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

  • NDC Code(s): 0299-4112-00, 0299-4112-05
  • Packager: Galderma Laboratories, L.P.
  • DEA Schedule: None

Drug Label Information

Updated December 12, 2023

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

  • Active Ingredients

    Titianium Dioxide 4.9% 
    Zinc Oxide 4.7%  

  • Purpose


  • 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

    alumina, arachidyl alcohol, arachidyl glucoside, ascorbic acid, avena sativa (oat) kernel extract, beeswax, behenyl alcohol, benzyl alcohol, bisabolol, butylene glycol, butyloctyl salicylate, calendula officinalis flower extract, camellia sinensis leaf extract, carbomer, ceramide AP, ceramide EOP, ceramide NP, cetyl dimethicone, chamomilla recutita (matricaria) flower extract, cholesterol, dimethicone, dimethicone PEG-8 laurate, dipotassium glycyrrhizate, disodium EDTA,  ethylhexylglycerin, glycerin, glyceryl stearate, hydrated silica, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, isohexadecane, maltodextrin, methicone, panthenol, pantothenic acid, PEG-100 stearate, PEG-8, phytosphingosine, polyaminopropyl biguanide, polymethyl methacrylate, polysorbate 60, potassium sorbate, propylene glycol, sodium lauroyl lactylate, stearic acid, styrene/acrylates copolymer, tocopheryl acetate(vitamin E), triethoxycaprylylsilane, trimethylsiloxysilicate, trisiloxane, VP/eicosene copolymer, water, xanthan gum.

  • Questions or comments?



    P54713-0 tube art


    Dermatologist Recommended Brand

    Sheer Mineral

    Broad Spectrum SPF 50

    Formulated for Sensitive Skin

    Microbiome Gentle

    Contains prebiotics and Vitamin E

    Water Resistant (80 minutes)

    Paraben and Fragrance Free

    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.

    titanium dioxide, zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0299-4112
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide49 mg  in 1 mL
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide47 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Aluminum Hydroxide (UNII: 5QB0T2IUN0)  
    Arachidyl Alcohol (UNII: 1QR1QRA9BU)  
    Arachidyl Glucoside (UNII: 6JVW35JOOJ)  
    Ascorbic Acid (UNII: PQ6CK8PD0R)  
    Oat (UNII: Z6J799EAJK)  
    Yellow Wax (UNII: 2ZA36H0S2V)  
    Docosanol (UNII: 9G1OE216XY)  
    Benzyl Alcohol (UNII: LKG8494WBH)  
    Levomenol (UNII: 24WE03BX2T)  
    Butylene Glycol (UNII: 3XUS85K0RA)  
    Butyloctyl Salicylate (UNII: 2EH13UN8D3)  
    Calendula Officinalis Flower (UNII: P0M7O4Y7YD)  
    Green Tea Leaf (UNII: W2ZU1RY8B0)  
    Carbomer Homopolymer, Unspecified Type (UNII: 0A5MM307FC)  
    Ceramide Ap (UNII: F1X8L2B00J)  
    Ceramide 1 (UNII: 5THT33P7X7)  
    Ceramide Np (UNII: 4370DF050B)  
    Cetyl Dimethicone 150 (UNII: 5L694Y0T22)  
    Chamomile (UNII: FGL3685T2X)  
    Cholesterol (UNII: 97C5T2UQ7J)  
    Dimethicone (UNII: 92RU3N3Y1O)  
    Dimethicone Peg-8 Laurate (UNII: 72MF9C2A18)  
    Glycyrrhizinate Dipotassium (UNII: CA2Y0FE3FX)  
    Edetate Disodium (UNII: 7FLD91C86K)  
    Ethylhexylglycerin (UNII: 147D247K3P)  
    Glycerin (UNII: PDC6A3C0OX)  
    Glyceryl Monostearate (UNII: 230OU9XXE4)  
    Hydrated Silica (UNII: Y6O7T4G8P9)  
    Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer (100000 Mpa.S At 1.5%) (UNII: 86FQE96TZ4)  
    Isohexadecane (UNII: 918X1OUF1E)  
    Maltodextrin (UNII: 7CVR7L4A2D)  
    Methicone (20 Cst) (UNII: 6777U11MKT)  
    Panthenol (UNII: WV9CM0O67Z)  
    Pantothenic Acid (UNII: 19F5HK2737)  
    Peg-100 Stearate (UNII: YD01N1999R)  
    Polyethylene Glycol 400 (UNII: B697894SGQ)  
    Phytosphingosine (UNII: GIN46U9Q2Q)  
    Polihexanide (UNII: 322U039GMF)  
    Poly(Methyl Methacrylate; 450000 Mw) (UNII: Z47NNT4J11)  
    Polysorbate 60 (UNII: CAL22UVI4M)  
    Potassium Sorbate (UNII: 1VPU26JZZ4)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    Sodium Lauroyl Lactylate (UNII: 7243K85WFO)  
    Stearic Acid (UNII: 4ELV7Z65AP)  
    Styrene/Acrylamide Copolymer (500000 Mw) (UNII: 5Z4DPO246A)  
    .Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0)  
    Triethoxycaprylylsilane (UNII: LDC331P08E)  
    Trimethylsiloxysilicate (M/Q 0.6-0.8) (UNII: 5041RX63GN)  
    Trisiloxane (UNII: 9G1ZW13R0G)  
    Vinylpyrrolidone/Eicosene Copolymer (UNII: 035MV9S1C3)  
    Water (UNII: 059QF0KO0R)  
    Xanthan Gum (UNII: TTV12P4NEE)  
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0299-4112-0089 mL in 1 TUBE; Type 0: Not a Combination Product11/01/2020
    2NDC:0299-4112-0510 mL in 1 TUBE; Type 0: Not a Combination Product11/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02011/01/2020
    Labeler - Galderma Laboratories, L.P. (047350186)
    NameAddressID/FEIBusiness Operations
    Fruit of The Earth Research Laboratories, Inc.008193513manufacture(0299-4112)
    NameAddressID/FEIBusiness Operations
    Fruit of The Earth, Inc.080086802manufacture(0299-4112)