Label: SHEER SUNSCREEN SPF 30 MEIJER- avobenzone 3.00% homosalate 8.00% octisalate 5.00% octocrylene 4.00% oxybenzone 4.00% lotion

  • 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 May 24, 2018

If you are a consumer or patient please visit this version.

  • Active ingredients                                 Purpose


    Avobenzone - 3.00%
    Homosalate - 8.00%
    Octisalate - 5.00%
    Octocrylene - 4.00%
    Oxybenzone - 4.00%                         Sunscreen

  • PURPOSE

  • INDICATIONS & USAGE

    - 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.

  • KEEP OUT OF REACH OF CHILDREN

  • Directions

    applyliberally and spread evenly by hand 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

  • Inactive ingredients

    Behenyl Alcohol
    BHT
    Butyloctyl Salicylate
    Caprylyl Methicone
    Dimethicone
    Dimethyl Capramide
    Disodium EDTA
    Ethylhexyl Stearate
    Ethylhexylglycerin
    Fragrance
    Glyceryl Stearate
    Hydrated Silica
    PEG-100 Stearate
    Phenoxyethanol
    Polyester-8
    Sodium Polyacrylate
    Styrene/Acrylate Copolymer
    Trideceth-6
    Trimethylsiloxysilicate
    VP/Hexadecene Copolymer
    Water
    Xanthan Gum

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    SHEER SUNSCREEN SPF 30  MEIJER
    avobenzone 3.00% homosalate 8.00% octisalate 5.00% octocrylene 4.00% oxybenzone 4.00% lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41250-783
    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) Homosalate8 g  in 100 mL
    Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) Octisalate5 g  in 100 mL
    Octocrylene (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) Octocrylene4 g  in 100 mL
    Oxybenzone (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) Oxybenzone4 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    DOCOSANOL (UNII: 9G1OE216XY)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    Butyloctyl Salicylate (UNII: 2EH13UN8D3)  
    CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)  
    Dimethicone (UNII: 92RU3N3Y1O)  
    Dimethyl Capramide (UNII: O29Y6X2JEZ)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    Ethylhexyl Stearate (UNII: EG3PA2K3K5)  
    Ethylhexylglycerin (UNII: 147D247K3P)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    Hydrated Silica (UNII: Y6O7T4G8P9)  
    PEG-100 Stearate (UNII: YD01N1999R)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)  
    Trideceth-6 (UNII: 3T5PCR2H0C)  
    Water (UNII: 059QF0KO0R)  
    Xanthan Gum (UNII: TTV12P4NEE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41250-783-0489 mL in 1 TUBE; Type 0: Not a Combination Product03/09/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35203/09/2017
    Labeler - Meijer (006959555)
    Registrant - Product Quest Mfg (927768135)
    Establishment
    NameAddressID/FEIBusiness Operations
    Product Quest Mfg927768135manufacture(41250-783) , label(41250-783)