Cetaphil Oil Absorbing Spf 30 Lotion
FDA Label NDC 0299-4134

Full FDA labeling including 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 Oil Absorbing Spf 30 (NDC 0299-4134). 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, use(s), warnings, directions, inactive ingredients, other information, questions?, principle display panel - 4oz carton, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients......Purpose

AVOBENZONE 3%......Sunscreen
OCTISALATE 5%........Sunscreen
OCTOCRYLENE 7%....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 sunglasses.

Inactive Ingredients

Allantoin, Aluminum Starch Octenylsuccinate, Caprylyl Glycol, Carbomer, Ceramide NP, Diisopropyl Sebacate, Dimethicone, Dimethiconol, Disodium EDTA, Glycerin, Glycyrrhetinic Acid, Isopropyl Lauroyl Sarcosinate, Panthenol, Pentylene Glycol, Phenoxyethanol, Polymethyl Methacrylate, Polysorbate 61, Potassium Sorbate, Silica, Sodium Stearoyl Glutamate, Sucrose Tristearate, Tocopheryl Acetate, Triethanolamine, Water, Xanthan Gum, Zinc Gluconate

Other Information

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

Questions?

1-866-735-4137

Distributed By:
Galderma Laboratories, L.P.
Fort Worth, TX 76177 USA

All trademarks are the property of their respective owners.

Made in Canada

cetaphil.com

Principle Display Panel - 4Oz Carton


#1 Doctor Recommended
Sensitive Skincare Brand

Cetaphil®


DERMACONTROLTM

Oil Absorbing Moisturizer

with sunscreen

BROAD SPECTRUM SPF 30

Oily, Sensitive Skin

Clinically proven to reduce shine
and hydrate without irritation with
added UVA/UVB protection

Mattifying & Soothing
Zinc Technology

Skin Cancer Foundation logo
4 FL OZ (118 mL)

P55322-2

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