Label: CREAM OIL SUNSCREEN- zinc oxide, titanium dioxide sunscreen cream

  • NDC Code(s): 59958-408-01, 59958-408-02
  • Packager: Owen Biosciences, Inc.
  • 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 January 16, 2023

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  • Active Ingredients Purpose

    Zinc Oxide 21.50%...... Sunscreen

    Titanium Dioxide 1.25%...... Sunscreen

  • Uses

    Helps protect against sunburn
    provides moderate protection against sunburn

  • Warnings

    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 doctor if rash occurs

    Keep out of reach of children If swallowed, get medicl help or contact poison control center.

  • Directions

    Apply generously and evenly 15 minutes before sun exposure.
    Children under 6 months of age: ask doctor.
    Sun protection measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the 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 10a.m. - 2p.m.
    wear long sleeve shirts, pants, hats and sunglasses.
    Reapply at least every 2 hours
    Use a water-resistant sunscreen if swimming or sweating

  • Other Information

    Protect the product in this contianer from heat and direct sun.

  • INACTIVE INGREDIENT

  • PRINCIPAL DISPLAY PANEL

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  • INGREDIENTS AND APPEARANCE
    CREAM OIL SUNSCREEN 
    zinc oxide, titanium dioxide sunscreen cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59958-408
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE21 g  in 100 g
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE1.25 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R) 32.6 g  in 100 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59958-408-021 in 1 CARTON04/04/2020
    1NDC:59958-408-0150 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35204/04/2020
    Labeler - Owen Biosciences, Inc. (790003045)
    Establishment
    NameAddressID/FEIBusiness Operations
    Owen Biosciences, Inc.790003045manufacture(59958-408)
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