Stop The Clock Broad Spectrum Spf 50
FDA Label NDC 42485-006

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Biopelle, Inc. for the product Stop The Clock Broad Spectrum Spf 50 (NDC 42485-006). 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 ingredients, purpose, uses, warnings, otc - do not use, otc - when using, otc - stop use, otc - 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 Ingredients

Avobenzone 3%

Homosalate 7%

Titanium Dioxide 3.5%

Zinc Oxide 1%

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

Otc - Do Not Use

Do not use on damaged or broken skin

Otc - When Using

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

Otc - Stop Use

Stop use and ask a doctor if rash occurs

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • apply to face and under throat after cleansing
  • reapply:
    • after excessive perspiration
    • 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 15 or higher and other sun 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, butylene glycol dicaprylate/dicaprate, c12-15 alkyl benzoate, sodium hyaluronate, hydrolyzed potato protein, gamma aminobutyric acid, decamethylcyclopentasiloxane, polysilicone-15, c18-36 acid triglyceride, hexapeptide-11, silica, dipalmitoyl hydroxyproline, polyacrylate-13, hexanoyl dipeptide-3 norleucine acetate, thermus thermophillus ferment, uncaria tomentosa extract, porphyra umbilicalis extract, sodium tocopheryl phosphate, hydrolyzed vegetable protein, adenosine triphosphate, acetyl tyrosine, proline, sodium stearoyl glutamate, dimethicone, dimethiconol, cyclopentasiloxane, lecithin, sodium lactate, triethoxycaprylylsilane, cyclomethicone, peg-10 dimethicone, silica dimethyl silylate, glycerin, polyisobutene, polysorbate 20, phenoxyethanol, caprylyl glycol, butylene glycol, citric acid, xantham gum, hexylene glycol, disodium edta, methicone, alcohol, eugenol

Other Information

  • protect this product from excessive heat and direct sun

Questions Or Comments?

Call toll free - 1-866-424-6735 (weekdays)


PRESCRIBEDsolutions is DISTRIBUTED BY BIOPELLE, INC., A FERNDALE PHARMA GROUP COMPANY, FERNDALE, MI 48220.

www.BIOPELLE.com

MADE IN USA

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