MedPath
FDA Approval

Eezysun SPF 50

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
BIO EARTH MANUFACTURING (PTY) LTD
DUNS: 639768436
Effective Date
May 28, 2025
Labeling Type
HUMAN OTC DRUG LABEL
Titanium dioxide(8 g in 100 mL)
Zinc oxide(10 g in 100 mL)

Products1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Eezysun SPF 50

Product Details

NDC Product Code
70116-014
Application Number
M020
Marketing Category
OTC Monograph Drug (C200263)
Route of Administration
TOPICAL
Effective Date
May 28, 2025
ALOE VERA LEAFInactive
Code: ZY81Z83H0XClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
ASCORBIC ACIDInactive
Code: PQ6CK8PD0RClass: IACT
BARIUM SULFATEInactive
Code: 25BB7EKE2EClass: IACT
CETOSTEARYL ALCOHOLInactive
Code: 2DMT128M1SClass: IACT
CETEARYL GLUCOSIDEInactive
Code: 09FUA47KNAClass: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QPClass: IACT
CITRONELLA OILInactive
Code: QYO8Q067D0Class: IACT
CITRUS X LIMON FLOWERING TOP OILInactive
Code: 4C38SS0J60Class: IACT
GLYCERINInactive
Code: PDC6A3C0OXClass: IACT
GLYCERYL MONOSTEARATEInactive
Code: 230OU9XXE4Class: IACT
SOYBEAN OILInactive
Code: 241ATL177AClass: IACT
HYDROXYETHYL CELLULOSE, UNSPECIFIEDInactive
Code: T4V6TWG28DClass: IACT
CYMBOPOGON CITRATUS LEAFInactive
Code: 06JMS448M5Class: IACT
AZADIRACHTA INDICA SEED OILInactive
Code: 4DKJ9B3K2TClass: IACT
POLYSORBATE 20Inactive
Code: 7T1F30V5YHClass: IACT
POTASSIUM CETYL PHOSPHATEInactive
Code: 03KCY6P7UTClass: IACT
POTASSIUM SORBATEInactive
Code: 1VPU26JZZ4Class: IACT
VITAMIN A PALMITATEInactive
Code: 1D1K0N0VVCClass: IACT
CASTOR OILInactive
Code: D5340Y2I9GClass: IACT
HYDROGENATED CASTOR OILInactive
Code: ZF94AP8MEYClass: IACT
CARNAUBA WAXInactive
Code: R12CBM0EIZClass: IACT
ROSA MOSCHATA OILInactive
Code: J99W255AWFClass: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EUClass: IACT
SODIUM LACTATEInactive
Code: TU7HW0W0QTClass: IACT
.ALPHA.-TOCOPHEROL ACETATEInactive
Code: 9E8X80D2L0Class: IACT
VANILLA PLANIFOLIA OILInactive
Code: 0A3F415158Class: IACT
Code: 15FIX9V2JPClass: ACTIBQuantity: 8 g in 100 mL
Code: SOI2LOH54ZClass: ACTIMQuantity: 10 g in 100 mL

Drug Labeling Information

Complete FDA-approved labeling information including indications, dosage, warnings, contraindications, and other essential prescribing details.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Product label

image descriptionimage description


INDICATIONS & USAGE SECTION

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

DOSAGE & ADMINISTRATION SECTION

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

Shake well before use


WARNINGS SECTION

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


OTC - ACTIVE INGREDIENT SECTION

Active ingredients

Zinc Oxide 10%, Titanium Dioxide 8%

OTC - PURPOSE SECTION

Purpose

Sunscreen

OTC - KEEP OUT OF REACH OF CHILDREN SECTION


SPL UNCLASSIFIED SECTION

Other information

store at or below 77°F/25°C . Do not use if seal is broken

INACTIVE INGREDIENT SECTION

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


© Copyright 2025. All Rights Reserved by MedPath