Eezysun After Sun Cooling
462a2822-b2e9-4d63-8706-0755c2ca0a21
HUMAN OTC DRUG LABEL
May 28, 2025
BIO EARTH MANUFACTURING (PTY) LTD
DUNS: 639768436
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Aniba Rossadora,Calendula Officinalis,Lavandula Officialls,Matricaria Chamomilla,Mentha Piperita,Sodium Hyaluronate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (13)
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Product label
INDICATIONS & USAGE SECTION
Uses
Cooling down the skin
INACTIVE INGREDIENT SECTION
Inactive ingredients
Aloe Vera, Aqua, Carbomer, Ethylhexlglycerin, Glycerin, Phenoxyethanol, Sodium Hydroxide
SPL UNCLASSIFIED SECTION
Other information
Store at or below 77⁰ F/25⁰C
Do not use if seal is broken.
product the product in this container from excessive heat and direact sun
OTC - ACTIVE INGREDIENT SECTION
Active ingredients
Aniba Rossadora 0.35 %
Calendula Officinalis 0.95 %
Lavandula Officialls 0.75 %
Matricaria Chamomilla 0.6 %
Mentha Piperita 0.8 %
Sodium Hyaluronate 0.1 %
OTC - PURPOSE SECTION
Purpose
Relaxing, cooling, anti-inflammatory, soothing, relieving
WARNINGS SECTION
Warnings
For external use only.
- Not suitable for epileptics
- Not suitable for people with uncontrolled hyper-tension.
- Not recommended during pregnancy and lactation
- Not suitable for individuals with known sensitivity to any of the ingredients.
- Avoid contact with eyes.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
DOSAGE & ADMINISTRATION SECTION
Directions
Shake well before use
Adults: Apply up to three times per day as needed
Children: Use conservatively for children younger than two years