Daily Facial Moisturizer Broad Spectrum Spf15 Sunscreen
FDA Label NDC 42421-326

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Emilia Personal Care Inc. for the product Daily Facial Moisturizer Broad Spectrum Spf15 Sunscreen (NDC 42421-326). 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, keep out of reach of children, directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Active Ingredients

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.

Use a water resistant sunscreen if swimming or sweating

Reapply at least every 2 hours

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, diisopropyl adipate, cyclopentasiloxane, glycerin, glyceryl stearate, PEG-100 stearate, titanium dioxide, alumina, simethicone, cetyl alcohol, polymethyl methacrylate, phenoxyethanol, triethanolamine, benzyl alcohol, xanthan gum, acrylates/C10-30 alkyl acrylate crosspolymer, tocopheryl acetate (vitamin E), carbomer, potassium cetyl phosphate, disodium EDTA.

Package/Label Principal Display Panel

America's Choice® daily facial moisturizer

non-greasy and lightweight

non-comedogenic

(won't clog pores)

fragrance-free & paba-free

dermatologist tested

*Compare to Cetaphil® Daily Facial Moisturizer SPF 15 ingredients

BROAD SPECTRUM SPF15 SUNSCREEN

UVA/UVB PROTECTION

4 FL OZ (118 mL)

*This product is not manufactured or distributed by Galderma®, owner of the registered trademark Cetaphil®

DISTRIBUTED BY ONPOINT, INC.
2 PARAGON DRIVE
MONTVALE, NJ 07645

Manufactured in Israel 2T326 AD C1

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Carton Label

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