FDA.reportPublic FDA data

ALOE UP SPORT NATURAL BALM

Manufacturer
Aloe Care International, LLC
Effective date
2026-01-30
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 01:35:46

Label at a glance#

ProductALOE UP SPORT NATURAL BALM SPF-15
Active ingredientAVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE
Label structure10 sections

Indications and uses

HELPS PREVENT SUNBURN.

Dosage and administration

APPLY LIBERALLY 15 MINUTES BEFORE SUN EXPOSURE. USE A WATER RESISTANT SUNSCREEN IF SWIMMING OR SWEATING. REAPPLY AT LEAST EVERY 2 HOURS. CHILDREN UNDER 6 MONTHS: ASK A DOCTOR.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

Avobenzone (2%)

Octinoxate (6.5%)

Octisalate (5%)

Octocrylene (1.5%)

PURPOSE

OTC - PURPOSE SECTION

SUNSCREEN

USES

INDICATIONS & USAGE SECTION

  • HELPS PREVENT SUNBURN.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

  • APPLY LIBERALLY 15 MINUTES BEFORE SUN EXPOSURE.
  • USE A WATER RESISTANT SUNSCREEN IF SWIMMING OR SWEATING.
  • REAPPLY AT LEAST EVERY 2 HOURS.
  • CHILDREN UNDER 6 MONTHS: ASK A DOCTOR.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

WARNINGS

WARNINGS SECTION

Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.

For external use only

Do not use on damaged or broken skin

Stop use and ask a doctor if rash occurs

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

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Aloe Vera Leaf Extract, Avocado Oil, Beeswax, BHT, Canola Oil, Caprylic/Capric Triglyceride, Castor Seed Oil, Coconut Oil,
Hydrogenated Vegetable Oil, Lanolin Oil, Mango Butter, Sunflower Seed Oil, Tocopherol, Tocopheryl Acetate.

OTHER INFORMATION

OTHER SAFETY INFORMATION

  • Protect this product from excessive heat and direct sun

QUESTIONS OR COMMENTS?

OTC - QUESTIONS SECTION

Toll Free 800-950-2563 www.aloeup.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SPORT BALM NaturalSPORT BALM Natural

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61477-219-112024-02-13C16284748780-1d6a99b39-6a66-a426-e053-dadaa90af4c2ALOE UP SPORT - NATURAL LIP SUNSCREEN SPF 15 (61477-219)
61477-219-112024-01-30C16284748780-1d6a99b39-6a66-a426-e053-dadaa90af4c2ALOE UP SPORT - NATURAL LIP SUNSCREEN SPF 15 (61477-219)
61477-219-112022-04-14C16284748780-1d6a99b39-6a66-a426-e053-dadaa90af4c2ALOE UP SPORT - NATURAL LIP SUNSCREEN SPF 15 (61477-219)
61477-219-112022-01-28C16284748780-1d6a99b39-6a66-a426-e053-dadaa90af4c2ALOE UP SPORT - NATURAL LIP SUNSCREEN SPF 15 (61477-219)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61477-219-11ALOE UP SPORT NATURAL BALMSPF-154.25 g in 1 TUBESTICK4.256

Products#

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

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61477-21961477-219-11

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALOE VERA LEAFZY81Z83H0XIACT
AVOCADO OIL6VNO72PFC1IACT
YELLOW WAX2ZA36H0S2VIACT
BUTYLATED HYDROXYTOLUENE1P9D0Z171KIACT
CANOLA OIL331KBJ17RKIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
CASTOR OILD5340Y2I9GIACT
COCONUT OILQ9L0O73W7LIACT
HYDROGENATED SOYBEAN OILA2M91M918CIACT
LANOLIN7EV65EAW6HIACT
MANGIFERA INDICA SEED BUTTER4OXD9M35X2IACT
SUNFLOWER OIL3W1JG795YIIACT
TOCOPHEROLR0ZB2556P8IACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
AVOBENZONEG63QQF2NOXACTIB
OCTINOXATE4Y5P7MUD51ACTIB
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 NATURAL BALM SPF-15AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENEAloe Care International, LLC3de029ed-97f7-4cb3-a32e-d412bf3b58742026-01-30WarningsExact identifier
ndc (package): 61477-219-11
ndc (product): 61477-219
ndc11 (package): 61477021911
spl id: 49a27042-9bea-5114-e063-6294a90a45cd
spl set id: 3de029ed-97f7-4cb3-a32e-d412bf3b5874

Reported adverse events (FAERS/openFDA)#

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