Cetaphil Lotion
FDA Label NDC 0299-3928

10 label sections · Submitted to the FDA by Galderma Laboratories, L.p. · Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Galderma Laboratories, L.p. for the product Cetaphil (NDC 0299-3928). 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, use(s), warnings, keep out of reach of children., directions, inactive ingredients:, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Avobenzone  3%
Octocrylene 10%

Purpose

Sunscreen

Use(S)

  • 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.
Stop use and ask a doctor if rash occurs.
When using this product keep out of eyes.
 Rinse with water to remove.

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: ask a doctor.
    SUN PROTECTION MEASURES: Spending time in the sun increases your risk of 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 10am - 2pm.
  • Wear long-sleeved shirts, pants, hats and sun glasses.

Inactive Ingredients:

Water, Diisopropyl Adipate, Cyclopentasiloxane, Glycerin, Glyceryl Stearate, PEG-100 Stearate, Polymethyl Methacrylate, Phenoxyethanol, Benzyl Alcohol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Tocopheryl Acetate, Carbomer, Disodium EDTA, Sodium Hydroxide

Other Information

• Protect this product from excessive heat and direct sun.
• May stain some fabrics.

Questions?

1-866-735-4137

Principal Display Panel - 4 Fl Oz Carton

                    

NEW LOOK

Cetaphil®          

Daily Facial
Moisturizer
AM

15 BROAD SPECTRUM
     SPF 15 (UVA/UVB)
     SUNSCREEN

All Skin Types

Ultra lightweight lotion hydrates
and protects skin

Glycerin

Oil-Free

Recommended
Skin Cancer Foundation
Daily Use

4 FL OZ (118 mL)


Distributed by:
Galderma Laboratories, L.P.
Dallas, TX 75201 USA

All trademarks are the property of their respective owners.


Made in Canada

cetaphil.com
P57752-0

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