Label: CVS HEALTH 50 HYDRATING MINERAL SUNSCREEN- titanium dioxide, zinc oxide lotion

  • Category: HUMAN OTC DRUG LABEL

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 April 25, 2023

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  • Active ingredients

    Titanium Dioxide 9.0%, Zinc Oxide 7.0%

  • 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
    • use a water resistant sunscreen if swimming or sweating
    • reapply 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, materials or surfaces
  • 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, PHENOXYETHANOL, CAPRYLOYL GLYCINE, UNDECYLENOYL GLYCINE.

  • Label

    CVS62392A

  • INGREDIENTS AND APPEARANCE
    CVS HEALTH 50 HYDRATING MINERAL SUNSCREEN 
    titanium dioxide, zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51316-046
    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
    LEVOMENOL (UNII: 24WE03BX2T)  
    CETYL DIMETHICONE 45 (UNII: IK315POC44)  
    DIMETHICONE PEG-8 LAURATE (UNII: 72MF9C2A18)  
    FARNESOL (UNII: EB41QIU6JL)  
    GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    CERAMIDE NP (UNII: 4370DF050B)  
    SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    CERAMIDE AP (UNII: F1X8L2B00J)  
    CAPRYLOYL GLYCINE (UNII: 8TY5YO42NJ)  
    CETYL PALMITATE (UNII: 5ZA2S6B08X)  
    CHOLESTEROL (UNII: 97C5T2UQ7J)  
    PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)  
    SORBITAN MONOPALMITATE (UNII: 77K6Z421KU)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    UNDECYLENOYL GLYCINE (UNII: 4D20464K2J)  
    SORBITAN OLIVATE (UNII: MDL271E3GR)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    WATER (UNII: 059QF0KO0R)  
    CETEARYL OLIVATE (UNII: 58B69Q84JO)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYACRYLIC ACID (8000 MW) (UNII: 73861X4K5F)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    ISOHEXADECANE (UNII: 918X1OUF1E)  
    OLIVE OIL POLYGLYCERYL-6 ESTERS (UNII: 4KDO9AFM9I)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    BUTYL METHACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID/STYRENE CROSSPOLYMER (UNII: V5RS026Q0H)  
    EICOSYL POVIDONE (UNII: XQQ9MKE2BJ)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    SODIUM STEAROYL LACTYLATE (UNII: IN99IT31LN)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51316-046-15150 mL in 1 TUBE; Type 0: Not a Combination Product12/09/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM02012/09/2019
    Labeler - CVS PHARMACY (062312574)
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