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

  • 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 February 1, 2013

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Zinc Oxide 20%

  • Purpose

    Sunscreen

  • 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.
  • 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.
  • 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.
  • 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
  • Other Information

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

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

  • 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
  • INGREDIENTS AND APPEARANCE
    ANDALOU BB UNTINTED WITH SPF-30 
    zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55560-0101
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide20 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    glyceryl monostearate (UNII: 230OU9XXE4)  
    sage (UNII: 065C5D077J)  
    saw palmetto (UNII: J7WWH9M8QS)  
    willow bark (UNII: S883J9JDYX)  
    pomegranate seed oil (UNII: 0UI45XV0T6)  
    aloe vera leaf (UNII: ZY81Z83H0X)  
    zinc gluconate (UNII: U6WSN5SQ1Z)  
    medium-chain triglycerides (UNII: C9H2L21V7U)  
    sorbitan monostearate (UNII: NVZ4I0H58X)  
    mandarin oil (UNII: NJO720F72R)  
    magnesium sulfate (UNII: DE08037SAB)  
    helianthus annuus flowering top (UNII: BKJ0J3D1BP)  
    jojoba oil (UNII: 724GKU717M)  
    tocopherol (UNII: R0ZB2556P8)  
    magnesium ascorbyl phosphate (UNII: 0R822556M5)  
    hyaluronate sodium (UNII: YSE9PPT4TH)  
    palmarosa oil (UNII: 0J3G3O53ST)  
    phenylethyl alcohol (UNII: ML9LGA7468)  
    ethylhexylglycerin (UNII: 147D247K3P)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55560-0101-158 mL in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35212/10/2012
    Labeler - Andalou naturals (011472720)
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