Label: BABO SPF 30 SHEER ZINC SUNSCREEN- mineral sunscreen spray

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 November 1, 2020

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

  • SPL UNCLASSIFIED SECTION

    This is a sunscreen manufactured according the sunscreen final monograph. Active ingredients Zinc oxide and Titanium Dioxide

  • Active Ingredient(s)

    Titanium Dioxide 4.65%
    Zinc Oxide 15.0%

  • Purpose

    Sunscreen

  • Use

    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 a product is swallowed get medical help or contact a Poison Control center right away.

  • Do not use

    • on damaged or broken skin.
  • WHEN USING

    Keep out of eyes. Rinse with water to remove.

  • STOP USE

    Stop use and ask a doctor if irritation or rash occurs.

  • KEEP OUT OF REACH OF CHILDREN

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

  • Directions

    Directions• Apply liberally to exposed areas 15 minutes before sun exposure. Reapply at least every two hours, after 80 minutes of swimming or sweating, or immediately after towel-drying

  • Other information

    • Protect this product from excessive heat and direct sun
  • Inactive ingredients

    Aloe Barbadensis Leaf Juice
    Bentonite
    Butyloctyl Salicylate
    Calendula Officinalis Flower Extract*
    Caprylhydroxamic Acid
    Caprylyl Glycol
    Carthamus Tinctorius (Safflower) Seed Oil
    Cetearyl Alcohol
    Chamomilla Recutita (Matricaria) Flower Extract*
    Coco Glucoside
    Glycerin
    Helianthus Annuus (Sunflower) Seed Oil
    Heptyl Undecylenate
    Jojoba Esters
    Methyl Dihydroabietate
    Nasturtium Officinale (Watercress) Flower/leaf Extract*
    Pueraria Lobata (Kudzu) Root Extract*
    Spiraea Ulmaria (Meadowsweet) Flower Extract*
    Water (Aqua)

    *Certified Organic Ingredient

  • Package Label - Principal Display Panel

    6 fl.oz. 177 ml NDC: 79265-8097-6

    8097 Label

  • INGREDIENTS AND APPEARANCE
    BABO SPF 30 SHEER ZINC SUNSCREEN 
    mineral sunscreen spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79265-8097
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE12.222 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD) 0.001 mL  in 100 mL
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) 0.715 mL  in 100 mL
    CHAMOMILE (UNII: FGL3685T2X) 0.001 mL  in 100 mL
    SUNFLOWER OIL (UNII: 3W1JG795YI) 0.095 mL  in 100 mL
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) 10 mL  in 100 mL
    METHYL DIHYDROABIETATE (UNII: 7666FJ0J9F) 2 mL  in 100 mL
    PUERARIA MONTANA VAR. LOBATA ROOT (UNII: PET93F4I3C) 0.001 mL  in 100 mL
    FILIPENDULA ULMARIA FLOWER (UNII: 06L18L32G6) 0.001 mL  in 100 mL
    BENTONITE (UNII: A3N5ZCN45C) 2.5 mL  in 100 mL
    CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W) 0.15 mL  in 100 mL
    CAPRYLYL GLYCOL (UNII: 00YIU5438U) 0.7 mL  in 100 mL
    WATER (UNII: 059QF0KO0R) 66.69 mL  in 100 mL
    SAFFLOWER OIL (UNII: 65UEH262IS) 2 mL  in 100 mL
    HYDROGENATED JOJOBA OIL, RANDOMIZED (UNII: Q47ST02F58) 0.378 mL  in 100 mL
    NASTURTIUM OFFICINALE FLOWERING TOP (UNII: W1N2U8I64G) 0.001 mL  in 100 mL
    COCO GLUCOSIDE (UNII: ICS790225B) 0.385 mL  in 100 mL
    HEPTYL UNDECYLENATE (UNII: W77QUB6GXO) 2 mL  in 100 mL
    ALOE VERA LEAF (UNII: ZY81Z83H0X) 0.01 mL  in 100 mL
    GLYCERIN (UNII: PDC6A3C0OX) 0.15 mL  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79265-8097-6177 mL in 1 CAN; Type 0: Not a Combination Product11/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35211/01/2020
    Labeler - Babo Botanicals, Inc. (058258734)
    Registrant - Bell International Laboratories (967781555)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bell International Laboratories967781555manufacture(79265-8097)