Label: YES TO CUCUMBERS NATURAL SUNSCREEN SPF 30 STICK- zinc oxide, titanium dioxide stick

  • 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 September 25, 2013

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  • Active Ingredient

    Zinc Oxide (10.8%) Titanium Dioxide (4.9%)

  • Purpose

    Sunscreen

  • Uses

    Helps prevent sunburn • Higher SPF gives more sunburn protection • Provides high protection against sunburn

  • Warnings:

    For external use only.  When using this product avoid contact with eyes • If contact occurs, rinse with water to remove.  Stop use and ask Doctor if rash or irritation develops and lasts.  Keep out of reach of children • If swallowed, get medical help or contact a Poison Control Center immediately. 

  • Directions

    Apply liberally and evenly 15 minutes before sun exposure • reapply after 40 minutes of swimming or sweating, immediately after towel drying, and at least every 2 hours • Children under 6 months of age, ask doctor.

  • Sun Protection Measure

    Spending time in the sun increases your risk of skin cancer and early skin aging.  To decrease the risk, regularly use a sunscreen with Broad Spectrum SPF value of 15 or higher and other sun protection measures including: Limit time in the sun, especially from 10am - 2pm. Wear long-sleeved shirts, pants, hats, and sun-glasses.

  • Inactive Ingredients

    Beeswax, Ethylhexyl Palmitate, Carthamus Tinctorius (Safflower) Seed Oil, Ethyl Palmate*, Theobroma Cacao (Cocoa) Seed Butter, Butyrospermum Parkii (Shea) Butter, Fragrance, Polyglyceryl-3 Diisostearate, Aluminum Hydroxide, Helianthus Annuus (Sunflower) Seed Oil, Hydrated Silica, Triethoxycaprylylsilane, Tocopherol, Cucumis Sativus (Cucumber) Seed Extract*.  * Certified Organic Ingredient

  • Principal Display Panel

    Image Components

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  • INGREDIENTS AND APPEARANCE
    YES TO CUCUMBERS NATURAL SUNSCREEN SPF 30 STICK 
    zinc oxide, titanium dioxide stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51514-0315
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE10.8 g  in 100 g
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE4.9 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    SAFFLOWER OIL (UNII: 65UEH262IS)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    ETHYL PALMATE (UNII: PY7890FR5M)  
    COCOA BUTTER (UNII: 512OYT1CRR)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    CUCUMBER (UNII: YY7C30VXJT)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    cucumber seed (UNII: BT3S9L53JK)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51514-0315-115 g in 1 CONTAINER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35201/11/2013
    Labeler - Autumn Harp, Inc. (064187883)
    Establishment
    NameAddressID/FEIBusiness Operations
    Autumn Harp, Inc.064187883manufacture(51514-0315)
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