Label: SPF-30 BB- 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 January 12, 2023

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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 other information) , decreases the risk of skin cancer and early skin aging caused by the sun.
  • Warnings

    • For external use only.

    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.

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

  • Directions

    Due to the nature of mineral formulations, separation may occur. Shake tube before use. Apply a smooth, even layer to face, neck and top of hands before sun exposure and as needed. Children under 6 months of age, ask a doctor.

  • Other Information

    Sun Protection Measures

    Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use 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 a.m. – 2 p.m. Wear long-sleeved shirts, pants, hats and sunglasses.

  • Inactive Ingredients

    Purified Water, Aloe Barbadensis Leaf Juice, Capric Caprylic, Triglycerides, Sorbitan Sesquioleate, Hydrogenated Castor Oil, Polyglycerol-10 Laurate, Magnesium Sulfate, Tetrahexyldecyl Ascorbate, Palmitoyl Tripeptide-3, Sunflower Oil, Jojoba Oil, Tocopherols, Hyaluronic Acid, Montmorillonite, Malakite Extract, Phenoxyethanol, Ethyl Hexyl Glycerin, Iron Oxides.

  • SPL UNCLASSIFIED SECTION

    Manufactured by: Zion Health
    P.O. Box 282249, San Francisco
    CA 94128

  • PRINCIPAL DISPLAY PANEL - 110 mL Tube Label

    zionhealth

    ADAMA

    BEAUTYBALM

    AGE DEFENSE
    MINERAL CREAM

    Anti-Aging Minerals
    Hydrating Formula

    SPF 30 SUNSCREEN

    2 fl. oz
    60 ml

    Principal Display Panel - 110 mL Tube Label
  • INGREDIENTS AND APPEARANCE
    SPF-30 BB 
    zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69090-0100
    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
    WATER (UNII: 059QF0KO0R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
    HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
    POLYGLYCERYL-10 LAURATE (UNII: MPJ2Q8WI8G)  
    MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  
    TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    JOJOBA OIL (UNII: 724GKU717M)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    HYALURONIC ACID (UNII: S270N0TRQY)  
    MONTMORILLONITE (UNII: A585MN1H2L)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69090-0100-1110 mL in 1 TUBE; Type 0: Not a Combination Product01/20/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35201/20/2014
    Labeler - ZION HEALTH (044641282)
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