ENVIRONMENTAL DEFENSE

Product NDC: 58518-010
11-digit product format: 585180010
Labeler code: 58518
Product ID: 58518-010_49534937-860f-bf99-e063-6394a90a0e02
Type: HUMAN OTC DRUG
Nonproprietary name: ZINC OXIDE
Dosage form: CREAM
Route: TOPICAL
Labeler: Avasol LLC
Application: M020
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2013-07-18
Substance: ZINC OXIDE
Active strength: 225 mg/100mL
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product	58518-010		I	Inactivated by FDA		excluded / ndc_excluded.zip	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	58518-010	58518-010-01	I	Inactivated by FDA		excluded / ndc_excluded.zip	`110d247fa046…`	`a55b01930146…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: ENVIRONMENTAL DEFENSE
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ZINC OXIDE	225 mg/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
SOI2LOH54Z	Internal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1fbddab4-71f7-4167-ad21-30040b7c71bb	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
58518-010-01	2023-04-20	ENVIRONMENTAL DEFENSE- zinc oxide
58518-010-02	2023-04-20	ENVIRONMENTAL DEFENSE- zinc oxide
58518-010-01	2023-01-30	ENVIRONMENTAL DEFENSE- zinc oxide
58518-010-02	2023-01-30	ENVIRONMENTAL DEFENSE- zinc oxide
58518-010-01	2020-01-02	ENVIRONMENTAL DEFENSE- zinc oxide
58518-010-01	2019-11-27	ENVIRONMENTAL DEFENSE- zinc oxide

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
58518-010-02	ENVIRONMENTAL DEFENSE	60 mL in 1 POUCH	CREAM	60		6

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ZINC OXIDE	ACTIVE INGREDIENT	SOI2LOH54Z	ENVIRONMENTAL DEFENSE (ZINC OXIDE) CREAM [AVASOL]	1
ZINC OXIDE	ACTIVE MOIETY	SOI2LOH54Z	ENVIRONMENTAL DEFENSE (ZINC OXIDE) CREAM [AVASOL]	1
ARGAN OIL	INACTIVE INGREDIENT	4V59G5UW9X	ENVIRONMENTAL DEFENSE (ZINC OXIDE) CREAM [AVASOL]	1
CANDELILLA WAX	INACTIVE INGREDIENT	WL0328HX19	ENVIRONMENTAL DEFENSE (ZINC OXIDE) CREAM [AVASOL]	1
CHINESE CINNAMON LEAF OIL	INACTIVE INGREDIENT	4U4V2F2E4Y	ENVIRONMENTAL DEFENSE (ZINC OXIDE) CREAM [AVASOL]	1
EMU OIL	INACTIVE INGREDIENT	344821WD61	ENVIRONMENTAL DEFENSE (ZINC OXIDE) CREAM [AVASOL]	1
FERROUS OXIDE	INACTIVE INGREDIENT	G7036X8B5H	ENVIRONMENTAL DEFENSE (ZINC OXIDE) CREAM [AVASOL]	1
HAEMATOCOCCUS PLUVIALIS	INACTIVE INGREDIENT	31T0FF0472	ENVIRONMENTAL DEFENSE (ZINC OXIDE) CREAM [AVASOL]	1
JOJOBA OIL	INACTIVE INGREDIENT	724GKU717M	ENVIRONMENTAL DEFENSE (ZINC OXIDE) CREAM [AVASOL]	1
MANUKA OIL	INACTIVE INGREDIENT	M6QU9ZUH2X	ENVIRONMENTAL DEFENSE (ZINC OXIDE) CREAM [AVASOL]	1
MAURITIA FLEXUOSA WHOLE	INACTIVE INGREDIENT	83ULF8L5FI	ENVIRONMENTAL DEFENSE (ZINC OXIDE) CREAM [AVASOL]	1
MEDIUM-CHAIN TRIGLYCERIDES	INACTIVE INGREDIENT	C9H2L21V7U	ENVIRONMENTAL DEFENSE (ZINC OXIDE) CREAM [AVASOL]	1
MICA	INACTIVE INGREDIENT	V8A1AW0880	ENVIRONMENTAL DEFENSE (ZINC OXIDE) CREAM [AVASOL]	1
PROPOLIS WAX	INACTIVE INGREDIENT	6Y8XYV2NOF	ENVIRONMENTAL DEFENSE (ZINC OXIDE) CREAM [AVASOL]	1
