Label: BABO BOTANICALS SENSITIVE BABY MINERAL SUNSCREEN SPF50- zinc oxide stick

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 25, 2023

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

  • Drug Facts

  • Active ingredient

    Zinc Oxide 19.7%

  • 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 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
    • 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 protection measures including:
    • Limit time in the sun, especially from 10 a.m. – 2 p.m.
    • Wear long-sleeve shirts, pants, hats, and sunglasses
    • Children under 6 months: ask a doctor
  • Other information

    • Protect this product from excessive heat and direct sun.
    • May stain some fabrics and surfaces.
  • Inactive ingredients

    Oryza Sativa (Rice) Bran Oil*, Persea Gratissima (Avocado) Oil*, Euphorbia Cerifera (Candelilla) Wax, Octyldodecyl Oleate, Simmondsia Chinensis (Jojoba) Seed Oil*, Beeswax*, Theobroma Cacao (Cocoa) Seed Butter*, Oryzanol, Butyrospermum Parkii (Shea) Butter*, Jojoba Esters, Helianthus Annuus (Sunflower) Seed Oil*, Calendula Officinalis Flower Extract*, Chamomilla Recutita (Matricaria) Flower Extract*, Nasturtium Officinale (Watercress) Flower/Leaf Extract*, Spiraea Ulmaria (Meadowsweet) Flower Extract*, Bisabolol*, Calophyllum Inophyllum (Tamanu) Seed Oil*, Tocopherol.

    *Certified Organic Ingredients

  • Company Information

    Dist: by Babo Botanicals, Inc.
    60 East 56th Street New York, NY 10022

  • Package Labeling

    1

  • INGREDIENTS AND APPEARANCE
    BABO BOTANICALS SENSITIVE BABY MINERAL SUNSCREEN SPF50 
    zinc oxide stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79265-5608
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE197 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    TAMANU OIL (UNII: JT3LVK84A1)  
    JOJOBA OIL (UNII: 724GKU717M)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    HYDROGENATED JOJOBA OIL, RANDOMIZED (UNII: Q47ST02F58)  
    ORYZANOL (UNII: SST9XCL51M)  
    WHITE WAX (UNII: 7G1J5DA97F)  
    CHAMOMILE (UNII: FGL3685T2X)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    RICE BRAN OIL (UNII: LZO6K1506A)  
    OCTYLDODECYL OLEATE (UNII: MCA43PK7MH)  
    FILIPENDULA ULMARIA FLOWER (UNII: 06L18L32G6)  
    COCOA BUTTER (UNII: 512OYT1CRR)  
    CALOPHYLLUM TACAMAHACA SEED OIL (UNII: 05G85L61OE)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    AVOCADO OIL (UNII: 6VNO72PFC1)  
    NASTURTIUM OFFICINALE FLOWERING TOP (UNII: W1N2U8I64G)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79265-5608-11 in 1 CARTON10/25/2023
    117 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02010/25/2023
    Labeler - Babo Botanicals, Inc. (058258734)