EEZYSUN SUNSCREEN SPF 50 WITH ALOE VERA, MARINE FRIENDLY- titanium dioxide,zinc oxide cream

Eezysun Sunscreen SPF 50 with Aloe Vera, Marine Friendly by

Drug Labeling and Warnings

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

Drug Details [pdf]

Drug Facts

Active ingredients

Titanium Dioxide 3.5%,   Zinc Oxide 9.5%

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.

Warnings

For external use only.
Do not use: on damaged or broken skin.
When using this product: keep out of the eyes, rinse with water to remove.
Stop using this product if: Rash occurs

Keep out of reach of children 

If swallowed, get medical help or contact a poison control center right away.

Directions

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

EEZYSUN SUNSCREEN SPF 50 WITH ALOE VERA, MARINE FRIENDLY 
titanium dioxide,zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70116-012
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)
CARNAUBA WAX (UNII: R12CBM0EIZ)
CASTOR OIL (UNII: D5340Y2I9G)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
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: 70116-012-01	100 mL in 1 TUBE; Type 0: Not a Combination Product	03/30/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	03/30/2021

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

Establishment
Name	Address	ID/FEI	Business Operations
BIO EARTH MANUFACTURING (PTY) LTD		639768436	manufacture(70116-012)