FDA.reportPublic FDA data

Eezysun Sunscreen SPF 50 with Aloe Vera, Marine Friendly

Manufacturer
BIO EARTH MANUFACTURING (PTY) LTD
Effective date
2024-10-24
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:32:16

Label at a glance#

ProductEezysun Sunscreen SPF 50 with Aloe Vera, Marine Friendly
Active ingredientTITANIUM DIOXIDE, ZINC OXIDE
Label structure9 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 40 minutes if swimming or sweating immediately after towel drying at least every two hours Sun protection measures use a broad-spectrum sunscreen with an SPF value of 50 or higher limit time in the sun, especially from 10am - 2pm wear long-sleeve shirts, pants, hats, sunglasses Children under 6 months of age: ask a doctor

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Titanium Dioxide 3.5%,   Zinc Oxide 9.5%

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: on damaged or broken skin.
When using this product: keep out of the eyes, rinse with water to remove.
Stop using this product if: 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 liberally 15 minutes before sun exposure

Reapply

  • after 40 minutes if swimming or sweating
  • immediately after towel drying
  • at least every two hours

Sun protection measuresuse a broad-spectrum sunscreen with an SPF value of 50 or higher

  • limit time in the sun, especially from 10am - 2pm
  • wear long-sleeve shirts, pants, hats, sunglasses
  • Children under 6 months of age: ask a doctor

Other Information

SPL UNCLASSIFIED SECTION

store at or below 77℉. Do not use if seal is broken
protect the product in this container from excessive heat and direct sun

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aloe Vera, Ascorbic Acid, Barium Sulphate, Bulbinella, Carnauba, Castor Seed Oil, Cetearyl Alcohol, Ethylhexylglycerin, Glycerin, Glyceryl Stearate, Hydrogenated Castor Oil, Hydroxyethyl Cellulose, Phenoxyethanol, Rosehip, Soybean Oil, Tocopheryl Acetate, Water, Xanthan Gum

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage descriptionimage descriptionimage descriptionimage descriptionimage description

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
baf7f49c-75b6-496b-a00e-8e766a8e4f03Product name120210127
5dbf91a8-ec29-4ffc-807c-e3bae7fb67b1Product name120201123
85bed648-23ca-4804-98e6-e36aee999cadProduct name120190717
80de93b4-8a94-428d-beb7-d644353ee70bProduct name120180424
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
eb4f7d5b-1286-40dc-b8bf-ad87ff51c688Product name120170522
db8eb201-78c7-4590-8a71-fac0a539bd8cProduct name120170404
141092be-5eb5-452e-9f69-2d350aa70a87Product name120161208
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70116-012-012026-01-29C16284748780-149896155-a7b0-586f-e063-e6dba90add9083c6c235-4130-4d6f-b866-66b2ed047059

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70116-012-01Eezysun Sunscreen SPF 50 with Aloe Vera, Marine Friendly100 mL in 1 TUBECREAM1004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70116-012EEZYSUN SUNSCREEN SPF 50 WITH ALOE VERA, MARINE FRIENDLY (TITANIUM DIOXIDE,ZINC OXIDE) CREAM [BIO EARTH MANUFACTURING (PTY) LTD]4Legacy NDC, 1 package rows20241101_83c6c235-4130-4d6f-b866-66b2ed047059.zip

Products#

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

DailyMed product names page 1 of 1 · 22 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70116-01270116-012-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 19 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALOE VERA LEAF POLYSACCHARIDESW21O437517IACT
ASCORBIC ACIDPQ6CK8PD0RIACT
BARIUM SULFATE25BB7EKE2EIACT
BULBINE FRUTESCENS WHOLEM2U1C7UW6YIACT
CARNAUBA WAXR12CBM0EIZIACT
CASTOR OILD5340Y2I9GIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
HYDROGENATED CASTOR OILZF94AP8MEYIACT
HYDROXYETHYL CELLULOSE, UNSPECIFIEDT4V6TWG28DIACT
PHENOXYETHANOLHIE492ZZ3TIACT
ROSA MOSCHATA OILJ99W255AWFIACT
SOYBEAN OIL241ATL177AIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
WATER059QF0KO0RIACT
XANTHAN GUMTTV12P4NEEIACT
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
253d54ad-37d5-c0f9-e063-6294a90a0a6b83c6c235-4130-4d6f-b866-66b2ed0470592024-10-24WarningsExact identifier
spl id: 253d54ad-37d5-c0f9-e063-6294a90a0a6b
spl set id: 83c6c235-4130-4d6f-b866-66b2ed047059

Reported adverse events (FAERS/openFDA)#

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