Label: DESERT ESSENCE MINERAL SUNSCREEN SPF 35- zinc oxide cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 07/13

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  • Active Ingredient

    Zinc Oxide (15%)

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  • ´╗┐Purpose

    Sunscreen

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  • 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
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  • Warnings

    For external use only.

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  • ´╗┐Do not use

    Do not use on damaged or broken skin.

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  • When using this product

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

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  • Stop use and ask a doctor

    Stop use and ask a doctor if rash occurs.

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  • Keep out of reach of children

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

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  • Directions

    • apply liberally 15 minutes before sun sxposure
    • use a water resistant sunscreen if swimming or sweating
    • reapply at least every 2 hours
    • 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 Broad Spectrum SPF 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
    • children under 6 months: ask a doctor
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  • Other information

    • protect this product container from excessive heat and direct sun
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  • Inactive ingredients

    Ethyl Palmate, Aloe Barbadensis Leaf Juice, Helianthus Annuus (Sunflower) Seed Oil, Sorbitan Olivate, Butyrospermum Parkii (Shea Butter), Beeswax (Cera Alba), Anthemis Nobilis Flower Oil (Chamomile), Punica Granatum Extract (Pomegranate), Punica Granatum Fruit Juice (Pomegranate), Tocopherol (Vitamin E), Glycerin (Palm), Gluconolactone, Sodium Benzoate, Maltodextrin, Silica.

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  • Principal Display Panel

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  • INGREDIENTS AND APPEARANCE
    DESERT ESSENCE MINERAL SUNSCREEN SPF 35 
    zinc oxide cream
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:51514-0236
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ZINC OXIDE (zinc oxide) ZINC OXIDE 15 g  in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    WATER  
    SORBITAN OLIVATE  
    SHEA BUTTER  
    GLUCONOLACTONE  
    GLYCERIN  
    SODIUM BENZOATE  
    TOCOPHEROL  
    ALOE  
    CALCIUM GLUCONATE  
    POMEGRANATE JUICE  
    MALTODEXTRIN  
    SOYBEAN OIL  
    SILICON DIOXIDE  
    YELLOW WAX  
    POMEGRANATE  
    SUNFLOWER OIL  
    CHAMOMILE FLOWER OIL  
    ETHYL PALMITATE  
    ETHYL OLEATE  
    ETHYL LINOLEATE  
    Product Characteristics
    Color white Score     
    Shape Size
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:51514-0236-1 88.7 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part352 07/15/2013
    Labeler - Autumn Harp, Inc. (064187883)
    Establishment
    Name Address ID/FEI Business Operations
    Autumn Harp, Inc. 064187883 manufacture(51514-0236)
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