Broad Spectrum Spf 30 Up The Anti Cream
FDA Label NDC 42485-005

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 Broad Spectrum Spf 30 Up The Anti (NDC 42485-005). 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 broad spectrum spf 30 up the anti, active ingredients, purpose, uses, warnings, keep out of reach of children., directions, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Broad Spectrum Spf 30 Up The Anti


Active Ingredients

Zinc Oxide 6.0%
Titanium Dioxide 3.2%

Purpose

Sunscreen

Uses

  • helps prevent sunburn
  • if used as directed with other sun protections 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 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, ethylhexyl palmitate, cyclopentasiloxane, c12-15 alkyl benzoate, dimethicone, polysorbate 80, peg-100 stearate, glyceryl stearate, propylene glycol, polyglyceryl-6 isostearatem cetyl alcohol, sodium acrylate/sodium acryloyldimethyl laurate copolymer, glycerin, cyclohexasiloxane, caprylyl methicone, alumina, isohexadecane, boron nitride, triethoxysilylethyl polydimethylsiloxy hexyl dimethicone, sodium levulinate, lauryl  peg-9 polydimethylsiloxyethyl dimethicone, acrylates/ammonium methacrylate copolymer, phenoxyethanol, polyhydroxystearic acid, sodium anisate, triethoxycaprylylsilane, panthenol, iodopropynyl butylcarbamate, dmdm hydantoin, aloe barbadensis leaf juice, allantoin, disodium edta, methylparaben, ethylparaben, butylparaben, butylene glycol, propylparaben, isobutylparaben, chamomilla recutita (matricaria) flower extract, camellia sinensis leaf extract, iron oxides.

Other Information

  • protect this product from excessive heat and direct sun

Questions Or Comments?

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

Other

PRESCRIBEDsolutions is Distributed By Biopelle, Inc.

A Ferndale Pharma Group Company, Ferndale, MI 48220

Made In USA

Broad Spectrum Spf 30 Up The Anti 75Ml (42485-005-01)


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