Label: EQUATE ZINC OXIDE SUNSCREEN SPF 50- zinc oxide cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 March 25, 2019

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

  • Drug Facts

  • Active ingredients

    Zinc Oxide, 21.6%

    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

    avoid contact with 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 at least every 2 hours
    • use water resistant sunscreen if swimming or sweating
    • 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 sking 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 this product from excessive heat and direct sun

  • Inactive ingredients

    water, caprylic/capric triglyceride, styrene/acrylates copolymer, dimethicone, cety PEG/PPG-10/1 dimethicone, cetyl dimethicone, glycerin, octyldodecyl citrate crosspolymer, phenyl trimethicone, phenethyl alcohol, ethylhexylglycerin, coco-caprylate/caprate, isostearic acid, sodium chloride, colloidal oatmeal, silica, polyglyceryl-3 polyricinoleate, glycery behenate, cyclopentasiloxane, acrylates/dimethicone copolymer, behenyl dimethicone/bis divinyldimethicone crosspolymer, triethoxycaprylylsilane, crysanthemum parthenium extract.

  • Package Labeling:

    Label

  • INGREDIENTS AND APPEARANCE
    EQUATE ZINC OXIDE SUNSCREEN SPF 50 
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49035-961
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION216 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    PHENYLETHYL ALCOHOL (UNII: ML9LGA7468)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)  
    ISOSTEARIC ACID (UNII: X33R8U0062)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    OATMEAL (UNII: 8PI54V663Y)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    GLYCERYL DIBEHENATE (UNII: R8WTH25YS2)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    TANACETUM PARTHENIUM (UNII: 6GE7Z0761K)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49035-961-00235 mL in 1 TUBE; Type 0: Not a Combination Product08/01/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35208/01/2019
    Labeler - Wal-Mart Stores Inc (051957769)