DRUNK ELEPHANT UMBRA SHEER DEFENSE SPF-30- zinc oxide cream

DRUNK ELEPHANT UMBRA SHEER DEFENSE by

Drug Labeling and Warnings

DRUNK ELEPHANT UMBRA SHEER DEFENSE by is a Otc medication manufactured, distributed, or labeled by Drunk Elephant Distributors, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

ZINC OXIDE 20%

PURPOSE

SUNSCREEN

USES

• HELPS PREVENT SUBBURN
• 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

DO NOT USE ON DAMAGED OR BROKEN SKIN.

WHEN USING

WHEN USING THIS PRODUCT KEEP OUT OF EYES. RINSE WITH WATER TO REMOVE.

STOP USE

STOP USE AND ASK A DOCTOR IF RASH OCCURS.

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN. IF PRODUCT IS SWALLOWED, GET MEDICAL HELP OR CONTACT A POSON CONTROL CENTER RIGHT AWAY.

DIRECTIONS

• APPLY LIBERALLY 20 MINUTES PRIOR TO SUN EXPOSURE AS NEEDED.
• REAPPLY:
• AFTER SWIMMING OR SWEATING,
• IMMEDIATELY AFTER TOWEL DRYING,
• AT LEAST EVERY TWO HOURS.
• DO NOT USE ON INFANTS UNDER 6 MONTHS OF AGE.
• SUN PROTECTION MEASURES. SPENDING TIME IN THE SUN INCREEASES YOUR RISK OF SKIN CANCER AND EARLY SKIN AGING. TO DECREASE THIS RISK, REGULARLY USE A SUNSCREEN WITH A BROAD SPECTRUM SPF 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-SLEEVED SHIRTS, PANTS, HATS, AND SUNGLASSES.

INACTIVE INGREDIENTS

ACETYL GLUCOSAMINE, ALGAE EXTRACT, ALOE BARBADENSIS LEAF EXTRACT, CAPRYLHYDROXAMIC ACID, CAPRYLYL GLYCOL, CETEARYL ALCOHOL, COCOS NUCIFERA (COCONUT) OIL, DICAPRYLYL CARBONATE, DISODIUM EDTA, GLYCERIN, HAEMALECOCCUS PINNALIS EXTRACT, HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL, HELIANTHUS ANNUUS (SUNFLOWER) SPROUT EXTRACT, HYDROLYZED WHEAT PROTEIN, LECITHIN, MICA, CARMINE (CI 75470), PENTYLENE GLYCOL, PHENOXYETHANOL, POLYHYDROXYSTEARIC ACID, POTASSIUM SORBATE, PROPANEDIOL, RASPBERRY SEED OIL, TOCOPHERYL SUCCINATE AMINOPROPANEDIOL ESTERS, SCLEROCARYA BIRREA (MARULA) SEED OIL, SEA WATER, SILICA, SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL, STEARETH-2, STEARETH-21, SUCROSE, TETRAHEXYLDECYL ASCORBATE, TOCOPHEROL, TRIETHOXYCAPRYLYLSILANE, VITIS VINIFERA (GRAPE) JUICE EXTRACT, WATER (AQUA), XANTHAN GUM

OTHER INFORMATION

• PROTECT THIS PRODUCT FROM EXCESSIVE HEAT AND DIRECT SUN.

QUESTIONS OR COMMENTS

• INFO@DRUNKELEPHANT.COM

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DRUNK ELEPHANT UMBRA SHEER DEFENSE  SPF-30
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69455-101
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 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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)
ASTAXANTHIN (UNII: 8XPW32PR7I)
HELIANTHUS ANNUUS SPROUT (UNII: 4P26HG1S5W)
WINE GRAPE JUICE (UNII: JHQ6158A7R)
WHEAT (UNII: 4J2I0SN84Y)
COCONUT OIL (UNII: Q9L0O73W7L)
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)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
MICA (UNII: V8A1AW0880)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
WATER (UNII: 059QF0KO0R)
.ALPHA.-TOCOPHEROL SUCCINATE, D- (UNII: LU4B53JYVE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69455-101-14	118 g in 1 TUBE; Type 0: Not a Combination Product	01/01/2014	01/01/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	01/01/2014	01/01/2021

Labeler - Drunk Elephant Distributors, LLC (057204632)