UMBRA SHEER MINERAL CREAM SPF 30- zinc oxide cream

Umbra Sheer Mineral Cream SPF 30 by

Drug Labeling and Warnings

Umbra Sheer Mineral Cream SPF 30 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, Ethylhexyl Olivate, Squalane, C9-12 Alkane, Propanediol, Polyglyceryl-3 Diisostearate, Glycerin, Polyglyceryl-6 Polyricinoleate, Silica, Disteardimonium Hectorite, Lauroyl Lysine, Kaolin, Sclerocarya Birrea Seed Oil, Camellia Sinensis Seed Oil, Coco-Caprylate/Caprate, Rubus Idaeus (Raspberry) Seed Oil, Simmondsia Chinensis (Jojoba) Seed Oil, Acacia Senegal Gum, Silybum Marianum Fruit Extract, Tetrahexyldecyl Ascorbate, Vitis Vinifera (Grape) Juice Extract, C12-15 Alkyl Benzoate, Haematococcus Pluvialis Extract, Ubiquinone, Astaxanthin, Dextrin, Sea Water, Brassica Campestris (Rapeseed) Seed Oil, Tocopheryl Acetate, Potassium Sorbate, Chlorphenesin, Sea Salt, Sodium Benzoate, Tetrasodium Glutamate Diacetate, Phenoxyethanol, Sodium Hydroxide, Tocopherol, Iron Oxides

Questions or Comments

800.604.1795

PRINCIPAL DISPLAY PANEL - 60 ml Tube Box

ESTD
2012

DRUNK ELEPHANT™

Umbra Sheer™
Mineral
Cream

PROTECT + PRESERVE

SPF 30

BROAD SPECTRUM
SUNSCREEN
PA+++

20% Zinc Oxide
Astaxanthin

60 ml / 2 fl oz

INGREDIENTS AND APPEARANCE

UMBRA SHEER MINERAL CREAM SPF 30 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69455-163
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	12 g  in 60 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ETHYLHEXYL OLIVATE (UNII: HTC7G3S2PV)
SQUALANE (UNII: GW89575KF9)
C9-12 ALKANE (UNII: 7J5R5W72QM)
PROPANEDIOL (UNII: 5965N8W85T)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
GLYCERIN (UNII: PDC6A3C0OX)
POLYGLYCERYL-6 POLYRICINOLEATE (UNII: YPM0ZOC2HR)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
LAUROYL LYSINE (UNII: 113171Q70B)
KAOLIN (UNII: 24H4NWX5CO)
SCLEROCARYA BIRREA SEED OIL (UNII: WDO4TLS35F)
CAMELLIA SINENSIS SEED OIL (UNII: O5R6DK2M9K)
COCO-CAPRYLATE (UNII: 4828G836N6)
RASPBERRY SEED OIL (UNII: 9S8867952A)
JOJOBA OIL (UNII: 724GKU717M)
ACACIA (UNII: 5C5403N26O)
MILK THISTLE (UNII: U946SH95EE)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
WINE GRAPE JUICE (UNII: JHQ6158A7R)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
HAEMATOCOCCUS PLUVIALIS (UNII: 31T0FF0472)
UBIDECARENONE (UNII: EJ27X76M46)
ASTAXANTHIN (UNII: 8XPW32PR7I)
ICODEXTRIN (UNII: 2NX48Z0A9G)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
HYDROGENATED RAPESEED OIL (UNII: K168T6Y0YU)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
CHLORPHENESIN (UNII: I670DAL4SZ)
SEA SALT (UNII: 87GE52P74G)
SODIUM BENZOATE (UNII: OJ245FE5EU)
TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
TOCOPHEROL (UNII: R0ZB2556P8)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Product Characteristics
Color	WHITE (Light Pink)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69455-163-10	1 in 1 BOX	06/11/2024
1		60 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 69455-163-20	1 in 1 CARTON	06/11/2024
2		5 mL in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 69455-163-30	2 mL in 1 PACKET; Type 0: Not a Combination Product	06/11/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH DRUG	M020	06/11/2024

Labeler - Drunk Elephant, LLC (057204632)