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
  • 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

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  • Active Ingredients.....Purpose

    Titianium Dioxide 3% .............Sunscreen
    Zinc Oxide 10% .....................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 finalpart35211/01/2020
    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)
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