BABY GENTLE SUNSCREEN SPF 50 (AVOBENZONE - 3.0% HOMOSALATE - 13.0% OCTISALATE - 5.0% OCTOCRYLENE - 7.0% OXYBENZONE 4%) LOTION [TOPCO]

BABY GENTLE SUNSCREEN SPF 50 (AVOBENZONE - 3.0% HOMOSALATE - 13.0% OCTISALATE - 5.0% OCTOCRYLENE - 7.0% OXYBENZONE 4%) LOTION [TOPCO]
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NDC 36800-870-06
Set ID 94a11f26-2de6-446f-8122-d82b2d64f5ee
Category HUMAN OTC DRUG LABEL
Packager TopCo
Generic Name
Product Class
Product Number
Application Number PART352
  • Active ingredients                         Purpose

    Avobenzone 3.0%..........................Sunscreen
    Homosalate 13.0%.........................Sunscreen
    Octisalate 5.0%..............................Sunscreen
    Octocrylene 7.0%...........................Sunscreen
    Oxybenzone 4.0%..........................Sunscreen

  • PURPOSE

  • INDICATIONS & USAGE

    Uses • helps prevent sunburn • higher SPF gives more
    sunburn protection • retains SPF after 80 minutes of activity in
    the water or sweating • provides high protection against sunburn

  • 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 occurs
    Keep out of reach of children. If product is swallowed, get
    medical help or contact a Poison Control Center 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:
    • 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: Ask a doctor

  • OTHER SAFETY INFORMATION

    Other information • protect the product in this
    container from excessive heat and direct sun • may stain fabrics

  • INACTIVE INGREDIENT

    Inactive ingredients \

    Aluminum Starch
    Octenylsuccinate, Benzyl Alcohol, Carbomer, Dimethicone,
    Disodium EDTA, Fragrance, Methylparaben, Polyglyceryl-3
    Distearate, Propylparaben, Sorbitan Isostearate, Sorbitol, Stearic
    Acid, Tocopherol, Triethanolamine, VP/Eicosene Copolymer, Water

  • Questions? 1-888-423-0139

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    BABY GENTLE SUNSCREEN SPF 50 
    avobenzone - 3.0% homosalate - 13.0% octisalate - 5.0% octocrylene - 7.0% oxybenzone 4% lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-870
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Avobenzone (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) Avobenzone3 g  in 100 mL
    Homosalate (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) Homosalate13 g  in 100 mL
    Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) Octisalate5 g  in 100 mL
    Octocrylene (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) Octocrylene7 g  in 100 mL
    Oxybenzone (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) Oxybenzone4 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    Aluminum Starch Octenylsuccinate (UNII: I9PJ0O6294)  
    Benzyl Alcohol (UNII: LKG8494WBH)  
    CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED) (UNII: Z135WT9208)  
    Dimethicone (UNII: 92RU3N3Y1O)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    Methylparaben (UNII: A2I8C7HI9T)  
    Polyglyceryl-3 Distearate (UNII: ZI1LK470XV)  
    Propylparaben (UNII: Z8IX2SC1OH)  
    Sorbitan Isostearate (UNII: 01S2G2C1E4)  
    Sorbitol (UNII: 506T60A25R)  
    Stearic Acid (UNII: 4ELV7Z65AP)  
    Tocopherol (UNII: R0ZB2556P8)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    VINYLPYRROLIDONE/EICOSENE COPOLYMER (UNII: 035MV9S1C3)  
    Water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:36800-870-06237 mL in 1 BOTTLE; Type 0: Not a Combination Product04/21/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35204/21/2016
    Labeler - TopCo (006935977)
    Registrant - Product Quest Mfg. (927768135)
    Establishment
    NameAddressID/FEIBusiness Operations
    Product Quest Mfg.927768135manufacture(36800-870) , label(36800-870)

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