EEZYSUN SPF50 BABIES AND KIDS- titanium dioxide, zinc oxide cream 
BIO EARTH MANUFACTURING (PTY) LTD

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Active ingredients 

Titanium Dioxide 3.5%, Zinc Oxide 9.5%

Purpose

Topical SPF50 Sun Cream for the prevention of sun burn

Uses

Helps prevents 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 ondamaged or broken skin
When using this productkeep out of eyes.
rinse with water to remove
Stop use and ask doctor ifrash occurs
Keep out of reach of children

Direction

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 measuresuse 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, Chamomile Oil, Ethylhexylglycerin, Glycerin, Glyceryl Stearate, Hydrogenated Castor Oil, Hydroxyethyl Cellulose, Phenoxyethanol, Rosehip, Soybean Oil, Tocopheryl Acetate, Water, Xanthan Gum

Product label

image description

EEZYSUN SPF50 BABIES AND KIDS 
titanium dioxide, zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70116-013
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)  
CHAMOMILE FLOWER OIL (UNII: 60F80Z61A9)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
CASTOR OIL (UNII: D5340Y2I9G)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
GLYCERIN (UNII: PDC6A3C0OX)  
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:70116-013-0170 in 1 CARTON08/31/2022
1100 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02008/31/2022
Labeler - BIO EARTH MANUFACTURING (PTY) LTD (639768436)
Establishment
NameAddressID/FEIBusiness Operations
BIO EARTH MANUFACTURING (PTY) LTD639768436manufacture(70116-013)

Revised: 10/2023
Document Id: 0804955c-809b-ff9e-e063-6294a90ac9f0
Set id: edc89031-7071-4820-a6d1-5b0da9e069c0
Version: 3
Effective Time: 20231018
 
BIO EARTH MANUFACTURING (PTY) LTD