DRUNK ELEPHANT  UMBRE TINTE PHYSICAL DAILY DEFENSE PROTECTION 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
Umbre Tinte Physical Daily Defense Protection 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, 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

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

PRINCIPAL DISPLAY PANEL - 60 ml Tube Box

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
DRUNK ELEPHANT   UMBRE TINTE PHYSICAL DAILY DEFENSE PROTECTION SPF-30
zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69455-463
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
WATER (UNII: 059QF0KO0R)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
GLYCERIN (UNII: PDC6A3C0OX)  
PENTYLENE GLYCOL (UNII: 50C1307PZG)  
STEARETH-2 (UNII: V56DFE46J5)  
PROPANEDIOL (UNII: 5965N8W85T)  
STEARETH-21 (UNII: 53J3F32P58)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SCLEROCARYA BIRREA SEED OIL (UNII: WDO4TLS35F)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
CHONDRUS CRISPUS (UNII: OQS23HUA1X)  
HAEMATOCOCCUS PLUVIALIS (UNII: 31T0FF0472)  
HELIANTHUS ANNUUS SPROUT (UNII: 4P26HG1S5W)  
WINE GRAPE JUICE (UNII: JHQ6158A7R)  
SUNFLOWER OIL (UNII: 3W1JG795YI)  
JOJOBA OIL (UNII: 724GKU717M)  
RASPBERRY SEED OIL (UNII: 9S8867952A)  
HYDROLYZED WHEAT PROTEIN (ENZYMATIC; 3000 MW) (UNII: J2S07SB0YL)  
.ALPHA.-TOCOPHEROL SUCCINATE, D- (UNII: LU4B53JYVE)  
AMINOPROPANEDIOL (UNII: RH369P864X)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
TOCOPHEROL (UNII: R0ZB2556P8)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
N-ACETYLGLUCOSAMINE (UNII: V956696549)  
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)  
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
GLYCINE (UNII: TE7660XO1C)  
SUCROSE (UNII: C151H8M554)  
SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)  
LECITHIN, SUNFLOWER (UNII: 834K0WOS5G)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
XANTHAN GUM (UNII: TTV12P4NEE)  
TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q)  
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
Product Characteristics
ColorBROWN (TAN) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69455-463-111 in 1 BOX01/15/2019
160 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35201/15/2019
Labeler - Drunk Elephant, LLC (057204632)

Revised: 8/2022
Document Id: 8e80f47b-c919-43cf-83e3-c228f76b524d
Set id: 272689a1-476c-426b-9c3e-c9fde4e1bf06
Version: 3
Effective Time: 20220808
 
Drunk Elephant, LLC