Cetaphil Healthy Renew Day Cream Broad Spectrum Spf 30 Lotion
FDA Label NDC 0299-4136

13 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 Healthy Renew Day Cream Broad Spectrum Spf 30 (NDC 0299-4136). 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, purpose, uses, warnings, do not use, when using this product, stop use and ask a doctor if, 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.....Purpose

Homosalate 9.5% .................Sunscreen
Octocrylene 9.5% .........… Sunscreen
Octisalate 4.8% ...............…   Sunscreen
Avobenzone 2.8% ................. Sunscreen

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
  • may stain or damage some fabrics

Inactive Ingredients

WATER, GLYCERIN, DIPROPYLENE GLYCOL, PANTHENOL, BUTYLOCTYL SALICYLATE, SILICA, BEESWAX, NIACINAMIDE, CETEARYL OLIVATE, SODIUM STEAROYL LACTYLATE, GLYCERYL STEARATE, POTASSIUM CETYL PHOSPHATE, SORBITAN OLIVATE, TOCOPHERYL ACETATE, CAPRYLYL GLYCOL, ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER, PALMITIC ACID, ETHYLHEXYLGLYCERIN, LEONTOPODIUM ALPINUM EXTRACT, STEARIC ACID, 1,2-HEXANEDIOL, ORYZA SATIVA (RICE) LEES EXTRACT, SODIUM HYDROXIDE, PROPANEDIOL, ADENOSINE, CITRIC ACID, HYDROLYZED SOY FLOUR, BUDDLEJA DAVIDII EXTRACT, THYMUS VULGARIS (THYME) EXTRACT

Questions Or Comments?

1-866-735-4137

Principal Display Panel - 1.7 Oz Carton

Cetaphil®

DAY
CREAM

HEALTHY RENEW

30
BROAD SPECTRUM
SPF 30 (UVA/UVB)
SUNSCREEN

Retinol Alternative

All Skin Types
Hydrates, and visibly
smooths fine lines 

Purified Peptides,
Vitamins B3 & B5

Dermatologist Recommended Sensitive Skin Icon

NET WT 1.7 OZ (48 g)

Distributed by:
Galderma Laboratories, L.P., Dallas, TX 75201 USA
All trademarks are the property of their respective owners.
cetaphil.com  
P57224-2













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