DRUNK ELEPHANT  UMBRE SHEER DEFENSE SPF-30- zinc oxide lotion 
Drunk Elephant, LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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DRUNK ELEPHANT™ UMBRA SHEER™ DEFENSE
SPF-30

Drug Facts

Active ingredient

Zinc Oxide 20%

Purpose

Sunscreen

Uses

Warnings

For external use only

Do not use on damaged or broken skin

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

Stop use and ask a doctor if rash occurs

Keep out of reach of children.

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

Directions

For sunscreen use:

Other information

Inactive ingredients

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

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

PRINCIPAL DISPLAY PANEL - 90 ml Tube Box

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
DRUNK ELEPHANT   UMBRE SHEER DEFENSE SPF-30
zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69455-964
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE20 mg  in 100 mL
Inactive Ingredients
Ingredient NameStrength
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
GLYCERIN (UNII: PDC6A3C0OX)  
PENTYLENE GLYCOL (UNII: 50C1307PZG)  
STEARETH-2 (UNII: V56DFE46J5)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
STEARETH-21 (UNII: 53J3F32P58)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
CHONDRUS CRISPUS (UNII: OQS23HUA1X)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
HELIANTHUS ANNUUS SPROUT (UNII: 4P26HG1S5W)  
WINE GRAPE JUICE (UNII: JHQ6158A7R)  
WHEAT (UNII: 4J2I0SN84Y)  
SUNFLOWER OIL (UNII: 3W1JG795YI)  
JOJOBA OIL (UNII: 724GKU717M)  
SCLEROCARYA BIRREA SEED OIL (UNII: WDO4TLS35F)  
N-ACETYLGLUCOSAMINE (UNII: V956696549)  
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
RASPBERRY SEED OIL (UNII: 9S8867952A)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
TOCOPHEROL (UNII: R0ZB2556P8)  
GLYCINE (UNII: TE7660XO1C)  
SUCROSE (UNII: C151H8M554)  
EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
XANTHAN GUM (UNII: TTV12P4NEE)  
PROPANEDIOL (UNII: 5965N8W85T)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
WATER (UNII: 059QF0KO0R)  
.ALPHA.-TOCOPHEROL SUCCINATE, D- (UNII: LU4B53JYVE)  
HAEMATOCOCCUS PLUVIALIS (UNII: 31T0FF0472)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69455-964-151 in 1 BOX12/13/2018
190 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35212/13/2018
Labeler - Drunk Elephant, LLC (057204632)

Revised: 8/2022
Document Id: 9a109fc3-9f85-43db-8b2e-3f49d78e407b
Set id: abbd9dd4-7853-46f0-ac47-478db6490429
Version: 2
Effective Time: 20220808
 
Drunk Elephant, LLC