EEZYSUN BARE SPF 50 TINTED SUNSCREEN TAN- titanium dioxide, zinc oxide cream 
BIO EARTH MANUFACTURING (PTY) LTD

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Active ingredients 

Zinc Oxide 10%, Titanium Dioxide 8%

Purpose

Sunscreen

Uses

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

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

Product label

image description

EEZYSUN BARE SPF 50 TINTED SUNSCREEN TAN 
titanium dioxide, zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70116-016
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE8 g  in 100 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION10 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70116-016-0150 mL in 1 TUBE; Type 0: Not a Combination Product03/31/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02003/31/2024
Labeler - BIO EARTH MANUFACTURING (PTY) LTD (639768436)
Establishment
NameAddressID/FEIBusiness Operations
BIO EARTH MANUFACTURING (PTY) LTD639768436manufacture(70116-016)

Revised: 2/2024
Document Id: 10f2cd76-8198-7c80-e063-6394a90a3cb4
Set id: e3c1d689-36a1-4486-a173-d66e4618118c
Version: 1
Effective Time: 20240209
 
BIO EARTH MANUFACTURING (PTY) LTD