Drunk Elephant
FDA Label NDC 69455-463

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Drunk Elephant, Llc for the product Drunk Elephant (NDC 69455-463). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, active ingredient, purpose, uses, otc - do not use, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

For external use only

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

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

Otc - Do Not Use

Do not use on damaged or broken skin

Otc - When Using

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

Otc - Stop Use

Stop use and ask a doctor if rash occurs

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • apply liberally 15 minutes before sun exposure
  • use a water resistant sunscreen if swimming or sweating
  • reapply at least every 2 hours
  • 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

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, Sodium C14•16 Olefin Sulfonate, Lecithin, Triethoxycaprylylsilane, Xanthan Gum, Trisodium Ethylenediamine Disuccinate, Caprylhydroxamic Acid, Mica, Caprylyl Glycol, Phenoxyethanol, Titanium Dioxide (CI 77891), Iron Oxides (CI 77491, CI 77492, CI 77499)

Other Information

  • protect this product from excessive heat and direct sun.

Questions Or Comments

  • 800.604.1795

Principal Display Panel - 60 Ml Tube Box

ESTD
2012
DRUNK ELEPHANT™

Umbra Tinte™
Physical
Daily Defense

Protection

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)

Principal Display Panel (60 ml Tube Box)

* Please review the disclaimer below.