FDA.reportPublic FDA data

ENVIRONMENTAL DEFENSE

Manufacturer
Avasol LLC
Effective date
2026-01-26
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 01:34:51

Label at a glance#

ProductENVIRONMENTAL DEFENSE
Active ingredientZINC OXIDE
Label structure9 sections

Indications and uses

Helps prevent sunburn

Dosage and administration

Apply liberally before sun Reapply: after 80 minutes of swimming or sweating, immediately after towel drying, at least every 2 hours, or as needed Children under 6 months: Ask a doctor May stain some fabrics.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide (Non-nano) 22.5%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • Helps prevent sunburn

Warnings

WARNINGS SECTION

  • For external use only
  • Keep out of eyes. Rinse with water to remove

OTC - STOP USE SECTION

Stop use and ask a doctor if rash or irritation occurs.

OTC - DO NOT USE SECTION

Do not use if allergic to ingredients.

  • Test small area first.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Apply liberally before sun
  • Reapply: after 80 minutes of swimming or sweating, immediately after towel drying, at least every 2 hours, or as needed
  • Children under 6 months: Ask a doctor
  • May stain some fabrics.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Caprylic/Capric Triglyceride (Coconut), *Simmondsia Chinensis (Jojoba) Seed Oil,*Helianthus annuus (Sun flower) Oil,*Cocos Nucifera (Coconut) Oil,*Calophyllum Inophyllum (Tamanu)Oil,*Argania spinosa (Argan) Oil, Silica, *Beeswax,*Theobroma Grandiflorum (Cupuacu) Seed Butter,*Butyrospermum parkii (Shea Butter),**Mauritia Flexuosa (Buriti) Fruit Oil, Rubus idaeus (Raspberry) Seed Oil, Tocopherol (Vitamin E), Mica, Iron oxides, *Vanilla Planifolia(Vanilla) Fruit Extract, Plankton Extract,*Propolis,*Rosmarinus Officinalis (Rosemary) Leaf Extract,**Leptospermum scoparium (Manuka)Oil, *Cinnamomum Zeylanicum (Cinnamon) Bark Oil, Love. *Organic **Wildcrafted

Other information

OTHER SAFETY INFORMATION

Shake well before use. Warm as needed.

Questions?

OTC - QUESTIONS SECTION

Call 888-805-1507or visit www.avasol.com

Principal Display Panel - 2 Fl Oz Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

avasol®

mineral sunscreen

30 SPF

2 FL OZ (59 mL)

Principal Display Panel - 2 Fl Oz Bottle Label
Principal Display Panel - 2 Fl Oz Bottle Label

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130798304287707GTIN-13: 0798304287707
EAN-13: 0798304287707
GTIN-12: 798304287707
UPC-A: 798304287707
GTIN storage (14 digits): 00798304287707		env04-0003-01.jpg

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58518-010-012023-04-20C16284748780-19855d018-e45f-cd31-e053-dbdaa90ab51aENVIRONMENTAL DEFENSE- zinc oxide
58518-010-022023-04-20C16284748780-19855d018-e45f-cd31-e053-dbdaa90ab51aENVIRONMENTAL DEFENSE- zinc oxide
58518-010-012023-01-30C16284748780-19855d018-e45f-cd31-e053-dbdaa90ab51aENVIRONMENTAL DEFENSE- zinc oxide
58518-010-022023-01-30C16284748780-19855d018-e45f-cd31-e053-dbdaa90ab51aENVIRONMENTAL DEFENSE- zinc oxide
58518-010-012020-01-02C16284748780-19855d018-e45f-cd31-e053-dbdaa90ab51aENVIRONMENTAL DEFENSE- zinc oxide
58518-010-012019-11-27C16284748780-19855d018-e45f-cd31-e053-dbdaa90ab51aENVIRONMENTAL 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
IngredientTypeUNIISPL versionUploaded
ZINC OXIDEACTIVE INGREDIENTSOI2LOH54Z1
ZINC OXIDEACTIVE MOIETYSOI2LOH54Z1
ARGAN OILINACTIVE INGREDIENT4V59G5UW9X1
CANDELILLA WAXINACTIVE INGREDIENTWL0328HX191
CHINESE CINNAMON LEAF OILINACTIVE INGREDIENT4U4V2F2E4Y1
EMU OILINACTIVE INGREDIENT344821WD611
FERROUS OXIDEINACTIVE INGREDIENTG7036X8B5H1
HAEMATOCOCCUS PLUVIALISINACTIVE INGREDIENT31T0FF04721
JOJOBA OILINACTIVE INGREDIENT724GKU717M1
MANUKA OILINACTIVE INGREDIENTM6QU9ZUH2X1
MAURITIA FLEXUOSA WHOLEINACTIVE INGREDIENT83ULF8L5FI1
MEDIUM-CHAIN TRIGLYCERIDESINACTIVE INGREDIENTC9H2L21V7U1
MICAINACTIVE INGREDIENTV8A1AW08801
PROPOLIS WAXINACTIVE INGREDIENT6Y8XYV2NOF1
ROSEMARYINACTIVE INGREDIENTIJ67X351P91
RUBUS IDAEUS SEEDINACTIVE INGREDIENTM3CL7US2ZG1
SHEANUTINACTIVE INGREDIENT84H6HBP32L1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU41
SUNFLOWER OILINACTIVE INGREDIENT3W1JG795YI1
TAMANU OILINACTIVE INGREDIENTJT3LVK84A11
THEOBROMA GRANDIFLORUM SEEDINACTIVE INGREDIENTQ7RNT1G37V1
TOCOPHEROLINACTIVE INGREDIENTR0ZB2556P81
YELLOW WAXINACTIVE INGREDIENT2ZA36H0S2V1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 23 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58518-01058518-010-02

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 22 matching rows.

