Label: PREP SPF 15 LIP GLOSS- zinc oxide sunscreen gel

  • 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 July 31, 2018

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  • Active Ingredient

    Zinc Oxide 11%

  • Purpose

    Sunscreen

  • Uses

    • helps prevent sunburn
  • 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 reach of children

    If product is swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • Apply generously 15 minutes before sun exposure
    • Reapply at least every 2 hours
    • Use a water-resistant sunscreen if swimming or sweating
    • Children under 6 months: 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 am- 2 pm
    • wear long-sleeved shirts, pants, hats. and sunglasses
  • Other Information

    Protect this product from excessive heat and direct sun

  • Questions?

    Call toll-free 1-800-401-6031

    www.prepyourskin.com

  • Inactive Ingredients

    Back carton labelCastor Oil, Coconut Oil, Diisostearyl Malate, Ethylhexylglycerin, Ferric Oxide Red, Isostearic Acid, Jojoba Oil, Potassium Sorbate, Propanediol, Spearmint Oil, Succinic Acid, Tocopherol, Triethoxycaprylylsilane, Yellow Wax

  • Carton Label

    Carton label

  • INGREDIENTS AND APPEARANCE
    PREP SPF 15 LIP GLOSS 
    zinc oxide sunscreen gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70231-0012
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE110 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    ISOSTEARIC ACID (UNII: X33R8U0062)  
    SUCCINIC ACID (UNII: AB6MNQ6J6L)  
    DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    JOJOBA OIL (UNII: 724GKU717M)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    SPEARMINT OIL (UNII: C3M81465G5)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70231-0012-71 in 1 CARTON01/11/2015
    17 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35201/11/2015
    Labeler - PREP Cosmetics LLC (053793815)
    Registrant - Richard Hamer Associates LLC (067731889)
    Establishment
    NameAddressID/FEIBusiness Operations
    Taka USA Inc. dba Cosmetic Innovations802860515manufacture(70231-0012) , pack(70231-0012)
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