Cetaphil Sheer Mineral Sunscreen Spf 50 Lotion
FDA Label NDC 0299-4122

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 Sheer Mineral Sunscreen Spf 50 (NDC 0299-4122). 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, warningsfor external use only, do not use, when using this product, stop use and ask a doctor if, keep out of reach of children., directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients.....Purpose

Titianium Dioxide 9.0% ............Sunscreen
Zinc Oxide 7.0%  ......................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

Warningsfor 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
  • reapply:  
    • after 80 minutes of swimming or sweating
    • immediately after towel drying
    • 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, ISOHEXADECANE, BUTYLOCTYL SALICYLATE, CETYL DIMETHICONE, STYRENE/ACRYLATES COPOLYMER, OLIVE OIL POLYGLYCERYL-6 ESTERS, SORBITAN OLIVATE, SODIUM STEAROYL LACTYLATE, VP/EICOSENE COPOLYMER, CETEARYL ALCOHOL, CETEARYL OLIVATE, CETYL PALMITATE, SORBITAN PALMITATE, DIMETHICONE PEG-8 LAURATE, CERAMIDE NP, CERAMIDE AP, CERAMIDE EOP, CHOLESTEROL, PHYTOSPHINGOSINE, HYDROLYZED HYALURONIC ACID, BENZYL ALCOHOL, BISABOLOL, DIPOTASSIUM GLYCYRRHIZATE, PROPANEDIOL, XANTHAN GUM, ALUMINUM HYDROXIDE, SODIUM LAUROYL LACTYLATE, CARBOMER, TOCOPHERYL ACETATE, DISODIUM EDTA, STEARIC ACID, TRIETHOXYCAPRYLYLSILANE, CITRIC ACID, MALTODEXTRIN, PHENOXYETHANOL, CAPRYLOYL GLYCINE, UNDECYLENOYL GLYCINE

Questions Or Comments?

1-866-735-4137

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NEW & IMPROVED

Dermatologist Recommended
#1 Facial Skincare Brand

Cetaphil®  
SUN
50
 

Sheer Mineral Sunscreen

Broad Spectrum SPF 50


Formulated for sensitive skin

Microbiome gentle formula

nourishes sensitive skin while
providing hydrating,
chemical-free sun protection

Water resistant (80 minutes)

Prebiotics and Vitamin E

National Eczema Association logo

3 FL OZ (89 mL)

Distributed by:

Galderma Laboratories, L.P.

Fort Worth, TX 76177 USA

All trademarks are the property of their respective owners.

cetaphil.com
P55348-0


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