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 dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2019-12-08 06:16 UTC · source 2019-12-05excluded productproduct58518-010IInactivated by FDAexcluded / ndc_excluded.zip110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage58518-01058518-010-01IInactivated by FDAexcluded / ndc_excluded.zip110d247fa046…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
IngredientStrength
ZINC OXIDE225 mg/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
SOI2LOH54ZInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
1fbddab4-71f7-4167-ad21-30040b7c71bbAvailable on FDA.report

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58518-010-02ENVIRONMENTAL DEFENSE60 mL in 1 POUCHCREAM606

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ZINC OXIDEACTIVE INGREDIENTSOI2LOH54ZENVIRONMENTAL DEFENSE (ZINC OXIDE) CREAM [AVASOL]1
ZINC OXIDEACTIVE MOIETYSOI2LOH54ZENVIRONMENTAL DEFENSE (ZINC OXIDE) CREAM [AVASOL]1
ARGAN OILINACTIVE INGREDIENT4V59G5UW9XENVIRONMENTAL DEFENSE (ZINC OXIDE) CREAM [AVASOL]1
CANDELILLA WAXINACTIVE INGREDIENTWL0328HX19ENVIRONMENTAL DEFENSE (ZINC OXIDE) CREAM [AVASOL]1
CHINESE CINNAMON LEAF OILINACTIVE INGREDIENT4U4V2F2E4YENVIRONMENTAL DEFENSE (ZINC OXIDE) CREAM [AVASOL]1
EMU OILINACTIVE INGREDIENT344821WD61ENVIRONMENTAL DEFENSE (ZINC OXIDE) CREAM [AVASOL]1
FERROUS OXIDEINACTIVE INGREDIENTG7036X8B5HENVIRONMENTAL DEFENSE (ZINC OXIDE) CREAM [AVASOL]1
HAEMATOCOCCUS PLUVIALISINACTIVE INGREDIENT31T0FF0472ENVIRONMENTAL DEFENSE (ZINC OXIDE) CREAM [AVASOL]1
JOJOBA OILINACTIVE INGREDIENT724GKU717MENVIRONMENTAL DEFENSE (ZINC OXIDE) CREAM [AVASOL]1
MANUKA OILINACTIVE INGREDIENTM6QU9ZUH2XENVIRONMENTAL DEFENSE (ZINC OXIDE) CREAM [AVASOL]1
MAURITIA FLEXUOSA WHOLEINACTIVE INGREDIENT83ULF8L5FIENVIRONMENTAL DEFENSE (ZINC OXIDE) CREAM [AVASOL]1
MEDIUM-CHAIN TRIGLYCERIDESINACTIVE INGREDIENTC9H2L21V7UENVIRONMENTAL DEFENSE (ZINC OXIDE) CREAM [AVASOL]1
MICAINACTIVE INGREDIENTV8A1AW0880ENVIRONMENTAL DEFENSE (ZINC OXIDE) CREAM [AVASOL]1
PROPOLIS WAXINACTIVE INGREDIENT6Y8XYV2NOFENVIRONMENTAL DEFENSE (ZINC OXIDE) CREAM [AVASOL]1
ROSEMARYINACTIVE INGREDIENTIJ67X351P9ENVIRONMENTAL DEFENSE (ZINC OXIDE) CREAM [AVASOL]1
RUBUS IDAEUS SEEDINACTIVE INGREDIENTM3CL7US2ZGENVIRONMENTAL DEFENSE (ZINC OXIDE) CREAM [AVASOL]1
SHEANUTINACTIVE INGREDIENT84H6HBP32LENVIRONMENTAL DEFENSE (ZINC OXIDE) CREAM [AVASOL]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ENVIRONMENTAL DEFENSE (ZINC OXIDE) CREAM [AVASOL]1
SUNFLOWER OILINACTIVE INGREDIENT3W1JG795YIENVIRONMENTAL DEFENSE (ZINC OXIDE) CREAM [AVASOL]1
TAMANU OILINACTIVE INGREDIENTJT3LVK84A1ENVIRONMENTAL DEFENSE (ZINC OXIDE) CREAM [AVASOL]1
THEOBROMA GRANDIFLORUM SEEDINACTIVE INGREDIENTQ7RNT1G37VENVIRONMENTAL DEFENSE (ZINC OXIDE) CREAM [AVASOL]1
TOCOPHEROLINACTIVE INGREDIENTR0ZB2556P8ENVIRONMENTAL DEFENSE (ZINC OXIDE) CREAM [AVASOL]1
YELLOW WAXINACTIVE INGREDIENT2ZA36H0S2VENVIRONMENTAL DEFENSE (ZINC OXIDE) CREAM [AVASOL]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58518-010ENVIRONMENTAL DEFENSE (ZINC OXIDE) CREAM [AVASOL LLC]5Current NDC, Legacy NDC, 1 package rows20241222_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 25 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Odacite Color Balm - Sienna RoseZINC OXIDEOdacite52ba7f12-2b79-79cf-e063-6294a90a92d82026-05-26WarningsExact identifier
application number: M020
