EEZYSUN SUNSCREEN WITH INSECT REPELLENT BROAD SPECTRUM SPF50- titanium dioxide, zinc oxide cream

Eezysun Sunscreen with Insect Repellent Broad Spectrum SPF50 by

Drug Labeling and Warnings

Eezysun Sunscreen with Insect Repellent Broad Spectrum SPF50 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 

Zinc Oxide 10%, Titanium Dioxide 8%

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.Repels insects.

Warnings

• For external use only
• Do not useon damaged 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

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 / 25°C . Do not use if seal is broken
• protect the product in this container from excessive heat and direact sun

Inactive ingredients

Aloe Barbadensis Leaf Oil, Aqua, Ascorbic Acid, Baryte, Cetearyl Alcohol, 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

Product label

INGREDIENTS AND APPEARANCE

EEZYSUN SUNSCREEN WITH INSECT REPELLENT BROAD SPECTRUM SPF50 
titanium dioxide, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70116-018
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)
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)
SORBITAN OLIVATE (UNII: MDL271E3GR)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
VANILLA PLANIFOLIA OIL (UNII: 0A3F415158)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70116-018-01	10 in 1 CARTON	03/31/2024
1		8 mL in 1 PACKET; 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	03/31/2024

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

Establishment
Name	Address	ID/FEI	Business Operations
BIO EARTH MANUFACTURING (PTY) LTD		639768436	manufacture(70116-018)