EEZYSUN ALOE VERA AFTER SUN- aniba rosaedora, calendula officinails, hyaluronic acid, lavandula officinalis, matricaria chamomilla, mentha piperita gel
BIO EARTH MANUFACTURING (PTY) LTD

Disclaimer: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

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Drug Facts

Active ingredients

Aniba Rosaedora 0.1%, Calendula Officinails 0.1% , Hyaluronic Acid 0.5%, Lavandula Officinalis 0.3%, Matricaria Chamomilla 0.4%, Mentha Piperita 0.15%

Purpose

Relaxing, cooling, anti-inflammatory, soothing, relieving

Uses

Cooling down and healing the skin. Alleviating the pain and swelling a
associated with over-exposure to the sun.

Warnings

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. For external use only. Avoid contact with eyes.

Directions

Adults: Apply up to three times per day as needed
Children: Use conservatively for children younger than two years

Inactive ingredients

Carbomer, Glycerin, Methylparaben, Methyl Sulfonyl Methane (MSM), Propylparaben, Triethanolamine, Water

Product label

image description

EEZYSUN ALOE VERA AFTER SUN
aniba rosaedora, calendula officinails, hyaluronic acid, lavandula officinalis, matricaria chamomilla, mentha piperita gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70116-011
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ANIBA ROSAEODORA WHOLE (UNII: 5ZTZ6VF78R) (ANIBA ROSAEODORA WHOLE - UNII:5ZTZ6VF78R)	ANIBA ROSAEODORA WHOLE	0.1 g in 100 mL
CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (CALENDULA OFFICINALIS FLOWERING TOP - UNII:18E7415PXQ)	CALENDULA OFFICINALIS FLOWERING TOP	0.1 g in 100 mL
HYALURONIC ACID (UNII: S270N0TRQY) (HYALURONIC ACID - UNII:S270N0TRQY)	HYALURONIC ACID	0.5 g in 100 mL
LAVANDULA ANGUSTIFOLIA SUBSP. ANGUSTIFOLIA FLOWER (UNII: 19AH1RAF4M) (LAVANDULA ANGUSTIFOLIA SUBSP. ANGUSTIFOLIA FLOWER - UNII:19AH1RAF4M)	LAVANDULA ANGUSTIFOLIA SUBSP. ANGUSTIFOLIA FLOWER	0.3 g in 100 mL
MATRICARIA CHAMOMILLA WHOLE (UNII: G0R4UBI2ZZ) (MATRICARIA CHAMOMILLA - UNII:G0R4UBI2ZZ)	MATRICARIA CHAMOMILLA WHOLE	0.4 g in 100 mL
MENTHA X PIPERITA WHOLE (UNII: 79M2M2UDA9) (MENTHA PIPERITA - UNII:79M2M2UDA9)	MENTHA X PIPERITA WHOLE	0.15 g in 100 mL

Ingredient Name	Strength
Inactive Ingredients
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
GLYCERIN (UNII: PDC6A3C0OX)
METHYLPARABEN (UNII: A2I8C7HI9T)
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
TROLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:70116-011-01	100 mL in 1 TUBE; Type 0: Not a Combination Product	03/26/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		03/26/2021

Labeler - BIO EARTH MANUFACTURING (PTY) LTD (639768436)

Name	Address	ID/FEI	Business Operations
Establishment
BIO EARTH MANUFACTURING (PTY) LTD		639768436	manufacture(70116-011)

Revised: 4/2021

Document Id: c0919fda-3cb4-2fce-e053-2a95a90aad64

Set id: acda25b7-a73c-47fa-b430-dc9ae2c04e57

Version: 1

Effective Time: 20210422

BIO EARTH MANUFACTURING (PTY) LTD