O HUI DAY SHIELD PERFECT SUN BLACK BROAD SPECTRUM SPF 50 SUNSCREENOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDELG H&H Co., Ltd.52ba9423-8b9b-38f7-e063-6394a90a95da2026-05-26WarningsExact identifier
application number: M020
Odacite Color Balm - Frosted PetalZINC OXIDEOdacite52ba9423-8b9d-38f7-e063-6394a90a95da2026-05-26WarningsExact identifier
application number: M020
Iris and Romeo Weekend Skin Moisture Lip Balm - DawnZINC OXIDEIris and Romeo52bb700b-ff56-2286-e063-6394a90ac4582026-05-26WarningsExact identifier
application number: M020
Iris and Romeo Weekend Skin Moisture Lip Balm - CamelliaZINC OXIDEIris and Romeo52bb52ec-2cd7-f8cc-e063-6294a90aa61b2026-05-26WarningsExact identifier
application number: M020
Bubble Solar Mate Daily Mineral Sunscreen SPF 40ZINC OXIDEBubble Beauty, Inc.d2eca90f-9463-4d2f-975d-02f2802ded3e2026-05-26WarningsExact identifier
application number: M020
Plexus Sun Shield Hydrating Mineral Sunscreen SPF 30ZINC OXIDEPlexus Worldwide, LLC55c391fa-37c6-47a2-befd-12888eb5fc182026-05-26WarningsExact identifier
application number: M020
Iris and Romeo Weekend Skin Moisture Lip Balm - SuedeZINC OXIDEIris and Romeo52bb7505-a027-2533-e063-6294a90a25202026-05-26WarningsExact identifier
application number: M020
Kiehls Dermatologist Solutions Better Screen UV Serum Broad Spectrum SPF 50 Plus SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENELOreal USA Products Inc9c909ae0-0117-4675-afc2-533d542f36592026-05-26WarningsExact identifier
application number: M020
Iris and Romeo Weekend Skin Moisture Lip Balm - CarobZINC OXIDEIris and Romeo52bbe9da-37f8-b3ba-e063-6394a90a139e2026-05-26WarningsExact identifier
application number: M020
Iris and Romeo Weekend Skin Moisture Lip Balm - CameoZINC OXIDEIris and Romeo52bc0174-872d-445b-e063-6294a90ab3292026-05-26WarningsExact identifier
application number: M020
Iris and Romeo Weekend Skin Moisture Lip Balm - IconicZINC OXIDEIris and Romeo52bbfdfe-dfc9-364f-e063-6294a90a646d2026-05-26WarningsExact identifier
application number: M020
Bloomeffects Tulip Dew BronzeZINC OXIDEBloomeffects52bc7f23-3594-3173-e063-6294a90a81ea2026-05-26WarningsExact identifier
application number: M020
Bloomeffects Tulip DewZINC OXIDEBloomeffects0fcb1b45-c04d-310a-e063-6294a90ab56d2026-05-26WarningsExact identifier
application number: M020
Bloomeffects Tulipscreen Hydrating Lip Oil Mauve MomentZINC OXIDEBloomeffects52bd7522-81b5-6189-e063-6394a90a29b42026-05-26WarningsExact identifier
application number: M020
Bloomeffects Tulipscreen Hydrating Lip Oil BarelyZINC OXIDEBloomeffects52bd8a43-a8c2-897e-e063-6394a90a9f3d2026-05-26WarningsExact identifier
application number: M020
Bloomeffects Tulipscreen Hydrating Lip Oil Fruit PunchZINC OXIDEBloomeffects52bdc0ec-ac5e-4a57-e063-6294a90a0b3b2026-05-26WarningsExact identifier
application number: M020
Bloomeffects Tulipscreen Hydrating Lip Oil Tulipy PinkZINC OXIDEBloomeffects52bdc5cc-9742-4af6-e063-6294a90aba222026-05-26WarningsExact identifier
application number: M020
Alleyoop Sun Serum Lip Oil - DaylightZINC OXIDENewAlley Innovations Inc52be1071-67cb-f2c0-e063-6294a90a368c2026-05-26WarningsExact identifier
application number: M020
Alleyoop Sun Serum Lip Oil - HazyZINC OXIDENewAlley Innovations Inc52be3c9e-a791-5053-e063-6294a90a1b302026-05-26WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58518-010-015851800100175 mL in 1 BOTTLE, PUMP (58518-010-01) 75 ml2013-07-180000-00-00NoNoCurrent
58518-010-025851800100260 mL in 1 POUCH (58518-010-02) 60 ml2021-11-290000-00-00NoNoCurrent