SUNSCREEN SPF 70 (AVOBENZONE 3% HOMOSALATE 15% OCTISALATE 5% OCTOCRYLENE 10% OXYBENZONE 6%) LOTION [TOP CARE]

SUNSCREEN SPF 70 (AVOBENZONE 3% HOMOSALATE 15% OCTISALATE 5% OCTOCRYLENE 10% OXYBENZONE 6%) LOTION [TOP CARE]
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NDC 36800-716-06
Set ID a24d01d9-066a-467d-bb7b-1e41c66eecff
Category HUMAN OTC DRUG LABEL
Packager Top Care
Generic Name
Product Class
Product Number
Application Number PART352
  • Active ingredients   

    Avobenzone 3%

    Homosalate 15%

    Octisalate 5%

    Octocrylene 10%

    Oxybenzone 6%

  • Purpose

    Sunscreen

  • Uses

    Uses • helps prevent 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 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
  • Inactive ingredients

    Behenyl Alcohol, Benzyl Alcohol, Butylated PVP, Butylene Glycol, Caprylic/Capric Triglyceride, Cellulose Gum, Cetyl Alcohol, Chlorphenesin, Diethylhexyl Syringylidenemalonate, Disodium EDTA, Glyceryl Stearate, Lauryl Alcohol, Lecithin, Microcrystalline Cellulose, Myristyl Alcohol, Palmitic Acid, Retinyl Palmitate, Sodium Ascorbyl Phosphate, Stearic Acid, Tocopherol, Water.

  • Other information

    • protect this product from excessive heat and direct sun
    • may stain fabrics.
  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    SUNSCREEN SPF 70 
    avobenzone 3% homosalate 15% octisalate 5% octocrylene 10% oxybenzone 6% lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-716
    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) HOMOSALATE15 g  in 100 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE10   in 100 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE6 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    DOCOSANOL (UNII: 9G1OE216XY)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    LAURYL ALCOHOL (UNII: 178A96NLP2)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    MYRISTYL ALCOHOL (UNII: V42034O9PU)  
    PALMITIC ACID (UNII: 2V16EO95H1)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:36800-716-06237 mL in 1 BOTTLE; Type 0: Not a Combination Product02/12/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35202/12/2016
    Labeler - Top Care (006935977)
    Registrant - Product Quest Mfg, LLC (927768135)
    Establishment
    NameAddressID/FEIBusiness Operations
    Product Quest Mfg, LLC927768135manufacture(36800-716) , label(36800-716)

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