Purminerals 4-in-1 Mineral Tinted Moisturizer Broad Spectrum Spf 20 (medium)
FDA Label NDC 67345-0002

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Purminerals for the product Purminerals 4-in-1 Mineral Tinted Moisturizer Broad Spectrum Spf 20 (medium) (NDC 67345-0002). 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, medicinal ingredient/active ingredient, purpose, uses, warnings, otc - do not use, otc - stop use, otc - when using, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Other

→ Medicinal Ingredient/active Ingredient

→ Purpose

→ Uses

→ Warnings

→ Otc - Do Not Use

→ Otc - Stop Use

→ Otc - When Using

→ Otc - Keep Out Of Reach Of Children

→ Directions

→ Sun Protection Measures

→ Non-medicinal Ingredients/ Inactive Ingredients

→ Principal Display Panel - 50 G Tube Carton - Light

→ Principal Display Panel - 50 G Tube Carton - Medium

→ Principal Display Panel - 50 G Tube Carton - Tan

→ Principal Display Panel - 50 G Tube Carton - Dark

Other

Drug Facts

Protect this product from excessive heat and direct sun

In the unlikely event of an adverse reaction, please contact 1.866.PUR.0022.

Distributed by pürminerals® Atlanta, GA 30327

Medicinal Ingredient/Active Ingredient

Titanium Dioxide 5.0% w/w, Zinc Oxide 5.0% w/w

Purpose

Sunscreen

Uses

Helps prevent sunburn.

Warnings

For external use only

Otc - Do Not Use

Do not use on damaged or broken skin

Otc - Stop Use

Stop use and ask a doctor if rash occurs

Otc - When Using

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

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

Use a water resistant sunscreen if swimming or sweating
Reapply at least every 2 hours
Children under 6 months: ask a doctor

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.

Non-Medicinal Ingredients/ Inactive Ingredients

Aqua, Cyclopentasiloxane, Butylene Glycol, Octyldodecyl Neopentanoate, PEG/PPG-18/18 Dimethicone, Dimethicone, Magnesium Chloride, Potassium Chloride, Sodium Chloride, Zinc Chloride, Lysine, Butyrospermum Parkii (Shea) Butter, Panax Ginseng Root Extract, Ginkgo Biloba Leaf Extract, Anthemis Nobilis Flower Extract, Camellia Oleifera Leaf Extract, Aloe Barbadensis Leaf Extract, Phytantriol, Magnesium Ascorbyl Phosphate, Retinyl Palmitate, Tocopheryl Acetate, Tocopherol, Tetrahexyldecyl Ascorbate, Aluminum Hydroxide, Stearic Acid, Lactic Acid, Triethoxycaprylylsilane, Boron Nitride, Glycerin, Palmitic Acid, Dextrin Palmitate, Sodium Starch Octenylsuccinate, Retinol, Ceramide AP, Sodium Hyaluronate, Sodium Dehydroacetate, Disodium EDTA, Phenoxyethanol, Caprylyl Glycol, Hexylene Glycol, May Contain: Mica, Iron Oxides (CI 77491, CI 77492, CI 77499), Titanium Dioxide (CI 77891)