVOBENZONE (3.0%)

HOMOSALATE (15.0%)

OCTISALATE (5.0%)

OCTOCRYLENE (15%)

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

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 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 a.m. – 2 p.m.
  • wear long-sleeve shirts, pants, hats, and sunglasses
  • children under 6 months of age: Ask a doctor

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.

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.

Stop use and ask a doctor if rash occurs

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

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

OTHER INFORMATION

OTHER SAFETY INFORMATION

  • protect this container from excessive heat and direct sun.

QUESTIONS AND COMMENTS?

OTC - QUESTIONS SECTION

Call toll free 1-800-950-2563

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SPORT SPF 50 lotionSPORT SPF 50 lotion

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61477-218-162024-02-13C16284748780-1d6a99b39-b8e0-a426-e053-dadaa90af4c2ALOE UP - SPORT SPF 50 LOTION (61477-218)
61477-218-162024-01-30C16284748780-1d6a99b39-b8e0-a426-e053-dadaa90af4c2ALOE UP - SPORT SPF 50 LOTION (61477-218)
61477-218-162022-04-14C16284748780-1d6a99b39-b8e0-a426-e053-dadaa90af4c2ALOE UP - SPORT SPF 50 LOTION (61477-218)
61477-218-162022-01-28C16284748780-1d6a99b39-b8e0-a426-e053-dadaa90af4c2ALOE UP - SPORT SPF 50 LOTION (61477-218)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61477-218-16ALOE UP SPORTSPF-50177 mL in 1 TUBELOTION1776

Products#

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

DailyMed product names page 1 of 1 · 25 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61477-21861477-218-16

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 23 matching rows.

Name, UNII, Kind table
NameUNIIKind
CARBOMER INTERPOLYMER TYPE A (55000 CPS)59TL3WG5COIACT
ALLANTOIN344S277G0ZIACT
ALOE BARBADENSIS LEAF JUICERUE8E6T4NBIACT
ALUMINUM STARCH OCTENYLSUCCINATEI9PJ0O6294IACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
CAMELLIA SINENSIS WHOLEC5M4585ZBZIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
ISODECYL NEOPENTANOATEW60VYE24XCIACT
PHENOXYETHANOLHIE492ZZ3TIACT
POLYETHYLENEUG00KM4WR7IACT
POLYSORBATE 207T1F30V5YHIACT
PROPANEDIOL5965N8W85TIACT
SORBITOL506T60A25RIACT
COCOA BUTTER512OYT1CRRIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
SODIUM HYDROXIDE55X04QC32IIACT
TRISODIUM ETHYLENEDIAMINE DISUCCINATEYA22H34H9QIACT
WATER059QF0KO0RIACT
AVOBENZONEG63QQF2NOXACTIB
HOMOSALATEV06SV4M95SACTIB
OCTISALATE4X49Y0596WACTIB
OCTOCRYLENE5A68WGF6WMACTIB

Source Document#

Source XML

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
ALOE UP SPORT SPF-50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEAloe Care International, LLC3f2f90f1-28dd-48e8-9083-ea04815acc6b2026-01-28WarningsExact identifier
ndc (package): 61477-218-16
ndc (product): 61477-218
ndc11 (package): 61477021816
spl id: 497ab2ef-0548-a4e1-e063-6294a90ab266
spl set id: 3f2f90f1-28dd-48e8-9083-ea04815acc6b

Reported adverse events (FAERS/openFDA)#

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