Circadia Circa-shield Mineral Sunscreen Spf 30 Cream
FDA Label NDC 76458-401

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Circadia By Dr Pugliese, Inc. for the product Circadia Circa-shield Mineral Sunscreen Spf 30 (NDC 76458-401). 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 active ingredient, purpose, uses, warnings, do not use, when using this product, stop use and ask a doctor if, 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

Active Ingredient

Zinc Oxide (17.3%)

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

Directions

apply liberally to skin 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 Broad Spectrum SPF or higher and other sun protection measures including:
  • limit time in the sun, especially from 10 a.m. - 2 p.m.
  • wear long-sleeved shirt, pants, hats and sunglasses.

Inactive Ingredients

C14-22 Alkane, Olea Europaea fruit Oil, Sorbitan Olivate, Diisopropyl Adipate, C9-12 Alkane, Silica, Oryza Sativa Bran Cera, Vegetable Oil, Simmondsia Chinensis Seed Oil, Curcuma Longa Root Extract, Saccharomyces Ferment, Polyglyceryl-4 Olivate/Polyricinoleate, Triethoxycaprylylsilane, Coco-Caprylate, Glycine Soja Oil, Polyhydroxystearic Acid, Triethyl Citrate, Lauroyl Lysine, Bis(Cyano Butylacetate) Antharacenediylidene, Polyglyceryl-3 Diisostearate, Oryza Sativa Germ Extract Oryza Sativa Extract, Caprylic /Capric Triglyceride, Camellia Sinensis Leaf Extract, Vanila Planifolia Fruit Extract, Salvia Officinalis Flower/Leaf/Stem Extract, Rosmarinus Officinalis Leaf Extract, Lavandula Angustifolia Flower/Leaf/Stem Extract, Salvia Triloba Leaf Extract, Jasminum Officinale Flower/Leaf Extract, Rosa Damascena Flower Extract, Linalool.

Other Information

protect this product from excessive heat and direct sun.

Questions?

Call toll-free (800) 630-4710

* Please review the disclaimer below.