Label: CETAPHIL SHEER MINERAL SUNSCREEN SPF 50- titanium dioxide, zinc oxide lotion

  • NDC Code(s): 0299-4122-00
  • Packager: Galderma Laboratories, L.P.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated August 2, 2022

If you are a consumer or patient please visit this version.

  • 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
  • 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
    • 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

  • PRINCIPAL DISPLAY PANEL - 3 FL OZ TUBE

    083840-P55348-1-Tube-Cetaphil-Sun-SPF-50-Lotion-3oz

    #1 Doctor Recommended
    Sensitive 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 & 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
    P55348-1


  • INGREDIENTS AND APPEARANCE
    CETAPHIL SHEER MINERAL SUNSCREEN SPF 50 
    titanium dioxide, zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0299-4122
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide90 mg  in 1 mL
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide70 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Isohexadecane (UNII: 918X1OUF1E)  
    Butyloctyl Salicylate (UNII: 2EH13UN8D3)  
    Cetyl Dimethicone 150 (UNII: 5L694Y0T22)  
    Styrene/Acrylamide Copolymer (500000 Mw) (UNII: 5Z4DPO246A)  
    Olive Oil Polyglyceryl-6 Esters (UNII: 4KDO9AFM9I)  
    Sorbitan Olivate (UNII: MDL271E3GR)  
    Sodium Stearoyl Lactylate (UNII: IN99IT31LN)  
    Vinylpyrrolidone/Eicosene Copolymer (UNII: 035MV9S1C3)  
    Cetostearyl Alcohol (UNII: 2DMT128M1S)  
    Cetearyl Olivate (UNII: 58B69Q84JO)  
    Cetyl Palmitate (UNII: 5ZA2S6B08X)  
    Sorbitan Monopalmitate (UNII: 77K6Z421KU)  
    Dimethicone Peg-8 Laurate (UNII: 72MF9C2A18)  
    Ceramide Np (UNII: 4370DF050B)  
    Ceramide Ap (UNII: F1X8L2B00J)  
    Ceramide 1 (UNII: 5THT33P7X7)  
    Cholesterol (UNII: 97C5T2UQ7J)  
    Phytosphingosine (UNII: GIN46U9Q2Q)  
    Benzyl Alcohol (UNII: LKG8494WBH)  
    Levomenol (UNII: 24WE03BX2T)  
    Glycyrrhizinate Dipotassium (UNII: CA2Y0FE3FX)  
    Propanediol (UNII: 5965N8W85T)  
    Xanthan Gum (UNII: TTV12P4NEE)  
    Aluminum Hydroxide (UNII: 5QB0T2IUN0)  
    Sodium Lauroyl Lactylate (UNII: 7243K85WFO)  
    Carbomer Homopolymer, Unspecified Type (UNII: 0A5MM307FC)  
    .Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0)  
    Edetate Disodium (UNII: 7FLD91C86K)  
    Stearic Acid (UNII: 4ELV7Z65AP)  
    Triethoxycaprylylsilane (UNII: LDC331P08E)  
    Citric Acid Monohydrate (UNII: 2968PHW8QP)  
    Maltodextrin (UNII: 7CVR7L4A2D)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    Capryloyl Glycine (UNII: 8TY5YO42NJ)  
    Undecylenoyl Glycine (UNII: 4D20464K2J)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0299-4122-0089 mL in 1 TUBE; Type 0: Not a Combination Product10/01/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35210/01/2021
    Labeler - Galderma Laboratories, L.P. (047350186)
    Establishment
    NameAddressID/FEIBusiness Operations
    Fruit of The Earth Research Laboratories, Inc.008193513manufacture(0299-4122)
    Establishment
    NameAddressID/FEIBusiness Operations
    Fruit of The Earth, Inc.080086802manufacture(0299-4122)