Sqween Mineral Sunscreen Broad Spectrum Spf 30 Blue Cream
FDA Label NDC 58419-011

13 label sections · Submitted to the FDA by Atlantis Laboratories, Inc. · Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Atlantis Laboratories, Inc. for the product Sqween Mineral Sunscreen Broad Spectrum Spf 30 Blue (NDC 58419-011). 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

Zinc Oxide 15%

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.

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.

Keep Out Of Reach Of Children.

  • If a product is swallowed, get medical help or contact a Poison Control right away.

Directions

  • Apply liberally to exposed areas 15 minutes before sun exposure.
  • Reapply at least every two hours, after 80 minutes of swimming or sweating, or immediately after towel drying.
  • Wash brush with soap and water after use.
  • 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 broad spectrum SPF of 15 or higher and other 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.

Inactive Ingredients

Water, C15-19 Alkane, Isocetyl Stearoyl Stearate, Undecane, Tribehenin, Silica, Tocopheryl Acetate, Helianthus Annuus (Sunflower) Seed Oil, Capryloyl Glycerin/Sebacic Acid Copolymer, Glyceryl Stearate, Simmondsia Chinensis (Jojoba) Seed Oil, Tridecane, Leuconostoc/Radish Root Ferment Filtrate, Lactobacillus, Aloe Barbadensis Leaf, Hyaluronic Acid, Acacia Senegal Gum, Xanthan Gum, Cocos Nucifera (Coconut) Fruit Extract. May Contain: Indigofera Tinctoria Leaf Extract, Caesalpinia Sappan Bark Extract, Synthetic Fluorphlogopite, Titanium Dioxide, Tin Oxide, Iron Oxide, Ferric Ferrocyanide.

Other Information

Protect this product from excessive heat and direct sun.

Contact For Questions

(877) 849-1983

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