EEZYSUN SPF 50- 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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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%

Product label

image description

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	06/30/2023

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

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