Label: CETAPHIL SHEER MINERAL SUNSCREEN SPF 30- titanium dioxide, zinc oxide lotion

  • NDC Code(s): 0299-4111-00
  • Packager: Galderma Laboratories, L.P.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 7, 2023

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

  • Active Ingredients

    Titianium Dioxide 3% 
    Zinc Oxide 10% 

  • 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
    • 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

    ALOE BARBADENSIS LEAF JUICE, ARACHIDYL ALCOHOL, ARACHIDYL GLUCOSIDE, AVENA SATIVA (OAT) KERNEL EXTRACT, BEHENYL ALCOHOL, BUTYLOCTYL SALICYLATE, C30-38 OLEFIN/ISOPROPYL MALEATE/MA COPOLYMER, CAPRYLIC/CAPRIC TRIGLYCERIDE, CETYL PEG/PPG-10/1 DIMETHICONE, CITRIC ACID, ETHYLHEXYLGLYCERIN, GLYCERIN, GLYCERYL STEARATE, GLYCINE SOJA (SOYBEAN) SEED EXTRACT, MAGNESIUM SULFATE, NEOPENTYL GLYCOL DIHEPTANOATE, PHENOXYETHANOL, POLYSORBATE 60, SILICA, SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL, SORBITAN TRISTEARATE, STEARYL ALCOHOL, STEARYL/OCTYLDODECYL CITRATE CROSSPOLYMER, TOCOPHEROL (VITAMIN E), VP/HEXADECENE COPOLYMER, WATER

  • Questions or comments?

    1-866-735-4137

  • PRINCIPAL DISPLAY PANEL - 3 FL OZ TUBE

    (083191)-P55338-1-Cetaphil-Sun-SPF-30-Lotion-3-oz-Tube-FOTE

    #1 Doctor Recommended
    Sensitive Skincare Brand

    Cetaphil®

    SUN
    30

    Sheer Mineral Sunscreen

    Broad Spectrum SPF 30


    Formulated for sensitive skin

    Microbiome gentle

    Water resistant (80 minutes)

    Paraben and fragrance free

    Prebiotics & Vitamin E

    National Eczema Association logo

    3 FL OZ (89 mL)

    Dist. by:

    Galderma Laboratories, L.P.

    Fort Worth, TX 76177 USA

    All trademarks are the property of their respective owners.

    cetaphil.com
    P55338-1


  • INGREDIENTS AND APPEARANCE
    CETAPHIL SHEER MINERAL SUNSCREEN SPF 30 
    titanium dioxide, zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0299-4111
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide30 mg  in 1 mL
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide100 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Aloe Vera Leaf (UNII: ZY81Z83H0X)  
    Arachidyl Alcohol (UNII: 1QR1QRA9BU)  
    Arachidyl Glucoside (UNII: 6JVW35JOOJ)  
    Oat (UNII: Z6J799EAJK)  
    Docosanol (UNII: 9G1OE216XY)  
    Butyloctyl Salicylate (UNII: 2EH13UN8D3)  
    Medium-Chain Triglycerides (UNII: C9H2L21V7U)  
    Cetyl Peg/Ppg-10/1 Dimethicone (Hlb 2) (UNII: V2W71V8T0X)  
    Citric Acid Monohydrate (UNII: 2968PHW8QP)  
    Ethylhexylglycerin (UNII: 147D247K3P)  
    Glycerin (UNII: PDC6A3C0OX)  
    Glyceryl Monostearate (UNII: 230OU9XXE4)  
    Soybean (UNII: L7HT8F1ZOD)  
    Magnesium Sulfate, Unspecified Form (UNII: DE08037SAB)  
    Neopentyl Glycol Diheptanoate (UNII: 5LKW3C543X)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    Polysorbate 60 (UNII: CAL22UVI4M)  
    Silicon Dioxide (UNII: ETJ7Z6XBU4)  
    Jojoba Oil (UNII: 724GKU717M)  
    Sorbitan Tristearate (UNII: 6LUM696811)  
    Stearyl Alcohol (UNII: 2KR89I4H1Y)  
    Stearyl/Octyldodecyl Citrate Crosspolymer (UNII: PN88NW0KPK)  
    Tocopherol (UNII: R0ZB2556P8)  
    Vinylpyrrolidone/Hexadecene Copolymer (UNII: KFR5QEN0N9)  
    Water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0299-4111-0089 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)
    Establishment
    NameAddressID/FEIBusiness Operations
    Fruit of The Earth Research Laboratories, Inc.008193513manufacture(0299-4111)
    Establishment
    NameAddressID/FEIBusiness Operations
    Fruit of The Earth, Inc.080086802manufacture(0299-4111)