Umbra Tinte Mineral Cream Spf 30 Cream
FDA Label NDC 69455-167

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 Umbra Tinte Mineral Cream Spf 30 (NDC 69455-167). 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, warnings, otc - do not use, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

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

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

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 Tinte™
Mineral
Cream

PROTECT + PRESERVE

SPF
30

BROAD SPECTRUM
SUNSCREEN
PA+++

20% Zinc Oxide
Astaxanthin

60 ml / 2 fl oz

Principal Display Panel (60 ml Tube Box)

Principal Display Panel (60 ml Tube Box)

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