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

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

Drug Label Information

Updated October 26, 2023

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

  • Drug Facts

  • Active ingredient

    Zinc Oxide 20.0%

  • 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 doctor if

    rash occurs

    Keep out of reach of children.

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

  • 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

    Water (Aqua), Helianthus Annuus (Sunflower) Seed Oil, Cocos Nucifera (Coconut) Oil, Butyloctyl Salicylate, Carthamus Tinctorius (Safflower) Seed Oil, Methyl Dihydroabietate, Butyrospermum Parkii (Shea) Butter, Cetearyl Alcohol, Sodium Stearoyl Glutamate, Microcrystalline Cellulose, Calendula Officinalis Flower Extract*, Chamomilla Recutita (Matricaria) Flower Extract*, Nasturtium Officinale (Watercress) Flower/Leaf Extract*, Spiraea Ulmaria (Meadowsweet) Flower Extract*, Theobroma Cacao (Cocoa) Seed Butter*, Bisabolol*, Tocopherol, Cetyl Alcohol, Caprylyl Glycol, Coco-Glucoside, Behenyl Alcohol, Arachidyl Glucoside, Arachidyl Alcohol, Polyhydroxystearic Acid, Citric Acid, Sodium Gluconate, Sodium Hyaluronate, Glycerin, Caprylhydroxamic Acid, Cellulose Gum..*Certified Organic Ingredients

  • Questions or comments?

    Call 1-800-422-2987 M-F 9:00AM-5:00PM EST

  • Product Packaging

    1

  • INGREDIENTS AND APPEARANCE
    BABO BOTANICALS SENSITIVE BABY MINERAL SUNSCREEN SPF50 
    zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79265-8758
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE200 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    NASTURTIUM OFFICINALE FLOWERING TOP (UNII: W1N2U8I64G)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    SODIUM GLUCONATE (UNII: R6Q3791S76)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
    CHAMOMILE (UNII: FGL3685T2X)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)  
    ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)  
    DOCOSANOL (UNII: 9G1OE216XY)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)  
    METHYL DIHYDROABIETATE (UNII: 7666FJ0J9F)  
    COCO GLUCOSIDE (UNII: ICS790225B)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    FILIPENDULA ULMARIA FLOWER (UNII: 06L18L32G6)  
    COCOA BUTTER (UNII: 512OYT1CRR)  
    SAFFLOWER OIL (UNII: 65UEH262IS)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79265-8758-189 mL in 1 TUBE; Type 0: Not a Combination Product10/26/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02010/26/2023
    Labeler - Babo Botanicals, Inc. (058258734)