ENVIRONMENTAL DEFENSE

Product NDC: 58518-010
Requested package NDC: 58518-010-01
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 · 1 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 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 1 of 361 · 7,216 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ultra Violette Sheen Screen Broad Spectrum Hydrating Lip Balm Dusk	SPF50	Grace And Fire USA Inc.	2735ab0f-5eec-04c5-e063-6394a90aa60e	2026-10-01	Warnings	Exact identifier application number: M020
Ultra Violette Sheen Screen Broad Spectrum Hydrating Lip Balm Bejewelled	SPF50	Grace And Fire USA Inc.	274a0544-6c71-4d91-e063-6394a90a2247	2026-10-01	Warnings	Exact identifier application number: M020
TRILIPIDERM All-Body Moisture Retention SPF-30	AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTOCRYLENE	Trilipid Research Institute, LLC	7f34de0a-eeb3-4b71-9abd-53d03266d993	2026-09-10	Warnings	Exact identifier application number: M020
Neutrogena Ultra Sheer Dry Touch Sunscreen Broad Spectrum SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	Kenvue Brands LLC	6a43173f-41f9-4207-a0db-53bc8db6f4a4	2026-09-10	Warnings	Exact identifier application number: M020
Neutrogena Ultra Sheer Body Mist Sunscreen Broad Spectrum SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	Kenvue Brands LLC	d69b4992-d7e6-4bd7-b144-0485e35818a6	2026-09-10	Warnings	Exact identifier application number: M020
Hydra Finish SPF 15	HOMOSALATE, OCTINOXATE	Guinot	4047e8ec-834a-41e6-a144-5649a7718de4	2026-09-10	Warnings	Exact identifier application number: M020
HYDRA BEAUTE SPF 15	AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE	Guinot	806d1e18-a3fc-43df-a52a-a640902d0887	2026-09-10	Warnings	Exact identifier application number: M020
Pur Confort SPF 15	AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE	Guinot	2fe0656f-f924-48da-91bf-d6f3d98e8fd9	2026-09-10	Warnings	Exact identifier application number: M020
Neutrogena Ultra Sheer Body Mist Sunscreen Broad Spectrum SPF 45	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	Kenvue Brands LLC	51f3d6ca-3189-4380-9afb-4259ba878274	2026-09-10	Warnings	Exact identifier application number: M020
Sun Logic Creme Solaire Visage et corps SPF 30	AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE	Guinot	b0a95379-998a-4cda-bae7-63faf3d6f3c8	2026-09-10	Warnings	Exact identifier application number: M020
Sun Logic Lait Solaire Corps SPF 20	AVOBENZONE, HOMOSALATE, OCTOCRYLENE	Guinot	d9d2cee0-9189-42d0-b1ab-78b97141b128	2026-09-10	Warnings	Exact identifier application number: M020
Sunscreen	BROAD SPECTRUM SPF 30	1226 W AESTHETICS	5b0ef395-a7dd-378e-e063-6394a90a5dce	2026-09-09	Warnings	Exact identifier application number: M020
Stay Ageless Tinted Mineral Sunscreen	BROAD SPECTRUM SPF30	W Aesthetics	5b0f2c8f-d6fa-5e25-e063-6394a90a084d	2026-09-09	Warnings	Exact identifier application number: M020
Baloom 2% Panthenol Hydro Airy Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE. OCTOCRYLENE	ARSN KOREA	5148b638-f8a4-fa8b-e063-6294a90ac208	2026-09-08	Warnings	Exact identifier application number: M020
Double-Duty Face Moisturizer	MOSITURIZING SUNSCREEN	Jack Black, LLC	672be406-e3a1-47b4-8ef6-ee2b62baae96	2026-09-08	Warnings	Exact identifier application number: M020
Intense Therapy Lip Balm Pineapple Mint	SUNSCREEN SKIN PROTECTANT LIP BALM	Jack Black, LLC	0862534c-5f48-4f67-a3b8-0876a667556f	2026-09-08	Warnings	Exact identifier application number: M020
Intense Therapy Lip Balm SPF25, Shea Butter and Vitamin E	LIP BALM SPF25	Jack Black, LLC	88e8752d-1fbf-4e28-b79d-7c05ecdce842	2026-09-08	Warnings	Exact identifier application number: M020
Jack Black Intense Lip Therapy SPF25, Natural Mint and Shea Butter	LIP BALM SUNSCREEN	Jack Black, LLC	e8730127-2d8d-4b80-ab90-d2f136d9e516	2026-09-08	Warnings	Exact identifier application number: M020
Jack Black Intense Therapy Lip Balm SPF25, Grapefruit and Ginger	LIP BALM SUNSCREEN	Jack Black, LLC	d961d22a-2125-41e9-94a3-5b53d12b320f	2026-09-08	Warnings	Exact identifier application number: M020
Intense Therapy Lip Balm Asian Pear	SUNSCREEN SKIN PROTECTANT LIP BALM	Jack Black, LLC	acace707-6671-4818-86f2-d9813792157a	2026-09-08	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