Label: POWDER- zinc oxide, titanium dioxide powder

  • 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 February 10, 2023

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  • Active ingredient

    Titanium Dioxide 15%

    Zinc oxide 17%

  • Purpose

    Sunscreen

  • Uses

    Help precent sunburn. If used as directed with other sun protection measures (see directions) decreases the risk of skin cancer and early skin again caused by the sun

  • Warnings

    For external use only

  • Do not use

    Do not use on damaged or broken skin

  • When using

    When using this product keep out of eyes. Rinse with water to remove.

  • Stop use

    Stop use and ask a doctor if rash occurs

  • Keep out of the reach of children

    If swallowed, get medical help or contact a poison controler center right away

  • Directions

    Apply generously 15 minutes before sun exposure. Children under 6 months of age: ask a doctor.

    Reapply: immediately after towel drying. At least every 2 hours. Use a water resistant sunscreen if swimming or sweating. Sun protections 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: lomit time in the sun, especially from 10 a.m-2p.m. wear long-sleeved shirts, pants, hats, and sunglasses

  • Other information

    protect the product in this container from excessive heat and direct sun

  • Iniactive ingredient

    pollymethylsilsesquoxane, silica, jojoba esters, alumina, oryza sativa (rice)extract, caprylyl glycol, phenoxyethanol, hexylene glycol, aluminum dimyristate, triethoxycaprylylsilane, disodium stearoyl glutamate, iron oxides, mica.

  • Questions or Comments

    (844) 821 8151

  • Pimary package

    61354-061-01_AW

  • Secondary package

    61354-061-01_AW

  • INGREDIENTS AND APPEARANCE
    POWDER 
    zinc oxide, titanium dioxide powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61354-061
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE15.09 g  in 100 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE17.55 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    JOJOBA OIL (UNII: 724GKU717M)  
    MICA (UNII: V8A1AW0880)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61354-061-011 in 1 CARTON02/23/202102/10/2023
    14 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35202/23/2021
    Labeler - Oxygen Development (137098492)
    Establishment
    NameAddressID/FEIBusiness Operations
    Oxygen development137098492manufacture(61354-061)
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