Cetaphil Tinted Daily Facial Moisturizer Spf 50 Lotion
FDA Label NDC 0299-4147

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 Tinted Daily Facial Moisturizer Spf 50 (NDC 0299-4147). 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, do not use, 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.

Label Section Quick Index

Active Ingredients

Homosalate 7% 
Octocrylene 7% 
Octisalate 4.8% 
Avobenzone 2.8% 

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.

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: 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

WATER, GLYCERIN, COPERNICIA CERIFERA (CARNAUBA) WAX, BUTYLOCTYL SALICYLATE, DIETHYLHEXYL 2, 6-NAPHTHALATE, DIETHYLHEXYL CARBONATE, PROPANEDIOL, CETEARETH-20, NIACINAMIDE, SILICA, CETYL ALCOHOL, PHENOXYETHANOL, AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER, TOCOPHERYL ACETATE, IRON OXIDES, ETHYLHEXYLGLYCERIN, ORYZA SATIVA (RICE) BRAN WAX, CICHORIUM INTYBUS (CHICORY) ROOT EXTRACT, CHROMIUM OXIDE GREENS, HYDROGENATED LECITHIN

Other Information

• Protect this product from excessive heat and direct sun.
may stain or damage some fabrics

Questions?

1-866-735-4137

Principal Display Panel - 1.7Oz Carton

NEW

Cetaphil®

Tinted Daily
Facial Moisturizer
AM

50 BROAD SPECTRUM SPF 50 (UVA/UVB) SUNSCREEN

All Skin Types

Lightweight sheer formula hydrates 24H and visibly evens skin tone

Vitamin E, Niacinamide

Blendable tint across skin tones

Dermatologist Recommended
Sensitive Skin

1.7 FL OZ (50 mL)

Distributed by:

Galderma Laboratories, L.P.

Fort Worth, TX 761771 USA

All trademarks are the property of their respective owners.

cetaphil.com

P59867-1

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