FDA.reportPublic FDA data

Broad Spectrum SPF 30 Water Resistant Mineral Sunscreen

Manufacturer
Aruba Aloe Balm NV
Effective date
2023-11-06
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:59:15

Label at a glance#

ProductBroad Spectrum SPF 30 Water Resistant Mineral Sunscreen
Active ingredientTITANIUM DIOXIDE, ZINC 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 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. 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: Sun Protection Measures. limit time in...

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Titanium Dioxide 10% Zinc Oxide 8%

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.
  • 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: Sun Protection Measures.
  • 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

Water (Aqua/Eau), Helianthus Annuus (Sunflower) Seed Oil, Propanediol, Aloe Barbadensis Leaf Juice (Aloe Vera Gel from Aruba), Acetylated Hydrogenated Vegetable Glyceride, Polyglyceryl-3 Polyricinoleate, Fragrance (Parfum), Butyloctyl Salicylate, Phenoxyethanol, Caprylyl Glycol, Chlorphenesin, Polyhydroxystearic Acid, Stearic Acid, Alumina, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Acrylates/Beheneth-25 Methacrylate Copolymer, Tocopheryl (Vitamin E) Acetate, Sodium Hydroxide.

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

TubeTube

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
53675-183-30Broad Spectrum SPF 30 Water Resistant Mineral Sunscreen30 mL in 1 TUBECREAM303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53675-183BROAD SPECTRUM SPF 30 WATER RESISTANT MINERAL SUNSCREEN (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [ARUBA ALOE BALM NV]3Legacy NDC, 1 package rows20231108_232f8af6-8fa5-4aee-be7a-40460c751ef6.zip

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
53675-18353675-183-30

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
SUNFLOWER OIL3W1JG795YIIACT
PROPANEDIOL5965N8W85TIACT
ALOE VERA LEAFZY81Z83H0XIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
PHENOXYETHANOLHIE492ZZ3TIACT
CAPRYLYL GLYCOL00YIU5438UIACT
CHLORPHENESINI670DAL4SZIACT
STEARIC ACID4ELV7Z65APIACT
ALUMINUM OXIDELMI26O6933IACT
SODIUM HYDROXIDE55X04QC32IIACT
TITANIUM DIOXIDE15FIX9V2JPACTIB
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
54b19b6a-75a4-902d-e063-6394a90ae3bb232f8af6-8fa5-4aee-be7a-40460c751ef62026-06-20WarningsExact identifier
spl set id: 232f8af6-8fa5-4aee-be7a-40460c751ef6

Reported adverse events (FAERS/openFDA)#

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