EEZYSUN SPF 50- titanium dioxide, zinc oxide cream

Eezysun SPF 50 by

Drug Labeling and Warnings

Eezysun SPF 50 by is a Otc medication manufactured, distributed, or labeled by BIO EARTH MANUFACTURING (PTY) LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Purpose

Sunscreen

Uses

Helps prevent sunburn and protects against insects
If used as directed with other sun protection measures ( See Directions) decreases the risk of skin cancer

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 doctor if rash occurs
• Keep out of reach of children

Direction

• Apply liberally 15 minutes before sun exposure. Reapply:
• after 80 minutes of swimming or sweating
• immediately after towel drying
• at least every 2 hours
• Sun protection measures. Use a broad spectrum sun-screen with an SPF value of 50 or higher
• limit time in the sun, especially from 10 am - 2 pm
• wear long-sleeve shirts, pants, hats and sunglasses
• Children under 6 months of age: ask a doctor

Other information

store at or below 77° F . Do not use if seal is broken

Inactive ingredients

Aloe Barbadensis Leaf Oil, Aqua, Ascorbic Acid, Baryte,Cetearyl Alcohol, Cetearyl Glucoside, Citric Acid, Citronella,Citrullus Vulgaris (Kalahari Melon) Oil, Glycerine, Glyceryl Stearate, Glycine Soja (Soybean) Oil, Hydroxyethyl Cellulose,Lemongrass, Neem, Polysorbate 20, Potassium Cetyl
Phosphate, Potassium Sorbate, Retinol Palmitate, Ricinus Communis (Castor) Seed Oil (and) Hydrogenated Castor Oil (and) Copernicia Cerifera (Carnauba) Wax, Rosa Mosqueta (Rosehip) Fruit, Sodium Benzoate, Sodium Lactate, Sorbitan Olivate, Tocopheryl Acetate, Vanilla Planifolia Fruit Oil

Active ingredients

Zinc Oxide 10%, Titanium Dioxide 8%

KEEP OUT OF REACH OF CHILDREN

Product label

INGREDIENTS AND APPEARANCE

EEZYSUN SPF 50 
titanium dioxide, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70116-014
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	8 g  in 100 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	10 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
BARIUM SULFATE (UNII: 25BB7EKE2E)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
CITRONELLA OIL (UNII: QYO8Q067D0)
CITRUS X LIMON FLOWERING TOP OIL (UNII: 4C38SS0J60)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
SOYBEAN OIL (UNII: 241ATL177A)
HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)
CYMBOPOGON CITRATUS LEAF (UNII: 06JMS448M5)
AZADIRACHTA INDICA SEED OIL (UNII: 4DKJ9B3K2T)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
CASTOR OIL (UNII: D5340Y2I9G)
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)
CARNAUBA WAX (UNII: R12CBM0EIZ)
ROSA MOSCHATA OIL (UNII: J99W255AWF)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM LACTATE (UNII: TU7HW0W0QT)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
VANILLA PLANIFOLIA OIL (UNII: 0A3F415158)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70116-014-01	70 in 1 CARTON	06/30/2023
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	06/30/2023

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

Establishment
Name	Address	ID/FEI	Business Operations
BIO EARTH MANUFACTURING (PTY) LTD		639768436	manufacture(70116-014)