Label: BABO BOTANICALS DAILY SHEER MINERAL SUNSCREEN SPF 40- zinc oxide, titanium dioxide lotion

  • 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 April 6, 2023

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  • Drug Facts

  • Active ingredients

    Titanium Dioxide 1.9%

    Zinc Oxide 15.7%

  • 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

    • Apply liberally to exposed areas15 minutes before sun exposure.
    • Use water resistant sunscreen if swimming or sweating
    • Reapply at least every two 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 sun 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 of age: ask a doctor
  • Other information

    • Protect this product from excessive heat and direct sun.
    • May stain some fabrics and surfaces.
  • Inactive ingredients

    Aloe Barbadensis (Aloe Vera) Leaf Juice, Caprylic/Capric Triglyceride, Calcium Sodium Borosilicate, Cocos Nucifera (Coconut) Oil, Simmondsia Chinensis (Jojoba) Seed Oil, Erythritol, Persea Gratissima (Avocado) Oil, Glyceryl Caprylate, Sodium Stearoyl Glutamate, Cetearyl Alcohol, Rubus Idaeus (Raspberry) Seed Oil, Bisabolol, Helianthus Annuus (Sunflower) Seed Oil, Calendula Officinalis Flower Extract, Chamomilla Recutita (Matricaria) Flower Extract, Nasturtium Officinale (Watercress) Flower/Leaf Extract, Spiraea Ulmaria (Meadowsweet) Flower Extract, Rosmarinus Officinalis (Rosemary) Leaf Extract, Jojoba Esters, Glycerin, Arachidyl Alcohol, Coco-Glucoside, Behenyl Alcohol, Polyhydroxystearic Acid, Arachidyl Glucoside, Sodium Gluconate, Xanthan Gum, Caprylhydroxamic Acid, Glyceryl Undecylenate, Citric Acid.

  • Questions and comments?

    Call 1-800-422-2987 Mon - Fri

    9:00am - 5:00pm EST

  • Product Packaging

    8078

  • INGREDIENTS AND APPEARANCE
    BABO BOTANICALS DAILY SHEER MINERAL SUNSCREEN SPF 40 
    zinc oxide, titanium dioxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79265-8078
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE157 mg  in 1 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE19 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)  
    CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)  
    GLYCERYL 1-UNDECYLENATE (UNII: B68LJT9544)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    FILIPENDULA ULMARIA FLOWER (UNII: 06L18L32G6)  
    ROSEMARY (UNII: IJ67X351P9)  
    JOJOBA OIL (UNII: 724GKU717M)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    AVOCADO OIL (UNII: 6VNO72PFC1)  
    ERYTHRITOL (UNII: RA96B954X6)  
    GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)  
    RASPBERRY SEED OIL (UNII: 9S8867952A)  
    SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)  
    COCO GLUCOSIDE (UNII: ICS790225B)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CHAMOMILE (UNII: FGL3685T2X)  
    NASTURTIUM OFFICINALE (UNII: YH89GMV676)  
    SODIUM GLUCONATE (UNII: R6Q3791S76)  
    JOJOBA OIL, RANDOMIZED (UNII: 7F0EV20QYL)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79265-8078-11 in 1 CARTON03/01/2023
    150 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM02003/01/2023
    Labeler - Babo Botanicals, Inc. (058258734)
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