FDA.reportPublic FDA data

Drunk Elephant

Manufacturer
Drunk Elephant, LLC
Effective date
2022-08-08
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 00:40:00

Label at a glance#

ProductDrunk Elephant Umbra Tinte Physical Daily Defense Protection 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

SPL UNCLASSIFIED 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, glycerin, pentylene glycol, 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, sodium C14-16 olefin sulfonate, phenoxyethanol, chlorphenesin, sodium dehydroacetate, iron oxides (CI 77491, CI 77492, CI 77499)

Questions or Comments

OTC - QUESTIONS SECTION

  • 800.604.1795

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 60 ml Tube Box

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ESTD
2012
DRUNK ELEPHANT™

Umbra Tinte™
Physical
Daily Defense

PROTECT + GLOW

SUNSCREEN
BROAD SPECTRUM
SPF 30

20% Zinc Oxide
Sunflower Shoot Extract

60 ml / 2 fl oz

PRINCIPAL DISPLAY PANEL - 60 ml Tube Box
PRINCIPAL DISPLAY PANEL - 60 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
69455-463-112022-08-09C16284748780-1d6a99b39-ebef-a426-e053-dadaa90af4c2Drunk Elephant ™ Umbre Tinte ™ Physical Daily Defense Protection SPF-30
69455-463-112022-01-28C16284748780-1d6a99b39-ebef-a426-e053-dadaa90af4c2Drunk Elephant ™ Umbre Tinte ™ Physical Daily Defense Protection SPF-30

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69455-463-11Drunk ElephantUmbra Tinte Physical Daily Defense Protection SPF-3060 mL in 1 TUBELOTION605
69455-463-11Drunk ElephantUmbra Tinte Physical Daily Defense Protection SPF-301 in 1 BOXLOTION15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69455-463DRUNK ELEPHANT UMBRA TINTE PHYSICAL DAILY DEFENSE PROTECTION SPF-30 (ZINC OXIDE) LOTION [DRUNK ELEPHANT, LLC]5Legacy NDC, 2 package rows20241204_272689a1-476c-426b-9c3e-c9fde4e1bf06.zip

Products#

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

DailyMed product names page 1 of 2 · 47 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69455-46369455-463-11

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 46 matching rows.

Name, UNII, Kind table
NameUNIIKind
ZINC OXIDESOI2LOH54ZACTIB
WATER059QF0KO0RIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
DICAPRYLYL CARBONATE609A3V1SUAIACT
GLYCERINPDC6A3C0OXIACT
PENTYLENE GLYCOL50C1307PZGIACT
STEARETH-2V56DFE46J5IACT
PROPANEDIOL5965N8W85TIACT
STEARETH-2153J3F32P58IACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
SCLEROCARYA BIRREA SEED OILWDO4TLS35FIACT
ALOE VERA LEAFZY81Z83H0XIACT
CHONDRUS CRISPUSOQS23HUA1XIACT
HAEMATOCOCCUS PLUVIALIS31T0FF0472IACT
HELIANTHUS ANNUUS SPROUT4P26HG1S5WIACT
WINE GRAPE JUICEJHQ6158A7RIACT
SUNFLOWER OIL3W1JG795YIIACT
JOJOBA OIL724GKU717MIACT
RASPBERRY SEED OIL9S8867952AIACT
HYDROLYZED WHEAT PROTEIN (ENZYMATIC; 3000 MW)J2S07SB0YLIACT
.ALPHA.-TOCOPHEROL SUCCINATE, D-LU4B53JYVEIACT
AMINOPROPANEDIOLRH369P864XIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
TOCOPHEROLR0ZB2556P8IACT
SODIUM CHLORIDE451W47IQ8XIACT
N-ACETYLGLUCOSAMINEV956696549IACT
CETEARYL GLUCOSIDE09FUA47KNAIACT
SODIUM STEAROYL GLUTAMATE65A9F4P024IACT
TETRAHEXYLDECYL ASCORBATE9LBV3F07AZIACT
GLYCINETE7660XO1CIACT
SUCROSEC151H8M554IACT
SODIUM C14-16 OLEFIN SULFONATEO9W3D3YF5UIACT
LECITHIN, SUNFLOWER834K0WOS5GIACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
XANTHAN GUMTTV12P4NEEIACT
TRISODIUM ETHYLENEDIAMINE DISUCCINATEYA22H34H9QIACT
CAPRYLHYDROXAMIC ACIDUPY805K99WIACT
CAPRYLYL GLYCOL00YIU5438UIACT

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
1cc2a0f5-2885-4f9f-ad92-f78308bc991e272689a1-476c-426b-9c3e-c9fde4e1bf062022-08-08WarningsExact identifier
spl id: 1cc2a0f5-2885-4f9f-ad92-f78308bc991e
spl set id: 272689a1-476c-426b-9c3e-c9fde4e1bf06

Reported adverse events (FAERS/openFDA)#

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