Eezy Pro SPF30

Product NDC: 70116-006
Requested package NDC: 70116-006-01
11-digit product format: 701160006
Labeler code: 70116
Product ID: 70116-006_a323a016-3251-4000-9729-87b462201107
Type: HUMAN OTC DRUG
Nonproprietary name: Meradimate, Octinoxate, Octocrylene, Titanium Dioxide, Zinc Oxide
Dosage form: CREAM
Route: TOPICAL
Labeler: BIO EARTH MANUFACTURING (PTY) LTD
Application: part352
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2020-03-17
Marketing end: 0000-00-00
Substance: MERADIMATE; OCTINOXATE; OCTOCRYLENE; TITANIUM DIOXIDE; ZINC OXIDE
Active strength: 3 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL
NDC exclude flag: No
Listing certified through: 2021-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	70116-006	70116-006-01	I	Inactivated by FDA		2026-10-05

Adverse event summaries are temporarily unavailable. Other product information remains available.

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
f47a510b-6679-4664-b2d6-47b5c4afe7cc	Product name	4	20260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61c	Product name	2	20250515
0306390c-dd77-4363-afe0-63c58088b2a1	Product name	1	20220120
503ea967-4b9c-48cf-9e87-c7975295849d	Product name	2	20220120
190f2a5b-bbc8-65c7-fcb0-97891307b917	Product name	1	20140508

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
70116-006-01	Eezy Pro SPF30	100 mL in 1 POUCH	CREAM	100		5

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70116-006	EEZY PRO SPF30 (MERADIMATE, OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIO EARTH MANUFACTURING (PTY) LTD]	5	Legacy NDC, 1 package rows	20241101_2916e39f-2dbd-46f7-925b-d1e22cf89985.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
J9QGD60OUZ	MERADIMATE	134-09-8	MERADIMATE
4Y5P7MUD51	OCTINOXATE	83834-59-7	OCTINOXATE
5A68WGF6WM	OCTOCRYLENE	6197-30-4	OCTOCRYLENE
15FIX9V2JP	TITANIUM DIOXIDE	13463-67-7	TITANIUM DIOXIDE
SOI2LOH54Z	ZINC OXIDE	1314-13-2	ZINC OXIDE

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
70116-006-01	70116000601	100 mL in 1 POUCH (70116-006-01)	100 ml	2020-03-17	0000-00-00	No	No	Current