EEZY PRO- meradimate, octinoxate, octocrylene, titanium dioxide, zinc oxide cream 
BIO EARTH MANUFACTURING (PTY) LTD

----------

Eezy pro

Active Ingredient

Meradimate, Octinoxate, Octocrylene, Titanium Dioxide, Zinc Oxide

Purpose

Sunscreen

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)

Warnings

For external use only.

Do not use on damaged or broken skin

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

Stop use and ask a doctor if rash occurs.

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

•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 Ingredient

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

Vitamin A & E, Water, White petrolatum, Xanthan gum,Niacinamide,hydrolysed soybean fibre.

Other Information

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

Product Label

image description

EEZY PRO 
meradimate, octinoxate, octocrylene, titanium dioxide, zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70116-010
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MERADIMATE (UNII: J9QGD60OUZ) (MERADIMATE - UNII:J9QGD60OUZ) MERADIMATE5 mg  in 100 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 mg  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE8 mg  in 100 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE7 mg  in 100 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION11 mg  in 100 mL
Inactive Ingredients
Ingredient NameStrength
BULBINE FRUTESCENS WHOLE (UNII: M2U1C7UW6Y)  
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
GLYCERIN (UNII: PDC6A3C0OX)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
NIACINAMIDE (UNII: 25X51I8RD4)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
WATER (UNII: 059QF0KO0R)  
VITAMIN A (UNII: 81G40H8B0T)  
PETROLATUM (UNII: 4T6H12BN9U)  
XANTHAN GUM (UNII: TTV12P4NEE)  
HYDROLYZED SOY PROTEIN (ENZYMATIC; 2000 MW) (UNII: 1394NXB9L6)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70116-010-01100 mL in 1 TUBE; Type 0: Not a Combination Product08/28/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02008/28/2020
Labeler - BIO EARTH MANUFACTURING (PTY) LTD (639768436)
Establishment
NameAddressID/FEIBusiness Operations
BIO EARTH MANUFACTURING (PTY) LTD639768436manufacture(70116-010)

Revised: 10/2023
Document Id: 08048b9f-ec6a-cc7e-e063-6394a90a957a
Set id: 7fe2ac6a-cde9-4021-a53e-cc8f42e8d5f5
Version: 3
Effective Time: 20231018
 
BIO EARTH MANUFACTURING (PTY) LTD