70116-025 NDC - EEZYSUN AFTER SUN COOLING (ANIBA ROSSADORA,CALENDULA OFFICINALIS,LAVANDULA OFFICIALLS,MATRICARIA CHAMOMILLA,MENTHA PIPERITA,SODIUM HYALURONATE)

Drug Information

  • Product NDC: 70116-025
  • Proprietary Name: Eezysun After Sun Cooling
  • Non Proprietary Name: Aniba Rossadora,Calendula Officinalis,Lavandula Officialls,Matricaria Chamomilla,Mentha Piperita,Sodium Hyaluronate
  • Active Ingredient(s): .35 g/100mL BRAZILIAN ROSEWOOD OIL; .95 g/100mL CALENDULA OFFICINALIS FLOWERING TOP; .1 g/100mL HYALURONATE SODIUM; .75 g/100mL LAVENDER OIL; .6 g/100mL MATRICARIA CHAMOMILLA WHOLE; .8 g/100mL PEPPERMINT OIL
  • Administration Route(s): TOPICAL
  • Dosage Form(s): CREAM
  • Pharmacy Class(es): Allergens [CS]; Cell-mediated Immunity [PE]; Dietary Proteins [CS]; Food Additives [CS]; Increased Histamine Release [PE]; Non-Standardized Food Allergenic Extract [EPC]; Non-Standardized Plant Allergenic Extract [EPC]; Plant Proteins [CS]

Labeler Information

Field Name Field Value
Labeler Name: BIO EARTH MANUFACTURING (PTY) LTD
Product Type: HUMAN OTC DRUG
FDA Application Number:
Marketing Category: UNAPPROVED HOMEOPATHIC
Start Marketing Date:5/23/2025

Package Information

No. Package Code Package Description Billing Unit
170116-025-011 TUBE in 1 CARTON (70116-025-01) / 100 mL in 1 TUBE

NDC Record

Field Name Field Value Definition
PRODUCT NDC70116-025The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
PRODUCT TYPE NAMEHUMAN OTC DRUGIndicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
PROPRIETARY NAMEEezysun After Sun CoolingThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMEAniba Rossadora,Calendula Officinalis,Lavandula Officialls,Matricaria Chamomilla,Mentha Piperita,Sodium HyaluronateThe non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAMECREAMThe translation of the dosage form Code submitted by the firm.
ROUTE NAMETOPICALThe translation of the route code submitted by the firm, indicating route of administration.
START MARKETING DATE5/23/2025This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMEUNAPPROVED HOMEOPATHICProduct types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
LABELER NAMEBIO EARTH MANUFACTURING (PTY) LTDName of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMEBRAZILIAN ROSEWOOD OIL; CALENDULA OFFICINALIS FLOWERING TOP; HYALURONATE SODIUM; LAVENDER OIL; MATRICARIA CHAMOMILLA WHOLE; PEPPERMINT OILAn active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
ACTIVE NUMERATOR STRENGTH.35; .95; .1; .75; .6; .8 
ACTIVE INGRED UNITg/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL 
PHARM CLASSESAllergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Food Additives [CS], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS] 

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This page was last updated on: 12/19/2025

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