FDA.reportPublic FDA data

Drunk Elephant

Manufacturer
Drunk Elephant, LLC
Effective date
2022-08-08
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:50:22

Label at a glance#

ProductDrunk Elephant Umbre Sheer Defense SPF-30
Active ingredientZINC OXIDE
Label structure11 sections

Indications and uses

helps prevent sunburn if used as directed with other sun protection measures (see Directions ), decreases the risk of skin cancer and early skin aging caused by the sun

Dosage and administration

For sunscreen use: apply liberally 15 minutes before sun exposure reapply at least every 2 hours use a water resistant sunscreen if swimming or sweating Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: limit time in th...

Storage and handling

protect this product from excessive heat and direct sun.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 20%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • helps prevent sunburn
  • if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

Warnings

WARNINGS SECTION

For external use only

OTC - DO NOT USE SECTION

Do not use on damaged or broken skin

OTC - WHEN USING SECTION

When using this product keep out of eyes. Rinse with water to remove.

OTC - STOP USE SECTION

Stop use and ask a doctor if rash occurs

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

For sunscreen use:

  • apply liberally 15 minutes before sun exposure
  • reapply at least every 2 hours
  • use a water resistant sunscreen if swimming or sweating
  • Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging.
    To decrease the risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
    • limit time in the sun, especially from 10 a.m. – 2 p.m.
    • wear long-sleeve shirts, pants, hats, and sunglasses
  • children under 6 months: Ask a doctor

Other information

STORAGE AND HANDLING SECTION

  • protect this product from excessive heat and direct sun.

Inactive ingredients

INACTIVE INGREDIENT SECTION

water, caprylic/capric triglyceride, dicaprylyl carbonate, pentylene glycol, glycerin, steareth-2, propanediol, steareth-21, polyhydroxystearic acid, cetearyl alcohol, silica, sclerocarya birrea seed oil, aloe barbadensis leaf extract, chondrus crispus extract, haematococcus pluvialis extract, helianthus annuus (sunflower) sprout extract, vitis vinifera (grape) juice extract, helianthus annuus (sunflower) seed oil, simmondsia chinensis (jojoba) seed oil, raspberry seed oil/tocopheryl succinate aminopropanediol esters, hydrolyzed wheat protein, tocopheryl acetate, tocopherol, sea water, acetyl glucosamine, cetearyl glucoside, sodium stearoyl glutamate, tetrahexyldecyl ascorbate, glycine, sucrose, lecithin, triethoxycaprylylsilane, xanthan gum, trisodium ethylenediamine disuccinate, caprylhydroxamic acid, caprylyl glycol, phenoxyethanol, chlorphenesin, sodium dehydroacetate, iron oxides (CI 77491)

Questions or comments

OTC - QUESTIONS SECTION

  • 800.604.1795

SPL UNCLASSIFIED SECTION

Dist. by:
Drunk Elephant®
Newport Beach, CA
92663, USA

PRINCIPAL DISPLAY PANEL - 90 ml Tube Box

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ESTD
2012

DRUNK ELEPHANT™

Umbra Sheer™
Physical
Daily Defense

PROTECT + PRESERVE

SUNSCREEN
BROAD SPECTRUM
SPF 30

20% Zinc Oxide
Sunflower Shoot Extract

90 ml / 3 fl oz

PRINCIPAL DISPLAY PANEL - 90 ml Tube Box
PRINCIPAL DISPLAY PANEL - 90 ml Tube Box

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69455-964-152025-01-30C16284748780-1e4f33bdf-b193-d8a0-e053-dadaa90a6e4eDRUNK ELEPHANT™ UMBRA SHEER™ DEFENSE SPF-30
69455-964-152022-08-09C16284748780-1e4f33bdf-b193-d8a0-e053-dadaa90a6e4eDRUNK ELEPHANT™ UMBRA SHEER™ DEFENSE SPF-30
69455-964-152022-07-29C16284748780-1e4f33bdf-b193-d8a0-e053-dadaa90a6e4eDRUNK ELEPHANT™ UMBRA SHEER™ DEFENSE SPF-30

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69455-964-15Drunk Elephant Umbre Sheer Defense SPF-301 in 1 BOXLOTION12
69455-964-15Drunk Elephant Umbre Sheer Defense SPF-3090 mL in 1 TUBELOTION902

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69455-964DRUNK ELEPHANT UMBRE SHEER DEFENSE SPF-30 (ZINC OXIDE) LOTION [DRUNK ELEPHANT, LLC]2Legacy NDC, 2 package rows20220811_abbd9dd4-7853-46f0-ac47-478db6490429.zip

Products#

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

DailyMed product names page 1 of 2 · 43 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69455-96469455-964-15

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 42 matching rows.

Name, UNII, Kind table
NameUNIIKind
ZINC OXIDESOI2LOH54ZACTIB
DICAPRYLYL CARBONATE609A3V1SUAIACT
GLYCERINPDC6A3C0OXIACT
PENTYLENE GLYCOL50C1307PZGIACT
STEARETH-2V56DFE46J5IACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
STEARETH-2153J3F32P58IACT
SODIUM CHLORIDE451W47IQ8XIACT
CHONDRUS CRISPUSOQS23HUA1XIACT
ALOE VERA LEAFZY81Z83H0XIACT
HELIANTHUS ANNUUS SPROUT4P26HG1S5WIACT
WINE GRAPE JUICEJHQ6158A7RIACT
WHEAT4J2I0SN84YIACT
SUNFLOWER OIL3W1JG795YIIACT
JOJOBA OIL724GKU717MIACT
SCLEROCARYA BIRREA SEED OILWDO4TLS35FIACT
N-ACETYLGLUCOSAMINEV956696549IACT
TETRAHEXYLDECYL ASCORBATE9LBV3F07AZIACT
RASPBERRY SEED OIL9S8867952AIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
TOCOPHEROLR0ZB2556P8IACT
GLYCINETE7660XO1CIACT
SUCROSEC151H8M554IACT
EGG PHOSPHOLIPIDS1Z74184RGVIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
CAPRYLHYDROXAMIC ACIDUPY805K99WIACT
EDETATE DISODIUM7FLD91C86KIACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
XANTHAN GUMTTV12P4NEEIACT
PROPANEDIOL5965N8W85TIACT
CAPRYLYL GLYCOL00YIU5438UIACT
PHENOXYETHANOLHIE492ZZ3TIACT
WATER059QF0KO0RIACT
.ALPHA.-TOCOPHEROL SUCCINATE, D-LU4B53JYVEIACT
HAEMATOCOCCUS PLUVIALIS31T0FF0472IACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
CETEARYL GLUCOSIDE09FUA47KNAIACT
SODIUM STEAROYL GLUTAMATE65A9F4P024IACT
CHLORPHENESINI670DAL4SZIACT

Source Document#

Source XML

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
9a109fc3-9f85-43db-8b2e-3f49d78e407babbd9dd4-7853-46f0-ac47-478db64904292022-08-08WarningsExact identifier
spl id: 9a109fc3-9f85-43db-8b2e-3f49d78e407b
spl set id: abbd9dd4-7853-46f0-ac47-478db6490429

Reported adverse events (FAERS/openFDA)#

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