FDA.reportPublic FDA data

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#

NDC, Effective, Related label table
NDCEffectiveRelated label
58518-010-012023-04-20ENVIRONMENTAL DEFENSE- zinc oxide
58518-010-022023-04-20ENVIRONMENTAL DEFENSE- zinc oxide
58518-010-012023-01-30ENVIRONMENTAL DEFENSE- zinc oxide
58518-010-022023-01-30ENVIRONMENTAL DEFENSE- zinc oxide
58518-010-012020-01-02ENVIRONMENTAL DEFENSE- zinc oxide
58518-010-012019-11-27ENVIRONMENTAL DEFENSE- zinc oxide

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 18 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BANANA BOATAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLC235a9430-b445-8d5c-e063-6394a90a93542026-06-24WarningsExact identifier
application number: M020
Cerave Developed with Dermatologists Hydrating Sunscreen SPF 30 Body Lightweight, non-greasy feel 3 essential ceramides Mineral SunscreenTITANIUM DIOXIDE AND ZINC OXIDEL'Oreal USA Products Inc54ecaea7-dafe-9694-e063-6394a90ae3b52026-06-23WarningsExact identifier
application number: M020
La Roche Posay Laboratoire Dermatologique Anthelios Broad Spectrum SPF 100 Body and Face Melt In Milk Sunscreen Water Resistant 80 MinutesAVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENEL'Oreal USA Products Inc511f6de9-264a-4cf2-97c3-aa8adbc52a872026-06-23WarningsExact identifier
application number: M020
fmg Cashmere Lip Glaze Broad Spectrum SPF 30 SunscreenZINC OXIDETHE AVON COMPANY54f1b153-c79b-bcf8-e063-6394a90ae4262026-06-23WarningsExact identifier
application number: M020
CVS 70 Daily Clear SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECVS PHARMACY54f25934-b4c4-4fc8-e063-6294a90a543a2026-06-23WarningsExact identifier
application number: M020
Soleil Set sunscreen SPF 50AVABENZONE 3% HOMOSALATE 10% OCTISALATE 5%The Soleil Groupcc4e4b99-5f42-4a93-a3a0-ea19f57d27832026-06-23WarningsExact identifier
application number: M020
AVON ANEW SOLAIRE EVERYDAY FACE PROTECTION BROAD SPECTRUM SPF 50 SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENETHE AVON COMPANY54f6d7c1-59d1-0b36-e063-6394a90a17a32026-06-23WarningsExact identifier
application number: M020
RYDEEN UV CLEARSUNSCREENGuangzhou Oupeng Cosmetics Co., Ltd.548000cd-1655-aeb3-e063-6294a90ad0042026-06-22WarningsExact identifier
application number: M020
Mama and Hapa s - Bulk Sunscreen Extra SensitiveZINC OXIDE SUNSCREENVEGANIC SKN LIMITED54e18569-2e51-366a-e063-6394a90af8ec2026-06-22WarningsExact identifier
application number: M020
ESPOIR BE VELVET COVER CUSHIONHOMOSALATE, TITANIUM DIOXIDEESPOIR Corporation54ce2420-4ac0-eb51-e063-6294a90a2de92026-06-21WarningsExact identifier
application number: M020
BABIES KIDSSUN PROTECTIONMINERAL SUNSCREENPANERGYTEK USA INC3a554118-b71d-a844-e063-6294a90a699f2026-06-20WarningsExact identifier
application number: M020
By the Beach SuncareSPF 30 SUNCARE COCO LOCOBy the Beach Suncare LLC549be1ca-df21-a643-e063-6394a90ac0262026-06-19WarningsExact identifier
application number: M020
By the Beach SuncareSPF 30 FACE AND BODY DRY OIL COCO LOCOBy the Beach Suncare LLC549bad35-3005-875b-e063-6394a90ad31e2026-06-19WarningsExact identifier
application number: M020
By the Beach SuncareSPF 30 FACE AND BODY DRY OIL MELON DAZEBy the Beach Suncare LLC549bbd19-8e22-e420-e063-6294a90a6a982026-06-19WarningsExact identifier
application number: M020
By the Beach SuncareSPF 30 FACE AND BODY DRY OIL CANDY CLOUDSBy the Beach Suncare LLC549bd1b1-a6e2-b35c-e063-6394a90a8d0e2026-06-19WarningsExact identifier
application number: M020
By the Beach SuncareSPF 30 FACE AND BODY DRY OIL CITRUS CRUSHBy the Beach Suncare LLC549bd1b1-a6ee-b35c-e063-6394a90a8d0e2026-06-19WarningsExact identifier
application number: M020
FHF Elevated Shade 100% Mineral SunscreenSUNSCREENSummer Soles, LLC dba Farm House Freash Goods5488fd8c-7ef2-22c2-e063-6394a90aff3c2026-06-18WarningsExact identifier
application number: M020
Stream2Sea Sport Lip Balm SPF 50ZINC OXIDEStream2Sea, LLC5489fea5-bc0e-82cf-e063-6294a90aa0972026-06-18WarningsExact identifier
application number: M020
Creamy Beige Perfecting Makeup Broad Spectrum SPF 25OCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc548b7c90-ef97-38ab-e063-6394a90ac6092026-06-18WarningsExact identifier
application number: M020
UV SOLUTIONS HYDRATING BROAD SPECTRUM SPF 50AVOBENZONE,HOMOSALATE,OCTISALATE, AND OCTOCRYLENECLINIQUE LABORATORIES LLC4a6f9be3-2a56-8b41-e063-6294a90a30f82026-06-18WarningsExact 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