Label: BABO SPF 30 CLEAR ZINC FRAGRANCE FREE SPORT- mineral sunscreen stick

  • NDC Code(s): 79265-8075-0, 79265-8075-1
  • Packager: Babo Botanicals, Inc.
  • Category: HUMAN OTC DRUG LABEL

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 healthcare professional or from the pharmaceutical industry please visit this version.

  • Inner Container Front Label

    79265-8075-1

    Inner Principal Panel

  • Drug Facts Panel

    Drug Facts Panel

  • Active Ingredients

    Zinc Oxide 15.32600%

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

  • Do not use

    on broken or damaged skin

  • Keep out of reach of children

    Keep out of reach of children. If product is swallowed get medical help or contact a Poison Control center right away.

  • Inactive Ingredients

    BEESWAX*
    BUTYROSPERMUM PARKII (SHEA) BUTTER*
    CALOPHYLLUM TACAMAHACA SEED OIL*
    CANNABIS SATIVA SEED OIL*
    EUPHORBIA CERIFERA (CANDELILLA) WAX
    JOJOBA ESTERS
    OCTYLDODECYL OLEATE
    ORYZA SATIVA (RICE) BRAN OIL*
    PERSEA GRATISSIMA (AVOCADO) OIL*
    SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL*
    THEOBROMA CACAO (COCOA) SEED BUTTER*
    TOCOPHEROL

    *CERTIFIED ORGANIC INGREDIENTS

  • 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.

  • SUN PROTECTION MEASURES

    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

    Other Information• Protect this product from excessive heat and direct sun

  • QUESTIONS AND COMMENTS

    Questions and comments? Call 1-877-537-BABO

  • INFORMATION PANEL

    Dist: by Babo Botanicals, Inc.

    14 Harwood Court, Scarsdale, NY 10583

    1.877.537.BABO

    www.babobotanicals.com

    MADE IN THE USA with US & imported materials.

    INFORMATION PANEL

  • 8075 Principal Display Panel

    Babo Botanicals

    Clear Zinc Sport Stick

    Sunscreen

    Broad Spectrum SPF 30

    Water & Sweat Resistant (80 minutes)

    For Face, Lips, Nose, & Ears

    SPF 30

    Fragrance Free

    0.6 oz / 17 g

    PDP

  • INGREDIENTS AND APPEARANCE
    BABO SPF 30 CLEAR ZINC FRAGRANCE FREE SPORT 
    mineral sunscreen stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79265-8075
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE15.326 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    JOJOBA OIL (UNII: 724GKU717M) 7.5 mL  in 100 g
    COCOA BUTTER (UNII: 512OYT1CRR) 3 mL  in 100 g
    CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S) 0.01 mL  in 100 g
    OCTYLDODECYL OLEATE (UNII: MCA43PK7MH) 8.75 mL  in 100 g
    SHEA BUTTER (UNII: K49155WL9Y) 1 mL  in 100 g
    WHITE WAX (UNII: 7G1J5DA97F) 6 mL  in 100 g
    AVOCADO OIL (UNII: 6VNO72PFC1) 15 mL  in 100 g
    TOCOPHEROL (UNII: R0ZB2556P8) 0.5 mL  in 100 g
    CALOPHYLLUM TACAMAHACA SEED OIL (UNII: 05G85L61OE) 0.01 mL  in 100 g
    RICE BRAN OIL (UNII: LZO6K1506A) 32.93 mL  in 100 g
    CANDELILLA WAX (UNII: WL0328HX19) 9.5 mL  in 100 g
    HYDROGENATED JOJOBA OIL, RANDOMIZED (UNII: Q47ST02F58) 0.47 mL  in 100 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79265-8075-01 in 1 BOX11/01/2020
    1NDC:79265-8075-117 g in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product
    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(79265-8075)