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 43 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
JAFRA SUN Body Sunscreen BROAD SPECTRUM SPF 50 WATER RESISTANT 40 MINUTESAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEDistribuidora Comercial Jafra, S.A. de C.V.12b64f66-0ec0-4dde-9446-4151ae001ae42026-04-15WarningsExact identifier
application number: M020
Tula 24-7 Moisture Plus SPF 30 Hydrating Day with Sunscreen Broad Spectrum SPF 30AVOBENZONE, HOMOSALATE, AND OCTISALATEPML NYC, LLC396dc7c7-a5e1-e1b2-e063-6294a90a75472026-04-15WarningsExact identifier
application number: M020
Sei Bella Tinted BB Moisturizing Cream115 NPML NYC, LLC316e8ac6-f8fa-7add-e063-6294a90a4f242026-04-15WarningsExact identifier
application number: M020
ZO Skin Health Daily Mineral Sunshade Broad-Spectrum Sunscreen SPF 45 (Light)TITANIUM DIOXIDE, ZINC OXIDEZO Skin Health Inc.4f8756bf-5b0d-5269-e063-6294a90ae6dc2026-04-15WarningsExact identifier
application number: M020
YOUR NAME MINERAL SHEERTINT BROAD SPECTRUM SPF 20 Cameo GlowYOUR NAME MINERAL SHEER TINTPML NYC, LLC316cd602-8af5-fbb6-e063-6294a90a287b2026-04-15WarningsExact identifier
application number: M020
Chanvida Broad Spectrum BB CreamCHANVIDA BROAD SPECTRUM BB CREAMGuangzhou Ariel Biotech Co., Ltd.4f8ade09-4f7a-80bd-e063-6394a90a08432026-04-15WarningsExact identifier
application number: M020
SKINTIFIC OUTDOOR SUN BROAD SPECTRUM SPF 50AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONEGold Inti Trade Corporation4f6dd01e-21ab-0aa3-e063-6394a90a51f82026-04-14WarningsExact identifier
application number: M020
TRACELESS MINERAL BROAD SPECTRUM SPF SUNSCREEN AND PRIMERTRACELESS MINERAL BROAD SPECTRUM SPF SUNSCREEN AND PRIMERBEAUTY PIE U.S.A. INC.fdefb670-510c-9f1f-e053-6394a90a6a162026-04-14WarningsExact identifier
application number: M020
DAILY SUPERGOOP DOSE BIORETINOL MINERAL SPF 40DAILY DOSE BIORETINOL MINERAL SPF 40PML NYC, LLC05574910-ddf9-b138-e063-6394a90adc8c2026-04-14WarningsExact identifier
application number: M020
ProtecTINT 20CHOMOSALATE, OCTISALATE, ZINC OXIDEPML NYC, LLC1bcc9f71-820f-eba2-e063-6394a90a33052026-04-14WarningsExact identifier
application number: M020
TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30BRIGHTENING SKIN TINTPML NYC, LLCf4c0f2d9-3e2f-5358-e053-2995a90aeb842026-04-14WarningsExact identifier
application number: M020
TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30BRIGHTENING SKIN TINTPML NYC, LLCf4c2a37d-f52d-2fb0-e053-2a95a90a9bfa2026-04-14WarningsExact identifier
application number: M020
TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30BRIGHTENING SKIN TINTPML NYC, LLCf4c3b1ef-0eae-6ac7-e053-2a95a90ac1dc2026-04-14WarningsExact identifier
application number: M020
NATURIUM Dew-Glow Moisturizer SPF 50NATURIUM DEW-GLOW MOISTURIZER SPF 50PML NYC, LLC00c93b11-754e-701c-e063-6294a90a3b1d2026-04-14WarningsExact identifier
application number: M020
Naturium Dew Glow Tinted Moisturizer SPF50-mediumHOMOSALATE, OCTISALATE, AVOBENZONEPML NYC, LLC1c3489a6-5b98-2dc2-e063-6294a90a06952026-04-14WarningsExact identifier
application number: M020
BANANA BOATTITANIUM DIOXIDE,ZINC OXIDEEdgewell Personal Care Brands LLC4f5896a6-0639-5589-e063-6294a90a45a92026-04-13WarningsExact identifier
application number: M020
SKINTIFIC OUTDOOR SUN BROAD SPECTRUM SPF 50AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE,OXYBENZONELongway Technology(Guangzhou)Co.,Ltd.4f2c83e4-e656-f81e-e063-6394a90a4c682026-04-11WarningsExact identifier
application number: M020
TRUST MD SPF30 STEM CELL FACEOCTINOXATE OCTISALATE HOMOSALATE AVOBENZONE TITANIUM DIOXIDEGuangzhou Yapheon Health Industry Co., Ltd.4f2ca12c-bc6f-61b8-e063-6294a90a0d7e2026-04-11WarningsExact identifier
application number: M020
MIDHA Rice Daily Moisture Sun CreamAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEMIDHA Cosmetic Co.,Ltd.4b394107-7830-c2c6-e063-6294a90a07d92026-04-10WarningsExact identifier
application number: M020
Abib Dewy tinted sunscreen Glow tube DeepOCTISALATE, OCTOCRYLENE, ZINC OXIDEFOURCOMPANY CO., LTD.4f15d5ba-6396-56bf-e063-6394a90adb062026-04-10WarningsExact 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