EEZYSUN BARE SPF 50 TINTED SUNSCREEN LIGHT- titanium dioxide, zinc oxide cream

Eezysun Bare SPF 50 Tinted Sunscreen Light by

Drug Labeling and Warnings

Eezysun Bare SPF 50 Tinted Sunscreen Light 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

• Prevents sunburn, Hydrates, Moisturizes and repairs skin with anti-aging properties. Suitable for all skin types.
• 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 eyes.
rinse with water to remove
Stop use and ask doctor if rash occurs
Keep out of reach of children

Direction

• Apply every morning or 15 min before sun exposure. For dry skin, apply after a layer of moisturizer. Reapply:
• after 80 minutes of swimming or sweating
• immediately after towel drying
• at least every 2 hours
• Sun protection measures. Use a broad spectrum sunscreen 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℉. Do not use if seal is broken

Inactive ingredients

Aqua, Cocos Nucifera Oil, Glycine Soja (Soybean) Oil, Baryte, Glyceryl Stearate, Sorbitan Olivate, Ricinus Communis (Castor) Seed Oil (and) Hydrogenated Castor Oil (and) Copernicia Cerifera (Carnauba) Wax,Hydroxyethyl Cellulose, Cetearyl Alcohol, Glycerine, Simmondsia Chinensis (Jojoba)Seed Oil, Citrullus Vulgaris (Kalahari Melon) Oil, Potassium Cetyl Phosphate, Sodium Lactate, Iron Oxides, Potassium Sorbate, Sodium
Benzoate, Citric Acid, Sodium Hyaluronate (Hyaluronic Acid), Rosa Mosqueta (Rosehip) Fruit Oil, Aloe Barbadensis Leaf Oil, Vanilla Planifolia Fruit Oil, Ascorbic Acid, Tocopherol, Retinol Palmitate

KEEP OUT OF REACH OF CHILDREN

Product label

INGREDIENTS AND APPEARANCE

EEZYSUN BARE SPF 50 TINTED SUNSCREEN LIGHT 
titanium dioxide, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70116-015
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)
CITRUS X LIMON FLOWERING TOP OIL (UNII: 4C38SS0J60)
COCONUT OIL (UNII: Q9L0O73W7L)
CARNAUBA WAX (UNII: R12CBM0EIZ)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
SOYBEAN OIL (UNII: 241ATL177A)
HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)
FERRIC OXIDE RED (UNII: 1K09F3G675)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
CASTOR OIL (UNII: D5340Y2I9G)
ROSA MOSCHATA OIL (UNII: J99W255AWF)
JOJOBA OIL (UNII: 724GKU717M)
SODIUM BENZOATE (UNII: OJ245FE5EU)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
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: 70116-015-01	50 mL in 1 TUBE; Type 0: Not a Combination Product	03/31/2024

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(70116-015)