Cetaphil Sheer Mineral Sunscreen Stick Spf 50 Stick
FDA Label NDC 0299-4108

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 Stick Spf 50 (NDC 0299-4108). 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 6% .........…..Sunscreen
Zinc Oxide 4.7%  ......................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

ALUMINUM HYDROXIDE, BEESWAX, BHT, BUTYLOCTYL SALICYLATE, C12-15 ALKYL BENZOATE, CETYL ALCOHOL, DIMETHICONE, EUPHORBIA CERIFERA (CANDELILLA) WAX, ISOSTEARIC ACID, NEOPENTYL GLYCOL DIETHYLHEXANOATE, OZOKERITE, PARAFFIN, POLYETHYLENE, STEARIC ACID, TOCOPHERYL ACETATE (VITAMIN E), TRIETHOXYCAPRYLYLSILANE

Questions Or Comments?

1-866-735-4137

Principal Display Panel - 0.5 Oz Card

Cetaphil®  
Dermatologist Recommended Brand

50

Sheer Mineral Sunscreen Stick

Broad Spectrum SFP 50

Water Resistant
(80 minutes)
Won't clog pores
Ideal for fragile areas -
eye-area skin, lips, nose, earlobes

NET WT 0.5 OZ (14 g)
National Eczema Association logo


Distributed by:
Galderma Laboratories, L.P.
Fort Worth, TX 76177 USA
All trademarks are the property of their respective owners
cetaphil.com
P54712-0


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