ROSEMARY	INACTIVE INGREDIENT	IJ67X351P9	ENVIRONMENTAL DEFENSE (ZINC OXIDE) CREAM [AVASOL]	1
RUBUS IDAEUS SEED	INACTIVE INGREDIENT	M3CL7US2ZG	ENVIRONMENTAL DEFENSE (ZINC OXIDE) CREAM [AVASOL]	1
SHEANUT	INACTIVE INGREDIENT	84H6HBP32L	ENVIRONMENTAL DEFENSE (ZINC OXIDE) CREAM [AVASOL]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	ENVIRONMENTAL DEFENSE (ZINC OXIDE) CREAM [AVASOL]	1
SUNFLOWER OIL	INACTIVE INGREDIENT	3W1JG795YI	ENVIRONMENTAL DEFENSE (ZINC OXIDE) CREAM [AVASOL]	1
TAMANU OIL	INACTIVE INGREDIENT	JT3LVK84A1	ENVIRONMENTAL DEFENSE (ZINC OXIDE) CREAM [AVASOL]	1
THEOBROMA GRANDIFLORUM SEED	INACTIVE INGREDIENT	Q7RNT1G37V	ENVIRONMENTAL DEFENSE (ZINC OXIDE) CREAM [AVASOL]	1
TOCOPHEROL	INACTIVE INGREDIENT	R0ZB2556P8	ENVIRONMENTAL DEFENSE (ZINC OXIDE) CREAM [AVASOL]	1
YELLOW WAX	INACTIVE INGREDIENT	2ZA36H0S2V	ENVIRONMENTAL DEFENSE (ZINC OXIDE) CREAM [AVASOL]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
58518-010	ENVIRONMENTAL DEFENSE (ZINC OXIDE) CREAM [AVASOL LLC]	5	Current NDC, Legacy NDC, 1 package rows	20241222_1fbddab4-71f7-4167-ad21-30040b7c71bb.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 8 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ceile tint PROTECT tinted serum SPF 50 Ivory	CEILE TINT PROTECT TINTED SERUM SPF 50 IVORY	LE COSMETICS INC	58547809-3480-1032-e063-6294a90a04c6	2026-08-05	Warnings	Exact identifier application number: M020
Ceile tint PROTECT tinted serum SPF 50 Medium Deep	CEILE TINT PROTECT TINTED SERUM SPF 50 MEDIUM DEEP	LE COSMETICS INC	58549160-3594-9056-e063-6394a90abf7d	2026-08-05	Warnings	Exact identifier application number: M020
Ceile tint PROTECT tinted serum SPF 50 Deep	CEILE TINT PROTECT TINTED SERUM SPF 50 DEEP	LE COSMETICS INC	585498d4-b29c-9580-e063-6394a90adf1e	2026-08-05	Warnings	Exact identifier application number: M020
Ceile tint PROTECT tinted serum SPF 50 Fair	CEILE TINT PROTECT TINTED SERUM SPF 50 FAIR	LE COSMETICS INC	58545633-cb36-6611-e063-6394a90a1f07	2026-08-05	Warnings	Exact identifier application number: M020
Ceile tint PROTECT tinted serum SPF 50 Light	CEILE TINT PROTECT TINTED SERUM SPF 50 LIGHT	LE COSMETICS INC	5853ae6b-0eaf-e614-e063-6394a90ae91a	2026-08-05	Warnings	Exact identifier application number: M020
Ceile tint PROTECT tinted serum SPF 50 Light Medium	CEILE TINT PROTECT TINTED SERUM SPF 50 LIGHT MEDIUM	LE COSMETICS INC	585473c3-3ee9-7d84-e063-6394a90abd33	2026-08-05	Warnings	Exact identifier application number: M020
Ceile tint PROTECT tinted serum SPF 50 Medium	CEILE TINT PROTECT TINTED SERUM SPF 50 MEDIUM	LE COSMETICS INC	58547b48-251a-10eb-e063-6294a90ac95c	2026-08-05	Warnings	Exact identifier application number: M020
Ceile tint PROTECT tinted serum SPF 50 Medium Tan	CEILE TINT PROTECT TINTED SERUM SPF 50 MEDIUM TAN	LE COSMETICS INC	58547e38-ae84-82ee-e063-6394a90a27d6	2026-08-05	Warnings	Exact identifier application number: M020
