Label: BABIENCE KIDS SUNSCREEN PINKFONG BABY SHARK SPF 50- ensulizole, octinoxate, octisalate, titanium dioxide, zinc oxide lotion

  • NDC Code(s): 53208-800-01
  • Packager: LG HOUSEHOLD & HEALTH CARE LTD
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 December 13, 2021

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  • Active ingredients

    Ensulizole 3.5%

    Octinoxate 7.00%

    Octisalate 4.5%

    Titanium Dioxide 4.57%

    Zinc Oxide 11.65%

  • 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

    Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.

    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 right away.

  • Directions

    For sunscreen use:

    • apply liberally 15 minutes before sun exposure
    • reapply at least every 2 hours
    • use a water resistent sunscreen if swimming or sweating
    • children under 6 months of age: Ask a doctor
  • Inactive ingredients

    WATER, CYCLOPENTASILOXANE, DIPROPYLENE GLYCOL, GLYCERIN, DICAPRYLYL CARBONATE, LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE, TROMETHAMINE, DIMETHICONE, VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER, PANTHENOL, DISTEARDIMONIUM HECTORITE, ALUMINUM HYDROXIDE, ZINC STEARATE, SORBITAN SESQUIOLEATE, DIMETHICONE/PEG-10/15 CROSSPOLYMER, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, STEARIC ACID, GLYCERYL CAPRYLATE, HYDROGEN DIMETHICONE, DISTEARYLDIMONIUM CHLORIDE, ETHYLHEXYLGLYCERIN, TRIETHOXYCAPRYLYLSILANE, TRISODIUM EDTA, HELIANTHUS ANNUS (SUNFLOWER) SRPOUT EXTRACT, MENTHYL PCA, SODIUM PCA, SODIUM BENZOATE, TITANIUM DIOXIDE (CI 77891), FRAGRANCE

  • Other information

    Protect this product in this container from excessive heat and direct sun

  • SPL UNCLASSIFIED SECTION

    U.S.A./E.-U.: 1-800-FOR-AVON www.avon.com

  • PRINCIPAL DISPLAY PANEL

    Babience
    KIDS
    Sunscreen
    Broad Spectrum
    SPF 50
    50 ml / 1.69 fl. oz.
    pinkfong

    BABY SHARK

    1-800-FOR-AVON www.avon.com

    MADE IN KOREA

    DIST. NEW AVON LLC, NEW YORK, NY 1006

    Babience kids sunscreen spf 50 pinkfong baby shart 50ml tube

    Babience kids sunscreen spf 50 pinkfong baby shart 50ml box

  • INGREDIENTS AND APPEARANCE
    BABIENCE KIDS SUNSCREEN PINKFONG BABY SHARK SPF 50 
    ensulizole, octinoxate, octisalate, titanium dioxide, zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53208-800
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE2.285 g  in 50 mL
    ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42) ENSULIZOLE1.75 g  in 50 mL
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE3.5 g  in 50 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE5.825 g  in 50 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE2.25 g  in 50 mL
    Inactive Ingredients
    Ingredient NameStrength
    DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
    LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER (UNII: 9NH1UDD2RR)  
    MENTHYL DL-PYRROLIDONECARBOXYLATE (UNII: 8P18J856U2)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    WATER (UNII: 059QF0KO0R)  
    DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ)  
    ZINC STEARATE (UNII: H92E6QA4FV)  
    SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    TROMETHAMINE (UNII: 023C2WHX2V)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)  
    EDETATE TRISODIUM (UNII: 420IP921MB)  
    SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)  
    HELIANTHUS ANNUUS SPROUT (UNII: 4P26HG1S5W)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53208-800-012 in 1 BOX04/27/2020
    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 not finalpart35204/27/2020
    Labeler - LG HOUSEHOLD & HEALTH CARE LTD (688276187)
    Establishment
    NameAddressID/FEIBusiness Operations
    fmg Co.Ltd690188305manufacture(53208-800)
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