Label: BOTAO BABY MINERAL FOAM- zinc oxide lotion

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

Drug Label Information

Updated February 19, 2024

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  • Drug Facts

  • Active Ingredients(in each 30 ml)

    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 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

    shake well before each use

    spray liberally and spread evenly by hand 15 minutes before sun exposure

    hold4 to 6 inches from the skin to apply

    do not spray directly into face.

    Spray on hands then apply to face

    do not apply in windy conditions

    Use in a well-ventilated area

    reapply: after 40 minutes of swimming or sweating

    immediately after towel drying

    at least every 2 hours

  • Inactive Ingredients

    Water,Coco-Caprylate, Styrene/Acrylates Copolymer,Butane,Isobutane, Propane, Octlydodecyl Citrate Crosspolymer,Cetearyl Olivate, Sorbitan Olivate, Caprylyl Glycol, Glycerin, Polyhydroxystearic acid, Aloe Barbadensis Leaf Juice, Panthenol, Triethoxycapryllsilane, Cetearyl Alcohol,Tocopherol, Butyrosperum Parkii (Shea) Butter,Silica, Silica Dimethyl Silyate , Xanthan Gum, Caprylhydroxamix Acid, Propanediol, Sodium Phytate, Dipotassium Glycyrrhizate, Chamomilla Recutita, (Matricaria) Flower Extract ,Calendula Officianlis Flower Extract,Citric Acid

  • Other Information

    • Store in room temparture
    • protect from freezing
    • may stain clothing
  • Package Labeling

    baby

  • INGREDIENTS AND APPEARANCE
    BOTAO BABY MINERAL FOAM 
    zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69435-1503
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE24 g  in 96 g
    Inactive Ingredients
    Ingredient NameStrength
    TOCOPHEROL (UNII: R0ZB2556P8)  
    CITRIC ACID ISOPROPYL ETHER (UNII: 19776V0481)  
    CETEARYL ETHYLHEXANOATE (UNII: 9M64UO4C25)  
    HEXASODIUM PHYTATE (UNII: ZBX50UG81V)  
    CALENDULA OFFICINALIS SEED OIL (UNII: 9JS8DS42SV)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)  
    DIPOTASSIUM GLUCOSE-6-PHOSPHATE (UNII: ZZW95F4360)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    COCO-CAPRYLATE (UNII: 4828G836N6)  
    SODIUM ACRYLATE/STYRENE SULFONATE COPOLYMER (11000 MW) (UNII: N30934870L)  
    ISOBUTANE (UNII: BXR49TP611)  
    WATER (UNII: 059QF0KO0R)  
    1-(ETHYLTRISULFANYL)PROPANE (UNII: 4SOS6O9G2X)  
    TRIOCTYLDODECYL CITRATE (UNII: 35X8CT063R)  
    ACRYLATES CROSSPOLYMER-4 (UNII: GEV2EL4D9G)  
    CETEARYL OLIVATE (UNII: 58B69Q84JO)  
    SORBITAN OLIVATE (UNII: MDL271E3GR)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPANEDIOL 1-PHOSPHATE (UNII: 48G71659RB)  
    CHAMOMILE (UNII: FGL3685T2X)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    ALOE (UNII: V5VD430YW9)  
    1,4-BUTANEDITHIOL (UNII: 7JD227IUMC)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69435-1503-196 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product05/19/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02005/19/2022
    Labeler - Peer Pharm Ltd. (514678390)
    Registrant - Peer Pharm Ltd. (514678390)
    Establishment
    NameAddressID/FEIBusiness Operations
    Peer Pharm Ltd.514678390manufacture(69435-1503)
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