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FDA Approval

Eezysun After Sun Cooling

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
brazilian rosewood oil(0.35 g in 100 mL)
Lavender oil(0.75 g in 100 mL)
matricaria chamomilla whole(0.6 g in 100 mL)
Peppermint oil(0.8 g in 100 mL)
HL-01(0.1 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 After Sun Cooling

Product Details

NDC Product Code
70116-025
Route of Administration
TOPICAL
Effective Date
May 28, 2025
ALOE VERA LEAF POLYSACCHARIDESInactive
Code: W21O437517Class: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPEInactive
Code: 0A5MM307FCClass: IACT
ETHYLHEXYLGLYCERINInactive
Code: 147D247K3PClass: IACT
GLYCERINInactive
Code: PDC6A3C0OXClass: IACT
PHENOXYETHANOLInactive
Code: HIE492ZZ3TClass: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
brazilian rosewood oilActive
Code: F2522O5L7BClass: ACTIMQuantity: 0.35 g in 100 mL
Code: ZBP1YXW0H8Class: ACTIBQuantity: 0.75 g in 100 mL
matricaria chamomilla wholeActive
Code: G0R4UBI2ZZClass: ACTIBQuantity: 0.6 g in 100 mL
Code: AV092KU4JHClass: ACTIBQuantity: 0.8 g in 100 mL
HL-01Active
Code: YSE9PPT4THClass: ACTIBQuantity: 0.1 g in 100 mL
Code: 18E7415PXQClass: ACTIBQuantity: 0.95 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

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INDICATIONS & USAGE SECTION

Uses

Cooling down the skin

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


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 - 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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION


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

INACTIVE INGREDIENT SECTION

Inactive ingredients

Aloe Vera, Aqua, Carbomer, Ethylhexlglycerin, Glycerin, Phenoxyethanol, Sodium Hydroxide


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