Label: ANDALOU BB UNTINTED WITH SPF-30- zinc oxide lotion

  • 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 02/13

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • Active Ingredient

    Zinc Oxide 20%

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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.
    • 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 a doctor if rash or irritation develops and lasts.
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  • Directions

    • Daily, alone or under make-up.
    • Apply liberally 15 minutes before sun exposure and as needed.
    • Reapply at least every 2 hours.
    • Use water resistant sunscreen if swimming or sweating.
    • 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 of 15 or higher and other sun protection measures including: limit time in the sun, especially from 10am-2pm, wear long sleeve shirts, pants and sunglasses.
    • Children under 6 months: ask a doctor.
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  • Inactive Ingredients

    Aloe Barbadensis Juice1, Simmondsia Chinensis (Jojoba) and Helianthus Annuus (Sunflower) Oils1, Sorbitan Stearate, Glyceryl Stearate, Fruit Stem Cell and BioActive 8 Berry Complex1, Caprylic/Capric Triglycerides, Hyaluronic Acid, Salvia Officinalis (Sage), Serenoa Rapens (Saw Palmetto) and Salix Alba (Willow Bark) Extracts1, Punica Granatum (Pomegranate) Oil1, Magnesium Ascorbyl Phosphate (Vitamin C), Algae Extract, Zinc Gluconate, Magnesium Sulfate, Aspalathus Linearis (Rooibos), Hibiscus Rosa-Sinensis and Camellia Sinensis (White Tea) Extracts12, Phenethyl Alcohol, Ethylhexylglycerin, Citrus Tangerina (Tangerine) and Cymbopogon Martini (Palmarosa) Oils1


    1
    Organic
    2
    Fair Trade
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  • Other Information

    • Protect the product in this container from excessive heat and direct sun.
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  • Questions

    Call (888) 898-6955 or visit www.Andalou.com

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  • PRINCIPAL DISPLAY PANEL - 58 mL Tube Carton

    NEW

    ANDALOU
    Naturals
    FRUIT STEM CELL SCIENCE

    BB
    Oil Control
    BEAUTY BALM
    Un-Tinted
    with SPF 30

    REGENERATING
    FRUIT STEM CELLS

    CLARIFYING

    FRUIT STEM CELLS
    RENEW ■ REPAIR ■ REGENERATE

    58 mL e 2 fl oz

    PRINCIPAL DISPLAY PANEL - 58 mL Tube Carton
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  • INGREDIENTS AND APPEARANCE
    ANDALOU BB UNTINTED WITH SPF-30 
    zinc oxide lotion
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:55560-0101
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Zinc Oxide (Zinc Oxide) Zinc Oxide 20 g  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    glyceryl monostearate  
    sage  
    saw palmetto  
    willow bark  
    pomegranate seed oil  
    aloe vera leaf  
    zinc gluconate  
    medium-chain triglycerides  
    sorbitan monostearate  
    mandarin oil  
    magnesium sulfate  
    helianthus annuus flowering top  
    jojoba oil  
    tocopherol  
    magnesium ascorbyl phosphate  
    hyaluronate sodium  
    palmarosa oil  
    phenylethyl alcohol  
    ethylhexylglycerin  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:55560-0101-1 58 mL in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part352 12/10/2012
    Labeler - Andalou naturals (011472720)
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