SUNSCREEN SPF 30 (AVOBENZONE 3.0% HOMOSALATE 10.0% OCTISALATE 5.0% OCTOCRYLENE 10.0%) LOTION [TOP CARE]

SUNSCREEN SPF 30 (AVOBENZONE 3.0% HOMOSALATE 10.0% OCTISALATE 5.0% OCTOCRYLENE 10.0%) LOTION [TOP CARE]
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NDC 36800-887-06
Set ID 82f265e7-5bb2-461d-9303-03616a2f8a2b
Category HUMAN OTC DRUG LABEL
Packager Top Care
Generic Name
Product Class
Product Number
Application Number PART352
  • Actives

    Avobenzone 3.0%

    Homosalate 10.0%

    Octisalate 5.0%

    Octocrylene 10.0%

  • ​​​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 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 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 measure 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

    Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Benzyl Alcohol, Caprylic/Capric Triglyceride, Chlorphenesin, Diethylhexyl Syringylidemaionate, Disodium EDTA, Ethylhexyl Palmitate, Fragrance, Oieth-3, Polyamide-8, Retinyl Palmitate, Sodium Ascorbyl Phosphate, Sorbitol, Tocopherol, Triethanolamine, Water.

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    SUNSCREEN SPF 30 
    avobenzone 3.0% homosalate 10.0% octisalate 5.0% octocrylene 10.0% lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-887
    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) HOMOSALATE10 g  in 100 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE10 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 809Y72KV36)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    OLETH-3 (UNII: BQZ26235UC)  
    NEOPENTYL GLYCOL (UNII: QI80HXD6S5)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)  
    SORBITOL (UNII: 506T60A25R)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:36800-887-06237 mL in 1 BOTTLE; Type 0: Not a Combination Product02/23/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35202/23/2016
    Labeler - Top Care (006935977)
    Registrant - Product Quest Mfg, LLC (927768135)
    Establishment
    NameAddressID/FEIBusiness Operations
    Product Quest Mfg, LLC927768135manufacture(36800-887) , label(36800-887)

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