EEZYSUN SPF50 BABIES AND KIDS- titanium dioxide, zinc oxide cream

Eezysun SPF50 Babies and Kids by

Drug Labeling and Warnings

Eezysun SPF50 Babies and Kids 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 

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

KEEP OUT OF REACH OF CHILDREN

Product label

INGREDIENTS AND APPEARANCE

EEZYSUN SPF50 BABIES AND KIDS 
titanium dioxide, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70116-013
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	3.5 g  in 100 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	9.5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70116-013-01	70 in 1 CARTON	08/31/2022
1		100 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	08/31/2022

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

Establishment
Name	Address	ID/FEI	Business Operations
BIO EARTH MANUFACTURING (PTY) LTD		639768436	manufacture(70116-013)