EEZY SUN SPF 30- meradimate, octinoxate, octocrylene, titanium dioxide, zinc oxide cream 
EEZY SUN SPF 50- meradimate, octinoxate, octocrylene, titanium dioxide, zinc oxide cream 
BIO EARTH MANUFACTURING (PTY) LTD

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Eezy Sun

Actives

 Meradimate, Octinoxate, Octocrylene, Titanium Dioxide, Zinc Oxide

Inactives

Bulbine Fruitescence leaf oil, Cellulose gum, Cetearyl alcohol, Glycerin, Glycerol Stearate, Methylparaben, Phenoxyethanol, Propylparaben, Vit E, Vit A, Water, White petrolatum, Xanthan gum 

Dosage and Administration 

Directions

Apply liberally 15 minutes before sun exposure Reapply

PLEASE RECYCLE

DISTRIBUTED BY SANRIA26 (PTY) LTD 9428 ASHFORD PLACE BRENTWOOD, TN 37027 INFO@EEZYSUN.COM PRODUCT OF SOUTH AFRICA

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:

Limit 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 docto 

Warnings

For external use only

Do not use  : On Damaged on broken skin.

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.

Product Label SPF 30

spf 30spf 30

Product Label SPF 50

spf 50spf 50

EEZY SUN SPF 30 
meradimate, octinoxate, octocrylene, titanium dioxide, zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70116-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MERADIMATE (UNII: J9QGD60OUZ) (MERADIMATE - UNII:J9QGD60OUZ) MERADIMATE30 mg  in 1 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE75 mg  in 1 mL
Octocrylene (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) Octocrylene40 mg  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE50 mg  in 1 mL
Zinc Oxide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION90 mg  in 1 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:70116-001-018 mL in 1 POUCH; Type 0: Not a Combination Product12/14/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35212/14/2017
EEZY SUN SPF 50 
meradimate, octinoxate, octocrylene, titanium dioxide, zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70116-002
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MERADIMATE (UNII: J9QGD60OUZ) (MERADIMATE - UNII:J9QGD60OUZ) MERADIMATE50 mg  in 1 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE75 mg  in 1 mL
Octocrylene (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) Octocrylene80 mg  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE70 mg  in 1 mL
Zinc Oxide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION110 mg  in 1 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:70116-002-018 mL in 1 POUCH; Type 0: Not a Combination Product12/14/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35212/14/2017
Labeler - BIO EARTH MANUFACTURING (PTY) LTD (639768436)
Establishment
NameAddressID/FEIBusiness Operations
BIO EARTH MANUFACTURING (PTY) LTD639768436manufacture(70116-001, 70116-002)

Revised: 12/2017
Document Id: fb6fde91-0a11-4eaf-b2d6-55a01d1d2ae1
Set id: ac941e78-85e1-4517-99a4-34879d3c9d15
Version: 1
Effective Time: 20171214
 
BIO EARTH MANUFACTURING (PTY) LTD