Label: SPF 50 TINTED FACE MINERAL FRAGRANCE FREE SUNSCREEN- mineral sunscreen stick

  • NDC Code(s): 79265-8068-0, 79265-8068-1
  • Packager: Babo Botanicals, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 12, 2024

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  • 79265-8068-0 SPF 50 Tinted Face Mineral Fragrance Free Sunscreen Stick

    This product is a mineral sunscreen semi solid stick manufactured pursuant to the sunscreen final monograph.

  • Primary Container Label

    79265-8068-1

    Primary container labeling

  • DRUG FACTS PANEL

    79265-8068-0

    Drug Facts Panel

    Drug Facts Panel 2

  • ACTIVE INGREDIENTS

    Zinc Oxide 20.2115%

  • USES

    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

    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

    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 A 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

    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

    ARGANIA SPINOSA KERNEL EXTRACT, BEESWAX*, BISABOLOL*, BUTYROSPERMUM PARKII (SHEA) BUTTER*, CALENDULA OFFICINALIS FLOWER EXTRACT*, CALOPHYLLUM INOPHYLLUM SEED OIL*, CHAMOMILLA RECUTITA (MATRICARIA) FLOWER EXTRACT*, COFFEA ARABICA (COFFEE) SEED EXTRACT, EUPHORBIA CERIFERA (CANDELILLA) WAX, HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL*, HIPPOPHAE RHAMNOIDES FRUIT EXTRACT, IRON OXIDES, JOJOBA ESTERS, NASTURTIUM OFFICINALE FLOWER/LEAF EXTRACT*, OCTYLDODECANOL, OCTYLDODECYL OLEATE, ORYZANOL, ORYZA SATIVA (RICE) BRAN OIL*, PERSEA GRATISSIMA (AVOCADO) OIL*, PUERARIA LOBATA ROOT EXTRACT*, ROSA CANINA FRUIT EXTRACT, SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL*, SPIRAEA ULMARIA FLOWER EXTRACT*, THEOBROMA CACAO (COCOA) SEED BUTTER*, TOCOPHEROL, TRIHYDROXYSTEARIN.

    *CERTIFIED ORGANIC INGREDIENT

  • OTHER INFORMATION

    Protect this product from excessive heat and direct sun.

  • QUESTIONS / COMMENTS?

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

  • INFORMATION PANEL

    79265-8068-0 INFORMATION PANEL

    INFORMATION PANEL

  • Principal Display Panel

    0.6 oz. 17 g 79265-8068-0

    Outer Package Box

  • INGREDIENTS AND APPEARANCE
    SPF 50 TINTED FACE MINERAL FRAGRANCE FREE SUNSCREEN 
    mineral sunscreen stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79265-8068
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE20.2115 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    FERRIC OXIDE RED (UNII: 1K09F3G675) 0.5362 mL  in 100 g
    PUERARIA MONTANA VAR. LOBATA ROOT (UNII: PET93F4I3C) 0.0015 mL  in 100 g
    FILIPENDULA ULMARIA FLOWER (UNII: 06L18L32G6) 0.0015 mL  in 100 g
    HIPPOPHAE RHAMNOIDES FRUIT (UNII: AVL0R9111T) 0.00125 mL  in 100 g
    SUNFLOWER OIL (UNII: 3W1JG795YI) 0.1875 mL  in 100 g
    TRIHYDROXYSTEARIN (UNII: 06YD7896S3) 0.0092 mL  in 100 g
    HYDROGENATED JOJOBA OIL, RANDOMIZED (UNII: Q47ST02F58) 0.9023 mL  in 100 g
    NASTURTIUM OFFICINALE FLOWERING TOP (UNII: W1N2U8I64G) 0.0015 mL  in 100 g
    ROSA CANINA FRUIT (UNII: 3TNW8D08V3) 0.00125 mL  in 100 g
    JOJOBA OIL (UNII: 724GKU717M) 7.5 mL  in 100 g
    COCOA BUTTER (UNII: 512OYT1CRR) 3 mL  in 100 g
    ARGANIA SPINOSA SEED (UNII: 8H7X7XB54H) 0.00125 mL  in 100 g
    TOCOPHEROL (UNII: R0ZB2556P8) 0.75 mL  in 100 g
    AVOCADO OIL (UNII: 6VNO72PFC1) 15 mL  in 100 g
    RICE BRAN OIL (UNII: LZO6K1506A) 23.07 mL  in 100 g
    CANDELILLA WAX (UNII: WL0328HX19) 9.5 mL  in 100 g
    ARABICA COFFEE BEAN (UNII: 3SW678MX72) 0.00125 mL  in 100 g
    OCTYLDODECYL OLEATE (UNII: MCA43PK7MH) 8.75 mL  in 100 g
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD) 0.0015 mL  in 100 g
    SHEA BUTTER (UNII: K49155WL9Y) 1 mL  in 100 g
    CALOPHYLLUM TACAMAHACA SEED OIL (UNII: 05G85L61OE) 0.01 mL  in 100 g
    CHAMOMILE (UNII: FGL3685T2X) 0.0015 mL  in 100 g
    WHITE WAX (UNII: 7G1J5DA97F) 6 mL  in 100 g
    LEVOMENOL (UNII: 24WE03BX2T) 0.2 mL  in 100 g
    OCTYLDODECANOL (UNII: 461N1O614Y) 0.3608 mL  in 100 g
    ORYZANOL (UNII: SST9XCL51M) 3 mL  in 100 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79265-8068-01 in 1 BOX11/01/2020
    1NDC:79265-8068-117 g in 1 CYLINDER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02011/01/202002/28/2026
    Labeler - Babo Botanicals, Inc. (058258734)
    Registrant - Bell International Laboratories (967781555)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bell International Laboratories967781555manufacture(79265-8068)
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