FDA.reportPublic FDA data

Aruba Aloe broad spectrum SPF 15 Lip sunscreen and Moisturizer

Manufacturer
Aruba Aloe Balm NV
Effective date
2024-01-11
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:07:02

Label at a glance#

ProductAruba Aloe broad spectrum SPF 15 Lip sunscreen and Moisturizer
Active ingredientAVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE
Label structure7 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 generously 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 ti...

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone (3%), Homosalate (7.34%), Octocrylene (5%), Octyl Salicylate (5%)

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.

Warnings

WARNINGS SECTION

For external use only.

Do not use

OTC - DO NOT USE SECTION

on damaged or broken skin.

When using this product

OTC - WHEN USING SECTION

keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if

OTC - STOP USE SECTION

rash occurs.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • apply generously 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-sleeved shirts, pants, hats, and sunglasses. 
  • children under 6 months of age: Ask a doctor.

Other Information

SPL UNCLASSIFIED SECTION

  • protect the product in this container from excessive heat and direct sun.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Petrolatum, Theobroma Cacao (Cocoa) Seed Butter, Euphorbia Cerifera (Candelilla) Wax, Jojoba Esters, Cocos Nucifera (Coconut) Oil, Aloe Barbadensis Leaf Juice (Aloe Vera Gel from Aruba), Tocopheryl Acetate (Vitamin E Acetate), Sorbitan Oleate.

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53675-208-00Aruba Aloe broad spectrum SPF 15 Lip sunscreen and Moisturizer4.8 g in 1 PACKAGESTICK4.81

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53675-208ARUBA ALOE BROAD SPECTRUM SPF 15 LIP SUNSCREEN AND MOISTURIZER (AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE) STICK [ARUBA ALOE BALM NV]1Current NDC, 1 package rows20240112_9e3ed6dc-14ba-4bb2-a633-1a1fe92099ce.zip

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
53675-20853675-208-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
PETROLATUM4T6H12BN9UIACT
COCOA BUTTER512OYT1CRRIACT
CANDELILLA WAXWL0328HX19IACT
COCONUT OILQ9L0O73W7LIACT
ALOE VERA LEAFZY81Z83H0XIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
SORBITAN MONOOLEATE06XEA2VD56IACT
AVOBENZONEG63QQF2NOXACTIB
HOMOSALATEV06SV4M95SACTIB
OCTOCRYLENE5A68WGF6WMACTIB
OCTISALATE4X49Y0596WACTIB

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
Aruba Aloe broad spectrum SPF 15 Lip sunscreen and MoisturizerAVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATEAruba Aloe Balm NV9e3ed6dc-14ba-4bb2-a633-1a1fe92099ce2024-01-11WarningsExact identifier
ndc (package): 53675-208-00
ndc (product): 53675-208
ndc11 (package): 53675020800
spl id: 0eae7a1b-f5ac-eb4a-e063-6394a90af2c5
spl set id: 9e3ed6dc-14ba-4bb2-a633-1a1fe92099ce

Reported adverse events (FAERS/openFDA)#

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