Label: SPF 50 SUPER SHIELD SPORT SUNSCREEN- mineral sunscreen stick

  • NDC Code(s): 79265-8098-0, 79265-8098-1
  • Packager: Babo Botanicals, Inc.
  • 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 January 31, 2022

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  • Primary Container Labeling

    79265-8098-1 17 g

    Inner Container Label

  • 79265-8098 SPF 50 Super Shield Sport Stick Sunscreen

    Sunscreen product manufactured pursuant to the Final Monograph. Active ingredient Zinc Oxide.

  • Active Ingredient

    Zinc Oxide 17.363%

  • 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.

  • Purpose

    Sunscreen

  • 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 this product

    When using this product Keep out of eyes. Rinse with water to remove.

  • Stop use and ask doctor

    Stop use and ask doctor if rash occurs. •

  • Keep out of reach of children

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

  • 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.

  • inactive Ingredients

    BEESWAX*
    BISABOLOL
    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*
    ORYZANOL
    PERSEA GRATISSIMA (AVOCADO) OIL*
    SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL*
    THEOBROMA CACAO (COCOA) SEED BUTTER*
    TOCOPHEROL

    *Certified Organic ingredient

  • Other Information

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

  • QUESTIONS/ COMMENTS?

    Questions and comments?

    Call 1-877-537-BABO

  • INFORMATION PANEL

    INFORMATION PANEL

  • DRUG FACTS PANEL

    Drug Facts Panel PART 1

    Drug Facts Panel PART 2

  • PRINCIPAL DISPLAY PANEL

    79265-8098-0

    Babo Botanicals

    Super Shield Sport Stick

    Broad Spectrum Sunscreen SPF 50

    100% Zinc Oxide Active Ingredient

    80 Minute Water & Sweat Resistant

    Ultra Sheer & Hypoallergenic

    Fragrance Free

    Outer Package Box

  • INGREDIENTS AND APPEARANCE
    SPF 50 SUPER SHIELD SPORT SUNSCREEN 
    mineral sunscreen stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79265-8098
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE17.363 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    SHEA BUTTER (UNII: K49155WL9Y) 1 mL  in 100 g
    CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S) 0.01 mL  in 100 g
    HYDROGENATED JOJOBA OIL, RANDOMIZED (UNII: Q47ST02F58) 0.537 mL  in 100 g
    RICE BRAN OIL (UNII: LZO6K1506A) 27.38 mL  in 100 g
    AVOCADO OIL (UNII: 6VNO72PFC1) 15 mL  in 100 g
    JOJOBA OIL (UNII: 724GKU717M) 7.5 mL  in 100 g
    ORYZANOL (UNII: SST9XCL51M) 3 mL  in 100 g
    WHITE WAX (UNII: 7G1J5DA97F) 6 mL  in 100 g
    CANDELILLA WAX (UNII: WL0328HX19) 9.5 mL  in 100 g
    OCTYLDODECYL OLEATE (UNII: MCA43PK7MH) 8.75 mL  in 100 g
    TOCOPHEROL (UNII: R0ZB2556P8) 0.75 mL  in 100 g
    LEVOMENOL (UNII: 24WE03BX2T) 0.2 mL  in 100 g
    CALOPHYLLUM TACAMAHACA SEED OIL (UNII: 05G85L61OE) 0.01 mL  in 100 g
    COCOA BUTTER (UNII: 512OYT1CRR) 3 mL  in 100 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79265-8098-01 in 1 BOX11/01/2020
    1NDC:79265-8098-117 g in 1 CYLINDER; 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)
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