Even Tone Mineral Sunscreen Broad Spectrum Spf 36 Medium - Dark Lotion
FDA Label NDC 71398-014

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Sent�, Inc. for the product Even Tone Mineral Sunscreen Broad Spectrum Spf 36 Medium - Dark (NDC 71398-014). 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, otc - purpose, uses, warnings, 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

→ Otc - Purpose

→ Uses

→ Warnings

→ Otc - Do Not Use

→ Otc - When Using

→ Otc - Stop Use

→ Otc - Keep Out Of Reach Of Children

→ Directions

→ Inactive Ingredients

→ Other Information

→ Questions Or Comments?

→ Principal Display Panel - 50 Ml Tube Carton

Other

Drug Facts

Otc - Purpose

Active ingredients	Purpose
Zinc Oxide 7.80%	Sunscreen
Titanium Dioxide 4.25%	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 keepout 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 swallowed, get medical help or contact a Poison Control Center right away.

Directions

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 this 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- sleeved shirts, pants, hats, and sunglasses.
- Children under 6 months of age: Ask a doctor

Inactive Ingredients

Water (Aqua), Dimethicone, Cyclopentasiloxane, PEG-10 Dimethicone, Pentylene Glycol, Hexyl Laurate, Polyglyceryl-4 Isostearate, Sodium Chloride, Heparan Sulfate, Glycerin, Fructose, Tocopheryl Acetate, Tocopherol, Withania Somnifera Root Extract, Iron Oxides (CI 77491, CI 77492, CI 77499), Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone, Dimethicone/Polyceryin-3 Crosspolymer, Stearic Acid, Alumina, Sodium Citrate, Dimethicone/Vinyl Dimethicone Crosspolymer, PEG/PPG-18/18 Dimethicone, Triethoxycaprylylsilane, Phenoxyethanol, Ethylhexylglycerin.