Careone Daily Facial
FDA Label NDC 41520-505

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by American Sales Company for the product Careone Daily Facial (NDC 41520-505). 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 on, when using this product, stop use and ask a doctor, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Active Ingredient

Avobenzone 3.0%

Octocrylene 10.0%

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 15 minutes before sun exposure.
  • Children under 6 months of age: 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 a Broad Spectrum SPF value 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

water, disopropyl adipate, cyclopentasiloxane, glycerin, glyceryl stearate, PEG-100 stearate, titanium dioxide, alumina, simethicone, polymethyl methacrylate, phenoxyethanol, benzyl alcohol, triethanolamine, acrylates/C10-30 alkylacrylate crosspolymer, tocopheryl acetate (vitamin E), carbomer, disodium EDTA

Package/Label Principal Display Panel - Carton Label

CareOne® daily facial moisturizer broad spectrum SPF15 sunscreen

  • non-greasy and lightweight
  • protects from UVA and UVB rays
  • non-comedogenic (won't clog pores)
  • fragrance-free and paba-free
  • dermatologist tested
  • 4 FL OZ (118 mL)

    DISTRIBUTED BY:
    AMERICAN SALES COMPANY
    4201 WALDEN AVENUE
    LANCASTER, NY 14086
    www.care1.info
    © 2012 S&S Brands, Inc.
    Quality guaranteed or your money back.
    Manufactured in Israel

    Carton Label (Ca3e908a Df71 42cf A4d1 65b9a6420a93 01)

    Carton Label (Ca3e908a Df71 42cf A4d1 65b9a6420a93 01)

    Carton Label

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