Allay Skin Solutions Protect Nourish Mineral Sunscreen Spf 42 Cream
FDA Label NDC 87419-978

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Allay Skin Solutions Llc for the product Allay Skin Solutions Protect Nourish Mineral Sunscreen Spf 42 (NDC 87419-978). 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 drug facts, active ingredients, purpose, uses:, warnings, do not use, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Active Ingredients

Titanium Dioxide 2.50 %

Zinc Oxide 14.00 %

Purpose

Sunscreen

Uses:

  • Helps prevent sunburn
  • Higher SPF gives more sunburn protection
  • 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

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 or irritation develops and lasts.

Keep Out Of Reach Of Children

If swallowed, get medical help or contact a Poison Control Center right away

If Pregnant Or Breast-Feeding,

ask a health professional before use

Directions

  • Apply liberally 15 minutes before sun exposure and as needed.
  • Children under 6 months of age: ask a doctor.
  • 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 broad spectrum SPF 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

Other Information

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

Inactive Ingredients

1,2-Hexanediol, Butyloctyl Salicylate, C18-21 Alkane, Camelina Sativa Seed Oil, Caprylic/Capric Triglyceride, Caprylyl Glycol, Cetearyl Alcohol, Cetearyl Glucoside, Cholecalciferol, Coco-Caprylate/Caprate, Cyclopentasiloxane, Glycerin, Glyceryl Laurate, Glyceryl Undecylenate, Glycyrrhiza Glabra (Licorice) Root Extract , Iron Oxides (CI 77491), Iron Oxides (CI 77492), Iron Oxides (CI 77499), Isododecane, Isostearyl Palmitate, Linum Usitatissimum Seed Oil, Niacinamide, Polyacrylate Crosspolymer-6, Polyhydroxystearic Acid, Polysorbate 20, Propanediol, Ricinus Communis (Castor) Seed Oil, Silybum Marianum Extract, Sodium Hyaluronate, Sodium Stearoyl Glutamate, Tetrasodium Glutamate Diacetate, Thermus Thermophillus Ferment, Trimethylsiloxysilicate,Water (Aqua), Xanthan Gum

Questions?

(385) 204-5618

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