Label: ALIVE PREBIOTIC BALANCING MOISTURIZER SPF 15- zinc oxide lotion

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 14, 2018

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  • Active Ingredients

    Zinc Oxide 13.65%

  • 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 consult a doctor if rash occurs

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

    Apply to the entire face, neck, and décolleté, avoiding the eye area, in the morning. Use only as directed. Apply liberally to the entire face in the morning or 15 minutes prior to sun exposure

    • Reapply at least every 2 hours
    • Use a water resistant sunscreen if swimming or sweating
    • Children under 6 months: Ask a doctor
    • Apply to clean face with fingertips or brush and blend well. Layer for additional coverage as needed.

    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 10 a.m. – 2 p.m.
    • Wear long-sleeve shirts, pants, hats, and sunglasses.
  • Inactive Ingredients

    Water (Aqua, Eau), Caprylic/ Capric Triglyceride, Coco-Caprylate, Glycerin, Glyceryl Behenate, Coco-Glucoside, Simmondsia Chinensis (Jojoba) Seed Oil, Cetearyl Alcohol, Glyceryl Caprylate, Sodium Stearoyl Glutamate, Parachlorella Beijerinckii Exopolysaccharides, Chlorella Vulgaris Extract, Lactococcus Ferment Lysate, Alteromonas Ferment Extract, Caesalpinia Spinosa Fruit Pod Extract, Helianthus Annuus (Sunflower) Sprout Extract, Caprylyl Glycol, Microcrystalline Cellulose, Polyglyceryl-3 Polyricinoleate, Xanthan Gum, Butylene Glycol, Isostearic Acid, Caprylhydroxamic Acid, Algin, Calcium Alginate, Propanediol, Maltodextrin, Lactic Acid, Sodium Benzoate, Sodium Chloride.

  • Other Information

    Protect this product from excessive heat and direct sun.

  • Questions

    Call toll free 1-877-650-1837

  • Principal Display Panel - 10 mL Box Label

    ALIVE

    Prebiotic Balancing
    Moisturizer SPF 15

    Soin Prébiotique
    Équilibrant FPS 15

    Broad Spectrum
    Sunscreen SPF 15

    Écran Solaire Large
    Spectre FPS 15

    ALGENIST
    Alguronic Acid + Prebiotic

    0.34 US fl. oz. / 10 ml

    Principal Display Panel - 10 mL Box Label
  • Principal Display Panel - 50 mL Box Label

    ALIVE

    Prebiotic Balancing
    Moisturizer SPF 15

    Soin Prébiotique
    Équilibrant FPS 15

    Broad Spectrum
    Sunscreen SPF 15

    Écran Solaire Large
    Spectre FPS 15

    ALGENIST
    Alguronic Acid + Prebiotic

    1.7 US fl. oz. / 50 ml

    Principal Display Panel - 50 mL Box Label
  • INGREDIENTS AND APPEARANCE
    ALIVE PREBIOTIC BALANCING MOISTURIZER SPF 15 
    zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71047-262
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE0.1365 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    COCO-CAPRYLATE (UNII: 4828G836N6)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL MONOBEHENATE (UNII: A626UU0W2A)  
    COCO GLUCOSIDE (UNII: ICS790225B)  
    JOJOBA OIL (UNII: 724GKU717M)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    GLYCERYL MONOCAPRYLATE (UNII: TM2TZD4G4A)  
    SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYGLYCERYL-3 RICINOLEATE (UNII: MZQ63P0N0W)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    ISOSTEARIC ACID (UNII: X33R8U0062)  
    CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)  
    SODIUM ALGINATE (UNII: C269C4G2ZQ)  
    CALCIUM ALGINATE (UNII: 8P20S56HZI)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    CHLORELLA VULGARIS (UNII: RYQ4R60M02)  
    CAESALPINIA SPINOSA FRUIT POD (UNII: EXY4496LWD)  
    LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71047-262-501 in 1 BOX09/14/2018
    150 mL in 1 TUBE; Type 0: Not a Combination Product
    2NDC:71047-262-101 in 1 BOX09/14/2018
    210 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35209/14/2018
    Labeler - Algenist, LLC (080380765)
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