Label: BOTAO - GROW NATURALLY MINERAL SUNSCREEN CLEAR FACIAL STICK FOR BABIES AND KIDS SPF 50- zinc oxide stick

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated February 1, 2024

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

View All Sections
  • Drug Facts

  • Active Ingredient

    Zinc Oxide 24.5 %

    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 useon damaged or broken skin
    • When using this productkeep out of eyes. Rinse with water to remove
    • Stop use and ask a doctor if rash occurs
    • Keep out of reach of children. If 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,

    • Keep out of eyes. Rinse with water to remove.

    Stop use and ask a doctor

    • if rash or irritation develops and lasts.

    Keep out of reach of children.

    If swallowed, call a poison control center or get medical help right  away.

  • Directions

    • apply liberally 15 minutes before sun exposure

    • reapply:
    • after 80 minutes of swimming or sweating
    • immediately after towel drying
    • at least every 2 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:
    •limiting time in the sun, especially from 10 a.m to 2 p.m. • wear long-sleeve shirts, pants, hats, and sunglasses
    •children under 6 months: ask a doctor.

  • KEEP OUT OF REACH OF CHILDREN

  • Other information

    Protect this product in this container from excessive heat and direct sun. Do not use if the seal is broken.

  • Inactive ingredients

    Caprylic/Capric Triglyceride, Coco-Caprylate, Ozokerite, Butyloctyl Salicylate, Polyhydroxystearic Acid, Tocopherol, Cocos Nucifera (Coonut) Oil, Triethoxycaprylylsilane, Simmondsia Chinensis (Jojoba) Seed Oil, Glycerin, Aloe Barbadensis (Aloe Vera) Leaf Juice, Water (Aqua), Bisabolol, Butyrospermum Parkii (Shea) Butter, Calendula Offcinalis(Calendula) Flower Extract, Chamomilla Recutita (Matricaria) Flower Extract.

  • Questions or comments

    Call 951-297-7976 or visit www.botaobaby.com

  • Product label

    image description

    image description

  • INGREDIENTS AND APPEARANCE
    BOTAO - GROW NATURALLY MINERAL SUNSCREEN CLEAR FACIAL STICK FOR BABIES AND KIDS SPF 50 
    zinc oxide stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69435-1508
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION24.5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    COCO-CAPRYLATE (UNII: 4828G836N6)  
    CERESIN (UNII: Q1LS2UJO3A)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    JOJOBA OIL (UNII: 724GKU717M)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    CHAMOMILE (UNII: FGL3685T2X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69435-1508-11 in 1 CARTON01/31/2024
    115 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02001/31/2024
    Labeler - Peer Pharm Ltd. (514678390)
    Registrant - Peer Pharm Ltd. (514678390)
    Establishment
    NameAddressID/FEIBusiness Operations
    Peer Pharm Ltd.514678390manufacture(69435-1508)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!