EEZYSUN SUNSCREEN SPF 50 WITH ALOE VERA, MARINE FRIENDLY- 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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Drug Facts

Active ingredients

Titanium Dioxide 3.5%,   Zinc Oxide 9.5%

Purpose

Sunscreen

Uses

helps prevent sunburn
If used as directed with other sun protection measures (see directions),
Decreases the risk of skin cancer and early skin aging caused by the sun.

Warnings

For external use only.
Do not use: on damaged or broken skin.
When using this product: keep out of the eyes, rinse with water to remove.
Stop using this product 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 if swimming or sweating
  • immediately after towel drying
  • at least every two hours

Sun protection measures use a broad-spectrum sunscreen with an SPF value of 50 or higher

  • limit time in the sun, especially from 10am - 2pm
  • wear long-sleeve shirts, pants, hats, sunglasses
  • Children under 6 months of age: ask a doctor

Other Information

store at or below 77℉. Do not use if seal is broken
protect the product in this container from excessive heat and direct sun

Inactive ingredients

Aloe Vera, Ascorbic Acid, Barium Sulphate, Bulbinella, Carnauba, Castor Seed Oil, Cetearyl Alcohol, Ethylhexylglycerin, Glycerin, Glyceryl Stearate, Hydrogenated Castor Oil, Hydroxyethyl Cellulose, Phenoxyethanol, Rosehip, Soybean Oil, Tocopheryl Acetate, Water, Xanthan Gum

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EEZYSUN SUNSCREEN SPF 50 WITH ALOE VERA, MARINE FRIENDLY 
titanium dioxide,zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70116-012
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE3.5 g  in 100 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION9.5 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF POLYSACCHARIDES (UNII: W21O437517)  
ASCORBIC ACID (UNII: PQ6CK8PD0R)  
BARIUM SULFATE (UNII: 25BB7EKE2E)  
BULBINE FRUTESCENS WHOLE (UNII: M2U1C7UW6Y)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
CASTOR OIL (UNII: D5340Y2I9G)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
ROSA MOSCHATA OIL (UNII: J99W255AWF)  
SOYBEAN OIL (UNII: 241ATL177A)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
WATER (UNII: 059QF0KO0R)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70116-012-01100 mL in 1 TUBE; Type 0: Not a Combination Product03/30/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35203/30/2021
Labeler - BIO EARTH MANUFACTURING (PTY) LTD (639768436)
Establishment
NameAddressID/FEIBusiness Operations
BIO EARTH MANUFACTURING (PTY) LTD639768436manufacture(70116-012)

Revised: 8/2022
 
BIO EARTH MANUFACTURING (PTY) LTD