EEZY PRO SPF50- meradimate, octinoxate, octocrylene, titanium dioxide, zinc oxide cream

Eezy Pro SPF50 by

Drug Labeling and Warnings

Eezy Pro SPF50 by is a Otc medication manufactured, distributed, or labeled by BIO EARTH MANUFACTURING (PTY) LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

 Meradimate, Octinoxate, Octocrylene, Titanium Dioxide, Zinc Oxide

Purpose

Sunsreen

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

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 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

INGREDIENTS AND APPEARANCE

EEZY PRO SPF50 
meradimate, octinoxate, octocrylene, titanium dioxide, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70116-009
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MERADIMATE (UNII: J9QGD60OUZ) (MERADIMATE - UNII:J9QGD60OUZ)	MERADIMATE	5 g  in 100 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	8 g  in 100 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	7 g  in 100 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	11 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70116-009-01	10 in 1 PACKET	03/17/2020
1		8 mL in 1 POUCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	03/17/2020

Labeler - BIO EARTH MANUFACTURING (PTY) LTD (639768436)

Establishment
Name	Address	ID/FEI	Business Operations
BIO EARTH MANUFACTURING (PTY) LTD		639768436	manufacture(70116-009)