Sheer Tint Mineral Sunscreen Broad Spectrum Spf 50 - Medium/deep Shade Lotion
FDA Label NDC 51514-0362

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Autumn Harp for the product Sheer Tint Mineral Sunscreen Broad Spectrum Spf 50 - Medium/deep Shade (NDC 51514-0362). 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 otc - active ingredient, otc - purpose, dosage & administration, warnings, instructions for use, other safety information, inactive ingredient, otc - questions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Otc - Active Ingredient

→ Otc - Purpose

→ Dosage & Administration

→ Warnings

→ Instructions For Use

→ Other Safety Information

→ Inactive Ingredient

→ Otc - Questions

→ Indications & Usage

→ Otc - Keep Out Of Reach Of Children

→ Package Label.principal Display Panel

Otc - Active Ingredient

Active Ingredient

Zinc Oxide 13.3%

Titanium Dioxide 2.3%

Otc - Purpose

Sunscreen

Dosage & Administration

Helps prevent sunburn

Warnings

For external use only

Keep out of reach of children. If swallowed get medical help or contact a Poison Control Center right awy

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

Instructions For Use

Apply generously 15 minutes before sun exposure

Reapply 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 10am - 2pm,
Wear long-sleeved shirts, pants, hats, and sunglasses

Children under 6 months of age: Ask a doctor

Other Safety Information

Store at 20-25C (68-77F)

Protect the product in this container from excessive heat and direct sun

Inactive Ingredient

Caprylic/Capric Triglyceride, Water, Diisopropyl Sebacate, Polymethylsilsesquioxane, Undecane, Aloe Barbadensis Leaf Juice, Glycerin, Polyglyceryl-6 Polyricinoleate, Isododecane, Dimethicone, Mica, Polysilicone-11, Tridecane, Argania Spinosa Kernel Oil, Polyhydroxystearic Acid, Tocopheryl Acetate, Polyglyceryl-2 Isostearate, Disteardimonium Hectorite, Phenoxyethanol, Dimethicone Crosspolymer, Sodium Chloride, Triethoxycaprylylsilane, Alumina, Propanediol, Iron Oxide (CI 77492), Magnesium Stearate, Jojoba Esters, Disodium EDTA, 1,2-Hexanediol, Bisabolol, Propylene Carbonate, Titanium Dioxide (CI 77891), Niacinamide, Iron Oxides (CI 77491), Cyclohexasiloxane, Laureth-12, Caprylhydroxamic Acid, Iron Oxides (Black, CI 77499), Sodium Hyaluronate, Ethylhexylglycerin, Tocopherol, Glycyrrhiza Glabra (Licorice) Root Extract, Iron Oxides (CI77499).