Name, UNII, Kind table
NameUNIIKind
COCONUT OILQ9L0O73W7LIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
JOJOBA OIL724GKU717MIACT
SUNFLOWER OIL3W1JG795YIIACT
TAMANU OILJT3LVK84A1IACT
ARGAN OIL4V59G5UW9XIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
YELLOW WAX2ZA36H0S2VIACT
THEOBROMA GRANDIFLORUM SEEDQ7RNT1G37VIACT
SHEANUT84H6HBP32LIACT
MAURITIA FLEXUOSA WHOLE83ULF8L5FIIACT
RUBUS IDAEUS SEEDM3CL7US2ZGIACT
TOCOPHEROLR0ZB2556P8IACT
VANILLA BEANQ74T35078HIACT
MICAV8A1AW0880IACT
HAEMATOCOCCUS PLUVIALIS31T0FF0472IACT
FERROUS OXIDEG7036X8B5HIACT
PROPOLIS WAX6Y8XYV2NOFIACT
MANUKA OILM6QU9ZUH2XIACT
ROSEMARYIJ67X351P9IACT
CINNAMON BARK OILXE54U569ECIACT
ZINC OXIDESOI2LOH54ZACTIB

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 24 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
CANDELILLA WAXCANDELILLA WAXWL0328HX19TABLET, DELAYED RELEASE / ORAL1 mgExact identifier — unii candidate
8 equally ranked IID candidates
CANDELILLA WAXCANDELILLA WAXWL0328HX19TABLET, EXTENDED RELEASE / ORAL3 mgExact identifier — unii candidate
8 equally ranked IID candidates
CANDELILLA WAXCANDELILLA WAXWL0328HX19TABLET / ORAL4 mgExact identifier — unii candidate
8 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UCREAM / TOPICAL3300 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
TOCOPHEROLTOCOPHEROLR0ZB2556P8CREAM / TOPICALNAExact identifier — unii+route+dosage form
2 equally ranked IID candidates
FERROUS OXIDEFERROUS OXIDEG7036X8B5HTABLET, DELAYED RELEASE / ORALNAExact identifier — unii candidate
6 equally ranked IID candidates
TOCOPHEROLTOCOPHEROLR0ZB2556P8CREAM / TOPICALNAExact identifier — unii+route+dosage form
2 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4GEL / TOPICAL6 mgExact identifier — unii+route
4 equally ranked IID candidates
FERROUS OXIDEFERROUS OXIDEG7036X8B5HTABLET / ORALNAExact identifier — unii candidate
6 equally ranked IID candidates
FERROUS OXIDEFERROUS OXIDEG7036X8B5HTABLET, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
6 equally ranked IID candidates
FERROUS OXIDEFERROUS OXIDEG7036X8B5HTABLET, DELAYED RELEASE / ORALNAExact identifier — unii candidate
6 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4CREAM / VAGINAL51 mgExact identifier — unii+dosage form
4 equally ranked IID candidates
YELLOW WAXYELLOW WAX2ZA36H0S2VCREAM / TOPICAL5 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
CANDELILLA WAXCANDELILLA WAXWL0328HX19TABLET, FILM COATED / ORAL0.8 mgExact identifier — unii candidate
8 equally ranked IID candidates
CANDELILLA WAXCANDELILLA WAXWL0328HX19TABLET / ORAL4 mgExact identifier — unii candidate
8 equally ranked IID candidates
FERROUS OXIDEFERROUS OXIDEG7036X8B5HTABLET / ORALNAExact identifier — unii candidate
6 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UCREAM / TOPICAL3300 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
CANDELILLA WAXCANDELILLA WAXWL0328HX19TABLET, FILM COATED / ORAL0.8 mgExact identifier — unii candidate
8 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4GEL / TOPICAL6 mgExact identifier — unii+route
4 equally ranked IID candidates
FERROUS OXIDEFERROUS OXIDEG7036X8B5HTABLET, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
6 equally ranked IID candidates
CANDELILLA WAXCANDELILLA WAXWL0328HX19TABLET, DELAYED RELEASE / ORAL1 mgExact identifier — unii candidate
8 equally ranked IID candidates
YELLOW WAXYELLOW WAX2ZA36H0S2VCREAM / TOPICAL5 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
CANDELILLA WAXCANDELILLA WAXWL0328HX19TABLET, EXTENDED RELEASE / ORAL3 mgExact identifier — unii candidate
8 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4CREAM / VAGINAL51 mgExact identifier — unii+dosage form
4 equally ranked IID candidates

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 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ENVIRONMENTAL DEFENSEZINC OXIDEAvasol LLC1fbddab4-71f7-4167-ad21-30040b7c71bb2026-01-26WarningsExact identifier
ndc (package): 58518-010-02
ndc (product): 58518-010
ndc11 (package): 58518001002
spl id: 49534937-860f-bf99-e063-6394a90a0e02
spl set id: 1fbddab4-71f7-4167-ad21-30040b7c71bb

Reported adverse events (FAERS/openFDA)#

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