FDA.reportPublic FDA data

Eezy Pro SPF 30

Manufacturer
BIO EARTH MANUFACTURING (PTY) LTD
Effective date
2024-10-30
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 00:32:21

Label at a glance#

ProductEezy Pro SPF 30
Active ingredientMERADIMATE, OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE
Label structure9 sections

Indications and uses

Helps prevent sunburn If used as directed with other sun protection measures decreases the risk of skin cancer and early skin aging caused by sun(see Directions)

Dosage and administration

Apply liberally 15 minutes before sun exposure Reapply After 40 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 use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: Limited time in ...

Label contents#

Full prescribing information#

Actives

OTC - ACTIVE INGREDIENT SECTION

 Meradimate, Octinoxate, Octocrylene, Titanium Dioxide, Zinc Oxide

Purpose

OTC - PURPOSE SECTION

Sunsreen

Uses

INDICATIONS & USAGE SECTION

  • Helps prevent sunburn
  • If used as directed with other sun protection measures decreases the risk of skin cancer and early skin aging caused by sun(see Directions)

Warnings

WARNINGS SECTION

For external use only

Do not useon damaged or broken skin

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

Stop use and ask a doctorif rash occurs

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.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Apply liberally 15 minutes before sun exposure

Reapply

  • After 40 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 use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
  • Limited time in the sun, espesially from 10 a.m - 2 p.m
  • Wear long-sleeved shirts, pants, hats and sunglasses
  • Children under 6 months of age: ask a doctor

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aloe barbadensis leaf juice, Cellulose gum, Cetearyl alcohol, Glycerin, Glycerol Stearate, Methylparaben, Phenoxyethanol, Propylparaben,

Vitamin A & E, Water, White petrolatum, Xanthan gum 

Other information

SPL UNCLASSIFIED SECTION

Protect the product in this container from excessive heat and direct sun

Product label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image 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
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70116-004-01Eezy Pro SPF 308 mL in 1 POUCHCREAM85
70116-004-01Eezy Pro SPF 3010 in 1 PACKETCREAM105

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70116-004EEZY PRO SPF 30 (MERADIMATE, OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIO EARTH MANUFACTURING (PTY) LTD]5Legacy NDC, 2 package rows20241101_dd1a85ae-2ccf-4270-a5a3-aa3b2ea6de3e.zip

Products#

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

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70116-00470116-004-01

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
BULBINE FRUTESCENS WHOLEM2U1C7UW6YIACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORMK679OBS311IACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
GLYCERINPDC6A3C0OXIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
METHYLPARABENA2I8C7HI9TIACT
PHENOXYETHANOLHIE492ZZ3TIACT
PROPYLPARABENZ8IX2SC1OHIACT
.ALPHA.-TOCOPHEROLH4N855PNZ1IACT
VITAMIN A81G40H8B0TIACT
WATER059QF0KO0RIACT
PETROLATUM4T6H12BN9UIACT
XANTHAN GUMTTV12P4NEEIACT
MERADIMATEJ9QGD60OUZACTIB
OCTINOXATE4Y5P7MUD51ACTIB
OCTOCRYLENE5A68WGF6WMACTIB
TITANIUM DIOXIDE15FIX9V2JPACTIB
ZINC OXIDESOI2LOH54ZACTIM

Source Document#

Source XML · Source PDF

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
25b87c57-313f-9c16-e063-6394a90abc3add1a85ae-2ccf-4270-a5a3-aa3b2ea6de3e2024-10-30WarningsExact identifier
spl id: 25b87c57-313f-9c16-e063-6394a90abc3a
spl set id: dd1a85ae-2ccf-4270-a5a3-aa3b2ea6de3e

Reported adverse events (FAERS/openFDA)#

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