EEZY PRO SPF50- meradimate, octinoxate, octocrylene, titanium dioxide, zinc oxide cream 
BIO EARTH MANUFACTURING (PTY) LTD

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Eezy Pro

Active Ingredients

 Meradimate, Octinoxate, Octocrylene, Titanium Dioxide, Zinc Oxide

Purpose

Sunsreen

Uses

Warnings

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

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Reapply

Inactive ingredients

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

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

Other information

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

Product Label

image description

EEZY PRO SPF50 
meradimate, octinoxate, octocrylene, titanium dioxide, zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70116-009
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MERADIMATE (UNII: J9QGD60OUZ) (MERADIMATE - UNII:J9QGD60OUZ) MERADIMATE5 g  in 100 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE8 g  in 100 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE7 g  in 100 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION11 g  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)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
VITAMIN A (UNII: 81G40H8B0T)  
WATER (UNII: 059QF0KO0R)  
PETROLATUM (UNII: 4T6H12BN9U)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70116-009-0110 in 1 PACKET03/17/2020
18 mL in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02003/17/2020
Labeler - BIO EARTH MANUFACTURING (PTY) LTD (639768436)
Establishment
NameAddressID/FEIBusiness Operations
BIO EARTH MANUFACTURING (PTY) LTD639768436manufacture(70116-009)

Revised: 10/2023
Document Id: 080481fe-6388-0252-e063-6294a90a3b13
Set id: b4c4a21e-e01c-4c5a-b5b0-210594298fb1
Version: 3
Effective Time: 20231018
 
BIO EARTH MANUFACTURING (PTY) LTD