Ceile tint PROTECT tinted serum SPF 50 Tan	CEILE TINT PROTECT TINTED SERUM SPF 50 TAN	LE COSMETICS INC	58548331-38cd-8668-e063-6394a90a3362	2026-08-05	Warnings	Exact identifier application number: M020
Ceile tint PROTECT tinted serum SPF 50 Medium Honey	CEILE TINT PROTECT TINTED SERUM SPF 50 MEDIUM HONEY	LE COSMETICS INC	5854861a-376d-8825-e063-6394a90a8aab	2026-08-05	Warnings	Exact identifier application number: M020
Ceile tint PROTECT tinted serum SPF 50 Honey	CEILE TINT PROTECT TINTED SERUM SPF 50 HONEY	LE COSMETICS INC	585488c5-fac5-212f-e063-6294a90a00ff	2026-08-05	Warnings	Exact identifier application number: M020
Ceile tint PROTECT tinted serum SPF 50 Medium Rich	CEILE TINT PROTECT TINTED SERUM SPF 50 MEDIUM RICH	LE COSMETICS INC	585488af-d14f-8d71-e063-6394a90ac4f0	2026-08-05	Warnings	Exact identifier application number: M020
Ceile tint PROTECT tinted serum SPF 50 Rich	CEILE TINT PROTECT TINTED SERUM SPF 50 RICH	LE COSMETICS INC	58548e6d-9c82-249c-e063-6294a90a11ad	2026-08-05	Warnings	Exact identifier application number: M020
12 Days of Derm-Loved Skincare	OCTINOXATE, ZINC OXIDE, OATMEAL, BENZOYL PEROXIDE, AVOBENZONE, OCTISALATE, OCTOCRYLENE	Rodan & Fields	a13f0275-5add-4464-88d4-ff9823274325	2026-08-03	Warnings	Exact identifier application number: M020
Luxe Gloss Hydrating Lip Gloss SPF 35-NAKED HONEY	OCTOCRYLENE 8%, OCTISALATE 5%, TITANIUM DIOXIDE 6%, ZINC OXIDE 8%	Lale Cosmetics LLC	581fb0cd-c55d-d562-e063-6394a90a7f11	2026-08-03	Warnings	Exact identifier application number: M020
Manyo Air Light Moisturizing Sunscreen SPF 50	ENSULIZOLE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Manyo Factory Corp.	86761577-a32c-41a2-a2e3-b339b1493701	2026-08-03	Warnings	Exact identifier application number: M020
EltaMD UV Active	ZINC OXIDE AND TITANIUM DIOXIDE SUNSCREEN	CP Skin Health Group, Inc	39d16479-d491-4c19-aa11-674461687c7b	2026-08-03	Warnings	Exact identifier application number: M020
AMBI SKINCARE Even and Clear Daily Facial Moisturizer SPF 30	OCTISALATE, OCTOCRYLENE, AVOBENZONE	AMBI Enterprises LLC	99bbe9a2-bb57-4a33-b339-1649d4b319c8	2026-07-31	Warnings	Exact identifier application number: M020
AMBI Even and Clear Facial Moisturizer SPF-30	AVOBENZONE, OCTISALATE, OCTOCRYLENE	AMBI Enterprises LLC	4701c0ba-4ceb-4d66-9f99-515ce33b4648	2026-07-31	Warnings	Exact identifier application number: M020
Continuous Correction Cream	TITANIUM DIOXIDE	Baxter of California, LLC	1cbcc648-f2e1-af60-e063-6294a90ad4bb	2026-07-31	Warnings	Exact identifier application number: M020

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
SOI2LOH54Z	ZINC OXIDE	1314-13-2	ZINC OXIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
58518-010-01	58518001001	75 mL in 1 BOTTLE, PUMP (58518-010-01)	75 ml	2013-07-18	0000-00-00	No	No	Current
58518-010-02	58518001002	60 mL in 1 POUCH (58518-010-02)	60 ml	2021-11-29	0000-00-00	No	No	Current