DRUNK ELEPHANT UMBRE TINTE PHYSICAL DAILY DEFENSE PROTECTION SPF-30- zinc oxide lotion

Drunk Elephant by

Drug Labeling and Warnings

Drunk Elephant by is a Otc medication manufactured, distributed, or labeled by Drunk Elephant, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

Zinc Oxide 20%

Purpose

Sunscreen

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

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:

• 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

• protect this product from excessive heat and direct sun.

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

• 800.604.1795

SPL UNCLASSIFIED SECTION

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

INGREDIENTS AND APPEARANCE

DRUNK ELEPHANT   UMBRE TINTE PHYSICAL DAILY DEFENSE PROTECTION SPF-30
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69455-463
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	ZINC OXIDE	20 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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
Color	BROWN (TAN)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69455-463-11	1 in 1 BOX	01/15/2019
1		60 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	01/15/2019

Labeler - Drunk Elephant, LLC (057204632)