FDA.reportPublic FDA data

ZINC OXIDE

Manufacturer
Aruba Aloe Balm NV
Effective date
2023-11-06
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:59:16

Label at a glance#

ProductSport Broad Spectrum SPF50 Water Resistant 80 minutes Mineral Sunscreen UVA UVB Protection Stick
Active ingredientZINC OXIDE
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 an 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 measures including: • limit time in the sun, especially from 10 a.m.-2 p.m. • wear long sleeved shirts, pants, ...

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 20.0%

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 an 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 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

Candelilla Wax, Caprylic/Capric Triglyceride, Cera Alba (Beeswax), Cocos Nucifera (Coconut) Oil, Myristyl Myristate, C18-20 Alkane, Butyrospermum Parkii (Shea) Butter, C13-14 Alkane, Tridecyl Salicylate, Theobroma Cacao (Cocoa) Seed Butter, Helianthus Annuus (Sunflower) Seed Wax, Tocopheryl Acetate, Fragrance (Parfum), Aloe Barbadensis Leaf Juice (Aloe Vera Gel from Aruba), Sorbitan Oleate, Simmondsia Chinensis (Jojoba) Seed Oil, Triethoxycaprylylsilane.

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ZINC CATION Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53675-203-00Sport Broad Spectrum SPF50 Water Resistant 80 minutes Mineral Sunscreen UVA UVB Protection Stick30 mL in 1 CONTAINERSTICK302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53675-203SPORT BROAD SPECTRUM SPF50 WATER RESISTANT 80 MINUTES MINERAL SUNSCREEN UVA UVB PROTECTION STICK (ZINC OXIDE) STICK [ARUBA ALOE BALM NV]2Current NDC, Legacy NDC, 1 package rows20231108_3201cc8b-5fee-4f3b-a826-e349786d1b32.zip

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
53675-20353675-203-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
CANDELILLA WAXWL0328HX19IACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
YELLOW WAX2ZA36H0S2VIACT
COCONUT OILQ9L0O73W7LIACT
MYRISTYL MYRISTATE4042ZC00DYIACT
SHEA BUTTERK49155WL9YIACT
TRIDECYL SALICYLATEAZQ08K38Z1IACT
COCOA BUTTER512OYT1CRRIACT
HELIANTHUS ANNUUS SEED WAX42DG15CHXVIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
ALOE VERA LEAFZY81Z83H0XIACT
SORBITAN MONOOLEATE06XEA2VD56IACT
JOJOBA OIL724GKU717MIACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
ZINC OXIDESOI2LOH54ZACTIM

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
Sport Broad Spectrum SPF50 Water Resistant 80 minutes Mineral Sunscreen UVA UVB Protection StickZINC OXIDEAruba Aloe Balm NV3201cc8b-5fee-4f3b-a826-e349786d1b322023-11-06WarningsExact identifier
ndc (package): 53675-203-00
ndc (product): 53675-203
ndc11 (package): 53675020300
spl id: 098688fd-eb12-29d6-e063-6294a90ade41
spl set id: 3201cc8b-5fee-4f3b-a826-e349786d1b32

Reported adverse events (FAERS/openFDA)#

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