Label: BABO BOTANICALS SENSITIVE BABY MINERAL SUNSCREEN SPF30- zinc oxide spray

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

Drug Label Information

Updated October 26, 2023

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  • Drug Facts

  • Active ingredient

    Zinc Oxide 14.5%

  • 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

    • Shake well
    • 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*, Butyloctyl Salicylate, Tetradecane, Caprylic/Capric Triglyceride, Carthamus Tinctorius (Safflower) Seed Oil, Methyl Dihydroabietate, Bentonite, Cetearyl Alcohol, Propanediol, Calendula Officinalis Flower Extract*, Chamomilla Recutita (Matricaria) Flower Extract*, Nasturtium Officinale Flower/Leaf Extract*, Spiraea Ulmaria Flower Extract*, Glycerin, Jojoba Esters, Bisabolol*, Tocopherol, Caprylyl Glycol, Microcrystalline Cellulose, Coco-Glucoside, Polyhydroxystearic Acid, 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 SPF30 
    zinc oxide spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79265-9758
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE145 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    TETRADECANE (UNII: 03LY784Y58)  
    WATER (UNII: 059QF0KO0R)  
    BENTONITE (UNII: A3N5ZCN45C)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CHAMOMILE (UNII: FGL3685T2X)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    HYDROGENATED JOJOBA OIL, RANDOMIZED (UNII: Q47ST02F58)  
    METHYL DIHYDROABIETATE (UNII: 7666FJ0J9F)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    SAFFLOWER OIL (UNII: 65UEH262IS)  
    COCO GLUCOSIDE (UNII: ICS790225B)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    NASTURTIUM OFFICINALE FLOWERING TOP (UNII: W1N2U8I64G)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    FILIPENDULA ULMARIA FLOWER (UNII: 06L18L32G6)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79265-9758-1177 mL in 1 BOTTLE, SPRAY; 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)
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