FDA.reportPublic FDA data

Eezysun SPF 50 Adults

Manufacturer
BIO EARTH MANUFACTURING (PTY) LTD
Effective date
2025-05-28
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:01:41

Label at a glance#

ProductEezysun SPF 50 Adults
Active ingredientTITANIUM DIOXIDE, ZINC OXIDE
Label structure8 sections

Indications and uses

helps prevent sunburn If used as directed with other sun protection measures (see Directions ), decreases the risk of skin cancer 

Dosage and administration

Shake well before use. Apply liberally 15 minutes before sun exposure Reapply after 80 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

Zink Oxide 10 % & Titanium Dioxide 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 

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • Shake well before use.
  • Apply liberally 15 minutes before sun exposure

Reapply

  • after 80 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

Other Information

SPL UNCLASSIFIED SECTION

  • Store at or below 77⁰ F/25⁰C
  • Do not use if seal is broken
  • protect from excessive heat and direct sun

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aloe Vera, Aqua, Ascorbic Acid, Barium Sulphate, Cetearyl Alcohol, Citric Acid, Glycerine, Glyceryl Stearate, Hydroxyethyl Cellulose, Citrullus Vulgaris (Kalahari Melon) Oil, Potassium Cetyl Phosphate, Potassium Sorbate, Retinol Palmitate, Ricinus Communis(Castor)Ceed Oil, Hydrogenated Castor Oil, Copernica Cerifera(Carnauba)Wax, Rosehip Fruit Oil, Sodium Benzoate, Sodium Lactate, Sorbitan Olivate, Soybean Oil, Tocopherol, Vanilla Planifolia Fruit Oil

Product label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image 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
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
80de93b4-8a94-428d-beb7-d644353ee70bProduct name120180424
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
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70116-027-01Eezysun SPF 50 Adults100 mL in 1 TUBECREAM1001
70116-027-01Eezysun SPF 50 Adults1 in 1 CARTONCREAM11

Products#

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

DailyMed product names page 1 of 1 · 28 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70116-02770116-027-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 25 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALOE VERA LEAF POLYSACCHARIDESW21O437517IACT
WATER059QF0KO0RIACT
ASCORBIC ACIDPQ6CK8PD0RIACT
BARIUM SULFATE25BB7EKE2EIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
GLYCERINPDC6A3C0OXIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
HYDROXYETHYL CELLULOSE, UNSPECIFIEDT4V6TWG28DIACT
CITRUS X LIMON FLOWERING TOP OIL4C38SS0J60IACT
POTASSIUM CETYL PHOSPHATE03KCY6P7UTIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
VITAMIN A PALMITATE1D1K0N0VVCIACT
CASTOR OILD5340Y2I9GIACT
HYDROGENATED CASTOR OILZF94AP8MEYIACT
CARNAUBA WAXR12CBM0EIZIACT
ROSA MOSCHATA OILJ99W255AWFIACT
SODIUM BENZOATEOJ245FE5EUIACT
SODIUM LACTATETU7HW0W0QTIACT
SORBITAN OLIVATEMDL271E3GRIACT
SOYBEAN OIL241ATL177AIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
VANILLA PLANIFOLIA OIL0A3F415158IACT
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
363230a0-af53-645d-e063-6294a90a2c56bc7edb7a-b356-40c2-aa24-472a909a54c52025-05-28WarningsExact identifier
spl id: 363230a0-af53-645d-e063-6294a90a2c56
spl set id: bc7edb7a-b356-40c2-aa24-472a909a54c5

Reported adverse events (FAERS/openFDA)#

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