Label: ANNMARIE SPF 20 SUNSCREEN- zinc oxide 15% lotion

  • NDC Code(s): 82052-157-01
  • Packager: Annmarie Gianni Skin Care LLC
  • 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 January 9, 2023

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  • Active Ingredients

    Zinc Oxide 15%

  • 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 eyes with water to remove.

    Stop use and ask a doctor if rash occurs.

  • Keep Out of Reach of Children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    Apply liberally 15 minutes before sun exposure. Reapply:

    • after 80 minutes of swimming or sweating
    • immediately after towel drying
    • at least every 2 hours
    • use a 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 risk, regularly use a sunscreen with broad spectrum SPF value of 15 or higher and other sun protection measure including:

    • limit time in the sun, especially from 10 am to 2 pm
    • wear long-sleeved shirts, pants, hats, and sunglasses.
    • Children under 6 months: ask a doctor.

  • Inactive Ingredients

    Helianthus Annuus (Sunflower) Seed Oil*, Sorbitan Olivate, Cannabis Sativa Seed Oil*, Olea Europaea (Olive) Fruit Oil*, Cucurbita Pepo (Pumpkin) Seed Oil*, Beeswax*, Lavandula Angustifolia (Lavender) Oil, Persea Gratissima (Avocado) Oil*, Mauritia Flexuosa Fruit Oil, Tocopherol. *Organic

  • Label

    Carton

  • INGREDIENTS AND APPEARANCE
    ANNMARIE SPF 20 SUNSCREEN 
    zinc oxide 15% lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82052-157
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE15 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    SORBITAN OLIVATE (UNII: MDL271E3GR)  
    CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    PUMPKIN SEED OIL (UNII: 6E5QR5USSP)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    AVOCADO OIL (UNII: 6VNO72PFC1)  
    MAURITIA FLEXUOSA FRUIT OIL (UNII: 48H19MS04L)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82052-157-0150 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product09/20/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35209/20/2021
    Labeler - Annmarie Gianni Skin Care LLC (050591758)
    Registrant - Derma Care Research Labs, LLC (116817470)
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